Below is a memo I wrote for a class. Much of the way I characterize some of it was influenced by Rebecca Dressers book When Science Offers Salvation, as well as my experience working to create the position of disability representative for the IRB at Duke University Health System (and where I still serve as the disability representative).
It is my opinion that bioethics is a form of science policy (it fits in my taxonomy idea). I'm sure others might disagree, but that's part of the fun of discussion!
Problem
Institutional Review Boards (IRB’s) are tasked with protecting the rights of human subjects in research. They are expected to abide by a litany of federal regulations, international declarations, and align the research with the sentiments of the community. They accomplish this through a committee decision-making process that brings stakeholders and knowledgeable scientists together in one place.
One particular voice is not heard in this process; the voice of the disability community. The federal regulations should include specific provisions requiring a disability representative be included in the constitution of an IRB for all research that is performed on a disabled population.
Background
It is estimated that one in every five people in the United States are disabled, and our last census showed that 50 million Americans claimed to be disabled.(1,2) This segment of our population is very heterogeneous. It crosses boundaries of race, gender, culture, background, sensitivities, morals, values, and level of education. A corollary with the large percentage of people that have disabilities would be that by the numbers an appreciable percentage will participate in biomedical research. This percentage, though no studies specifically have been done, is likely larger than that of the non-disabled populations.
This might be attributed to research protocols underway that need to be tested on those people who have a specific disease or disorder, many of which would allow the individual to self identify as disabled under definitions used in the Americans with Disabilities Act (ADA), and the definitions of disability used by the United Nations.(3)
The main themes for the disability community are inclusion and representation, as well as protection from discrimination. In the last 30+ years we have seen the creation of the Rehabilitation Act of 1973, the ADA in 1990, and the IDEA in 1997. The passing of these acts demonstrates another feature of the disability community, that the community is very vocal.(4)
Disability representatives are charged with representing this varied constituency. With respect to human subject research; the expertise these advocates bring is background knowledge of these many acts and laws that most people are unaware of the specifics about. Disability representatives provide insight into how to best meet the regulations and foster a more collaborative environment between the research enterprise and the disability community in order to more effectively develop research plans.
One very simple example would be making available large print, or Braille consent forms to participants in a study that specifically recruits blind or visually impaired subjects. Another example would be providing readers and other trained individuals to read consent forms to those with disabilities.
An ideal disability representative, displaying the following qualities, would be an immense help to IRB’s: (5)
1. Knowledgeable of the ethics of research with human subjects.
2. Knowledgeable of the underlying science.
3. Accurately and realistically portray information about research.
4. Pays attention to and connected to all the disability community.
5. Is prepared to / capable of addressing a wide variety of outcomes that disabled individuals face.
6. Appreciates the diversity of the disability community.
7. Avoids narrowness in seeking policy or public health change.
8. Avoids haste and oversimplification of the present state and the proposed direction of research.
9. Adopts conflict of interest guidelines in order to prevent an undermining of their position
10. Can direct individuals to useful materials, and warn them of misleading material.
11. Scrutinizes and helps set standards for reporting and media coverage about research.
In terms of our present policies, disability representatives meet criteria for inclusion as IRB members (6) : It is also noteworthy to relate that these guidelines are resonated in CIOMS, and the Common Rule, amongst others.
21 Code of Federal Regulations. 56.107
Subpart B—Organization and Personnel
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution . . . including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
(c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Altnernatives
1. Amend the Code of Federal Regulations to specifically denote the requirement of disability representatives on IRB’s similar to how prisoner representatives are included to protect that vulnerable population.
2. Create a guidance document from the Office of Human Research Protections (OHRP) at the National Institute of Health (NIH) concerning the review of research directly recruiting a disabled population.
Analysis
Since they are closely tied to the disability community, and are knowledgeable about their concerns, fears, attitudes and values; disability representatives are capable of representing the participant community. Their insight can augment the risk/benefit calculus by providing a perspective on what factors are weighted and to what extent they influence prospective participants. Thus, they would have valuable insight in the planning and implementation of a research protocol.(7)
While one may combat this with the argument that disability representatives may be overly enthusiastic about research, overemphasizing benefits, fostering therapeutic misconception, and at times narrow in their thinking; that risk is minimized by finding members who display the positive qualities previously noted.(8)
One might also argue that the inclusion of community members already in IRB’s would provide the same benefits, and would remove many of the possible drawbacks of having a representative specifically for disabled individuals. I do not find this to be compelling because public views in IRB’s are often subdued on account of four main reasons. These are; (1) a lack of technical expertise, (2) they are vastly outnumbered, (3) they are appointed by the institution and (4) they lack a formal role in the process.(9) Disability representatives, however, are in the unique position to be able to combat these points.
