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New Human Subjects Review Regulations On the Horizon?

Did it seem a bit much when you had to wait for weeks (months?) for your IRB’s “exempt status” approval for that 5-item questionnaire assessing hospital librarians’ attitudes toward web-based learning? Well, take heart. The Office of Management and Budget convened a working group to review – for the first time in 20 years – the current federal human subjects review regulations. The Department of Health and Human Services has posted proposed revisions for public comment at http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html. A recent article in the New England Journal of Medicine summarized proposed changes (source is listed below). Here are some of the highlights:

  • Review processes would be eliminated for “exempt” projects. Such projects really are no riskier for participants than everyday activities like laundry or housework. Under proposed guidelines, researchers would be permitted to begin low-risk projects immediately after registering them, which would involve submitting a brief description to their IRBs. (In other words, no waiting to see if your IRB agrees that your project is “exempt.”) The group also proposed, for consideration, allowing competent adults to provide oral consent to participation in focus groups, interviews, and surveys. The term “exempt” would be replaced by “excused,” because low-risk studies would be excused from the review process but not exempt from the oversight described in the next bullet.
  • Uniform data-security measures would be developed and enforced. While participants in “excused” studies face minimal risk from interventions, they can be harmed through inappropriate release of data. One huge blind spot in current human subjects regulations is a lack of uniform standards for data security. The committee proposes creation of uniform standards required for all projects, including low-risk ones. Institutions would oversee compliance with processes such as random audits of excused programs.
  • Studies using secondary sources of data would automatically be classified as “excused.”  Many publications and presentations that report evaluation data fit into this category. When we evaluate programs, our primary purpose is for program improvement and enhancement of services for our users. If we take evaluation data and analyze it for publication, it becomes a secondary source, meaning it was collected for program improvement and “recycled” for scholarship.
  • Multi-site research projects will have one IRB record. When libraries from different institutions collaborate, their projects often have to undergo separate review in each participating institution. Multiple reviews sometimes force variation in assessment practices that can compromise studies but does not enhance human subjects protection, so the working group recommends “one project, one record.”

 

Please note: No changes to federal policy have been made yet, so don’t stop following your institution’s IRB procedures. If you would like a more detailed, but readable, summary of proposed changes, please check out the following article:

Source: Emanuel EJ, Menikoff J. Reforming the Regulations Governing Research with Human Subjects New England Journal of Medicine, 2011 Jul 25. Available online at http://www.nejm.org/doi/full/10.1056/NEJMsb1106942)

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