Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Appendix B: PRIM&R Accreditation Standards
Appendix B: PRIM&R Accreditation Standards
Pages 115-134
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From page 115... ...
INTRODUCTION The research community, Congress, and the public have all voiced concerns regarding the adequacy of the system for the protection of human research participants. In response to these concerns, and to suspensions of research at a few institutions around the country, in May 1999 Public Responsibility in Medicine and Research (PRIM&R)
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The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (19 79J provides the philosophical basis for current laws governing human subjects research. This Report identifies three fundamental ethical principles that are relevant to all research involving human
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Human Research Protection Program (HRPP) A system that includes all components critical to protecting individuals studied in research and that is managed in accordance with these standards and with applicable federal, state, and local laws and regulations.
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Committees or boards that review research to ensure the protection of human subjects. The term includes, but is not limited to Institutional Review Boards (per the Common Rule, 45 CFR 46)
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1.2 The organization must uphold ethical principles underlying the protection of individuals studied in research. COMMENTARY on Standard 1.2: The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (19 79J provides the philosophical basis for federal regulatory requirements.
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Organizational policies need to define conflicts of interest, provide mechanisms for disclosure of conflicts, establish a process for evaluating whether a conflict of interest may interfere with protection of the individuals studied in research, and institute actions to manage conflicts of interest determined to have the potential to interfere with that protection. Organizations need to disseminate these policies to individuals responsible for the conduct of research involving humans and they need to determine what role the IRB should play in monitoring the application of these policies.
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New research personnel must also be provided with this information and all staff must be kept apprised of any changes. 1_10 The organization must assure that all personnel conducting or supporting human research or involved in the HRPP demonstrate and maintain sufficient knowledge of the protection of individuals studied in research appropriate to their role.
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COMMENTARY on Standard 1.13: The organization must both recruit and maintain a quality IRB by having high-caliber chairs, members, and staff. The organization's policies must foster the retention of individuals knowledgeable of and sensitive to the principles of the organization's human research protection program sufficient to assure continuity of high levels of performance.
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Persistent problems in human research protection and the changing nature of clinical research, public expectation, and organizational best practices have thus necessitated that the organization, IRBs, and investigators regularly evaluate their performance and assess outcomes. An organization seeking accreditation must propose its own methods/procedures for evaluating the performance of all aspects of the HRPP.
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. For example, organizations conducting research involving Native Americans must understand and appreciate tribal concerns that influence the conduct of such research.
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attentiveness to the details of applicable federal regulations and other legal and institutional requirements; (3) skillful facilitation of contextual interpretations and application of these requirements that will foster ethically and scientifically sound research involving human beings; (4)
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, and staff and continuing education for current staff, members, and chains) using performance feedback, mentoring, and monitoring techniques.
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; (4) Informed consent is sought from research participants or their authorized representatives unless waived by the IRB; (5)
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2.11 The IRB must have written policies and procedures pertaining to the following and which are appropriate and relevant to the types of research reviewed within the organization, including research involving special populations (children, persons who are decisionally impaired, the elderly, etc.) or certain types of research (e.g., social and behavioral research, drug washout studies, double-blinded placebo controlled studies, or research conducted in emergency circumstances)
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(N) Reporting IRB findings to investigators, appropriate institutional officials, and appropriate federal or other regulatory agencies (O)
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(I) Statements of significant new findings provided to research participants (J)
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3.1 The investigator should understand and apply the underlying ethical principles as delineated in The Belmont Report when designing, or when evaluating already designed studies, and when conducting human research. 3.2 Investigators must put the rights, welfare, and safety of each individual studied in their research ahead of their professional, academic, financial, personal, or other interests.
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must assure that all research involving human subjects is reviewed and approved by an IRB before study initiation and that it remains approved for the duration of the study. COMMENTARY on Standard 3.4: The IRB should be consulted when questions arise regarding whether a given research activity constitutes human research.
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COMMENTARY on Standard 3.7: Discussions about research with prospective research participants and/or the community in which the research will be conducted is a regulatory requirement in some circumstances (e.g., FDA and other DHHS requirements for research conducted in emergency circumstances, etc.~. However, investigators should be aware that community involvement in the design and conduct of some research studies may benefit research participants, researchers, and the community.
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134 PRESER DING PUBLIC TRUST Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979~. Copies are available at the following Web site: http://ohrp.
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