One of the strengths of including disability representatives on IRB’s is enforcement and implementation of procedures that comply with the ADA and the Rehab Act of 1973. These representatives could serve as a check on the rest of the research enterprise, ensuring that the types of rampant abuse of research participants that pop up does not continue.(10)
An example of where disability representatives could have helped to prevent such abuse is what happened at the Leben Home for Adults in Elmhurst, N.Y. In January of 1998, twenty-four men with mental disorders were made to sign consent forms allowing doctors to perform surgery for an enlarged prostate. Many of these patients were not even conclusively diagnosed with the problem (11). It is this type of breakdown of the review process and standard procedures, combined with neglecting valuable input from the disability community that causes these types of abuses.
Alternative 1
In section (a) of 21 CFR 56.107 Subpart B, disability representatives are especially qualified to address these considerations based on their close ties to the disability community. In section (c) a disability representative meets this since many are not primarily interested in science, and have backgrounds and professional positions elsewhere.
The pertinent sections of (d) and (f) respectively are truly where disability representatives can make their entry points. Most are not involved with the institutions as in part (d), and they provide the type of expertise that is spoken to in part (f).
Based on the criteria set out by the FDA, there is no reason to exclude disability representatives from IRB’s. We can extend this by mandating inclusion of a disability representative on IRB’s. Inclusion of a disability representative on an IRB would also serve as an ADA compliance check, given the familiarity they would have with that act.
Alternative 2
The Office of Human Research Protections produces guidance documents for IRB’s on a regular basis. These are intended to clarify the federal regulations and provide additional insight into how these regulations might be best applied by IRB’s on a day-to-day basis.
Changes in federal regulations regarding human subject research protections will most certainly benefit from providing this additional guidance documentation. However, should it be improbable that alternative 1 occur; this alternative could have the same affect.
Many IRB’s follow, to the letter, guidance documentation from OHRP. In this sense, any guidance that recommend including disability representatives on IRB’s and explain the roles and contributions that they can provide will likely be followed as if it was a change in the federal regulations.
Recommendatios
The need for disability representatives on IRB’s is there; now we must change our policies and guidelines to incorporate them in an appropriate manner. This means changing the federal regulations that we looked at before to include a minimum of one disability representative on each IRB and creating guidance documents from OHRP.
REFERENCES:
1 Private communication with Andy Imparato. President American Association of People with Disabilities (AAPD).
2 An estimated 17.3 million self-reported disabled persons per the 2000 US Census, which doesn’t take into account unemployed or other qualified groups based on ADA or UN definitons. US Disability Statistics, Cornell University. http://www.ilr.cornell.edu/edi/disabilitystatistics/census.cfm
3 Kaplan, Deborah. The Definition of Disability. The Center for an Accessible Society. http://www.accessiblesociety.org/topics/demographics-identity/dkaplanpaper.htm
4 Shapiro, Joseph. No Pity: People with Disabilities Forging a New Civil Rights Movement. © 1993 Three Rivers Press. New York, N.Y. pg 104-141
5 Dresser, Rebecca. When Science Offers Salvation. © 2001 Oxford University Press. New York. N.Y. (while not specifically stated, many of the criteria listed were inspired by this text, specifically pg 153-172)
6 FDA regulations obtained from Sugarman, J. Ethics of Research With Human Subjects. © 1998 University Publishing Group. Frederick, M.D. pg 91-92.
7 Dresser, R. pg 124
8 Dresser, R. pg 157
9 Beauchamp, T.L. & Childress, J.F. Principles of Biomedical Ethics , Oxford University Press, 5th ed. 2001.
10 Dresser, R. pg 111-128
11 Levy, C.J. ‘Inquiry finds mentally ill patients endured ‘assembly line’ surgery.’ New York Times. New York, N.Y. March 18th, 2001.