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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS

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Suggested Citation:"NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 73
Suggested Citation:"NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 74

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STANDARDS FOR ACCREDITATION 73 NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS Recommendation 8: Directly Involve Research Participants in Accreditation Programs and HRPPPs The formulation of accreditation standards, the accreditation process, and HRPPP operations should directly involve research participants.3 Current regulations lay a foundation for and even invite stronger involvement of those representing the interests of those participating in research. Yet, some “noninstitutional” members of IRBs have little experience as participants in research; they may be independent of the institution, but it does not follow that they represent the perspective of research participants. The regulations are necessarily nonspecific about the involvement of research participants in the review process and set a low standard for qualification. When HRPPPs are regularly judging the benefits and risks of studies that involve particular populations, there should be evidence that the review process directly involved those who genuinely understand and represent the perspective of those populations. This requirement could be incorporated into accreditation standards. Practices regarding membership on data safety and monitoring boards (DSMBs) are even more diverse. The only stipulated expertise on DSMBs is technical: a clinician familiar with the medical aspects and a statistician familiar with data analysis. In instances in which they attend explicitly to safety and the ethical conduct of research, DSMBs are more apt to include a bioethicist or a lawyer than someone who brings the perspective of research participants. Accreditation standards—and even more so, the guidance documents that accompany them by giving examples of good practices—can improve the HRPPP system to ensure stronger representation of the interests of the research participants. Given the primacy of the concepts of autonomy in research ethics and the training of IRB members, the relative lack of attention to standards and measures that would systematically cultivate these concepts in both the PRIM&R and NCQA proposed standards is somewhat surprising (see the discussion in the What's Missing section below). Several measures can be taken to bolster these concepts to improve the ethical conduct of research involving human participants. IRBs, DSMBs, research design teams, and merit review committees should increase their level of attention to the involvement of research participants or those who genuinely represent participants' perspectives in the design, selection, review, and monitoring of research involving human participants. In 3 By “participants,” the committee refers to those whose background and expertise are credible to a lay constituency external to the research institution and who are knowledgeable about the research process and research protections. The term is further defined in Chapter 1.

STANDARDS FOR ACCREDITATION 74 addition to including more research participants in the review and oversight process, standards could require institutions to engage in additional activities to improve the process for research participant involvement in the system. Institutions that conduct research can create ombudsman programs, particularly for studies that may cause confusion among participants or that entail significant risks. The ombudsman can receive information that participants have about the studies in which they are involved (or in which they are contemplating participation). The same mechanism can be used by research staff or other employees of the research institution who may be uncomfortable with how a study is being conducted, if confidentiality is ensured and anti-retaliation policies are clear (and credible) for prospective whistle blowers. IRBs can ensure safe, confidential, and reliable channels for the reporting of problems. The channels either can be linked to ombudsman programs or can be independent of them (e.g., having assigned staff and formal policies to encourage such reporting). Investigators (or IRBs) can test whether participants' consent is well informed by empirically testing it and following up when necessary. Several methods have been studied and reported in the scant empirical literature on research ethics (Sugarman, 2000). One method is to use consent monitors—that is, staff who interview participants after the participants have given their consent to participate in a study to see if they understood the study, the risks and potential benefits, and their ability to leave the study at any time. This option is expensive and time-consuming and cannot be routine, but it could be used for particularly confusing or risky studies and could be done as a general sampling technique or research strategy to guide IRBs about the research that they review. Likewise, consumer organizations can address the need for informed participant involvement by training representatives to participate directly in the design, review, and monitoring of research.4 Private organizations of citizens have long been a potent force in U.S. research policy. Hundreds of private voluntary health organizations are directly involved in advocacy for health research, and they often play decisive roles in decisions about research budgets and priorities, which is perhaps their best-known function. Their concerns do not stop at funding, however, but extend to the ethical conduct of research not only to encourage high-quality research to meet participants' health needs but also to protect the perspective of their constituents. Where the infrastructure already exists, HRPPPs merely need to solicit input more systematically and ensure that consumer groups are well represented on IRBs, DSMBs, and other design and oversight bodies. The constituencies for 4 The National Breast Cancer Coalition, for example, has Project LEAD (Leadership, Education and Advocacy Development) that trains advocates to serve on research review and advisory panels, and the National Alliance for the Mentally Ill has a program that trains members to serve on IRBs.

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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