FOOTNOTES February 2001
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IOM Hears Concerns About Human Subjects’ Protection

by Angela L. Sharpe, Associate Director for Government Affairs, Consortium of Social Science Associations

Federal and non-federal organizations continue to examine the issue of human research participants protection. On January 22, the Institute of Medicine’s (IOM) Committee on Assessing the System for Protecting Human Research Subjects held a public forum to gather information for its assessment of the system for protecting human research participants. The Committee heard the various perspectives (institutional, participant, and investigator) of those conducting research involving humans.

Representatives from the Department of Health and Human Services (Office of Human Research Protections, Centers for Disease Control and Prevention, and the Food and Drug Administration), the National Science Foundation, and the Veterans’ Administration also provided testimony. Opening the meeting, Chair Daniel Federman (Dean for Alumni Relations and Clinical Teachings, Harvard) emphasized that the committee will “deliberate thoroughly” before writing its draft report and that no conclusions or recommendations by the Committee would be made at the meeting.

Several individuals offered perspectives regarding the difficult and challenging problem of how to accommodate the social and behavioral sciences in a system based on a model created to deal with biomedical and clinical research.

Felice Levine, Executive Committee member of the Consortium of Social Science Associations (COSSA) and Executive Officer of the American Sociological Association (ASA), addressed the Committee on behalf of COSSA and from the perspective of researchers. Levine informed the Committee that most of the professional associations within COSSA have developed ethical guidelines for researchers to follow in conducting their research, particularly where human participants are part of the research design. She emphasized, however, that there was considerable concern about the “growing fault lines in the system that protects human participants and the gap that has developed between law and policy ‘on the books’ and ‘in action.’” For example, said Levine, researchers utilizing secondary data are being asked to seek approval by Institutional Review Boards (IRBs) to use these data even though the information is anonymous and the subjects are already protected under earlier protocols.

Commenting on proposed standards for accreditation of institutions’ human research protection plans, she noted that they provide further evidence of the inherent problem with the current system. If these standards are intended to be universal and to fit all research involving human participants, she said, they need to be framed in a way that meaningfully includes all research fields.

In addressing the Committee, Levine framed the concerns of the social and behavioral science community into ten recommendations. Written testimony from COSSA and ASA will provide specific illustrations of where the social and behavioral science community thinks that accreditation standards are problematic for achieving the proposed goals and where they are specifically problematic for the social and behavioral science community.

1. Seize the Moment for Effective Leadership on Behalf of all Science. The IOM has the opportunity to provide guidance on an accreditation system and a human research participant protection system that effectively reaches all areas of research and effectively serves all Federal funding agencies engaged in the support of such research—not just the biomedical sciences.

2. Slow the Process Down Sufficiently to Ensure Quality Decisions. There is virtue in moving ahead, but there is also virtue to slowing the process down enough to ensure that the standards are meaningful for all science. If the standards for accreditation are to be more effective than the current process for obtaining assurances of compliance under the Common Rule, then the two important IOM studies (concerning the overall structure and function of human participant activities, including IRBs, and criteria for evaluating the performance of human subject protection activities) yet to be undertaken should logically proceed before crafting and finalizing accreditation standards (a message echoed by several participants).

3. Ensure the Fit. The proposed accreditation standards integrate many pieces of the Common Rule but use these regulations in a different context, often coupled with other ideas. The disjuncture between the Common Rule and accreditation standards needs careful scrutiny and analysis.

4. Know the Devil is in the Details. The proposed standards are not couched in the language of any one science or arena of research per se, but when coupled with the commentary, are biomedical and heavily clinical. Accordingly, they pay only lip service to other substantive arenas of work; this is especially problematic for the social and behavioral sciences. If the commentary will be presented, its role needs to be clear and the examples across areas of research specified.

5. Keep Judgments of Best Ethical Practices Distinct from Judgments about the Quality of the Research. The proposed accreditation standards overreach to what constitutes quality science and do not sufficiently distinguish between these judgments and what constitutes ethical practices in science. The standards shift from the criteria for the accreditation of Institutional Review Boards to the assessment of the research and the researcher.

6. Assure Clarity, Simplicity, and Transparency; These Attributes are Fundamental to Accreditation Standards of Excellence. Many of the standards require judgments that are impossible to make. The standards should not tell an institution how it should achieve its goals, but should set forth what the standards or goals are.

7. Strengthen the Educative Role of the Standards Themselves. The proposed standards, especially the commentary, provide little in the way of education, particularly with regard to the social and behavioral sciences.

