TAG ARCHIVES FOR Common Rule

9
Jul2020

AEREO Project on Key Information: Templates and Other Documents Available on PRIM&R Site

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9 Jul
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A team comprising Holly Taylor of the NIH Clinical Center’s Department of Bioethics; Susan Kornetsky of Boston Children’s Hospital; and Megan Kasimatis Singleton of the Johns Hopkins University School of Medicine, and myself recently completed a project examining how, in the absence of federal guidance, institutions are interpreting and applying the key information requirement and, specifically, whether and to what extent they are developing policies, guidance, templates, or other tools to help researchers and IRBs apply this provision of the Common Rule. We undertook this project as part of the Consortium to Advance Effective Research Oversight (AEREO)—a group of leaders in human research oversight, research ethics, and empirical methods dedicated to evaluating and improving the effectiveness of IRBs and HRPPs through empirical research. PRIM&R is pleased to share with the human research protections community the materials collected during this project as a public resource. Read more

21
Apr2020

Webinar Follow-Up: Real-World Approaches to Informed Consent under the Revised Common Rule

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21 Apr
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On October 23, 2019, PRIM&R hosted a webinar, Real-World Approaches to Informed Consent under the Revised Common Rule. This webinar served as a check-in on how the human subjects research oversight community is adapting to the new requirements, particularly the revised Common Rule's implications for informed consent. Presenters Karen Blackwell, MS, CIP; Patrick Herbison, MEd, CIP, and Ann Johnson, PhD, MPH, covered challenges and successes pertaining to informed consent requirements in the revised Common Rule and helped attendees identify strategies to benefit their organizations in adapting to the regulatory changes. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more

9
Jul2019

Reflections on the Advancing Ethical Research Conference

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9 Jul
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PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an interesting learning opportunity, wherein I noted a common theme of this conference was to highlight the changes in the revised Common Rule and its practical implementation. Read more

13
May2019

Applying the new HIPAA Exemption: Are you in or out?

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13 May
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For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more

22
Feb2019

From the Director: Why We Need to Keep the Term “Research Subject” in Our Research Ethics Vocabulary

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22 Feb
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It’s been suggested by some that it is time to jettison the term “research subject” from our research ethics vocabulary—including in the regulations—and  exclusively use the term “research participant” to refer to those who enroll in research. While there are many compelling arguments for using "participant" instead of "subject" in the modern research context, PRIM&R's executive director, Elisa A. Hurley, PhD, argues that we need to keep both research "subject and research "participant" in our shared vocabulary. Read more