Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
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3 Regulatory History
3 Regulatory History
Pages 59-80
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From page 59... ...
Our discussion identifies five major periods, the end dates of which mark significant events in the development of regulations, major disputes, and media attention. The history of federal regulation for human research participant protection shows relatively less emphasis on issues of protecting the confidentiality of information from individual respondents, in contrast to the attention devoted to such issues as the definition of research involving human participants and the elements of informed consent.
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From page 60... ...
for intramural research at its clinical center and adopted a policy that all human research participants at the center must provide informed consent, although written consent was not always required for sick patients. By the mid-1960s many biomedical research organizations had voluntarily established ethics review mechanisms.
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From page 61... ...
notes, "contained no systematic analysis of the ethical issues at stake in research involving human subjects." Nor did the surgeon general explain why or under what circumstances informed consent in SEES research might not be required. FROM 1966 TO 1974 The years subsequent to the first USPHS policy guidelines saw continued interest in and attention to human research participant protection issues among regulators, researchers, and members of Congress.
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From page 62... ...
It stated that IRBs should make sure that secondary analysis was "within the scope of the original consent." Such consent could be oral or written, obtained "after the fact following debriefing," or could be "implicit in voluntary participation in an adequately advertised activity." There was no repetition of the surgeon's general statement allowing less than fully informed consent under some circumstances. Building on the Yellow Book, DHEW issued comprehensive regulations in May 1974 for the protection of human research participants (45 Code of Federal Regulations [CFR]
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From page 63... ...
In 1973 Senator Edward Kennedy (D-MA) held hearings and introduced legislation to establish an independent National Human Experimentation Board to regulate all federally funded research with human participants, not just that funded by DHEW.
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From page 64... ...
and established a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was charged to review the IRB system and to advise DHEW and the Congress about ethical issues in research involving vulnerable populations, such as pregnant women, fetuses, children, prisoners, and institutionalized mentally ill or retarded people.
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From page 65... ...
Finally, the commission recommended that DHEW should issue regulations applicable to all research over which it had regulatory authority and that Congress should pass legislation to cover human participants in all research over which the federal government might have regulatory authority.7 In 1979 the commission issued the landmark Belmont report, which articulated three basic principles for research studies involving humans: respect for persons, beneficence, and justice. This report quickly became the bedrock on which subsequent work on protecting human research participants was built.
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From page 66... ...
Commentary Had the Common Rule been in effect at the time of "Tearoom Trade," his research would not likely have been approved. Given the stigma attached to homosexuality, the study would not be categorized as minimal risk, and, therefore, deception could not be used (see Box A-9 in Appendix A on the criteria for waiver of informed consent)
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From page 67... ...
As a consequence of these debates and the growing concern with human participant protection in SBES research, both the American Anthropological Association and the American Sociological Association adopted new codes of ethics in 1971. The American Psychological Association, which had first adopted a code of ethics for clinical work and research in 1953, sponsored extensive research and discussion on ethical issues specific to psychological research and adopted a revised ethics code in 1973 (Faden and Beauchamp, 1986; see also Chapter 41.
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SOURCE: Verbatim quotes from Gray (1982:354) of testimony provided to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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From page 69... ...
drafted a revision of 45 CFR 46, which was published for comment in the Federal Register in August 1979.9 The proposed revision raised a firestorm in the SBES research community. The major problem appears to have been that the regulations proposed to extend the IRB system to all research involving human participants at institutions that received DHEW funds, regardless of whether the particular protocol was funded by DHEW, and to studies in all fields that sought generalizable knowledge by using methods that collected information by which living or dead individuals could be identified.
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From page 70... ...
Specifically, provisions were added to require IRB review to consider the adequacy of proposed data confidentiality protections, to enable IRBs to modify some or all of the elements of informed consent, and to enable IRBs to waive the requirement for written documentation of consent (see Boxes A-6, A-9, and A-10 in Appendix A)
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From page 71... ...
Friendly champions of social and behavioral sciences showed us how to back away from our unpopular positions while continuing to offer what we felt were reasonable protections for the dignity and rights of subjects involved in social and behavioral research to say nothing of saving the face and the jobs of OPRR staff. What were the indignities to subjects that we felt needed attention?
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From page 72... ...
research involving educational tests, if identifiers cannot be linked to the subjects; · survey and interview research and observational research, unless identifiers are being collected, disclosure could be damaging to the participant, and the data pertain to sensitive subject behavior; and studies using existing data, documents, records, and the like, if these materials are publicly available or if the data will not be recorded in a manner that would allow linkage with individuals. Finally, backing off from the 1979 proposal, the regulations applied only to research sponsored by DHHS, although language was included indicating DHHS's concern that the interests of all human research participants, regardless of funding source, be protected at institutions that received DHHS funding.
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From page 73... ...
In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (which met from 1980 to 1983) recommended that a Common Rule be developed that would apply to all federally supported research involving human participants.
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From page 74... ...
These reports dealt almost exclusively with concerns arising from biomedical, particularly clinical, research. The first such report emerged from the Advisory Committee on Human Radiation Experiments, convened in 1994 to follow up media reports of federally sponsored radiation research with human participants conducted between 1944 and 1974 that violated ethical no~s.~2 The committee also investigated the current state of human participant protection by reviewing the regulatory system, examining a sample of recent research proposals, and interviewing past, current, and prospective research participants.
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From page 75... ...
The first report (Office of Inspector General, 1998b:ii-iii) concluded that "the effectiveness of IRBs is in jeopardy" because "they face major changes in the research environment," "they review too much, too quickly, with too little expertise," "they conduct minimal continuing review of approved research," "they face conflicts that threaten their independence," "they provide little training for investigators and board members," and "neither IRBs nor HEIS devote much attention to evaluating IRB effectiveness." Furthermore, the report claimed that IRBs lacked adequate resources to do their job and were being pushed by regulations to focus on paperwork requirements more than on basic ethical issues.
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From page 76... ...
was established in the Once of the Secretary of DHHS, taking over responsibilities from OPRR and acquiring new responsibilities (see http://ohrp.osophs.dhhs.gov t4/10/031; 67 Federal Register 10217, March 6, 20021. OHRP was given a broad mandate, not only to monitor the operations of IRBs that review DHlIS-funded research, but also to provide guidance on human research participant protection for the federal and nonfederal sectors, develop educational programs, and exercise leadership for human participant protection in cooperation with other federal agencies.
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From page 77... ...
introduced a bill in May 2002 that would extend federal human participant protection to all federally funded research and require the harmonization of the Common Rule and Food and Drug Administration regulations. Senator Kennedy (D-MA)
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From page 78... ...
, a principal funder of SBES research, established an ad hoc Social, Behavioral, and Economic Subcommittee for Human Subjects. The subcommittee developed a guide for SBES researchers, which was put up on the NSF Policy Office website as "Frequently Asked Questions and Vignettes: Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research" (National Science Foundation, 20021.
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From page 79... ...
To assure the development of appropriate guidance, SBES researchers must actively continue to seek formal and informal channels for input to OHRP and other relevant agencies and organizations. The SBES research community must also actively seek to develop a knowledge base that can inform OHRP, IRBs, and researchers about appropriate procedures for informed consent, balancing of risks and benefits, and other aspects of ethically responsible research.
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From page 80... ...
apply to all federally supported research involving human participants. In response, in 1982 the Presiclent's Science Adviser, Office of Science and Technology Policy, appointed an interagency committee to develop a common framework on the basis of the DHHS regulations.
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