Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Session 1: Review of the Evidence
Session 1: Review of the Evidence
Pages 5-18
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From page 5... ...
The NRC and IOM have a long history of attention to this subject, she said, and a major focus of this attention has been the area of privacy, confidentiality, and data access, which is important in social and behavioral research. One of the earliest studies discussed (National Research Council, 1979)
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From page 6... ...
BOX S1-1 National Research Council and Institute of Medicine Reports on Privacy, Confidentiality, and Data Access 1979 Privacy and Confidentiality as Factors in Survey Response 1985 Sharing Research Data 1993 rivate Lives and Public Policies: Confidentiality and Accessibility of P Government Statistics 2000 Protecting Data Privacy in Health Services Research 2000 Improving Access to and Confidentiality of Research Data: Report of a Workshop 2005 xpanding Access to Research Data: Reconciling Risks and E Opportunities 2006 Effect of the HIPAA Privacy Rule on Health Research: Proceedings of a Workshop 2007 Engaging Privacy and Technology in a Digital Age 2007 utting People on the Map: Protecting Confidentiality with Linked Social P Spatial Data 2009 eyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health B Through Research 2010 onducting Biosocial Surveys: Collecting, Storing, Accessing, and C Protecting Biospecimens and Biodata SOURCE: Citro presentation at Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences, Washington, DC, March 21, 2013.
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From page 7... ...
The NRC and IOM have also done two systemwide studies on protection of human research participants, she noted Responsible Research: A Systems Approach to Protecting Research Participants (Institute of Medicine, 2002) and Protecting Participants and Facilitating Social and Behavioral Sciences Research (National Research Council, 2003)
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From page 8... ...
Another approach has been to license individual researchers, allowing them to work with confidential data as long as they agree to certain strict rules about protecting confidentiality. Researchers increasingly are also using remote monitored access, where they work online with data that are maintained behind a firewall at the agency in which they are housed.
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From page 9... ...
It underprotects in other ways, for example, potential re-identification for many rich social and behavioral datasets. For an alternative to the HIPAA approach, Citro pointed in particular to the recommendations of the 2003 report Protecting Participants and Facilitating Social and Behavioral Sciences Research and of the 2005 report Expanding Access to Research Data: Reconciling Risks and Opportunities.
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From page 10... ...
On the issue of exactly what consent forms should look like, Citro said that the typical advice has been to supply guidance instead of hardand-fast rules. Protecting Participants (National Research Council, 2003)
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From page 11... ...
Some of the IRB-related problems facing researchers in social and behavioral fields can be traced to major issues with biomedical research, including the deaths of some participants in the late 1990s, which led to the establishment of the OHRP and strengthening of protections for human research subjects. These developments led to tightened scrutiny by IRBs, which in turn led social and behavioral researchers to become even more frustrated with what they perceived as a one-size-fits-all approach to human subjects protection, Citro explained.
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From page 12... ...
on the burden created by IRBs reported that principal investigators on federal grants estimated that they spent about 42 percent of their time on "administrative burden" and that of the 24 administrative tasks in the survey, researchers reported that IRB-related tasks account for the largest burden. While the study, which had 6,295 respondents, may look convincing, there are a number of reasons for caution, Rodamar said.
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From page 13... ...
To explore how long it takes to get IRB approval, Rodamar combined data from two studies, one done by the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
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From page 14... ...
The gap between ratings for real and ideal IRBs was not particularly large, Rodamar noted, always less than one point. A 2012 survey found that the attitudes of social and behavioral researchers towards IRBs were not significantly different from the attitudes of biomedical researchers (DeVries et al., 2006; Pennell and Lepkowski, 2010)
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From page 15... ...
Risks Posed by Social and Behavioral Research As an example of the sorts of SBE research that can lead to serious harms to the participants, Rodamar mentioned the work of a sociology graduate student at the University of Chicago who studied people living in Chicago public housing (Venkatesh, 2008)
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. REFERENCES Association for the Accreditation of Human Research Protection Programs.
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Presenta tion at the Office of Human Research Protections Community Forum on Reducing Regulatory Burden: Real Strategies for Real Change, Ann Arbor, MI, May 14. Available: http://www.hrpp.umich.edu/education/OHRP2009/presentations/minimal-risk.pdf [June 2013]
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From page 18... ...
. Streamlining IRB approval process yields dramatic results in turn around time for University of Maryland.
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