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

10
May2019

From the Director: Transparency About Animal Research Ethics

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10 May
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The last few years have seen a growing call across the research enterprise to increase transparency around animal research—why we do it, why it’s important, and what it has accomplished. I also wonder whether there is another layer of transparency we ought to be promoting—namely, transparency about the ethical dimensions of animal research and its oversight. Specifically, how might being more open about the ethical issues and questions that are part of the day-to-day work of those involved in animal research serve our collective goals of educating and engaging the public; increasing their understanding, trust, and support for the animal research enterprise; and reframing the public conversation?  Read more

8
May2019

Creating a two-way, system-wide IRB infrastructure

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8 May
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I could never have guessed just how large and life changing a venture creating a two-way, system-wide IRB infrastructure would be when I received exactly that project in late 2010. Now, as we approach the single IRB mandate, I wanted to share a little bit about the efforts that I was fortunate to lead and participate in for the benefit of all the organizations not only contemplating this step, but being required to implement it at this juncture. I can only hope this brief effort to capitulate our successes and failures will lead you and your organization to even grander aspirations and achievements than my own. Read more