Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-8
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The third concern is that the review process may delay research or impair the integrity of research designs, without necessarily improving participant protection, because the type of review is not commensurate with risk—for example, full board review for minimal-risk research that uses such methods as surveys, structured interviews, participant observation, laboratory experiments, and analyses of existing data. PANEL CHARGE AND SCOPE The Panel on Institutional Review Boards, Surveys, and Social Science Research was established by the Committee on National Statistics and the Board on Behavioral, Cognitive, and Sensory Sciences, both standing committees of the National Academies' National Research Council.
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Despite decades of research on consent issues, mostly in biomedical research and mostly involving written forms, there appears to have been little progress in devising more effective forms and procedures for achieving informed consent or in adapting consent procedures to the needs of special pop
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Recommendation 4.2: The Office for Human Research Protections should develop detailed guidance for IRBs and researchers on appropriate consent procedures for different types of populations including language minorities and such vulnerable groups as undocumented immigrantsstudied in social, behavioral, and economic sciences research. 3 The issue of third-party consent has gained salience in recent years due to reports of studies in which third parties complained that their privacy was invaded by collection of sensitive data about them from others.
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Even if no sensitive information is obtained, maintaining confidentiality is required to respect participants when they have been assured that their information will be protected. The risk of inadvertent or advertent disclosure is increasing due to several factors: the growing number and variety of administrative records from public and private agencies that are readily available on the Internet and potentially linkable to research data; the growing number of rich, longitudinal data sets that require retention of contact information for respondents over long periods of time and that may be more readily linked to other data sources with sophisticated matching techniques; the increased emphasis by funding agencies on data sharing among researchers to permit replication and facilitate further research at low cost; and the increased use of Internet-based data collection technology that may be vulnerable to security breaches.
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Such review uses up scarce IRB and investigator resources yet is unlikely to afford greater protection to respondents than is already incorporated in the design and content of the file. Recommendation 5.2: To facilitate secondary analysis of public-use microdata files, the Office for Human Research Protections, working with appropriate federal agencies and interagency groups, should establish a new confidentiality protection system for these data.
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does not involve human subjects under the regulations, and research with publicly available microdata of individual records qualifies for exemption when the data are certified by the supplier agency to be protected against breach of confidentiality. Recommendation 6.1: To promote review appropriately tailored to risk, the Office for Human Research Protections should develop detailed guidance for IRBs and researchers (with clear examples for a variety of methods)
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Recommendation 6.4: The Office for Human Research Protections should establish an ongoing system for collecting and publishing data that can help assess how effectively IRBs protect human research participants, how efficiently they review research, and how commensurate review is with risk. Recommendation 6.5: Federal research funding agencies, including the National Science Foundation and the National Institutes of Health, should fund in-depth studies to better understand the operations and effects of the IRB system and to develop useful indicators of IRB performance.
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In two areas that are particularly important for SBES research we offer recommendations. Recommendation 7.1: To improve IRB-researcher communication and facilitate the review process, IRBs should: · clearly distinguish and justify changes to research designs that are required for human participant protection from suggested changes that are advisory; and develop ways to work cooperatively with investigators, such as providing opportunities for face-to-face meetings to discuss significant changes in research protocols that the IRB requires.
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