tion of human research. In 2012, 172 of the 1,024 new submissions to the university’s health sciences and behavioral sciences institutional review board (IRB-HSBS) were classified as not regulated.1 “We don’t want to over-regulate,” she said. A large percentage of the protocols submitted to the IRB-HSBS—more than 40 percent in 2011 and 2012—are exemptions by IRB staff reviewers. Exemptions do not have to be granted by the IRB itself, she noted; the process can be carried out by educated staff members. The IRB-HSBS is also constantly using and streamlining its expedited review process; in 2012 nearly 40 percent of the new submissions were given expedited review. She added that the IRB-HSBS regularly uses waivers or alteration of informed consent and waivers of documentation of informed consent, particularly for the social sciences, and it has established cooperative research arrangements to avoid duplicate review.

As a result, even though the IRB-HSBS has about 1,200 projects ongoing, the workload of the full committee has been reduced, and the time it takes the committee to make decisions has been significantly decreased, Brako said. 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. One demonstration allows two-year approvals, and another created a new exemption category for secondary data analysis with identifiers. “In the first two years of our projects,” Brako said, “we saved ourselves about 1,000 project reviews….We also audited, and we found no problems.”

Comments on ANPRM Proposals

Brako offered several comments about the proposed changes to the Common Rule. The advance notice of proposed rulemaking (ANPRM), she noted, proposed to create a category of “excluded” research that would require only a one-page application and no review before research began; there would be a data security check and a random audit later (Emanuel and Menikoff, 2011). This is similar, Brako said, to a current University


1For details, see http://www.hrpp.umich.edu/Indicators_Report_January_2013_Final.pdf [March 2013].



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement