Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
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Appendix B: Protecting Particpants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and ...
Appendix B: Protecting Particpants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and ...
Pages 236-248
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From page 236... ...
Concerns are of two types. One is the potential for serious harm to participants and the need to better protect them from such harm.1 The other is unnecessary burdens that may result from applying review standards for high-risk research to low-risk studies burdens on institutional review boards (IRBs)
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From page 237... ...
This letter provides an SBES perspective on the assumption that your committee by design is more concerned with biomedical research. In the letter we primarily address field, laboratory, and archival research conducted by such typical SBES methods as mail, telephone, and inperson surveys, structured interviews, participant observation, laboratory research, and other methods that ordinarily pose low risk to participants.
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From page 238... ...
. This letter provides the panel's initial recommendations on four topics: protection of confidentiality of information obtained from human research participants; requirements for informed consent, particularly for advance written consent; procedures for determination of exempt research and for expedited review of low-risk research; and system-level issues, such as training of researchers and accreditation.
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From page 239... ...
For some sensitive studies, such as those in which a participant may report illegal behavior, it is particularly important that researchers understand their responsibilities and limits with regard to confidentiality protection and that IRBs review carefully the proposed procedures for preventing disclosure. In some cases, it may be important to obtain a certificate of confidentiality to protect the data from subpoena in legal proceedings.7 Another class of studies for which confidentiality protection poses special problems comprises longitudinal panels in which participants are interviewed more than once over a period of time.
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From page 240... ...
Recommendation 1: The Office for Human Research Protections and other relevant federal agencies, working with professional associations in the social, behavioral, and economic sciences, should document and promulgate good practices for using state-of-the-art computer science and statistical methods to protect the confidentiality of SBES data that are made available for secondary analysis. OHRP should also provide guidance on good practices for protecting confidentiality at every stage of the research process.
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From page 241... ...
a few years ago required advance written consent for participation in the ongoing National Health Interview Survey, although no evidence existed that lack of advance written consent misled participants about the nature of the research in more than 30 years of conducting the survey, and a pilot test estimated that such a requirement would add significant costs to the data collection. From the results of the pilot test, the IRB agreed to a set of procedures, implemented nationwide starting in July 1999, whereby the respondent may sign at the beginning of the interview, after hearing some questions, or at the end of the interview.
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From page 242... ...
Consequently, IRBs may require signed consent forms for all research, even when other consent processes or a waiver of consent would be more appropriate, in order to obtain documentation that is easily archived and retrieved for defending the procedure. Recommendation 5: As provided by federal regulations, IRBs should consider a variety of procedures for obtaining informed consent and grant waivers of written consent when to do otherwise would inhibit useful SBES research with no appreciable added protection for the · ~ participants.
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From page 243... ...
In response to tragic incidents in biomedical research and increased scrutiny of IRB operations, IRBs appear to be increasingly applying review procedures that are appropriate for high-risk research to studies that are low risk, thereby placing unnecessary burdens on researchers, IRBs, and, sometimes, human participants. A recent survey of IRBs found that onehalf or fewer research protocols eligible for exemption are in fact exempted from review and that full IRBs convene to review anywhere from 15 to 83 percent of low-risk protocols that are eligible for expedited review (Bell, Whiton, and Connelly, 1998:Figs.
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From page 244... ...
Examples of specific SBES procedures that could be added to the existing list for using the expedited review procedure are experiments that test responses to noninvasive auditory or visual stimuli of competent adult participants; experiments that study decision-making with competent adult participants; and surveys of competent adults that include standard demographic and socioeconomic questions and other questions (e.g., attitudes) for which there is no reasonable expectation of harm (e.g., from experience with the same or similar questions in other surveys)
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From page 245... ...
Recommendation 9: OHRP and other relevant agencies, working with professional associations in the social, behavioral, and economic sciences, should develop an ongoing survey of IRB composition and practices, as an informational resource that can help assess strengths and weaknesses of the system for protecting human participants in SBES research. The design should permit analysis of review practices for SBES research by type of IRB (all fields, SBES fields only)
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From page 246... ...
For long-run success, the ethics of protection must be woven into the fabric of the research preparation of all scientists. Recommendation 11: Academic institutions, working with scientific and professional associations in the social, behavioral, and economic sciences, should develop in-depth training curricula and materials that are customized for social, behavioral, and economic scientists regarding the ethical involvement of human research participants.
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From page 247... ...
2001 Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy.
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From page 248... ...
1999 U.S., citing safety, suspends human research aid at Duke. The New York Times, May 12.
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