Dnp-806 program dev. implem & evaluation

COMMUNITY RESPONSE TO NEEDS ASSESSMENT 15

AN URBAN AMERICAN INDIAN HEALTH CLINIC’S RESPONSE
TO A COMMUNITY NEEDS ASSESSMENT

Mary Kate Dennis, MSW, PhD, Sandra L. Momper, MSW, PhD,
and the Circles of Care Project Team

Abstract: Utilizing community-based methods, we assessed the behavioral
and physical health needs of a Detroit metropolitan Indian health clinic.
The project goal was to identify health service needs for urban American
Indians/Alaska Natives and develop the infrastructure for culturally
competent and integrative behavioral and physical health care. We
conducted 38 semi-structured interviews and 12 focus groups with service
providers and community members. Interview and focus group data
indicated a need for 1) more culturally competent services and providers,
2) more specialized health services, and 3) more transportation options.
We then report on the Indian health clinic’s and community’s accomplish-
ments in response to the needs assessment.

Major difficulties exist when attempting to identify the health service needs of urban

American Indians and Alaska Natives (AI/ANs) and develop the appropriate infrastructure for

care delivery. Of the 2.9 million people who identify solely as AI and/or AN, 67% live outside of

reservation or tribal lands (U.S. Census Bureau, 2012). Providing for the health service needs of

urban AI/ANs is imperative, as, compared to the general population they struggle with

disproportionate rates of obesity and chronic diseases and are more likely to smoke, less likely to

visit a dentist, more likely to report their health as poor or fair, and less likely to use primary care

services (Glasnapp, Butrick, Jamerson, & Spinoza, 2009; U.S. Commission on Civil Rights,

2004). Urban AI/ANs experience worse health outcomes than the general population as a result

of racial and social inequities; high unemployment rates; cultural and historical trauma; and

limited social, health, and cultural resources (Moy, Smith, Johansson, & Andrews, 2006;

Weaver, 2012).

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Urban programs also have the difficult task of providing culturally appropriate behavioral

and physical health care for AI/ANs who represent multiple tribal backgrounds and have varying

levels of knowledge regarding health care that utilizes traditional Native methods of healing

(Urban Indian Health Institute [UIHI], Seattle Indian Health Board [SIHB], 2012b).

Furthermore, urban AI/ANs have limited access to health care and fewer available health

professionals. A U.S. Commission on Civil Rights report (2004) notes that there were 101

mental health professionals available per 100,000 AIs, compared to 173 per 100,000 Whites. The

Detroit metropolitan area, where the clinic in this study is located, is a designated Health

Provider Shortage Area with a score of 17 out of 20 (higher scores indicate more shortages),

revealing the lack of providers throughout the health system (U.S. Department of Health and

Human Services [USDHHS], 2014). Another common barrier to providing the highest quality of

care lies in the significant gaps in behavioral health data for the AI/AN population. An analysis

of the 2006 National Health Disparities report indicated that only 50% of the data for AI/ANs

were available, data were unreliable, samples were too small to be statistically significant, and

only two-thirds of the utilization data were usable.

DETROIT METROPOLITAN INDIAN HEALTH CLINIC

Services Provided by the Indian Health Clinic

American Indian Health and Family Services of Southeast Michigan, Inc. (AIHFS or “the

center”) is funded by Indian Health Service (IHS). Like many urban Indian health clinics, it

receives little funding. For example, tribally run health services and IHS facilities received

approximately 53% and 43% of the 2010 IHS budget respectively, while urban programs

received only 1%, although the majority of AI/ANs reside in urban areas (USDHHS Fiscal Year

2010 Budget in Brief: IHS, as cited in UIHI, SIHB, 2012b.) AIHFS’ service area is composed of

seven counties in southeast Michigan where over 47,900 AI/AN people reside (U.S. Census

Bureau, 2010). AIHFS’ mission is to “empower and enhance the physical, spiritual, emotional,

and mental wellbeing of American Indian families and other underserved populations in SE MI

through culturally grounded health and family services” (AIHFS, 2014). AIHFS provides

medical care, women’s health care, maternal and child health care, diabetes management, dental

referrals, behavioral health care, substance abuse counseling and prevention, tobacco cessation

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 17

programs, youth programming, parent support programming, fitness programs, and traditional

healing ceremonies (e.g., sobriety lodge). AIHFS aspires to integrate traditional AI healing and

spiritual practices with contemporary Western medicine in both treatment and prevention

(AIHFS, 2014). AIHFS also hosts annual health fairs, celebrations, and other cultural events.

Indian Health Clinic Service Needs and Response

At the time of this study, AIHFS served 2,304 clients, approximately 10% of whom were

receiving behavioral health services. Identifying and recruiting specialized providers (e.g., in

behavioral health) who are AI/AN is challenging. The behavioral health program was not able to

provide services to all of the clients in need of those services.

In response, AIHFS recognized that a needs assessment was necessary to increase

organizational capacity and build an infrastructure that could better provide for the health care

needs of the AI/AN population in its service area. A Substance Abuse and Mental Health

Services Administration Circles of Care Infrastructure Development grant funded AIHFS to plan

and perform an in-depth needs assessment of the systems of care impacting the physical and

mental health and wellness of AI/AN children, youth, and their families. The specific purpose

was to assess, plan, and design a culturally appropriate integrative system of behavioral and

physical health care that incorporated traditional healing.

In this paper, we present needs assessment data from AIHFS’ 2008-2011 community

project entitled Gda’shkitoomi (“We are Able”). The data reported here were collected between

April of 2008 and October of 2009. Additionally, we report on the AIHFS’ and the community’s

response to the needs assessment data. This community-based project posed the following

questions: 1) Are health services in general available, accessible, and appropriate? and 2) What

are the culturally appropriate health services needed in the Detroit metropolitan area?

METHODS

Study Purpose

Between April of 2008 and October of 2009, the team conducted 38 semi-structured

interviews with 27 community members and 11 service providers, and also conducted 12 focus

groups, 10 with just community members and 2 with just service providers. We chose these

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qualitative data methods as we felt they would elicit richer data. Data saturation, community and

staff composition, and cost were considered when choosing the number of interviews and focus

groups. The purpose was to collect information from a diverse group of people who could

provide insight into the nature of the health issues (e.g., availability, accessibility, and

appropriateness of treatment; cultural and spiritual relevance of services), recommend solutions,

and provide guidance about integrating behavioral and physical health services. We determined

that it was important to get the views of community members, as they receive the services and

are aware of service improvement needs and preferences, and the views of service providers, as

they were more knowledgeable about currently provided services.

Research Design

Study Team and Advisory Council
The study team was composed of the second author/evaluator, a research assistant, the

project manager, and AIHFS staff members. The team collaboratively designed, developed, and

conducted this community-based study. An advisory council was formed by recruiting

community members via telephone calls, flyers posted at the center, notices in the center

newsletter, and word of mouth. The advisory council met once a month (in the evening, to

accommodate participants’ work and school schedules). Attendance varied from 15 to 22

members. The council was composed of tribal elders and leaders, parents, youth, AIHFS staff

members from various departments, and representatives from local organizations interested in

developing programs to support the community. This group reviewed the study processes and

offered oversight on cultural appropriateness and viability of the project. This study was

approved by AIHFS and the University of Michigan Institutional Review Board.

Recruitment and Consent
Interview and focus group participants were recruited via face-to-face discussions, flyers

posted at the center and at local community events, and at AIHFS. The interviews and talking

circles occurred at AIHFS, at other Indian centers in the Detroit metropolitan area, and at

community venues. All participants signed consent forms, and parental consent was obtained for

youth under the age of 18 years.

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 19

Data Collection
We conducted both individual interviews and focus groups in order to tailor the venues

toward the comfort of the participants, as we thought some might be more apt to share in a

private setting and others might need group interactions to elicit detailed perspectives. The

interviews were conducted in private areas of the venues and/or in interviewee homes. The focus

groups took place in a private area of the center. Interviews and focus groups were digitally

recorded and lasted between 45 and 75 minutes. Community member participants filled out a

demographic survey and were provided transportation, child care, a meal, and a $20 gift card.

Service provider participants filled out a different demographic survey (asking for less

identifying information) that included questions on individual service provision, role, and length

of time in this role at AIHFS and elsewhere.

Talking Circles
The focus groups were conducted as talking circles, a traditional method of group

communication in Indian country (Becker, Affonso, & Blue Horse Beard, 2006; Montejo, 1994).

In typical focus groups, the moderator plays an active role in eliciting information; in talking

circles, the moderator defers to elders. If an elder is speaking, it is inappropriate for anyone to

interrupt. The team began the talking circle by sharing a meal, and an elder (or other participant,

if no elder was present) offered a brief prayer. Everyone sat in a circle and the moderator passed

around a shell which a participant held while only he/she was talking. When the speaker was

finished, he/she then passed it to another person; then, only that person could speak. Everyone

was given the opportunity to talk, and no one was interrupted. If a person did not want to talk

he/she passed the shell to the next participant. The shell was passed multiple times for each

question to ensure that everyone was able to share his/her views.

Interview and Focus Group Questions
Three major topics were addressed: 1) availability of, access to, and appropriateness of

treatment; 2) culturally and spiritually appropriate services; and 3) gaps or limitations in current

services. The questions posed in both the interviews and the talking circles were: 1) What do you

think about the way health care is provided for American Indians in general? 2) What do you

think about the appropriateness (cultural and spiritual) of services for American Indians in our

community? and 3) What do you think about the availability and accessibility of health services

for American Indians in our community?

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Analyses
The interview and talking circle data were transcribed verbatim and reviewed by the

study team for accuracy. Then, the team utilized a content analysis approach whereby three

project staff members became familiar with the data by reading through the transcripts (Tutty,

Rothery, & Grinnell, 1996). We used this approach so we could analyze the text to define

common themes in participants’ views of community needs (Berg, 1989; 2004). During the first

stage of coding, the staff members re-read the transcripts to define categories from repeating

ideas. The team met to review the independently coded data, and then organized it into broad

categories that highlighted the specific themes reported in this paper. Themes identified by

participants were very consistent throughout the interviews, and were repeated in the talking

circles. Therefore, themes from the interviews and talking circles were combined and

subsequently catalogued using taxonomic method and arranged into a matrix format (Berg,

2004). All results were reported to the AIHFS advisory council at their meetings and to the

AIHFS community at large community events. Dissemination methods included PowerPoint

presentations, posters, and discussions.

RESULTS
Select Characteristics of the Participants

Interview Participants
Of the 27 community member interviewees, 18 were women; the age range was 12 to 82

years, and 25 were tribally affiliated (many urban AI/ANs identify as affiliated, but are not

enrolled in a tribe). Of the 11 service provider interviewees, 6 were women; the age range was

26 to 70 years, and 5 were tribally affiliated. The services they provided were mental health (n =

5), physical health (n = 2), administrative (n = 1), and support (n = 3).

Talking Circle Participants
Twelve talking circles were conducted, 10 with community member participants and 2

with service provider participants. The groups were organized by gender or age. Some groups

were composed solely of women or men, some of only youth, and some of elders of both

genders. Of the 73 community members, 37 were women; the age range was 12 to 77 years, and

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 21

62 were tribally affiliated. Of the 10 service providers, 8 were women; the age range was 21 to

70 years, and 1 was tribally affiliated. The services they provided were behavioral health (n = 6),

physical health (n = 3), and support (n = 1).

Participants shared feedback regarding the services that currently are provided in the

Detroit metropolitan area. The themes that emerged were needs for 1) more culturally competent

services and providers, 2) more specialized health services, and 3) more transportation options.

Need for More Culturally Competent Services and Providers

Community member participants requested more services tailored to their cultural needs:

more traditional healing; more cultural programming; more marketing of provided services

(especially traditional services); AI/AN and/or culturally competent providers, both at AIHFS

and offsite; service integration so the whole body and mind could be served; and collaboration

between providers and community members.

A community member interviewee (#26) stated, “I have more faith in Indigenous healing

now than I have in any other.” Another community member interviewee (#2) stated:

I think [traditional healing] is better than [Western medicine] because they deal

with the spirituality, they deal with the mind and the mind has a lot of control

over the body, where the Western medicine they don’t consider the mind, and it’s

just the physical but that’s not what it is.

Talking circles where people can gather to share wisdom and knowledge, support one another,

and experience the cultural components of prayer were important for participants. When a

community member interviewee (#39) was asked what kind of mental health services she would

like to see the center provide, the response was, “Talking circles…like bringing in more like

Native teachers, like elders, community members that could like lead a talking circle or share a

teaching.” Another participant, in the male community member talking circle (#2), shared:

You know, myself, sometimes I wish I had somebody to talk to. You know what I

mean? I am 49 years old and sometimes I wish I just had somebody to open up

to. A lot of people hold stress inside of them…A lot of people just do not know

where to turn, you know. Or a lot of people do not trust people to talk to. You

know. You have got to be around somebody that you can trust, somebody you can

open up to.

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Overwhelmingly, participants wanted AIHFS to provide both Western medicine and

cultural and social programming that includes education and activities that teach language,

culture, spirituality, and traditional ways of life. AIHFS does incorporate cultural activities into

its programming, but this study highlighted the gap between what is offered and what the

participants expressed as their cultural needs. Participants also noted that there are many AI/AN

community members who want more traditional healing and cultural knowledge, but do not

know what these might look like. Many times, the ceremonies and spiritual beliefs that the

participants wanted were not passed down as a result of cultural trauma, family dysfunction,

intermarriage, or shame. Many AI/AN children are being raised by non-AI/AN family

members/caregivers who may need assistance to learn about AI/AN cultures and teach them to

their children. Youth who receive cultural programming via AIHFS’ after-school program, are

aware of the need for their caregivers (both AI/AN and non-AI/AN) to be involved in cultural

programming tailored to their needs. One youth talking circle participant (#2) observed: “But not

just the children need to know, I think they should, you know? … More Native parents should be

involved in learning as well, not just the children.” Youth revealed that they are struggling at

home, struggling as adolescents, and struggling over school pressures. One youth (#1) remarked

in a talking circle that, “For me, it’s kind of hard to keep seeing my family like one unit… my

dad is going through depression and he’s using it through alcohol, and getting drunk, coming

home at two o’clock in the morning.” Many shared stories of challenging home environments

and the benefit of connecting and sharing with others to alleviate their stress at events at the

center (e.g., the Dreamseekers traditional youth after-school program).
Community awareness of services—or the lack of marketing of services—was a
dominant theme throughout, appearing in all the interviews and talking circles. A community
member interviewee (# 27) stated:

Um, I wasn’t aware there was a clinic here. You know, I have been without

insurance for a long time, struggling, and, um, I didn’t know that you guys offered

any service, because I was not aware that the clinic was here. So it should be like

more advertisement around our city.

