9
Apr2018

How did you prepare for the revised Common Rule?

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9 Apr
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With much anticipation, the Office of Human Research Protections (OHRP) released the final version of the 2018 Common Rule on January 19, 2017.  However, with the issuance of an Interim Final Rule on January 22, 2018, the changes are not to be implemented until July 19, 2018. The HRPP at Wake Forest University Health Sciences has developed a short survey to assess the time and effort put into preparing for the 2018 Common Rule before this announcement of the Interim Final Rule. The results of the survey may be useful as IRBs prepare to allocate resources for the future effective date. Complete the survey to share your feedback on the amount of time spent preparing for the 2018 Common Rule, strategies that your institution plans to employ, and what additional guidance would be most helpful. Read more

6
Apr2018

The Importance of Listening

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6 Apr
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One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more

5
Apr2018

Adapting Certificates of Confidentiality Policy Under the 21st Century Cures Act: Benefits and Challenges

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5 Apr
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At PRIM&R’s 2017 SBER conference, I had the opportunity to sit in on the excellent didactic session, “Certificates of Confidentiality (CoCs) and National Institute of Justice (NIJ) Privacy Certificates,” given by Petrice Brown-Longenecker, PhD, CIP (Extramural Human Research Protection Officer, NIH); Elonna Ekweani, JD (Public Health Analyst, NIH); Mary Ramirez, MA, CIP (Assistant Director, Health Sciences and Behavioral Sciences IRB, University of Michigan); and Leslie E. Wolf, JD, MPH (Professor; Director, Center for Law, Health, and Society, Georgia State University College of Law). Read more

29
Mar2018

From the Director: An Opportunity to Shape the Future of Animal Research Regulations

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29 Mar
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On March 14, 2018, the National Institutes of Health (NIH), in coordination with USDA and FDA, published a 90-day request for comments “seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d).” The animal research community now has an important opportunity to address long-standing concerns about regulatory burden—requirements that add administrative work without enhancing animal welfare or good science—and to help shape the future of animal research regulations. I urge you to take this opportunity to share with the federal regulators your ideas about how we can best streamline regulatory and administrative inefficiencies that don’t promote animal welfare or good science.  Read more

26
Mar2018

Webinar Follow-up: SBER Across Borders

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26 Mar
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Research conducted in international settings poses particular challenges for the reviewing IRB, as it must possess adequate knowledge of laws and regulations in the country where the research is taking place, and be sensitive to the area’s cultural norms, in order to appropriately evaluate the study. Social, behavioral, and educational research (SBER) in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. Conducting research on these topics is important, but it is equally essential that IRBs and researchers mitigate the risk of social consequences that might result from subjects’ participation in the study, such as rejection in their communities or conflict within their families. The regulations regarding human subjects protections vary greatly between countries as well, which can lead to additional difficulties for IRBs. Read more