Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Session 6: Purview and Roles of Institutional Review Boards
Session 6: Purview and Roles of Institutional Review Boards
Pages 73-82
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From page 73... ...
PERSPECTIVE OF A HUMAN RESEARCH PROTECTIONS PROGRAM THAT MAXIMIZES OPPORTUNITIES TO BE FLEXIBLE AND INNOVATIVE Lois Brako, of the University of Michigan, Ann Arbor, offered some observations and suggestions about the proposed changes to the Common Rule, based on her experiences with regulatory and compliance oversight at the University of Michigan. She described the university's human research protections program as one that seeks to maximize its opportunities to be flexible and innovative, and noted ways the university works to take full advantage of the flexibility in the regulations concerning human subjects protection.
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From page 74... ...
For example, the median turnaround time for an exempt determination went from five to six days in the first part of 2011 to one or two days by the end of 2012.2 The median turnaround time for expedited approvals also has dropped, she said, and was at about 14 to 15 days in the second half of 2012.3 The university's IRB-HSBS has also conducted demonstration projects on minimal risk research. The projects cannot be federally funded or regulated by the Food and Drug Administration, and they must not hold certificates of confidentiality.
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From page 75... ...
An expert panel composed of social scientists and other researchers, IRB members and chairs, IRB administrators, and nonscientific IRB members should be formed to determine what the new categories should be, she added, and the panel should update the list regularly. The list from the Council on Governmental Relations comments on the ANPRM, which suggested new expedited categories for studies of Internet behavior, functional magnetic resonance imaging at standard exposure levels, the establishment of registries for future research purposes, and occupational health activities, such as walking, deep breathing, and mild exercise, could provide a starting point for this work, she noted.4 Brako also suggested letting IRBs use expedited procedures for any other activities they determine to be of minimal risk.
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From page 76... ...
Proposed Changes That Would Increase Burden Some of the proposed changes in the ANPRM are likely to increase the burden for institutions, and Brako identified several that would likely prove particularly burdensome at the University of Michigan. Requiring federal oversight of all human subjects research at an institution that receives federal funding would be overly burdensome, she said.
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From page 77... ...
EFFECTS OF PROPOSED CHANGES ON SOCIOCULTURAL ANTHROPOLOGY Rena Lederman, of Princeton University, discussed how the proposed changes to the Common Rule -- and, in particular, the creation of an "excused" category of research that has only informational risks -- would be likely to affect anthropologists and other ethnographers. Lederman described the distinctive features of participant observation, which she described as "my discipline's way of understanding human experience." This approach to research is quite different from the approach in other areas of science, she explained, which makes it a poor fit for the Common Rule in many ways.
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From page 78... ...
This provision "encourages the rest of us to offer misleadingly formalized accounts of our prospective work," Lederman said. However, she continued, the special data privacy protections envisioned by the ANPRM, based on the Health Insurance Portability and Accountability Act privacy standards, would be equally ill-suited for ethnographical fieldwork.
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From page 79... ...
Then alternative approaches could be developed to more adequately address the actual ethical dilemmas of sociocultural anthropology fieldwork and related forms of scholarship: approaches that promote rather than undermine these sciences. Lederman suggested forming a national commission to develop a rationale and framework for promoting ethical conduct in those areas of scholarship poorly served by or newly excused from the Common Rule.
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From page 80... ...
This exception can bring a researcher into conflict with state mandatory disclosure laws, she noted. Whereas the certificate of confidentiality required by many other federal agencies allows a researcher to disclose matters, such as child abuse, reportable communicable diseases, or a subject threatening to harm someone, the privacy certificate required by DOJ does not, she noted.
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From page 81... ...
In other cases, the IRBs are simply confused by the regulations, she added, as they are somewhat different from what IRBs usually encounter. In at least two cases, researchers have decided not to take DOJ funding -- in one case after it had already been awarded -- because the DOJ will not accept informed consent forms that include mandatory disclosure statements.
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