The service providers also acknowledged their responsibility to the community and their

shortcomings in providing information about available services. For example, a service provider

interviewee (#6) stated, “…Just getting the word out is what we really need, as well as more

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 23

transparency where people [service providers] are open, honest, accountable, and communicate

well.” One service provider shared that AIHFS has AI staff, including behavioral and physical

health specialists, paraprofessionals, and programming staff members; however, many of the

participants were unaware of their existence (e.g., that AIHFS has an AI physician in the health

clinic).

Community member and service provider participants discussed culturally competent

service and practice as it relates to interactions with health care providers. Participants wanted

both AI/AN physicians and service providers at the clinic, as well as service providers at non-

IHS clinics who are not AI/AN affiliated, to be more culturally competent (AIHFS’ employees,

as well as its service population, are diverse in terms of tribal affiliation, and level of cultural

competence). The desire for AI/AN service providers and for cultural competence reflects

participants’ need to be comfortable working with providers who understand that AI/ANs have

had historical, cultural, geographical, and social experiences that may differ from those of the

general population. An AI service provider (#8) shared in an interview: “I’m hoping that people

will get comfortable with being a community and see me as a resource when they need me.”

Participants often found themselves educating the service providers in non-IHS clinics about

their cultures. Participants stressed the need for building trust with their service providers, noting

that providers can help by considering their patients’ cultural needs. One service provider

interviewee (#4) said that “building a network of traditional people who can be consultants or

provide traditional services would increase the appropriateness of the services we offer.”

Participants advocated for the integration of services as an effective way to meet

community needs. One community member interviewee (#2) shared:

A lot of times with Native people they’re not going to tell you they have needs,

and by addressing both a counselor and a physical doctor at the same visit you

might be able to find out more of what they need.

AIHFS attempts to provide services that treat the whole person, and includes spiritual and

cultural aspects in services. Despite the existence of these services, the participants wanted more

integration of Western medicine and traditional medicine. A male community member in a

talking circle (#1) talked about what is important to him: “Reconnecting with tribal heritage…

going back to tribal practices and healing along with Western medicine.” The theme of culturally

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24 VOLUME 23, ISSUE 5

competent services and providers also included collaboration between staff and community

members. Collaboration is an AI/AN value and traditional way of interacting. A service provider

interviewee (#7) noted the importance of collaboration:

Having like really good communication about the changes, like with all the staff,

and…involving the staff in like creating the…programs so that everybody knows

how it’s going to work….asking the community’s opinion and feedback on it.

Need for More Specialized Health Services

Participants wanted more specialized services at AIHFS, as external providers were not

receptive to, or knowledgeable about, AI/AN cultures. They suggested that offering specialized

services in both the behavioral and medical health programs would help to build trust in AIHFS.

A service provider interviewee (#26) stated:

We provide here just a basic medical health…if they need any specialized

services, we have to refer them out for those services…if they need an internist, a

pulmonary specialist…any sort of specialist, we have to refer them out.

AIHFS provides a range of services, but some clients felt there were limitations that forced them

to go to more than one clinic, some non-IHS, for their health needs, as shared by this service

provider interviewee (#11):

I had one patient yesterday that told me that she goes to the other county . . . for

her women’s health screening, but she came to us for family medicine and I was

able to at least give her that information, that we are working on it . . . So I think

that is going to have more of a central, kind of continuity of care, rather than

breaking up women’s health in their county and them coming here for family

members.

There is a greater demand for services than AIHFS currently is able to meet financially, which

leads to waiting lists and patients left with unmet health needs. Lack of onsite services results in

referrals, often leaving the uninsured to maneuver through a great deal of paperwork and a 25- to

30-day wait for an appointment. Participants desired more mental health services (e.g., case

management; support groups for loss, grief, and stress management), a psychologist or

psychiatrist on staff, drug and alcohol treatment targeted at AI/AN populations, and more youth-

tailored services. A community member talking circle participant (#1), who is a mother, shared

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 25

her experiences with the general mental health system and her wish that AIHFS could provide

advocacy and guidance in helping families work with multiple providers and systems in the

greater Detroit metropolitan area.

Need for More Transportation Options

Participants wanted more transportation options to be able to attend events. Given that

services are provided to a seven-county metropolitan area, many of the participants, including

one community member interviewee (#27), stated, “Transportation is one of the biggest

challenges.” Participants cited lack of public transportation and not having a vehicle as

transportation barriers that prevented them from accessing services. AIHFS is located on the

fringe of the Detroit metropolitan area, and there was a desire for it to be more centrally located

or to have more locations, as some patients have to drive more than 60 miles for services. A

community member interviewee (#30) shared:

I think that if they’re able to get here, it’s a wonderful thing, because [patients]

may not be located near it, some people decide not to come this far. I think that a

lot of people don’t know they can use these services.

Transportation in the Detroit metropolitan area is automotive-centric, so public transportation is

underfunded, is nonexistent or sporadic in many areas, and does not connect the greater

metropolitan area to the city. As a service provider interviewee (#1) stated, “With our programs

they [clients] would get so much out of it, if we could just get them here…”

To offset the challenges posed by limited transportation, participants requested extended

or evening hours of operation at AIHFS. In particular, participants who held traditional workday

jobs asked AIHFS to provide health services on weekends and later in the evening to better

accommodate travel time. One community member interviewee (#15) suggested, “Being able to

come in an evening, seeing a therapist, for instance, that the kids go to school all day and the

parent works, um, maybe even on the weekends.” Another community member interviewee

(#29) added, “You know, available times… in the evening hours after you work.”

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AIHFS’ and the Community’s Response to the Results of the Needs Assessment

AIHFS reviews service delivery and programming at the advisory council’s monthly

meetings. At these meetings, elder members receive updates, provide input, and also teach

younger members traditional ways of praying, dancing, and singing. To facilitate youth input on

programming and service needs, a monthly youth advisory council has also been formed. More

creative, low-cost, and potentially high-impact solutions to the unmet mental, emotional,

physical, and cultural needs of the local AI/AN community are being generated by management,

providers, and staff and community members. Oral reports from the advisory council and

community members, as well as increased community participation in events (measured by sign-

in sheets) have been positive.

Overall, participants were satisfied with the quality of services provided at AIHFS, but

wanted even more culturally appropriate services to be available both offsite site with other

providers, and onsite at AIHFS.

Need for More Culturally Competent Services and Providers’ Response

In response to the needs assessment, AIHFS has provided more traditional healing,

culturally competent programming, marketing, AI/AN or ally providers; and service integration.

AIHFS has a made a concerted effort to increase the use of traditional healers and elders

practiced in traditional healing methods (e.g., use of medicinal plants and herbs) to conduct

teaching and ceremonies. AIHFS has launched a weekly Native-specific women’s Wellbriety

group and more regularly scheduled peer-led men’s and women’s talking circles that include

traditional activities. It has also initiated a nutrition program where members learn how to cook

healthy Native foods, more regular sweat lodges, and naming ceremonies. These activities

require only space and minimal funds.

To increase its marketing efforts and reach more community members, especially youth,

AIHFS updated its website with available programs and links to social media accounts, made its

newsletter accessible on the website, and developed a listserv for weekly emails. Finally, a

marketing committee was formed to increase visibility and membership with videos, brochures,

flyers, and signs posted on the website and distributed at community venues around the Detroit

metropolitan area.

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 27

The participants asked for AI/AN health providers and staff members, of which there are

now several at AIHFS, working in the health, youth, parenting, suicide prevention, and substance

abuse programs, as well as in the facilities and administrative departments. AIHFS’ increased

marketing efforts and infrastructure development enabled it to recruit and support these AI/AN

staff members, as well as local university interns, many of whom are AI/AN. AIHFS continues

to have an AI physician as well.

AIHFS services are being integrated. For example, a behavioral health provider was

relocated to the physical health clinic for quick onsite assessments and referrals for behavioral

health. More services that involve a holistic, traditional healing approach are being introduced

and also are being integrated with Western medicine. For example, the newly hired AI/AN staff

members are professionally trained in the Western model, but have backgrounds in AI/AN

cultures.

Need for More Specialized Health Services Response

Due to funding restrictions, more specialized services are difficult to access at AIHFS.

However, AIHFS’ response has been to increase collaboration with providers and community

members, internally and externally, particularly in the behavioral health program. Via a grant-

funded project, Detroit metropolitan service providers are working to integrate AIHFS into

Detroit Wayne Mental Health Authority’s system of care management team, and the agencies

involved are participating in training that infuses more cultural programming with an emphasis

on AI/AN cultures. At AIHFS, more substance abuse and mental health programming is being

developed. The center has received funding for a suicide prevention project that provides

gatekeeper trainings, which teach those who are positioned to recognize and refer someone at

risk of suicide (e.g., parents, friends, neighbors, teachers, coaches, caseworkers, police officers)

about the warning signs of a suicide crisis and appropriate responses (Suicide Prevention

Resource Center, n.d.). Suicide screenings and referrals for ongoing mental health services also

are provided. To increase behavioral and physical health staffing numbers in specialized areas

(addictions, children and youth mental health, innovative behavioral interventions) AIHFS has

formed internship programs with local universities and has accessed grant funding for suicide

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prevention and addictions programming. Finally, the center is applying for accreditation, which

can lead to an increase in reimbursements from regulators, thus generating more income for

specialized services.

To develop more cultural activities and programs, AIHFS, tribal organizations, tribal

communities in Michigan, and First Nations people in nearby Canada are doing more

networking. As part of this effort, AIHFS and two local Native agencies formed a coalition to

collaborate in services, funding, and events. Each site is working to decrease redundancy in

services and maximize participation in funded programs. AIHFS and one of the agencies have

jointly sponsored a powwow. Together, the three coalition partners are conducting more cross-

agency behavioral and physical health trainings and events to share funding and increase

collaboration and participation among staff and community members.

Additionally, AIHFS staff and community members are involved in accessing funds for

capital improvements, capacity building, mental health, substance abuse, and medical services.

The advisory councils and staff members collaborate on grant applications, and, when funds are

awarded, they collaborate on the implementation of programs. Community input is frequently

obtained for projects, especially those involving youth.

Need for More Transportation Response

Understanding these challenges related to transportation has allowed AIHFS to

brainstorm solutions and apply for funding to alleviate this burden for its community members.

AIHFS has acquired two additional vehicles (for a total of 4) since these data were collected, and

additional staff members have been trained as qualified drivers. Furthermore, in order to

accommodate patient work schedules and travel time to the center, AIHFS has added evening

hours and walk-in days.

DISCUSSION

This study identified the following needs: more culturally competent services and

providers, more specialized services, and improved transportation options. The participants’

desire for culturally competent services is not unique to AIHFS. For example, in a study in the

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 29

Chicago metropolitan area, AI/AN participants indicated a need for culturally relevant services

that utilize traditional medicine or spiritual healing (West, Williams, Suzukovich, Strangeman, &

Novins, 2012).

Many AI/AN elders and adults experienced assimilation strategies imposed by the federal

government, including forced attendance at boarding schools and the Indian Relocation Act of

1956. In particular, relocation created a chronically disenfranchised and traumatized urban

Indian population (Nebelkopf & King, 2003). These assimilation practices estranged AI/AN

adults from their traditions and increased their need for programming to reclaim culture for

themselves and their children.

There are challenges to providing culturally competent programming, including the

diversity of tribes and cultural practices within an urban setting, which prevents a one-size-fits-

all approach. Further, few providers know about AI/AN cultures; most need to be educated about

the cultural and historical contexts that influence the diagnoses and treatments providers can

offer. Traditional healers can help to bridge this gap, but they are few in number and often must

travel far to provide services. In order to tackle these obstacles, funding is needed to improve the

quantity and quality of culturally competent services at urban Indian health clinics and positively

impact health outcomes in the community.

Another interesting result of the needs assessment is the desire for more onsite

specialized services, especially mental health services. A 2012 Urban Indian Health Institute

report shows that, among AI/AN adults residing in urban areas, 15.1% reported at least 14 poor

mental health days within the last month, compared with 9.9% of the all races population (UIHI,

SIHB, 2012a). The mental and physical health of AI/AN people are affected by the traumas

associated with historical events. These traumas often are not understood, recognized, or

discussed in the current U.S. health care system (UIHI, SIHB, 2012a).

Even with an increase in funds for more comprehensive culturally competent services and

providers, and the provision of more onsite specialized services, many AI/ANs in the Detroit

metropolitan area are unable to get to the center. The effects of insufficient transportation on

AI/ANs’ ability to access health care in Michigan is noted in the 2009 Bemidji area urban Indian

needs assessment. Among 389 respondents, a lack of insurance (23.3%), and then a lack of

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30 VOLUME 23, ISSUE 5

transportation (13.9%) were the major reasons for not being able to access health care (UIHI,

2009). These findings reaffirm that urban Indian health clinics need more funds to be able to

provide transportation as well as cultural and specialized services.

For this study, the following limitations should be noted. The results of the study from

one urban AI/AN health center cannot be generalized beyond this specific sample. While the

sample in the study represents community member and service provider perspectives, the sample

size was small and purposive, and the results may not reflect the needs of AI/ANs in the entire

Detroit metropolitan area. Additional research would be needed to develop a more

comprehensive understanding of the health needs of urban AI/AN populations.

CONCLUSION

As a result of this study, AIHFS’ staff and community members, service providers, and

external service providers have enhanced and expanded physical and mental health programs, as

well as integrated more culturally competent programming into their present services.

Community members, staff members, service providers, regional AI/AN centers, and Detroit

metropolitan area social service agencies need to continue to collaborate in order to provide

services effectively and reduce health disparities for this urban Indian population.

“We need to stand together as a whole Nation…We need to lift each other up, you know,

to keep us strong. We need to be strong” (Community member interviewee #28).

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COMMUNITY RESPONSE TO NEEDS ASSESSMENT 33

ACKNOWLEDGEMENTS

We thank the Circles of Care Project Team: Jerilyn L. Church, Cecilia LaPointe,

Elizabeth E. Chapleski, Terry D. Lerma, Debbie Tauiliili, John Marcus, Tina Louise, Nickole

Fox, and Mona Stonefish. We would like to express Miigwetch (Thanks) to all of the youth,

adults and elders who participated in this study and to all community members and service

providers, especially the advisory council, who provided input throughout the study. Research

reported in this publication was supported by the Substance Abuse and Mental Health Services

Administration (1HS5 SM05 8836-01). The content is solely the responsibility of the authors and

does not necessarily represent the official views of the Substance Abuse and Mental Health

Services Administration.

