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

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STANDARDS FOR ACCREDITATION 64 ICH-GCP represents an “international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects” (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, p. 1). In addition to being widely accepted in the clinical trials community, the ICH-GCP standards are recognized by the Office for Human Research Protections (OHRP) and included within the Food and Drug Administration (FDA) guidance document for clinical trials. Although these are guidelines for investigators and research sponsors conducting or supporting clinical trials, they specifically address the roles and responsibilities of these parties at a level of detail not found in either the PRIM&R or NCQA standards and are thus directly relevant to the assessment of HRPPPs. As the committee struggled in a short period of time to develop a “theory” on which the standards for accreditation of HRPPPs could be based, the challenges and perhaps impossibility of developing a “one-size-fits-all” approach became apparent. The three sets of standards were reminders of the vastness of the research enterprise and the distinctive nature of certain types of research and research settings. For example, the PRIM&R standards appear to focus on research conducted in traditional academic health care settings, the NCQA standards encompass research conducted by the VA in its own self-contained health care system, and the ICH-GCP guidelines are specific to investigators and sponsors conducting clinical trials, a specialized type of research with human participants. Even so, the three distinct research situations described above all pertain to biomedical research environments. As discussed in Chapter 1, this does not adequately represent the multiple contexts in which human research occurs. The breadth of these research contexts creates layers of complexity that are not easily absorbed when a single set of standards is being developed for the assessment of performance. An organization's scope of activities should define which standards apply. Moreover, the accreditation body must consider the degree to which an HRPPP must comply with the standards. That is, must an organization be in full compliance with every standard to become accredited? Or should the organization demonstrate overall compliance with the full set of applicable standards? The answers to these questions might dictate the magnitude and scope of a set of standards and the level of detail that is necessary to support them. If the goal is to develop a single set of standards, such standards must accommodate several types of organizations engaged in the review and conduct of research with human participants. STANDARDS FOR STANDARDS At a minimum, standards should address an organization's level of performance in specific areas and, some would argue, not just what the organization is capable of doing but what it actually does (JCAHO, 2000). In theory, stan 

STANDARDS FOR ACCREDITATION 65 dards should set forth maximum achievable performance expectations for activities that affect the protection of human research participants. Perhaps most importantly, they should be based on widely accepted ethical principles that form the norms for research behavior. In the United States, the principles embodied in The Belmont Report have served as the foundation for the ethical requirements in human research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The three basic ethical principles in The Belmont Report are (1) respect for persons, (2) beneficence, and (3) justice. The first principle, respect for persons, encompasses two ethical concepts: first, “individuals should be treated as autonomous agents” and their decisions respected; and second, “persons with diminished autonomy are entitled to protection” (p. 4). The second principle, beneficence, incorporates the rules of “do no harm” and “maximize possible benefits and minimize possible harms” (p. 4). The third principle, justice, refers to a fair and equitable distribution of benefits and burdens, fair selection of participants, assurance that participants receive what is deserved or due, and ascertainment that equals are treated equally (p. 5). In the United States, these principles strongly influenced the development of federal regulations—in particular, regulations governing research sponsored by the federal government or regulated by the FDA—via the Federal Policy for the Protection of Human Subjects (45 CFR 46, subpart A, also known as the “Common Rule”) or parallel FDA regulations (21 CFR 50, 56; international studies of devices are covered by 21 CFR 312.120). The ethical principles found in The Belmont Report are also found in many international documents, including the Declaration of Helsinki and guidelines promulgated by the Council for International Organizations of Medical Sciences, a source on the ethics of international research involving human subjects (CIOMS, 1993; World Medical Association, 2000). The ethical principles should be accompanied by procedural requirements, which then form the basis of the standards. Thus, standards should have an explicit rationale that is consistent with the goal of protecting individuals or populations that participate in research. The committee's “standards for standards” are contained in two recommendations. Recommendation 3: Articulate Sound Goals Within Acreditation Standards The goals of accreditation standards should be to ensure 1. that the proposed research promises to contribute knowledge sufficient to justify research involving human participants; 2. independent review of research by a board knowledgeable about protection standards and the fields of research being reviewed; 

STANDARDS FOR ACCREDITATION 66 3. that the perspectives of participants are represented on institutional review boards (IRBs), on research monitoring bodies, and throughout the research oversight system; 4. that IRB members do not review protocols with which they have financial or nonfinancial conflicts of interest;1 5. that investigator and institutional conflicts of interest, both financial and nonfinancial, are disclosed to IRBs and participants and are managed responsibly by research institutions; 6. a review process that balances risks and potential benefits, keeps risks to the minimum necessary, and monitors research on a continuing basis; 7. that an effective process for obtaining voluntary informed consent of participants is in place; 8. that policies and procedures to assess the quality of HRPPP operations, enhance accountability, and improve performance are in place; 9. there is fairness in the recruitment and selection of participants; 10. that the privacy and confidentiality of research participants are protected; and 11. that the HRPPP is transparent so that participants can judge the research process to be trustworthy. Recommendation 4: Establish Flexible, Ethics-Based, and Meaningful Standards Accreditation standards should meet the following minimal criteria: 1. They should be based on sound and widely accepted ethical principles.2 1 The committee does not mean that any member who could have a conflict with any conceivable protocol coming to an IRB for review should be excluded from service on an IRB but, rather, that the individual should recuse himself or herself from reviewing such protocols. 2 The principles laid out in The Belmont Report are one foundation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Accreditation standards, however, should also incorporate the recommendations of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission, 1981, 1983), the recommendations of the Advisory Committee for Human Radiation Experiments (ACHRE, 1995), recommendations presented in reports of the National Bioethics Advisory Commission (NBAC, 1997, 1998, 1999a,b, forthcoming-a,b), the recommendations of the Office of the Inspector General of DHHS (DHHS OIG, 1998b, 2000b), and the recommendations of the General Accounting Office (GAO, 1996). In addition, recommendations from reports and declarations of private bodies and independent scholars should be incorporated. This presupposes that an advisory apparatus is available to cull this literature.