8. Safeguard the Human Research Protection System by Ensuring That It Does Not Overreach Its Role and Stays on Task. The human research protection system needs to ensure that research proceeds and knowledge is advanced in accordance with the highest standards of ethical practice with respect to human participant protection. The system needs to ensure that work that comports to ethical standards is facilitated and not impeded by the process.

9. Assure That the Accreditation Standards Clarify What the Scope of the Human Protection System Is and Is Not. Human research participants refer to actual participation in a study underway or being proposed. The analysis, for example, of public-use data where information is maintained in anonymous form and without personal identifiers is research about people but not on people.

10. Focus on the Ethical Considerations Regarding Human Research Participants in Various Types of Research. The answer to the concerns in the social and behavioral sciences is not necessarily to create a dual human research protection system, but to ensure a system that is more sophisticated about ethical practices across fields of science. Social and behavioral research is increasingly interdisciplinary within these fields and across other arenas, especially biomedical, environmental, and engineering fields. Separation of the review by field could create redundancy and limit researchers mutually benefit ing from the ethical expertise of each other.

Levine emphasized that COSSA believes this guidance can help structure the next round of revisions for a final set of “testable” accreditation standards. COSSA, the social and behavioral science societies, as well as many, many top quality researchers behind us, are eager to help in any way that we can, Levine concluded.

Comments from Federal Agencies

Several of the agencies that are part of the “Common Rule” offered insight from their agency. The Department of Health and Human Services (HHS) considers accreditation the cornerstone of overall improvement of the human participant system, stated Irene Stith-Coleman, Public Health Advisor to the Assistant Secretary of Health and the Surgeon General. Her comments were made on behalf of the agency and Office of Human Research Protections (OHRP) Director Greg Koski. The Department envisions a system of objective, uniform, nationally-recognized standards that provide the basis of accreditation, she stressed. The two-year IOM study, requested by OHRP, is designed to realize this system.

According to the Centers for Disease Control and Prevention (CDC) Deputy Associate Director for Science John R. Livengood, there are three areas of concern for the CDC: (1) diversity of IRBs; (2) ownership of the standards; and (3) plans for implementation. While the CDC agrees with the overall process, the agency asks the Committee to be sensitive to the entire range of IRBs. The CDC, said Livengood, believes that it is “important to strengthen the IRBs.” Further, CDC encourages the Committee to realize there are other IRBs, “other than those associated with medicine.” To narrow the focus on the biomedical models may create unintended consequences, stressed Livengood, noting that the CDC works with many partners. With regard to the ownership of the standards, Livengood emphasized that the copyrighted standards “strike the wrong tone.” He noted that for implementation purposes, any final standards must be adaptable to different situations.

Philip Rubin, Director of the Behavioral and Cognitive Sciences Division at the National Science Foundation, expressed concern with the proposed standards and their impact on the social and behavioral sciences. Rubin warned the Committee that the draft standards have the potential to cause harm if a different kind of expertise is needed on IRBs, other than biomedical and clinical. He highlighted the fact that interdisciplinary research is a priority throughout the sciences and the federal research agencies. Rubin further stressed that the federal government also collects data (e.g., Panel Study of Income Dynamics, housing, education, and medical care) and that the proposed standards could be detrimental to the federal government’s ability to collect that data. Finally, Rubin reminded the Committee that it has an opportunity to be responsive to the needs of the social and behavioral sciences, emphasizing that the current standards are not.

Stephen Erickson, Director of the Office of Research Administration at Boston University, informed the Committee that his University was rapidly becoming more research intensive, overwhelmingly behavioral in nature. Erickson made several observations regarding the proposed standards:

  • The standards appear to have been drafted with large academic biomedical and clinical programs in mind.
  • The standards are so detailed as to impede flexibility.
  • To participate in a voluntary accreditation process places additional administrative costs and burdens on institutions.
  • Benefits to participating need to be made clearer. Benefits should outweigh the costs of participating.
  • There is a need to incorporate a statement describing the accreditation process. Two core questions need addressing in the review/redraft of the standards: (1) Will the standards assist different sizes of institutions to better fulfill their mission?; and (2) Do the standards facilitate the work of IRBs, institutions, and researchers?

Next Steps

Written comments (to be considered in deliberations) on the proposed standards (which have not been endorsed by the committee) needed to be received by the IOM by February 2, 2001. IOM is on a fast track in addressing accreditation standards and is expected to report by April 1 on this phase of its work. The draft standards can be found on the IOM website at: www.iom.edu/IOM/IOMHome.nsf/Pages/human+research+protections. Levine’s written testimony submitted on behalf of COSSA and ASA is posted on both websites. Interested ASA members can find this statement at www.asanet.org.