AUTHOR INFORMATION

Dr. Dennis is with the School of Social Welfare at the University of Kansas.
Dr. Momper is Associate Professor in the School of Social Work at the University of
Michigan. She is the corresponding author for this article and can be reached at 1080 South
University Avenue, Ann Arbor, MI, 48109, at (734) 763- 6578, or at [email protected]
The Circles of Care Project Team is composed of Jerilyn L. Church, MSW, Cecilia
LaPointe, MS, Elizabeth E. Chapleski, MSW, PhD, Amelia Mueller-Williams, LLMSW, MPH,
Terry D. Lerma, LMSW, PhD, Debbie Tauiliili, MSW, MS, John Marcus, AS, Tina Louise,
LMSW, Nickole Fox, MA and Mona Stonefish, Tribal Elder.

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Copyright of American Indian & Alaska Native Mental Health Research: The Journal of the
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individual use.

Science, Ideology, and Health Care

NEEDS IN HEALTH CARE: WHAT BEAST IS THAT?

James D. Harrison, Jane M. Young, Phyllis N. Butow,

and Michael J. Solomon

Need is a pivotal concept within health systems internationally given its

driving force in health care policy, development, and delivery at population

and individual levels. Needs assessments are critical activities undertaken

to ensure that health services continue to be needed and to identify new

target populations that demonstrate unmet need. The concept of need is

underpinned by varied theoretical definitions originating from various disci-

plines. However, when needs are assessed, or health interventions developed

based on need, little, if any, detail of the theoretical or conceptual basis of

what is being measured is ever articulated. This is potentially problematic and

may lead to measurement being invalid and planned health services being

ineffective in meeting needs. Seldom are theoretical definitions of need ever

compared and contrasted. This critical review is intended to fill this gap in

the literature. Interpretations of the concept of need drawing from areas such

as psychology, social policy, and health are introduced. The concept and

relevance of unmet need for health services are discussed. It is intended that

these definitions can be used to operationalize the term “need” in practice,

theoretically drive needs assessment, and help guide health care decisions

that are based upon need.

One of the primary goals of health care systems internationally is to provide

good health care based on need (1�3). It is need that drives government, clinicians,

policymakers, health managers, public health practitioners, and health service

researchers to develop and provide effective, relevant health care services.

Attempts are made to meet population and individual needs through a hybrid of

initiatives, which seek to create the best experience and the best possible outcomes

International Journal of Health Services, Volume 43, Number 3, Pages 567–585, 2013

© 2013, Baywood Publishing Co., Inc.

doi: http://dx.doi.org/10.2190/HS.43.3.l

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567

for those who use the myriad of health services and interventions available to

meet health care need.

At a most basic level, need triggers the delivery of health care when a clini-

cian assesses an individual patient’s need for care before prescribing treatment.

Responding to individual patient need, however, is not the sole process of health

care needs assessment (4). Needs assessments are also undertaken periodically to

appraise whether health services and their activities continue to be needed. These

exercises validate current populations targeted for services and identify new target

populations that report unmet need (5). From a public health perspective, needs

assessment provides empirical data to define, refine, or redefine public health and

health service objectives and goals, leading to potential improvements in health

and well-being (5). From a health service management perspective, identification

of health consumers’ need for health services can provide impetus for health

service modification that has the potential to improve patients’ perceived quality

of care (6). Health needs assessment is also used to prioritize resource allocation,

whether that means financial, workforce, equipment, or facility investment in

individuals or populations where there is most need (7). This particular aspect of

health needs assessment is becoming increasingly important in this era of finite

financial resources, which is increasingly pressured by aging populations and

expanding, costly advances in medical technology.

Given the role of need and needs assessment in health care systems, it is not

surprising these are pivotal concepts that feature internationally within health and

cancer care policy. Health system performances are now benchmarked against

their responsiveness to individual and population health care need (8, 9). Ensuring

that individual and population health needs are met is a central policy objective

to delivering patient-centered health services. Patient-centered care has been

described as care that is respectful of, and responsive to, individual patient

preferences, values, and needs (3, 10). A more recent development in the need

debate has been the introduction of the concept of unmet need (4).

The word “need” is a relatively recent addition to our lexicon, with no equiv-

alent word or translation in the ancient Greek or Roman languages (11).

However, human need is now considered a subjective, culturally relevant concept

(12) that is underpinned by varied theoretical, conceptual, social, and ethical

definitions. These definitions have been described from a variety of perspectives

by individuals in disciplines such as psychology, philosophy, epidemiology,

health economics, sociology, health policy, and public health. These diverse

perspectives have resulted in a range of interpretations. As such, these are often

described largely in isolation and written for discipline-specific audiences; seldom

are the diverse definitions of need presented collectively. Further, despite the

fact that the language of need is often used emotively to justify service develop-

ment or re-development (13), there is little discourse on what is actually meant

by need. When needs are assessed or health service interventions are developed

that are based on need, little, if any, detail of the theoretical or conceptual basis of

568 / Harrison et al.

what is being measured, or of which framework is applied, is ever articulated.

This is potentially problematic given that, without a clear understanding of what is

meant by need, attempts to measure need may be invalid and fail. Also, without a

theoretical basis to guide decisions about health system development, there is the

potential for resulting health services to be actually ineffective at meeting need.

This has direct consequences for practice, given that need is used consistently

within health care as a basis to drive health service policy and delivery.

Therefore, the aim of this article is to provide a critical overview of a range of

perspectives that seek to define and conceptualize need. The concept of unmet

need will also be discussed, given its increasing relevance to health care delivery.

This review does not intend to state which perspective or interpretation of need

is correct; rather, it should be used to stimulate debate regarding what is actually

meant by the term need. However, this review will assess the potential application

of these theories to health service development and delivery. This critical review

also seeks to provide guidance to professionals concerned with delivering health

care on the range of theoretical frameworks that can be used to operationalize a

definition of need in practice.

NEED AS AN INFLUENCE OF HUMAN PERSONALITY

Some theories of human need have developed from theories of human instinct.

Murray, in his explorations of human personality, stated that human action is

motivated and behavior driven by need (14). Needs were viewed as a readiness

to respond in a particular way under given circumstances, with people having a

need to satisfy a lack of something. Murray (14) divided needs into two categories:

primary biological needs, such as for food and water, and 27 secondary, psycho-

genic needs, including achievement, exhibition, and understanding. Although

Murray’s investigations are recognized as one of the first academic attempts

to define need, its psychological focus limits its application and relevance to

health care need and health service development.

A PSYCHOLOGICAL PERSPECTIVE OF NEED:

MASLOW’S HIERARCHY

One of the most widely acknowledged attempts to define human need and

development is Maslow’s hierarchy of needs (15). Maslow specified five levels

of need that were predetermined in order of importance, as shown in Figure 1

(16). The first four levels were categorized as deficiency needs, initially defined

by physiological needs such as for food, water, and homeostatic functions, similar

to those described by Murray (14).

According to Maslow, primary deficiency needs (at the bottom of the hierarchy)

must first be satisfied, followed in sequential order by the remaining needs.

Once these have been fulfilled, the final need for self-actualization is manifested.

Needs in Health Care: What Beast is That? / 569

Maslow’s hierarchy highlighted how need, therefore, drives personal growth

to the highest level of development, that of self-actualization. Maslow suggested

that this pinnacle corresponds to a self-accepted, emotionally balanced, fully

mature person.

While Maslow’s hierarchy is acknowledged in any academic discourse

when conceptualizing need, the theory is not without its detractors. Wahba and

Bridwell (17), for example, provide evidence that only partial support, at most,

for a need hierarchy could be demonstrated in a critical review of studies that

tested Maslow’s hierarchical concept.

Tulchinsky and Varavikiva (18), however, have suggested that Maslow’s

theory is particularly relevant for the purpose of planning and managing health

systems, because it identifies need beyond the usual physical context. Further,

they state that the hierarchy can explain the motivation of client behavior related to

570 / Harrison et al.

Figure 1. Maslow’s Hierarchy of Needs. Source: Finkelstein (16).

the social determinants of health and disease (18). Concrete examples of appli-

cation of Maslow’s theory into practice, however, are limited. Attempts to apply

this framework have produced varying results, in a palliative care setting but

not within a large set of geriatric patients (19, 20).

Miller (21) has criticized the sequential hierarchical concept of need, asserting

that behavior was likely to be in response to several different need hierarchies

at any given time. McGregor (22) adds that in many situations, empirical studies

have demonstrated that humans will trade off the satisfaction of basic physical

needs for those higher in the hierarchy. Further, Miller (21) argued that the specific

types of need described by Maslow are not relevant and universal to everyone.

From a practical perspective, McCall (23) noted that, except for physiological

needs, it is hard to determine which physical, interpersonal, and social aspects

of life are causally related to each end state. This subsequently hinders any attempt

by individuals or agencies assigned to meet needs when using this theory as a

basis. Therefore, the biggest criticism of Maslow’s theory is that it is inflexible,

primitive, and too general, particularly when assessing needs related to aspects

of health (13, 23).

THE BASIC NEEDS APPROACH

A more modest and minimalist approach to defining needs is the Basic Needs

Approach (24, 25). Principally, this was the basis of a strategy for aid and

development (26). It primarily focused on needs such as access to food, water,

shelter, and clothing. These basic items are complemented by a series of secondary

basic services such as sanitation, health care, and education. The primary basic

items and services are weighted equally in terms of importance and both must be

satisfied. Philips (27) supported the Basic Needs Approach because it describes

a minimal standard of basic needs required for basic human development and a

decent life. For health care practice, this approach to need supports the notion

of universal health care and, therefore, can be used as a basis for health care

interventions that seek to address health inequalities.

However, some have criticized the Basic Needs Approach. Wiggins (28), for

example, suggested it does not provide a sophisticated framework for human

personality or motivation. Similarly, Griffith (29) stated that the omission of types

of need other than basic ones leads to an overall failure of this approach to

appreciate the complexity and finer aspects of human well-being. The Basic Needs

Approach has also been viewed as being too minimalist in its approach as a result

of its positioning at the survival end of the existence spectrum, therefore poten-

tially limiting its application if adopted within complex health systems inter-

nationally. Additionally, a major problem is that this approach does not weight

items for importance (i.e., the approach does not determine which basic items

or services are most important to fulfill) (27, 29). Furthermore, no benchmarks

are prescribed to help operationalize which basic needs relate to health care.

Needs in Health Care: What Beast is That? / 571

BRADSHAW’S TYPOLOGY

In the early 1970s, Bradshaw provided a social policy interpretation to describe

a taxonomy of needs (30, 31). Four domains of need were detailed: normative,

felt, expressed, and comparative. Bradshaw’s approach was flexible, acknowl-

edging that in reality, different definitions of need were required to correspond

with different groups in society (32). This was a fundamental shift in the progress

of conceptualizing need.

Normative need relates to needs determined by professionals. A standard is

set and if people do not reach or maintain the standard, they are identified as in

need. Examples of normative need are evidence-based clinical practice guidelines.

Normative needs are value judgments that are often, but not always, based

on scientific evidence, and they are not absolute; they are likely to alter as

values, knowledge, and technology change. The main objection to the concept of

normative need is that it is seen as a paternalistic or elitist approach to defining

need, since individuals are not given any autonomy or freedom to define their

own need. However, since the normative approach was described, socio-political

changes and consumerism, among other influences, have altered the delivery

of many aspects of health care. Treatment decision making, for example, is now

more interactive and collaborative. Another potential concern with the normative

approach to defining need is the suggestion that those charged with delivering

health care, from government to individual clinicians, can be influenced and

pressured by external factors such as the pharmaceutical industry, media, and

economic institutions (33�36).

The next type of need Bradshaw described was felt need. Felt need is

equated with want, or the subjective value judgments defined by individuals.

Bradshaw emphasized that felt needs are important in democratic societies,

but are not necessarily an adequate measure of actual need since they are

limited by an individual’s perception of his or her need. Perception is heavily

influenced by personal characteristics and expectations, which may hinder an

individual’s ability to self-assess need. For example, if people are unaware that

a health service is available, they will never feel a need for that health service

because they do not know it exists (32). Similarly, there will be situations

when people express a need for health services when, in fact, they do not

actually need it. Liss (37) believed that wants and needs are two distinctly

separate concepts, while McCall (23) noted that wants are not always justified

compared to needs. In terms of health care, the concept of felt need involves

no clinical judgment; therefore, it is unclear how this definition would fit with

current, established structures of health care delivery. Furthermore, given that

the number and variety of felt needs are potentially immeasurable, this concept

as a sole measure is restricted in practice largely because it does not consider

the economic or human capital limitations that are currently experienced within

health systems.

572 / Harrison et al.

Expressed need refers to felt needs that are turned into action. Action is

expressed through demand for services. However, it is important to acknowl-

edge that not all felt needs will result in demand. In terms of health care,

demand is influenced by a variety of factors, including individual health

behaviors, availability of health services, and access to health services. Boulding

(38) criticized provision of services according to demand on the basis that it

is a libertarian, rather than egalitarian, concept. He stated that if health care is

distributed by demand, it is more likely the rich will be recipients of health

care compared to the poor. Another possible criticism of expressed need is that

it may underestimate need if it is solely used as an indicator of need.

Comparative need is the final construct that Bradshaw defined. Need in this

instance is determined by analyzing the characteristics of specific individuals

or groups who receive a type of service and comparing them to individuals or

groups with similar characteristics who do not receive that service. Those not

receiving the service are subsequently identified and defined as having a need.

Bradshaw (11) suggested that comparative need is fundamentally about equity

and the process should be used, particularly at a population level, to investigate

and identify inequalities in health service provision. Identification of comparative

need is dependent on the existence of services to be supplied. Need, therefore, can

only be assessed for items or issues for which services are currently available.

Stevens et al. (39) note that a potential problem with comparative needs is that

they will be informed by historical funding allocations and service development

successes and failures. The implication is that there could be a potential over-

estimation or underestimation of actual level of need.

