Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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1 Introduction, Background, and Definitions
1 Introduction, Background, and Definitions
Pages 23-44
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From page 23... ...
Such protections were not explicitly and systematically addressed in the United States, however, until the late 1940s, when scientists and policy makers recognized the need to respond to crimes committed by Nazi scientists during World War II. Since then national and international policies have evolved to create a system of protections requiring the involvement of investigators, research sponsors, research institutions, health care providers, federal agencies, and patient and consumer groups.
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A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES In response to the atrocities committed by Nazi scientists during World War II, the Nuremberg Military Tribunal created the Nuremberg Code, a set of 10 principles for research involving human participants, including an absolute requirement for voluntary consent (Nuremburg Code, 1946 1949; United States v. Karl Brandt et al.
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A PHS advisory panel reviewing the Tuskegee study determined that existing procedures for the protection of research subjects were inadequate and that the U.S. Congress should establish a "permanent body with the authority to regulate at least all federally supported research involving human subjects" (Tuskegee Syphilis Study Ad Hoc Advisory Panel, 1973, p.
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In response, President Bill Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE3 to investigate reports of federally sponsored human research involving radioactive materials conducted 3 45 CFR 46; the FDA regulations are at 21 CFR 50, 56.
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implemented this recommendation.4 The National Bioethics Advisory Commission NBAC was established by executive order in October 1995 and was asked by President Clinton to look into the protection of human subjects in research, with "protection of the rights and welfare of human research subjects" listed as its first priority (Clinton, 1995~. As one of its first actions, in May 1997 NBAC unanimously resolved that "no person in the United States should be enrolled in research without the twin protections of informed consent by an authorized person and independent review of the risks and benefits of the research" (NBAC, forthcoming-lo, p.
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The April 2000 DHHS OIG update specifically lauded the efforts of PRIM&R to develop standards for accreditation of IllBs and research institutions. A pair of reports published in June 2000 focused on recruiting human subjects, with one describing pressures in industry-sponsored clinical research and the other listing sample guidelines for practice (DHHS OIG, 2000c,d)
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. The NBAC papers all cited a need to elevate the administrative hub for protecting human research participants up and out of NIH, but differed in whether the location should be within DHHS or in an independent executive agency.
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The Death of Jesse Gelsinger Attention was already focused on the protection of human research participants when 18-year-old Jesse Gelsinger died in a phase I gene transfer study at the University of Pennsylvania in September 1999. He was a relatively healthy (i.e., medically stable)
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Phase 2 will continue the 24-month study of the structure, function, and performance of activities for the protection of human research subjects.9 The results of this future work will be presented as a separate report. DEFINITIONS In this section on definitions, the committee wishes to clarify its choice of terms to avoid confusion within this report and also to signal its awareness of the ~ In the course of committee deliberations, the term "human research participant protection program" was substituted for "human research review program" as the former term better reflected the system of oversight that the committee hopes will result from its recommendations.
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However, some of the terms apply only in a particular research context. Federal regulations and international guidelines refer to "human subjects" of research.
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and have only glancing contact with any investigator. Even within the confines of clinical trials for drugs, a person participating in the trial may truly be the healthy "subject" in whom a prospective drug is being tested for dose and toxicity, may be someone choosing among small twigs of an elaborate and extensive decision tree, or may be a desperately ill patient choosing among options that are all risky and experimental.
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Collectively, the IRB rulings for the same protocol may result in disparate or even contradictory findings. The committee's first task was to make recommendations about accreditation standards for "human research participant protection programs," a term by implication (tautologically)
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It is directly pertinent to accreditation standards and their use in the accreditation process because many of the most detailed aspects of federal regulations and, consequently, of both NCQA and PRIM&R standards—deal with the documentation of informed consent. This is an area in which the standards may be most onerous and in which a shift to the use of performance measures ways of getting and documenting genuine informed consent that do not rely as heavily on formal written, signed documents, as current practice does would be most welcome.
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Dept. of Education, Bureau of the Census, etc.~; pharmaceutical, device, and biotechnology firms; private foundations; marketing firms T C p A N T S RESEARCH ORGANIZATIONS Examples: academic health centers, survey research organizations, contract research organizations, cooperative groups, research management unit of sponsor's organization INVESTIGATORS 1 PERFORMANCE ASSESSMENT Monitoring Education and Feedback Including in Including data vestigators, IRB safely and members and monitoring staff, and boards, data community centers, adverse members event reporting, ombudsman programs Quality Improvement Including selfassessment of program function, outcomes, and support ~ ~ 1 - 1 l RESEARCH INVOLVING HUMAN PARTICIPANTS FIGURE 1-1 Human research participant protection programs.
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In large multicenter trials, individual research institutions are at too low a level for meaningful accreditation because many such institutions are involved in the trial and none has meaningful control over the study design and overall safety. The appropriate locus of accreditation for multicenter clinical trials might prove to be different from that for research in general and might be focused on the organizations that have developed to manage the research, such as contract research organizations for privately funded trials or cooperative groups for both private and publicly funded trials.
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Therefore, the risks and benefits of such projects will be analyzed differently from those of clinical trials, and such projects will require different kinds of expertise and sensitivities to different categories of research participants. Research in anthropology, sociology, journalism, law, and economics, for example, requires distinct methods.
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Guidelines for the ethical conduct of such clinical trials already exist, however. These are the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP)
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Sponsors To accredit HRPPPs as a system representing the complement of necessary activities that ensure the protection of human research participants, the responsibilities of research sponsors must also be included within the accreditation structure. Although existing FDA regulations, for example, assign the ultimate accountability for ensuring the management of ethical research to the sponsor, this does not alleviate the need for organizations seeking to run an HRPPP from incorporating this responsibility into their programs.
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The committee believes that adverse event reporting and research moni~' Involvement of the National Breast Cancer Coalition was instrumental, for example, in clinical trials of the drug herceptin, when early clinical trials were having difficulty recruiting participants. The National Breast Cancer Coalition became involved, however, only when it could directly participate in trial design and oversight (Bazell, 1998~.
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NIH and several universities (e.g., Case Western Reserve University and the University of Rochester) , for example, have recently adopted requirements that investigators take a World Wide Web-based interactive test that demonstrates knowledge of human research protections before they can seek IRB approval of a protocol (Case Western Reserve University, 2001; Chadwick and Liders, 2000; Office of Human Subjects Research, National Institutes of Health, 20019.
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