While each of Bradshaw’s definitions of need has limitations, the over-

whelming benefit of his taxonomy is that four interpretations of defining need

were provided. Although each definition has inherent weaknesses, McGregor

(22) believes Bradshaw’s interpretations sensitizes those in charge of defining

need to the fact that the term can have different meanings. The advantage of these

four definitions is that they can be used collectively to measure and understand

need from a variety of perspectives.

DOYAL AND GOUGH’S THEORY

OF HUMAN NEED

The basis of most need theories described is that need is a subjective, relative

concept that is strongly influenced by individual perception and beliefs rather

than absolute facts. Most academic commentators with this opinion argue

that needs based on facts, referred to as objective needs, do not exist and that

within human society there are simply divergent interpretations of need, with

one type no more objective than another (32). Furthermore, the subjective inter-

pretation conceptualizes need as a relative construct that is context-specific to

both place and time. For example, individuals in developed and developing

Needs in Health Care: What Beast is That? / 573

countries are likely to have different needs and perceptions of need today than

50 years ago (32). Doyal and Gough challenged this view by presenting an

alternate theoretical interpretation in A Theory of Human Need (12). The tenet

of this theory is that it is unreliable to determine needs on the basis of subjective

feelings alone. Rather, need should be viewed as objective, universal items that

are common to everyone and independent of individual preference.

Doyal and Gough’s (12) Theory of Human Need is ultimately ideological, with

satisfaction of need enabling an individual to participate fully in society. Two

universal, needs-based goals were presented to form the framework of this theory:

first, avoiding serious harm, and second, an ability to participate. These goals

are met through the satisfaction of two basic needs, physical health and autonomy

of agency, which are universal to everyone, are not place- or time-dependent, and

are prerequisites for individual participation in society. Doyal and Gough (12)

believe the need for physical health and autonomy is a fundamental human

right and there is a moral imperative within society to ensure these needs are met

for all. For optimal physical health and autonomy to be achieved, 11 intermediate

needs were proposed, including adequate nutrition, clean water, appropriate health

care, physical security, and a basic education. These items mirror those described

by the Basic Needs Approach (24, 25). According to Doyal and Gough’s (12)

theory, all intermediate needs must be independently satisfied for physical health

and autonomy to be accomplished. Each intermediary need is viewed as equally

important, with no one type of need having a greater priority than another (12).

An obvious limitation to the Theory of Human Need is that no standards of

physical health, autonomy, or intermediary needs are defined. Benchmarks are

not provided, for example, of what should be considered appropriate physical

security or what determines appropriate health care or a basic education. Similarly,

there is a question of who sets these benchmarks, an ambiguity that hinders

attempts to develop practical strategies to meet each need. These concerns limit

the application of this theory, particularly to the health care arena.

HEALTH CARE NEED

While some of the need theories described conceptualize aspects of need in

relation to health, most seek to provide general philosophical interpretations.

As such, they have limited application to health care delivery. An alternative

interpretation is to view health care need in more operational terms. For example,

Liss (37) provided a comprehensive overview of four methods to conceptualize

health care need: ill health, supply, normative, and instrumental.

First, in relation to a definition of need as Donabedian’s (40) “some dis-

turbances in health and well-being,” Liss (41) interprets “disturbances” as a

tension or disequilibrium in the organism induced by external or internal stimuli,

causing the individual to struggle to maintain homeostasis. These disturbances

or deficiencies cause ill health, requiring health care intervention. Thomson (42)

574 / Harrison et al.

noted that this inner state initiates a drive that triggers a motivational force or

behavior toward an object that will reduce, or eliminate, the tension to return

functioning to normal or acceptable parameters. Need is therefore considered

an object that, once obtained, eliminates the tension and satisfies the need

(37, 41). Liss (37) described this position as the ill health notion of health care.

The primary role of the health care system in response to ill health is to satisfy

these disturbances and reduce the impact of ill health.

This interpretation has been criticized as a humanitarian view of need (43).

Although one of the primary roles of health services is to treat and manage ill

health, this definition of need is perhaps too focused, given that it does not

consider health needs related to prevention. Also, Acheson (43) and Matthew (44)

believed the ill health notion of need does not consider the limited resources

available to the health sector. They recommend that a more realistic approach is

required, since not all needs can be met and provided for. Matthew (44) suggested

that health care need exists when a person has an “illness or disability for which

there is effective and acceptable treatment or care.” Culyer (45) added to this

interpretation by stating that health care need relates to a situation where there

is the potential to avoid reductions in health status or the potential to improve

health status. These interpretations move the need debate from an ill health

perspective to suggest that a need exists only when there is a procedure or

intervention available that can have a positive outcome on health.

Liss (37) summarized these opinions to define a second interpretation, the

supply notion of health care need. The supply notion depends on the existence

of a treatment or intervention that can achieve improvements in health or reduc-

tions in health risk. This is potentially problematic for a number of reasons. First,

if there is no intervention available, then need is considered not to exist, which

is logically incorrect. A person can still have health care need even when there is

no intervention available to meet that need. Second, the supply of an intervention

may not always meet the level of demand, or need; therefore, the level of need

inferred will underestimate the actual level of need within the population. Third,

where an intervention is ineffective, an individual would remain in need, despite

this interpretation of need stating the contrary. Bjorn (46) stated that the supply

interpretation is static, non-dynamic, and in fact counterintuitive. For example,

if you were trapped in a desert without any water, you would still have a need for

water (46). According to the supply notion of need, however, this need would

not exist. Stevens et al. (39) have argued that the concept of supply has little

relevance to health needs, since supply has more to do with political motiva-

tions and campaigns, funding allocation, and the availability of health profes-

sionals to deliver health care interventions.

The third need concept that Liss (37) classified was the normative notion

of health care need. This was largely based on Bradshaw’s (30, 31) normative

approach to need, where a health care need exists when an assessor believes that

health care ought to be provided. The normative approach does consider finite

Needs in Health Care: What Beast is That? / 575

resources of the health system, with medical practitioners acting as gatekeepers

to treatment or services. The obvious flaw of this model, as discussed earlier,

is its paternalistic approach, particularly in the current era of patient-centered

care and the potential impact of conflicts of interest that can unduly influence

health care decisions.

The final concept that Liss (37) described was the instrumental notion of

health care need. In this interpretation, health care is needed for something: to

maintain or improve health or to reduce health risk. Need, therefore, is something

instrumental or teleological. The fact that there is a need, together with what is

needed, is related to reaching and satisfying a certain goal. That something

is required to realize that goal implies there is something deficient or lacking

because of disease or disability. Nguyen (47) and Windsor (48) noted there is a

gap between an actual state and a necessary level of health. Existence of this gap

is a necessary condition for need to occur. The notion of a gap also corresponds

with the notion of need being a disequilibrium or tension, as described by

Donabedian (40). The goal determines the thing that is needed, the object of need,

and health care needs are the medical interventions required for attaining health,

the goal (41). When this view of need is applied to health care, health care is

needed to reach a certain goal and the goal must first be defined. Boulding (38)

suggested that the goal of the health care system must be health. The practical

implication of the instrumental definition is that specific health goals must be

defined. This naturally leads to the concept of prioritizing which needs should

be addressed, given the limited resources available within the health sector. This

approach to need, therefore, has direct synergy with how health care systems

function today.

NEED: A PUBLIC HEALTH AND HEALTH

ECONOMIC PERSPECTIVE

Interestingly, many health economists avoid using the word need and view it

unfavorably. Mooney (49), for example, stated that need is an emotive word that

confuses and “stifles rational thought and debate.” Words such as wants, demands,

and preferences are used instead by health economists.

Within public health, health needs have also been defined as health losses,

similar to the concept described by Liss (37) as the ill health notion of need.

Identification of health needs is therefore reliant on construction of health profiles

of individuals or populations. Greater amount of ill health has been equated to

greater need (50, 51). Mallmann (52) used the ill health definition to consider

need as a generic requirement that everyone has in order not to be ill. While

the basis of the approach appears to stem from the notion that need is disequi-

librium (in this instance, ill health is the cause of the disequilibrium or tension),

it is perhaps an overly simplistic approach to defining health care need. First,

as already discussed, this view does not consider people’s health needs related to

576 / Harrison et al.

prevention or health promotion. Further, this view is limited as it does not provide

any guidance about what should be done by health service providers once a

health loss has been identified.

Therefore, need is often defined in a public health context as the capacity to

benefit from health care (53�58). Within this hypothesis, identification of health

needs alone is not sufficient (4). An effective intervention should also be made

available to meet these needs. Needs assessment is a process of both evaluating

problems and providing solutions for specific populations (59). A unique aspect

of this definition is that it requires discourse about what outcomes should be

considered beneficial and, importantly, by whom. Value judgments are therefore

intrinsic to this definition. This is potentially problematic, however, because

the capacity to benefit, in practice, is often decided by clinicians and policy-

makers whose values and judgments may be different from those of patients

and whose judgments may be conflicted. To compensate for disparities in values

between patients and clinicians, the capacity to benefit approach encourages

rigorous research to provide evidence-based data and to use these data to decide

which treatments and health service intervention are effective and which have

a capacity to benefit.

The capacity to benefit definition depends on the potential of effective pre-

ventive or treatment services to rectify existing or potential health problems.

An obvious criticism is that if an individual does not have the capacity to benefit,

then logically they are not in need. This assumption is incorrect. Culyer (45)

argued that people who will not benefit, or who have limited capacity to benefit,

are still in need. The need is for research to determine an effective strategy that

will result in a positive outcome. Other considerations of the capacity notion are

that in certain situations, the capacity to benefit is likely to be inversely related

to the severity of the patient’s health complaint (32). For example, there may

be a higher capacity to benefit from treatment for people with more serious

conditions, if an effective treatment exists, compared to people with a minor

complaint. This is because the original health state has greater morbidity, which

an effective intervention can reduce. What this interpretation of need does

achieve, however, is to force health care providers to assess a variety of ways

in which benefit can be achieved. For example, it shifts focus on outcomes such

as survival to other rubrics of quality of life.

Robinson and Elk (32) also considered it important, when defining need

through the capacity to benefit interpretation, to recognize that in some circum-

stances, capacity to benefit will depend on the effectiveness of the therapy, not

the severity of the health problem, which would determine the actual level of

need. Health economists such as Mooney (49, 50), while having a preference for

the capacity to benefit proposition over other definitions, are keen to point out

that within the finite resources of the health sector, the capacity to benefit will

always be larger than what can be provided. Health care needs must therefore

be ranked, prioritized, or rationed as in the supply definition of need.

Needs in Health Care: What Beast is That? / 577

In recognition of this, health needs have been further differentiated as needs,

demands, and supply. These ideas are not new and reflect hypotheses originally

proposed by Bradshaw (30, 31), as described previously. Spiegel (60) proposes

that the relationship between need and demand is at the heart of health planning.

More recently, however, these concepts have been explored to consider how they

interact with each other and their implications for health service delivery.

Two ways of conceptualizing the relationship between the constructs of need,

demands, and supply in relation to health care need are shown in Figures 2 and 3

(4, 39). McKee (58) and Stevens et al. (54�56, 61) considered that demand is

what people ask for and is an expression of their needs. Demand, they assert, is

typically controlled by clinicians, who traditionally are the gatekeepers to health

interventions and services. Supply is the health care interventions and services

that are available to provide the capacity to benefit. Demand is a state induced by

supply; for example, hospital admissions are likely to be more closely related to

the supply of hospital beds than to indicators of ill health. Supply, as previously

discussed, is also thought to be dependent on the interests of health professionals

and the availability of resources and subject to political pressure from government

and the media. An illustration of the overlapping nature of need, demand, and

supply and potential influences thereon is shown in Figure 2 (39). In comparison,

Wright et al. (4) consider health care need as a sequential process (Figure 3).

They provide a practical, process-driven interpretation of health care need in

which consumers’ decision to express, or demand, a need that they feel, or want,

results in action by a clinician to provide treatment. Arguments presented pre-

viously in this article regarding the potential problems associated with expressed

and felt needs remain relevant to Wright et al.’s (4) interpretation.

UNMET NEED

On closer observation of Wright et al.’s (4) model of need, two new concepts are

introduced: met need and unmet need. Met needs refer to circumstances in which

individuals or populations are supplied with adequate health care to meet their

health needs. In contrast, unmet need occurs in situations in which health care

services or support are either inadequate, inaccessible, or not in existence. Despite

the range of concepts, theories, and definitions of need, unmet need is relatively

more easily classified. Simply, unmet need occurs when a need, regardless of

how it has been identified, is not met. This notion of unmet need can be applied to

each of the theories of need that have been described and have been acknowledged

by various commentators, including Maslow (15) and Culyer (45). Unmet need,

however, has a specific application to health care, when need is considered either

a deficiency or gap between what is and what should be, or as a disturbance in

health and well-being. When these deficiencies or disturbances are not addressed

or satisfied, then an unmet need is defined as being present. From the capacity to

benefit perspective, unmet need can be conceptualized as a situation in which an

578 / Harrison et al.

individual or population has the potential to benefit from an intervention or

procedure, but for some reason, they are not able to benefit.

Originally, the concept of unmet need appears to derive from the gerontology

literature (62, 63). Mor et al. (62) conceptualized unmet need as a function of

both the physiological effects of disease and treatment and associated support

pressures. Specifically, measurement of unmet need in these instances was

based on health-related functional deficits, where a patient could not perform

or had difficulty performing tasks independently or did not have sufficient sup-

port from family or formal services to help them meet the need. This defini-

tion relies on an objective assessment of deficit. Foot (64) argued that this

approach does not take into account directly the issues that patients themselves

perceive as issues. The process of “perceptual needs assessments,” which Foot

(64) equated with the notion of felt needs described by Bradshaw (30, 31),

provides the opportunity for a more patient-centered, valid index of the support

services or programs that are required or would be used by individuals, groups,

Needs in Health Care: What Beast is That? / 579

Figure 2. The overlapping relationship between need, supply, and demand.

Source: Stevens et al. (39).

or populations. Foot (64) concluded that met needs are the “recognition of

adequate provision of assistance to enable resolution of problems and attainment

of goals,” with unmet needs defined as “problems for which people express

a requirement for assistance, out of recognition of existing resource deficits,

to enable problem resolution and attainment of goals.” Areas where there is

unmet need and where there is a requirement for patient-perceived assistance are

potential targets for health care intervention (65).

580 / Harrison et al.

Figure 3. The sequential relationship between need, demand, and supply.

Source: Wright et al. (4).

From a health system perspective, this dichotomy identified where support

deficiencies exist (unmet need) as well as where current service provision is

effective (met need). Specifically, this distinction determined where action is

potentially required to ensure the capacity to benefit is realized. Acknowledging

needs that are met is essential, because otherwise there is the potential of

redirecting services from a place where needs are successfully being met (66).

Unmet need has also been acknowledged in areas such as oncology, psychiatry,

and cardiovascular care (67�69).

It is important to consider that need and unmet need are conceptually distinct

and different. In terms of improving health service delivery and patient outcomes,

identification of need is limited in its scope, in that it only identifies a potential

problem. An individual may state that he or she has a need, but this identification

does not provide adequate information about whether that need has been met.

For example, there is an exhaustive body of literature that provides evidence

of a range of health care needs of people with cancer (70�74). Yet, while this

information can assist in health service development and, at a doctor-patient level,

can convey the types of issues patients would like addressed during consultations,

identification of need alone does not provide any information about whether

current service interventions are adequate in addressing and satisfying that need.

Furthermore, knowing that a person has a need does not necessarily mean that

a person requires an intervention. This has been shown by Steele and Fitch (75),

who found that for many needs identified by people with cancer, assistance was

not required. Therefore, measuring unmet need may have more direct relevance to

health service development. In terms of patient outcomes, unmet need identifies

areas where patient care is compromised and has the potential to negatively affect

patients’ well-being. Knowledge of unmet need can also provide information

about the perceived magnitude of needs, which can assist in prioritizing which

unmet needs should be addressed first and allow for better targeting of health and

support services (76).

CONCLUSION

In summary, need is defined in many ways, with differing implications for

health care service development. This critical review has described a variety of

definitions and theories of the concept of need and unmet need, drawing from

areas such as psychology, social policy, and health. It is important to consider

that many of these definitions provide general philosophical interpretations that

have limited application to health care delivery. However, components of these

theoretical definitions are still used within the health arena when conceptual-

izing need. An alternative interpretation is to view health care need in more

operational terms, which has greater practice implications for health services.

These approaches have a number of merits and limitations. This review presents,

collectively, a number of diverse perspectives on how the term need is considered.

Needs in Health Care: What Beast is That? / 581

These definitions can be used to operationalize the term “need” in practice,

theoretically drive needs assessment, and help guide health care decisions that

are based upon need.

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Direct reprint requests to:

James Harrison, Ph.D.

Senior Research Specialist

Division of Hospital Medicine

University of California–San Francisco

533 Parnassus Avenue, Box 0131

San Francisco, CA 94143

[email protected]

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/NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken die zijn geoptimaliseerd voor prepress-afdrukken van hoge kwaliteit. De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 5.0 en hoger.)
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the future of informed consent • spring 2018 145
The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)
DOI: 10.1177/1073110518766028

Researchers seeking to collect data through
“intervention or interaction” with living
human beings, through the use of their “iden-

tifiable private information,”1 or as part of “clinical
investigations”2 will typically find their work subject to
oversight by one or more Institutional Review Boards
(IRBs). IRBs are responsible under various federal
regulations, and often under institutional policies, to
oversee research with human participants funded by
U.S. government dollars or for submission to U.S. reg-
ulatory authorities; many other countries have similar
systems. IRBs review and have authority to approve,
require modifications to, or disapprove research activ-
ities.3 They are charged with ensuring that risks to
research participants are minimized and reasonable
in relation to anticipated benefits, selection of partici-
pants is equitable, informed consent is appropriately
obtained, data is appropriately monitored to protect
participants’ safety, and adequate provisions are in
place to protect participant privacy and confidential-
ity, among other criteria.4

Despite this hefty responsibility and its potential
impact on researchers, participants, and the public,5
IRB processes are largely ensconced in a black box —
conducted, as one author explained, “behind closed
doors.”6 Meetings are often closed, sometimes even
to the researcher whose protocol is under review, and
minutes are typically not disclosed other than to regu-
lators and accreditors.7 Decisions are provided to the

researcher and maintained in institutional records,
but are usually not published or otherwise shared;8
IRB members themselves may even find it difficult to
review prior board determinations and materials rel-
evant to their current decisions because the records
that are kept generally are not curated, indexed, or
easily-searchable by topic or type of issue raised. There
are few parameters demanding robust explanation of
IRB decisions, whether favorable or unfavorable, and
recent evidence suggests that IRBs frequently fail to
justify the stipulations they impose on research as a
condition of approval, often leaving ethical and regu-
latory concerns implicit.9 This opacity makes it diffi-
cult to assess how well reasoned (or not) board deter-
minations may be. While there have been studies of
IRB processes, including decision times, approval
rates, and other generalized statistics,10 nothing in the
regulations requires that IRBs transparently provide
such data, or conduct such analysis themselves.

Against this backdrop, there have been calls for
greater IRB transparency in the research ethics litera-
ture. However, they have been short on analysis and
often embedded in calls to establish a system of IRB
precedent to address inconsistency in IRB approaches
and outcomes.11 While transparency and precedent
are important and related concepts, they are distinct:
transparency will not automatically result in a system
of decision-making-by-precedent among IRBs or a
commitment to consistency, nor is transparency a nec-
essary prerequisite. Boards, or even individual mem-
bers, could share their decisions with no one else, but
still bind themselves (by policy or informally) to their
own prior determinations — and vice versa. That said,
as will be discussed below, transparency can facili-
tate consistency by exposing the rationales behind

Opening Closed Doors:
Promoting IRB Transparency
Holly Fernandez Lynch

Holly Fernandez Lynch, J.D., M.B.E., is the John Russell
Dickson, MD Presidential Assistant Professor of Medical
Ethics and Assistant Faculty Director of Online Education,
Department of Medical Ethics and Health Policy, Perelman
School of Medicine, University of Pennsylvania; Senior Fel-
low, Leonard Davis Institute of Health Economics, University
of Pennsylvania.

146 journal of law, medicine & ethics

INDEPENDENT

The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)

IRB decisions, both strong and weak, and promoting
learning from the experiences of others.

Transparency itself has received little direct atten-
tion in the IRB context, although its virtues have been
extolled in many other settings, from court decisions12
to allocation of health resources13 to clinical trial data14
to the FDA approval process.15 Is transparency an
independent good that we ought to demand of IRBs?
In this article, I argue that the answer is yes.

In what follows, I provide the first comprehen-
sive taxonomy of what transparency means (or could
mean) for IRBs; this descriptive enterprise is essen-
tial to assessing the ethical sufficiency of the status
quo and the proper scope of needed change. With that
conceptual foundation in place, I then describe cur-
rent regulatory requirements and practices, and pro-
vide arguments in favor of greater IRB transparency,
from the perspective of several different stakeholders.
In closing, I offer recommendations for improvement.

What Do We Mean By Transparency?
When thinking about IRB transparency, it is impor-
tant to be specific: transparency to whom, about what,
and by what mechanisms? Recognizing what it is not
— namely, a mandate to use or do anything with the
information obtained — is also helpful. In this regard,
transparency is best viewed as a means to other ends,
such as trust, efficiency, and quality, as explored below.

To Whom?
The most obvious type of transparency in the IRB con-
text refers to accessibility to and openness with inves-
tigators whose research protocols are under review, as
they are the individuals in closest contact with IRBs,
and whose work hangs in the balance. The same is
generally true of research sponsors, particularly those
with a financial interest in the research. Other stake-
holders also have a clear interest in IRB decisions and
decision-making, including the research participants
whose interests IRBs are charged with protecting

and the institutions hosting research studies who will
bear the legal brunt of any IRB shortcomings. IRBs at
other institutions may also have an interest in trans-
parency among their peer boards, because they are
engaged in collaborative research or because they are
interested in benchmarking behavior of other IRBs
as a learning exercise. Regulators, of course, need
to know what IRBs are doing and how well they are
doing it for compliance purposes, and the same is true
for voluntary IRB accreditors, such as the Association
for the Accreditation of Human Research Protection
Programs (AAHRPP).

The public in general also has a claim to transpar-
ency on a variety of grounds. IRBs are often deciding
whether and how publicly-funded research may pro-
ceed, they are overseeing compliance with public laws
and regulations, and they may play an important role
in promoting public trust in the research enterprise
(to the extent the public knows they exist). Sometimes,

they are situated within public institutions (e.g., pub-
lic universities) subject to government transparency
requirements. And they may be approving research
that the public will be affected by, and may even con-
sider participating in, a potentially distinct role from
protecting individuals who are already enrolled as
participants.

A final stakeholder group is comprised of research-
ers who wish to study IRBs, analyzing for example
how they are composed, how members engage with
one another, how they make decisions and set policy,
what hurdles they face, how they might be affected by
certain types of reform, and a variety of other impor-
tant questions. As others have recognized, the trans-
parency needed to conduct such research has tradi-
tionally been lacking,16 but is sorely needed.17

About What?
Each of these stakeholders may have a desire (or
need) for transparency regarding different aspects of
IRB operations and outcomes. At a foundational level,

In what follows, I provide the first comprehensive taxonomy of what
transparency means (or could mean) for IRBs; this descriptive enterprise

is essential to assessing the ethical sufficiency of the status quo and the
proper scope of needed change. With that conceptual foundation in place,
I then describe current regulatory requirements and practices, and provide

arguments in favor of greater IRB transparency, from the perspective of several
different stakeholders. In closing, I offer recommendations for improvement.

Lynch

the future of informed consent • spring 2018 147
The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)

transparency as to the source of IRB authority, whether
regulations, agency guidance, or institutional policy,
as well as transparency — or education — about the
historical ethical rationale for IRBs, can help enhance
the perceived legitimacy of board actions, while mini-
mizing perceptions of arbitrary or senseless imposi-
tion of burden.18 Indeed, at least some complaints that
get leveled at IRBs seem upon closer examination to
be complaints about the regulations they are charged
with administering.

Beyond this, investigators need transparency about
IRB determinations regarding their protocols, which
they receive via approvals, disapprovals, and requests
for modifications. In addition to bare determinations
as to whether or not research can proceed, however, it
is helpful to have transparency about various under-
lying determinations as well, for example, the IRB’s
assessment regarding a protocol’s risk level and its
ratio of benefit to risk, on what grounds it agreed to
waive informed consent, which exemption category a
study was deemed to fall under, and why certain pay-
ment amounts were accepted or rejected. Knowing
how and why decisions were reached can be impor-
tant for compliance purposes, crafting amendments,
and designing future research such that it will be
approved as expeditiously as possible. This may come
in the form of conversations with the IRB chair or
administrative staff, for example, or in written form
such as a determination letter, although the level of
detail provided can vary substantially — and in some
cases, no detail is provided at all.19

Investigators, institutions, and regulators are not
the only ones with an interest in this information, as
noted above, but at present, it is typically not accessible
to others. Indeed, the more extensive details regarding
rationale may be inaccessible beyond the IRB itself. It
is important to note here that information about IRB
approvals and deferrals (outright disapprovals are
exceedingly rare) can be equally valuable. Both pro-
vide insight into the IRB’s overarching philosophy, its
interpretation of relevant regulations, how it is likely
to behave in the future, what should be emulated or
avoided, and potentially what should be protested and
changed. In fact, shedding light on IRB deferrals can
be particularly important since, unlike protocols that
are approved and proceed, deferred proposals will not
be available as a teaching tool unless active steps are
taken. In this regard, there are strong analogies to
arguments for transparency of all clinical trial results,
both positive and negative.20

In addition to the outcome and basis for IRB deter-
minations regarding specific protocols, transparency
regarding IRB procedures and policies is also impor-
tant. Investigators need to know what to submit, to

whom, about what, and by when. They also need to
understand how IRBs are interpreting various regu-
latory requirements that leave them with substantial
discretion, as well as any institutional policies that may
exceed what regulations require. It is in no one’s inter-
est to hide the ball on these matters — IRBs want and
need investigators to comply. That said, IRBs vary in
the extent to which they facilitate investigators’ proto-
col development and submissions, with the best (and
typically most well-funded and institutionally-sup-
ported) boards providing easy-to-navigate websites,
training sessions, and the like. While some IRBs have a
robust library of formal policies covering a wide range
of circumstances, it is also often the case that there will
be informal policies that have developed over time,21
which can be difficult to track, circulate, and under-
stand. In some contexts, decisions may be “driven by
tacit, unwritten practices that are neither standardized
nor subjected to adequate critical scrutiny.”22 There is
also wide variability as to whether written IRB policies
and procedures are available on an institution’s public
website — thereby available for all to see, learn from,
and analyze — or whether they are made available only
via password within an institution or available only
to IRB members and staff (and those responsible for
institutional or regulatory oversight). IRB policies pro-
vide an important mechanism for institutions to learn
from one another and potentially avoid unnecessarily
reinventing the wheel,23 and may also be of interest to
research participants and others.

Finally, IRBs may have and maintain a variety of
information about their own work, for example how
many protocols they review, on what timeline, and
of what nature. They may have built search func-
tions and other data analysis components into their
protocol submission templates and review software.
And they may generally have mechanisms in place for
self-assessment, quality improvement, and the like.
Ideally, IRBs will analyze the data across these vari-
ous parameters on a systematic basis, use it to adjust
their own approaches, and publish it for the benefit of
others. This is not technically within the IRB’s regula-
tory purview, however, and many boards may simply
lack adequate resources to conduct these additional
activities. Nonetheless, transparency about these
details — whether the analysis is done by IRBs them-
selves or the data is simply shared for analysis by oth-
ers — is critically important to permit ongoing assess-
ment of the current IRB system and evidence-based
policymaking.

By What Mechanisms?
In terms of the mechanisms of IRB transparency, this
can be achieved in a variety of ways depending on the

148 journal of law, medicine & ethics

INDEPENDENT

The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)

goal to be achieved and stakeholder of interest. Some
information may be provided verbally, for example
through informal conversation between investiga-
tors and IRB staff or responses to questions raised
by research participants via phone call to the contact
person listed on research consent forms. While bet-
ter than nothing, in general, written communication
is preferable for transparency purposes, creating a
record that can be referred to later and shared with
others. Another mechanism might be to open IRB
meetings, either a little bit — at least to the team of
investigators whose protocol is under review (as some
IRBs already do) — or a lot — to any investigator at the
institution, to other IRBs, to researchers interested in
studying IRBs, to potential or current participants, or
to members of the public more generally. Alternatively
or in addition, IRBs might share their meeting min-
utes with any of these stakeholders (ideally, with suffi-
cient detail to understand what actually transpired at
the IRB meeting),24 perhaps upon request or even as
a matter of course. And similarly, IRBs could choose
to make their determinations available beyond the
affected investigator, ideally including robust ratio-
nales. As with IRB policies, this information could be
shared only within an institution or via an open-access
public website, with a range of options in between. Of
course, in any of these scenarios, appropriate confi-
dentiality requirements would need to be established,
as discussed below.

Current Regulatory Requirements
So far, we can see that IRB transparency is a broad
concept, encompassing a range of stakeholders, types
of information, and mechanisms of disclosure. But
what must IRBs actually do when it comes to trans-
parency? At present, not very much.

The Declaration of Helsinki provides that IRBs
(“research ethics committees”) “must be transparent
in [their] functioning,”25 and the Council for Interna-
tional Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Health-related
Research Involving Humans states that IRBs must
conduct reviews “according to clear and transparent
procedures.”26 Both of these sources offer aspirational
principles, rather than regulatory requirements, and
not much specificity regarding the transparency par-
ticulars described above.

With regard to U.S. regulatory requirements, the
Federal Policy for the Protection of Human Subjects
(the “Common Rule”), which governs most research
conducted or supported by federal agencies, and reg-
ulations for research under the purview of the Food
and Drug Administration (FDA) do offer a bit more
specificity, although still leaving wide latitude for
IRBs. IRBs are required to have (but not necessarily
publish or share) a variety of written procedures for
review and oversight of research, including policies
for “reporting its findings and actions to the investi-
gator and the institution.”27 Beyond policies, the regu-
lations require IRBs to “notify investigators and the
institution in writing of its decision to approve or dis-
approve the proposed research activity, or of modifica-
tions required to secure IRB approval of the research
activity. If the IRB decides to disapprove a research
activity, it shall include in its written notification a
statement of the reasons for its decision and give the
investigator an opportunity to respond in person or in
writing.”28 Similarly, in the event an IRB suspends or
terminates a protocol’s approval, it must provide the
“investigator, appropriate institutional officials, and
the department or agency head” with a statement of
reasons.29

Transparency to whom About what By what mechanisms

• Investigators
• Sponsors
• Research participants
• Research institution
• Other IRBs
• Regulators
• The public
• Researchers of IRBs

• Source of authority
• Protocol approvals, disapprovals,

requests for modification (and
rationale)

• Specific regulatory determinations (and
rationale)

• Deliberations
• Correspondence
• Policies
• Board statistics/data

• Verbal communication
• Written communication
• Open IRB meetings
• Accessible meeting minutes
• Accessible IRB determinations
• Accessible IRB websites and training

tools

Figure 1
Defining IRB Transparency Parameters

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There are a few important points to distill from
these regulations. First, the regulations require that
IRBs provide a statement of reasons — a rationale
— for their decisions only when they are disapprov-
ing research or suspending or terminating their prior
approval. When IRBs approve a protocol, however,
they must simply report the decision, without refer-
ence to reasons. As between the two, it certainly makes
sense to provide a justification when IRBs preclude a
study from proceeding, so that investigators can make
appropriate changes to strengthen the protocol or
clarify and resolve elements of misunderstanding or
concern. But importantly, IRBs rarely flat out disap-
prove a protocol, and instead frequently defer a deci-
sion until amendments are made. The regulations do
not appear to account for this possibility. Moreover,
providing clear reasons need not be a zero sum game.
Explaining a rationale for disapproving a protocol in
no way impedes an IRB’s ability to provide
a similar explanation in the context of pro-
tocol approvals; reasons are not a scarce
resource to be allocated judiciously. Even
when the IRB’s decision is favorable, inves-
tigators and others can learn from the IRB’s
reasons; what did it find convincing and
why did it deem the relevant criteria to be
satisfied? As noted above, both sides of the
coin are important.

A second point is that the regulations
provide no hint as to what might count as
an adequate statement of reasons, when
one is required. Is it necessary or sufficient
to simply point to the regulatory provisions not satis-
fied by a protocol, or must the statement of reasons
be more fleshed out to explain why those regulatory
sections or institutional policies preclude approval?
Unfortunately, examination of regulatory guidance
and agency enforcement letters sheds no light on the
parameters of this requirement. Third, and related,
although IRB determinations must be provided in
writing, the regulations do not specify their scope or
content more precisely. Ultimately, the regulations
require transparency about the bare outcome of the
IRB’s deliberation in all cases and transparency about
the IRB’s rationale in some cases. However, even that
required transparency is limited at most to the inves-
tigator, institution, and regulators.

By comparison, sharing IRB meeting minutes could
generate more substantial transparency. By regula-
tion, minutes must be “in sufficient detail to show…
actions taken by the IRB; the vote on these actions
including the number of members voting for, against,
and abstaining; the basis for requiring changes in
or disapproving research; and a written summary of

the discussion of controverted issues and their reso-
lution.”30 Regulatory guidance further specifies that
meeting minutes include documentation of findings,
“including protocol-specific information justifying
each IRB finding,” regarding specific regulatory pro-
visions governing consent waiver and documentation
and research with special populations.31 Although
regulatory guidance acknowledges that IRB minutes
are intended to “provide information to persons not
present at the meeting (e.g., investigators, institu-
tional officials, regulators, IRB members who could
not attend),”32 meeting minutes are not required to
be shared with anyone, including the investigator.
Instead, they must simply be maintained with IRB
records and made available for review by regulators.

To summarize, the bottom line is that “IRBs are
rarely required to explain or justify their decisions.”33
Investigators must be given some information, insti-

tutions and regulators have full access (to the extent
that IRBs record their rationales), but everyone else
can be left in the dark.

Current IRB Practice
In terms of what happens in practice, there is wide vari-
ety in what IRBs communicate to whom and how, with
some IRBs much more open and transparent (beyond
the regulatory requirements) than others. At the front
end, some IRBs provide substantial outreach and edu-
cation to help investigators understand what IRBs are
looking for and how to avoid common mistakes, both
in general and as to specific protocols.34 This requires
resources, however — personnel, time, and money.
As Professor Robert Klitzman has explained in his
work on IRBs, the “time demands of such enhanced
IRB availability can necessitate difficult tradeoffs, and
cause tensions. IRB chairs and administrators can
become overwhelmed, and need to weigh the advan-
tages of open doors vs. limited resources.”35

In many cases, IRB “deliberations are conducted
behind closed doors, and minutes of meetings are

To summarize, the bottom line is that “IRBs
are rarely required to explain or justify their
decisions.” Investigators must be given some
information, institutions and regulators have
full access (to the extent that IRBs record
their rationales), but everyone else can be left
in the dark.

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made available to outsiders only under limited circum-
stances…the process is both insular and secretive.”36
Little is known about the issues that IRBs “consider
important to their decisions or about the substance of
IRB deliberations.”37 Specific reviewers of any given
protocol may not be identified (even if board rosters
are available), which can have the salutary effects of
reducing conflicts and protecting reviewers from
institutional retaliation by investigators, but can also
make reviewers less accountable. On the other hand,
some IRBs invite investigators and others to attend
their meetings. Typically, however, they are asked to

provide information and answer questions, and then
to leave before deliberation and discussion begin.38

Beyond deliberations, decisions themselves are
generally kept private, shared only with the particu-
lar investigators whose research is affected. How IRBs
communicate their decisions to investigators is also
variable. Some IRBs write “lengthy memos to [princi-
pal investigators] in response to submitted protocols,
assisting these PIs in rewriting studies,” and some
try to point out the specific regulations and ethical
principles behind their decisions.39 But again, this is
resource-intensive, and not all IRBs choose (or can
choose) to take this approach. Indeed, many do not.40

While there are no systematic mechanisms in
place for IRBs to learn laterally from one another’s
processes, deliberations, and determinations, some
information is shared at conferences, through train-
ings, and in journals aimed at IRB professionals.41
Networks have also developed for sharing resources
through email listservs and other informal approaches
that are often used to crowdsource responses to
IRB challenges, including policy development, how
to approach unusual studies, and the like. As new
requirements for single IRB review of multisite stud-
ies take effect,42 increased sharing will be necessary
between boards (or at least between the institutional
human research protection programs of which boards
are a part), and novel approaches are currently being

developed. For example, IRBShare is a collaborative
review model and electronic sharing resource that
allows institutions to share documents and data used
in review decisions, including minutes, protocols, and
approved consent documents.43

Ultimately, we lack empirical data about actual lev-
els of IRB transparency across different parameters,
which would itself be informative. But what we know is
that the regulations are permissive of relative nontrans-
parency, which is also common in practice. Typically,
IRBs are not writing opinions justifying their actions,
meeting minutes cover little of substance (especially

when a protocol is approved),44 and entire swaths of
stakeholders may be unable to access key information.

A Push for IRB Transparency
Is this status quo ideal — or even minimally accept-
able? I think not. For some reason, despite their simi-
larities to judicial and administrative decision-makers
(i.e., making binding decisions about specific cases
and policies for general application, both of which
impact not only particular parties but a wide range of
stakeholders), IRBs have developed in such a way that
nontransparency has become the default rule, even
while at least some substantive level of transparency
is expected in these other contexts. But I suggest that
rather than having to justify why IRB transparency is
the preferable approach, nontransparency ought to
be permitted only with good, explicit reason. Given
the benefits of transparency described below, and the
protections that can be put in place to avoid potential
negative consequences, the present level of IRB non-
transparency is unacceptable — and good reasons for
nontransparency in particular contexts are likely to be
few and far between.

General Benefits of Transparency
Consider, for example, the litigation system and court
decisions, agency rule-making through notice-and-
comment processes, and agency review decisions,

Ultimately, we lack empirical data about actual levels of IRB transparency
across different parameters, which would itself be informative. But what we

know is that the regulations are permissive of relative nontransparency,
which is also common in practice. Typically, IRBs are not writing opinions

justifying their actions, meeting minutes cover little of substance
(especially when a protocol is approved), and entire swaths of

stakeholders may be unable to access key information.

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such as those made by FDA in approving new medical
products. All entail processes that are more transpar-
ent than IRB oversight of research, and have in com-
mon not only analysis of applicable issues and argu-
ments, but also detailed written evaluations that are
made available to the public beyond the immediate
parties at issue to explain the outcome and rationale.
This forces development of articulable and defensi-
ble reasons, helps to provide a foundation for future
analyses (and potentially for a system of precedent),
and facilitates external oversight.45 These are each
important generalized benefits of a transparent sys-
tem of decision-making, which the current IRB sys-
tem fails to capitalize on. By contrast, when decisions
are not made transparently, there is not only a lack of
accountability, but also the possibility of confusion
and uncertainty for affected parties, inconsistency
between decision makers, ad hoc decision-making
and poor reasoning, and even abuse of power (or at
least not much to prevent it).46 These are each risks
facing IRBs. There are also more specific justifications
for transparency to particular stakeholders.

Benefits of Transparency to the Public
Beyond these baseline considerations in favor of trans-
parency, it is important to recognize the impact of IRB
decisions on the public. As noted above, IRBs have the
power to allow research to proceed on the basis of their
determination of compliance with federal regulations,
or to withhold approval when — in their estimation
— applicable requirements are not met. Given this
gatekeeping authority, IRBs can play a critical role in
promoting scientific advancement, for example facili-
tating and speeding the approval of useful research.
Conversely, however, they can stand in the way and
slow things down, beyond the appropriate impedi-
ment of scientifically or ethically unsound projects.
Both approaches have real implications for the public,
such that it is appropriate for the public to demand
to be given access to understand the how and why of
IRB determinations — just as they have an interest
in understanding the behavior of other gatekeepers,
from FDA and the Patent and Trademark Office to
government research funders and others. This allows
the public to gauge whether the gatekeeper is striking
the right balance and promoting the right priorities,
and to call for change where needed. Relatedly, given
that much of what IRBs review is government-funded
research, the public has an interest in understanding
the impact of IRB review on their tax dollars, and is
aggrieved by being shut out of the process.

There is also one more way in which the public
has an interest in IRB transparency, and that has to
do with the public’s interest in the transparency of

government entities. The Department of Health and
Human Services has never taken the position that
IRBs are themselves arms of the government, absent
some other factor, even though their existence is man-
dated by regulation and despite their role in overseeing
research according to regulatory terms.47 Nonetheless,
some IRBs are located within government agencies or
are part of public universities, and as such could be
subject to a full slate of transparency responsibilities
under federal and state laws.48 These might include
open meeting requirements,49 records requests under
freedom of information acts,50 notice-and-comment
rulemaking under various administrative laws,51 eth-
ics and conflict of interest rules, and the like.52 In light
of the quasi-governmental impact of IRBs as regula-
tory gatekeepers, it may be reasonable to extend these
public transparency features often expected of govern-
ment agencies to IRBs more generally.

Benefits of Transparency to Investigators
Investigators have a more direct interest in IRB trans-
parency, on at least two grounds. First, there is some
indication that the present lack of transparency, real
or perceived, can lead investigators to distrust IRBs,
or even to “demonize” them.53 This can result in a vari-
ety of problems, ranging from failure to engage IRBs
about research questions early on to rejection of the
resources that IRBs may make available to facilitate
research compliance to dismissal of the IRB process as
illegitimate, which in the extreme may spur disrespect
of ethical rules. If investigators are helped to under-
stand the goals of IRBs, why certain questions are
asked, on what grounds modifications are requested,
the ways in which IRBs can help support research,
timelines for review, IRB processes, and the like, this
can avoid misunderstandings, assuage feelings of arbi-
trariness and powerlessness, and improve investigator
trust in IRBs.54 This is even more likely if IRBs can
transparently demonstrate to investigators that they
are being treated fairly and consistently in relation to
other investigators and projects. There are numerous
“horror stories” about IRBs, but transparency on all
these fronts can help separate fact from myth, and with
regard to fact, can offer explanation of why certain IRB
actions have been taken. Ultimately, transparency
should improve the essential relationship between
IRBs and investigators, and facilitate weeding out IRB
activities that are irrational or overly conservative.

The second basis for investigator interest in IRB
transparency is simple efficiency. When investiga-
tors are uncertain why the IRB is imposing various
requirements or reaching particular outcomes, they
are obviously in a poor position to submit approv-
able protocols from the start or to make appropriate

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adjustments, particularly in light of IRB discretion in
interpreting and implementing the relevant regula-
tions. Similarly, when investigators are unclear as to
how previous protocols have fared (and why), they
may undertake unnecessarily duplicative work, for
example justifying methods that the IRB may already
be familiar or comfortable with, tracking down new
approaches that the IRB might have already decided
to be problematic, or developing mechanisms for
things like recruitment, informed consent, results
return, or confidentiality protection that the IRB
might be able to offer guidance on given prior experi-
ence, saving investigators valuable time and effort. In
short, “[w]ell-considered, thoughtful reviews could…
serve as exemplars and educational tools.”55

Relatedly, to the extent that investigators fear that
IRBs will slow down their research or behave conser-
vatively,56 likely rooted in the “horror stories” noted
above, they may self-censor what they submit for
review in hopes of getting approval as quickly and
painlessly as possible. While substantial empirical evi-
dence of such behavior is lacking, anecdotal evidence
is abundant.57 In so doing, investigators may some-
times make unnecessary sacrifices via wrong guesses
about how their IRB is likely to behave. For example,
investigators may fail to adopt a more scientifically
appropriate study design, a speedier mechanism of
recruitment, a fairer approach to paying participants
out of concern that their IRB would not approve. If,
rather than guessing, investigators had a better sense
of what really would impede IRB approval, and what
would not, such detrimental self-censoring could be
minimized or avoided.

Benefits of Transparency to IRBs
These efficiency concerns are also relevant in support
of IRB transparency in relation to other IRBs, as well
as systems to promote transparency within IRBs over
time, i.e., preservation of institutional memory via
easily accessible and searchable records of prior deci-
sions. As Professor Carl Coleman has explained, fail-
ure to work together to share information and insight
results in a scenario in which “IRBs are regularly chal-
lenged by issues of first impression — not necessarily
issues that are new to the world of research, but issues
that have never previously come before the particular
IRB.”58 When IRBs are unable to learn from each other
(and themselves), at the very least in terms of identi-
fying relevant considerations and offering guideposts
for their own decisions, the research enterprise suf-
fers; resources may be wasted and research slowed.

A related concern is that a lack of transparency
between IRBs, including failure to share policies,
determination letters, and meeting minutes, for exam-

ple, can contribute to variability between them. Shar-
ing these materials and rationales will not automati-
cally lead to consistency — courts do not necessarily
reach the same outcome simply because they have
access to the decisions rendered in other jurisdictions
(to which they are not bound by precedent) — but it
can help minimize thoughtless or ill-conceived varia-
tion.59 This is not to suggest that IRBs should blindly
“go with the crowd” once it becomes apparent what
others are doing.60 Sometimes, independent judgment
will be needed, and just as there may be majority and
minority rules in different legal jurisdictions, it may
be that there is no obvious “right” answer when it
comes to certain issues raised before IRBs, even with
transparency. The key is to have sufficient grounding
to know whether differences are considered and pur-
poseful, and to avoid accidental difference simply out
of ignorance to the behavior and decisions of peers. In
this way, transparency can help lay the foundation for
a system of IRB precedent, formally or informally,61 or
at the very least generation of best practices.

The self-reflection that is likely to arise from trans-
parency between IRBs may also help IRBs overcome
unnecessary conservatism and fears that may be asso-
ciated with risking “first mover” status in approving
something unfamiliar.62 On the other hand, transpar-
ency might cause IRBs to discover that they have been
more progressive than their peers, potentially result-
ing in increased conservativism in some instances.

Benefits of Transparency to Research Participants
When considering the benefits of IRB transparency,
we cannot overlook a primary beneficiary: research
participants. While participants would indirectly ben-
efit from the various advantages already described,
transparency regarding IRB processes and standards
could have a more direct impact on participant trust.
Given that participants may not be aware that IRBs
even exist at present, or that they exist to help protect
participant interests, or that the entire research enter-
prise is heavily regulated in a way that is skewed dra-
matically toward participant protection, disclosure of
these features and education regarding the IRB’s role
may be an untapped resource to promote participant
recruitment and retention. IRBs are sometimes con-
cerned about language being included in informed
consent materials indicating explicitly that a study has
been IRB approved, on the grounds that this could
appear to be an endorsement or encouragement to par-
ticipate.63 But helping participants understand why an
IRB found the regulatory criteria to be satisfied could
reasonably be relevant to the decision whether to par-
ticipate.64 And in the event that an IRB determines the
regulatory criteria have not been satisfied, this may be

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relevant to patient communities who stand to benefit
from research, who may help provide the IRB with
additional information or help researchers address
IRB concerns, for example.65 Other than potential
information overload, which can be addressed and
avoided, there seems to be little downside to greater
transparency with research participants regarding the
IRB process and outcomes. Empirical study of this
question would be valuable.

Additional Benefits
There are at least two additional benefits to IRB
transparency that span a variety of stakeholders. First,
under the status quo of nontransparency, it is difficult
to hold IRBs accountable for their decisions. This is
most obviously because many stakeholders may sim-
ply not know what IRBs are doing, and therefore may
not know to object, appeal, or push for change. But
at a more subtle level, when IRB materials are not
shared or available, and in particular, when IRB deci-
sions are not presented in written form with analy-
sis, IRBs can more easily fall back on “gut feelings”
or intuition.66 In an alternate scenario in which IRB
activities are made accessible to others, IRBs are more
likely to be compelled to articulate reasons and pro-
vide precise (or any) justifications for their decisions.
And when reasons are provided, they can be assessed,
analyzed, critiqued, praised, adjusted, and the like.67
Moreover, the process of articulating reasons may
cause IRBs to reassess their own views; perhaps they
are less well-supported than initially “felt,” and alter-
native approaches are warranted.68 Ultimately, IRB
transparency should improve the quality of IRB deci-
sions, just as publication of judicial decisions has been
correlated with higher quality.69

A second benefit of IRB transparency is that trans-
parent decisions, policies, and practices can be studied
empirically. Empirical evaluation of IRBs is essential,
given the resources devoted and impact on scientific
advancement, and important work has been done
already.70 But this sort of work can be challenging,
with important limitations, for example relying on
IRBs to voluntarily provide information, which some
may deny, or relying on investigators to pass along
their correspondence, which maybe incomplete. More
robust analysis via greater IRB transparency will pro-
vide important insights into the bases for IRB deci-
sions (e.g., regulations, institutional policy, ethical
principles, etc.); areas of focus (e.g., informed consent,
trial design issues, privacy, etc.); goals (e.g., partici-
pant protection, institutional liability avoidance, etc.);
consistency (e.g., within and between IRBs); and over-
all approaches (e.g., helpful or detached). It will allow
assessment of whether IRBs are being too conserva-
tive, too permissive, too bureaucratic, too conflicted,
too resource-intensive — and what they are doing
well, adding value to the research enterprise and par-
ticipant protection. Evidence-based policymaking, in
turn, will allow the IRB system to focus its energies on
areas where it can be most effective.

Objections and Responses
In light of all these benefits of IRB transparency, why
has greater transparency not yet been adopted —
what are the downsides? One key concern has to do
with confidentiality.71 IRBs are reviewing protocols
that may contain sensitive information, including
commercially valuable information about new prod-
ucts or even the investigator’s trial design and study
description. In a world of lucrative drugs and devices,
in which even a few months difference can result in

General To the public To investigators To IRBs To participants

• Accountability
• Defensible reasons
• Clarity and

certainty
• Foundation for

precedent — or
justification of
inconsistency

• Empirical study

• Check on
gate-keepers

• Interest in publicly-
funded research

• Open government

• Trust in IRBs
• Use of IRBs as a

resource
• Dispel myths
• Avoid unnecessary

self-censoring
• Efficient protocol

development

• Efficiency
(not reinventing
the wheel)

• Avoid
inappropriate
variation

• Self-reflection

• Trust in research
enterprise

• Challenge IRB
protectionism,
as needed

Figure 2
Benefits of IRB Transparency

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significant market advantage, and in the realm of aca-
demic research, in which investigators’ careers hinge
on publications and funding awards, the inclination
to wall-off commercial and intellectual competitors is
understandable.72

While this rationale may suggest caution with regard
to who is allowed to attend IRB meetings (which
could at least partially be addressed via confidential-
ity agreements), there is a relatively simple solution
when it comes to IRB minutes and decisions: redact
them. This is precisely what FDA does when releas-
ing the materials supporting its decisions to approve
new drug applications. Any member of the public is
able to download robust portfolios from the [email protected]
FDA website, including correspondence between
sponsors and the agency, scientific analyses, and deci-
sion memos; certain information may be redacted,
but enough remains to allow stakeholders to better
understand the agency’s rationale, the issues at stake,
and how they were resolved. Granted, this compari-
son may not be apples to apples with the IRB context
— for example, once FDA grants approval, the spon-

sor may be protected by various marketing exclusivi-
ties, rendering competition less worrisome, and FDA
does not publish the same information about applica-
tions that were denied (although perhaps it should).73
Nevertheless, court decisions often deal with various
types of sensitive information, and redaction or selec-
tive inclusion is possible in those contexts. Similarly,
IRB decisions can be written in such a way to focus
on rationales and outcomes without necessarily shar-
ing information that is best kept confidential.74 More-
over, this sort of confidentiality concern is no reason
not to be more transparent about IRB policies, rather
than protocol-specific decisions, nor is it a reason not
to be entirely forthcoming and direct with investiga-
tors themselves about the IRB’s decision and rationale
related to their own submissions.

There are other potential confidentiality concerns,
for example when IRBs are reviewing politically sen-
sitive research, such as that involving abortion, but
those special cases should not be allowed to wag the
dog, nor is it necessarily the case that fear of backlash is
adequate reason to avoid transparency. And there may
be another type of free-rider concern beyond issues
related to competition between sponsors or investiga-
tors, which is that if some IRBs are more transparent
than others, they will bear the burdens while others
learn from them without reciprocal benefits.75 The
answer to that concern, though, is not to avoid trans-
parency, but rather to make it more universal.

It is possible that greater IRB transparency could
have a range of unintended consequences. As noted
above, perhaps IRBs would become even more con-
servative if they fear that their activities will be sub-
ject to outside scrutiny or if they discover that their
board is not as conservative as others, or perhaps
the candor of IRB deliberations would be negatively
affected on a more transparent approach.76 IRBs may
actually be inclined to document and disclose less if

they fear opening themselves up to litigation.77 And it
is also possible that increased transparency will result
in more “IRB shopping” by sponsors and investigators
seeking the most lenient boards.

These are reasonable worries, but they need not be
insurmountable. First, given the general benefits of
IRB transparency described above, possible bad out-
comes seem inadequate to support the status quo. In
particular, with regard to litigation, there have been
relatively few lawsuits stemming from research stud-
ies,78 and there is so much discretion in the applicable
regulations that IRBs likely need not worry so long as
they are behaving reasonably. Moreover, transparency
can even help build an IRB “standard of care” based
on what others are and have been doing in similar
contexts. Second, these are empirical questions: we
could pilot test different approaches to transparency

Probably the most important argument against IRB transparency is not that
transparency itself is undesirable, but rather that it is costly. Many IRBs are

already woefully under-resourced, so asking them to write out and share robust
determinations and policies is an added burden, which could ultimately result

in delay. Nonetheless, if this is the argument against transparency, there are
even greater concerns — namely that IRBs are inadequately resourced to even
render justifiable determinations in the first place. Clearly, this cannot stand.

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to see how they work and what impact they have,
before accepting the status quo of nontransparency.
And third, it is also possible that IRB transparency
will have the salutary effect of facilitating more liberal
approaches as IRBs see others adopting creative solu-
tions to facilitate research. Most likely, transparency
would facilitate some “regression to the mean,” with
comparably conservative IRBs becoming less so as
they gain insight into the approaches taken by other
boards, and vice versa for some comparably liberal
IRBs, which would minimize any concerns about IRB
shopping. Since transparency is distinct from prec-
edent, however, justifiable differences in approach
could stand, so long as adequate care is taken to avoid
inflexible “groupthink.”

Probably the most important argument against IRB
transparency is not that transparency itself is undesir-
able, but rather that it is costly. Many IRBs are already
woefully under-resourced,79 so asking them to write
out and share robust determinations and policies is an
added burden, which could ultimately result in delay.
Nonetheless, if this is the argument against transpar-
ency, there are even greater concerns — namely that
IRBs are inadequately resourced to even render jus-
tifiable determinations in the first place. Clearly, this
cannot stand.

Resolving the IRB resource problem is beyond the
scope of this article, but one possibility is to include
IRB costs in grant awards and contracts as a line
item akin to a user fee, rather than as generalized
“overhead” or “indirects,” to help ensure that funds
are directed to this specific purpose. User fees raise
ethical concerns of their own,80 but IRB services are
not costless and the fee-for-service model is precisely
that utilized by external IRBs not affiliated with any
research institution and run as for-profit businesses.
These IRBs pride themselves on customer service and
efficiency, and being adequately resourced is part of
how they are able to deliver. With appropriate protec-
tion against conflict of interest, IRB user fees may be
a part of the solution, as some institutions have rec-
ognized, at least for industry-sponsored research.81 It
is also possible that new requirements for single-IRB
review of multi-site research will lead to certain effi-
ciency gains and more resources for reviewing IRBs.
Finally, note that some types of IRB transparency will
be less costly than others, such as making existing pol-
icies more freely available, such that cost cannot be an
unqualified defense of nontransparency in all cases.

To the extent that time is itself a resource, a related
worry is that if one goal of transparency is to allow
IRBs to learn from each other, IRBs need to have
time to review the cases that came before, as well as
some mechanism for sorting and searching them.

The technological issues associated with developing a
repository of decisions or policies need not be insur-
mountable, but adding more work to reviewers’ plates
is indeed a challenge. This might be addressed by rely-
ing more heavily on IRB staff and administrators to
help find and summarize relevant materials. Bioeth-
ics researchers interested in IRB issues can also help
distill key points of learning from their own empirical
analyses, which can be provided to IRBs through vari-
ous training and continuing education opportunities.

Recommendations and Conclusions
While it is certainly not the case across the board, the
default rule — permitted by the regulations governing
IRBs and demonstrated by the practices of many —
has been for IRBs to be closed-door, relatively secre-
tive bodies, making determinations with substantial
impact on a wide variety of stakeholders without
robust explanation, justification, or transparency. This
default ought to change, in line with other trends in
favor of transparency in the research enterprise, such
as sharing clinical trial data, posting results to clini-
caltrials.gov, and under the revised Common Rule,
sharing clinical trial consent forms. Importantly,
IRB transparency would be complementary — but
not redundant — to these other approaches because
it can provide key insight about IRB standards and
rationales, distinct from information about the sci-
entific validity and reliability of research findings and
the quality of information provided to research par-
ticipants. Given the clear benefits of IRB transpar-
ency in terms of accountability, consistency, trust,
and efficiency, the question is not whether to push for
improved transparency or why, but rather how and
along which parameters.

One option is regulatory change. The regulations
could, for example, impose more specificity with
regard to IRB minutes, set expectations in favor of
open meetings, flesh out the requirements for the
content of determination letters (both approvals and
rejections, perhaps offering templates or checklists
to encourage reason-giving and covering the regula-
tory criteria for IRB approval), and specify that these
materials be shared beyond institutional and regula-
tory audits. Regulatory change is procedurally diffi-
cult, but regulatory agencies could nonetheless offer
guidance to this effect. Regulators could also make
selected real-world cases available for training and
guidance, facilitate research on IRB decision-mak-
ing, and conduct their own analyses of trends and
approaches demonstrated by the records they have
exclusive access to in order to develop best practices.

IRBs (including board members and staff of institu-
tional human research protection programs) can also

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voluntarily accept the responsibility to promote trans-
parency, and in many ways have begun to so, as noted
above, through investigator-oriented websites to help
facilitate understanding of goals and processes, as well
as listservs, conferences, journals, and other venues to
share information between themselves.82 Note, how-
ever, that individuals likely face institutional restric-
tions and confidentiality requirements, such that they
may not be able to promote transparency without
institutional support and permission.

Even if IRBs fail to embrace transparency, however,
investigators could drive a movement themselves.
Although they cannot force IRBs to be more trans-
parent in the materials shared with them, investiga-
tors can commit to sharing the materials they do have
access to, for example publishing decision letters, shar-
ing protocols as they looked before and after the IRB
process, and the like. Indeed, one such initiative has
already launched in New Zealand, where “The Ethics
Application Repository” (TEAR) serves as a voluntary
digital archive of IRB applications and related materi-
als in which researchers from any institution around
the world can post their IRB’s requested changes and
ultimate decisions.83 The hope is that both researchers
and IRBs will learn from what came before. As Profes-
sor Laura Stark explains, this approach gives investiga-
tors “the opportunity to participate in creating a solu-
tion to the problem they rightly criticize.”84 Journals
may also have a role to play, perhaps by demanding that
approved study protocols and IRB correspondence be
made publicly accessible as a condition of publication.85

No one ought to prefer a black box system in which
the relevant stakeholders lack access to information
that can improve efficiency, quality, and accountabil-
ity. The nontransparent IRB system we have at pres-
ent is likely not the one that we would have selected
by conscious design, and so we ought to design a new
one — one that supports transparency about a wide
range of IRB activity to the wide range of stakehold-
ers who stand to be affected. Clearly transparency is
not all-or-nothing, but rather exists on a spectrum —
and the same is true for solutions to nontransparency.
We can begin with stepwise progress, first addressing
low-hanging fruit like thin explanation of IRB actions
to investigators and closed-door IRB meetings, while
working steadily toward the goal of full transparency
in this endeavor with such high stakes.

Note
The author has no conflicts to declare.

Acknowledgements
The views reflected in this article are only my own, and should not
be attributed to any organization with which I am affiliated. Thank
you to Mark Satta (Harvard Law School) for excellent research
assistance, and to Laura Odwazny, Emily Largent, and I. Glenn
Cohen for insightful comments. A version of this article will be
published as a chapter in Transparency in Health and Health Care,
Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Bar-
bara Evans, eds. (Cambridge University Press 2018, forthcoming).

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tions were published to update the “Common Rule.” 82 Fed.
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cle, citations will be provided both to the current regulatory
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2. 21 C.F.R. 50.3(c) (2016). The FDA regulations have not yet
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3. 45 C.F.R. 46.109(a) (2016)(2018); 21 C.F.R. 56.109(a) (2016).
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14. See Institute of Medicine, “Sharing Clinical Trial Data:
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15. See “FDA Transparency Initiative Overview,” available at
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16. Bozeman et al., supra note 11, at 1554 (“A frequent problem in
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legal protections (privacy, confidentiality) or simply because
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17. Abbott and Grady, supra note 10, at 8. See also S. Nicholls
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18. Clapp, Gleason, and Joffe, supra note 9.
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20. See, e.g., K. L. Hudson and F. Collins, “Sharing and Report-

ing the Results of Clinical Trials,” JAMA 313, no. 4 (2015):
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21. See, e.g., N. Dickert, E. Emanuel, and C. Grady, “Paying
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of Internal Medicine 136, no. 5 (2002): 368-373 (noting that
31/32 research organizations analyzed had rules of thumb
about paying research participants, compared to 12 with writ-
ten policies).

22. S. G. Henry, P. S. Romano, and M. Yarborough, “Building
Trust Between Institutional Review Boards and Researchers,”
Journal of General Internal Medicine 31, no. 9 (2016): 987-
989, at 987.

23. Abbott and Grady, supra note 10, at 7.
24. U.S. Department of Health and Human Services, Office of

Human Research Protections (OHRP) and Food and Drug
Administration (FDA), “Minutes of Institutional Review
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September 2017, available at <https://www.hhs.gov/ohrp/
minutes-institutional-review-board-irb-meetings-guidance-
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25. World Medical Association, “Declaration of Helsinki: Ethical
Principles for Medical Research Involving Human Subjects,”
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26. Council for International Organizations of Medical Sciences
(CIOMS), “International Ethical Guidelines for Health-
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27. 45 C.F.R. 46.103(b)(4) (2016), 46.108(a)(3)(i) (2018); 21
C.F.R. 56.108(a)(1).

28. 45 C.F.R. 46.109(d) (2016) (2018); 21 C.F.R. 56.109(e). In
the context of emergency research proposed to be conducted
without prospective consent, the FDA regulations further
provide that when an IRB determines that it cannot approve
a trial because it fails to meet the applicable criteria for such
emergency research or because it has other ethical concerns,
“the IRB must document its findings and provide these find-
ings promptly in writing to the clinical investigator and to the
sponsor of the clinical investigation.” Additionally, the spon-
sor (not the IRB) must provide this information to FDA, as
well as to all other of its investigators working on the same

or similar trials, and to all other IRBs reviewing its trials. 21
C.F.R. 50.24(e).

29. 45 C.F.R. 46.113 (2016) (2018); 21 C.F.R. 56.113.
30. 45 C.F.R. 46.115(a)(2) (2016) (2018); 21 C.F.R. 56.115.
31. Office for Human Research Protections, “Guidance: Written

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32. OHRP/FDA, supra note 24.
33. C.H. Coleman, “Rationalizing Risk Assessment in Human

Subject Research,” Arizona Law Review 46, no. 1 (2004):
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34. S.T. Fiske, “Institutional Review Boards: From Bane to Ben-
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30-31, at 31.

35. R. Klitzman, “From Anonymity to ‘Open Doors’: IRB
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36. Coleman, supra note 33, at 14. See also Stark, supra note 6;
Katz, supra note 11, at 800; Klitzman, supra note 11.

37. Abbott and Grady, supra note 10, at 6.
38. Klitzman, supra note 35.
39. Id.
40. Clapp, Gleason, and Joffe, supra note 9
41. Coleman, supra note 33, at 15, 50.
42. 82 Fed. Reg. at 7208-09 (2017).
43. Mascette et al., supra note 11.
44. Coleman, supra note 33, at 14, 40.
45. Id., at 41-43.
46. See, e.g., K. Swenson, “Federal District Court Judges and the

Decision to Publish,” Justice System Journal 25, no. 2 (2004):
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age: Reflections on the Debate over Unpublished Decisions,”
Washington & Lee Law Review 62, no. 4 (2005): 1667-1708,
at 1676-1681.

47. L. Odwazny, HHS Office of General Counsel, personal
communication.

48. In Maryland, IRBs must make final meeting minutes avail-
able for inspection within 30 days of receipt of a request from
any party, although they are permitted to redact confidential
or privileged information. Md. Code, Health §13–2003, avail-
able at <http://mgaleg.maryland.gov/2017rs/statute_google/
ghg/13-2003.pdf> (last visited May 27, 2017).

49. See, e.g., Federal Advisory Committee Act.
50. See, e.g., Freedom of Information Act.
51. See, e.g., Administrative Procedure Act.
52. This would also bolster arguments in favor of due process in

IRB approval.
53. Klitzman, supra note 35.
54. Id.; McMurphy et al., supra note 11; Dove et al., supra note

11; Henry et al., supra note 22.
55. Mascette et al., supra note 11. See also Katz, supra note 11, at

806; Tolich and Tumilty, supra note 11, at 202-203.
56. See, e.g., S. N. Whitney et al., “Principal Investigator Views of

the IRB System,” International Journal of Medical Sciences 5,
no. 2 (2008): 68-72.

57. See, e.g., J. Kempner, J.F. Merz, and C.L. Bosk, “Forbidden
Knowledge: Public Controversy and the Production of Non-
knowledge,” Sociological Forum 26, no. 3 (2011): 475-500, at
487.

58. Coleman, supra note 33, at 15. See also Halavais, supra note
11, at 175.

59. Studies demonstrate the desire for more IRB efficiency and
less IRB variation. Abbott and Grady, supra note 10, at 6.

60. According to Condorcet’s Jury Theorem, the fact that many
decision makers have taken a particular approach is only an
indication of the “truth” of that approach if (1) the individ-
ual decision makers are more likely than not to hold a true
opinion, and (2) the decision makers form their opinions
independently from one another. In that case, the more deci-
sion makers that have taken the approach, the more likely it
is to be true. In contrast, if the individual decision makers

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are more likely than not to hold a false opinion, adding more
decision makers has the opposite effect, making the group’s
likelihood of being right approach zero. See A. Goldman and
T. Blanchard, “Social Epistemology,” The Stanford Encyclope-
dia of Philosophy (2016), available at <https://plato.stanford.
edu/archives/win2016/entries/epistemology-social/> (last vis-
ited May 27, 2017). This theorem may have important impli-
cations for the utility of single versus multiple IRB review,
which are beyond the scope of this article.

61. Dove et al., supra note 6, at 39-40.
62. Stark, supra note 11, at 183.
63. See, e.g., “Duke University Health System Human Research

Protection System, Policy Statement Regarding the IRB
Approval Stamp on Consent Forms,” August 2015, avail-
able at <https://irb.duhs.duke.edu/sites/irb.duhs.duke.edu/
files/IRB%20Approval%20Stamp%20on%20Consent%20
Forms%208-19-2015.pdf> (last visited May 27, 2017).

64. This information need not be provided as a matter of course
in informed consent materials, which are already too lengthy.
But it could be provided in a link to more information, for
example, for participants who are interested in learning more.

65. L. Stark, “Gaps in Medical Research Ethics,” LA Times, Octo-
ber 8, 2010 (calling on the regulators to “empower research
participants by posting the results of ethics reviews online.”).

66. Dove et al. supra note 6, at 12; Coleman, supra note 33, at 14.
67. Katz, supra note 11, at 798 (2007)(noting, in the context of

the morality of law, that decision makers should articulate
reasons that can be reviewed publicly).

68. “The discipline of providing written reasons…often will show
weaknesses or inconsistencies in the intended decision that
may compel a change in the rationale or even in the ultimate
result.” W.L. Reynolds and W.M. Richman, “An Evaluation of
Limited Publication in the United States Courts of Appeals:
The Price of Reform,” University of Chicago Law Review 48
(1981): 573-631, at 603.

69. Id., at 598-604 (demonstrating that a large fraction of unpub-
lished judicial opinions failed to satisfy basic standards of
quality, such as providing a rationale for the judgment).

70. See Abbott and Grady, supra note 10.
71. Ashcroft and Pfeffer argue persuasively that secrecy in the

context of research ethics review cannot be justified. See
R. Ashcroft and N. Pfeffer, “Ethics Behind Closed Doors:
Do Research Ethics Committees Need Secrecy?” BMJ 322
(2001): 1294-96.

72. Stark, supra note 11, at 182; Coleman, supra note 33, at 14, n.
84.

73. See S. Gottlieb, “Other Voices: Do No Harm,” Barron’s 82, no.
24 (2002): 36.

74. See Klitzman, supra note 11 (suggesting that IRBs “post
examples, with details redacted, of the types of concerns
they have had about issues that arise in various protocols.”).
Another option might be delayed publication of IRB “cases”
so that they are available for reference later on, at some point
when confidentiality may be less important.

75. Stark, supra note 11, at 183.
76. Coleman, supra note 33, at 14, n. 84.
77. Id., at 15, n. 90.
78. In the early 2000s, there was a flurry of clinical trials litiga-

tion, including suits naming IRBs and individual members,
much of which was spearheaded by a single attorney, Alan
Milstein. See S. Silverstein, “Clinical Trial Litigation,” avail-
able at <https://www.sskrplaw.com/clinical-trial-litigation.
html> (last visited May 27, 2017). This raised some concern at
the time that research litigation would become an increasing
threat (see M. M. Mello, D. M. Studdert, and T. A. Brennan,
“The Rise of Litigation in Human Subjects Research,” Annals
of Internal Medicine 139, no.1 (2003): 40-45), but that does
not seem to have been borne out. Research litigation does
happen, but for a variety of reasons including lack of a pri-
vate right of action in the applicable regulations, is relatively
infrequent.

79. C. Grady, “Institutional Review Boards: Purpose and Chal-
lenges,” Chest 148, no. 5 (2015): 1148-1155, at 1150-1151.

80. J. Avorn, “Paying for Drug Approvals — Who’s Using Whom?,”
New England Journal of Medicine 356 (2007): 1697-1700.

81. See, e.g., “Fees for JHM IRB Review,” Johns Hopkins Medi-
cine Office of Human Subjects Research Institutional Review
Board (2013), available at, <http://www.hopkinsmedicine.
org/institutional_review_board/about/fees.html> (last visited
May 27. 2017).

82. Z. Schrag, “A Plea for ‘Networked Learning,’” Institutional
Review Blog, June 26, 2010, available at <http://www.insti-
tutionalreviewblog.com/2010/06/plea-for-networked-learn-
ing.html> (last visited May 27, 2017).

83. Tolich and Tumilty, supra note 11. Another approach would
be to create a website that would allow researchers to pub-
licly report their problematic experiences with IRBs and how
they were resolved, if at all. M. M. Feeley, “Legality, Social
Research, and the Challenge of Institutional Review Boards,”
Law & Society Review 41, no. 4 (2007): 757-776, at 766.

84. Stark, supra note 11, at 182.
85. Halavais, supra note 11, at 175.

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