Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 3, March, 2019

Back Issues

Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.

Research With Human Specimens

IRBs and Continuing Reviews … p. 3
IRBs and Research With Human Specimens … p. 4
IRBs and New Exemptions From Required Reviews … p. 6

IRBs and Risks of Investigational In Vitro Diagnostic Studies … p. 7
In Congress … p. 8
FDA Warning … p. 9
OHRP Determination … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and What to Do About Continuing Reviews – Pt. 2 … p. 3

As we covered in part last month, the federal Office for Human Research Protections (OHRP) has recently issued another guidance on IRB compliance with the newly revised Common Rule on protecting human subjects. The guidance is titled “2018 Requirements FAQs – IRB Review.” This guidance addresses the status of continuing IRB reviews in light of the new Common Rule. The guidance is an “FAQ” (i.e., “Frequently Asked Questions”) document. As a brief reminder, note that this FAQ begins with:

[Q] How should IRBs approach the continuing review of research that remains active beyond long-term follow-up or data analysis, but that is eligible for expedited review under categories 8(b) or 9 of the 1998 OHRP Expedited Review List in light of the new provision at §46.109(f)(1)(i) of the [new and now final] 2018 Requirements, which eliminates the requirement for such continuing review unless an IRB determines otherwise?” (guidance, January 16; on the Web at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html).

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IRBs and Research With Human Specimens – Pt. 2 … p. 4

We continue here with a topic of vital importance to IRBs, researchers, and research subjects; namely, new interpretations, uses, and reviews of informed consent. Due to unusually active human subject protection compliance developments in recent months, we’ve had to temporarily halt our presentation of one particular aspect of informed consent.

We now present that aspect as it is addressed in a set of recommendations from the Secretary’s Advisory Committee on Human Research Protections (or SACHRP) titled “Attachment C – FAQs [Frequently Asked Questions], Recommendations, and Glossary: Informed Consent and Research Use of Biospecimens and Associated Data.”

These recommendations are contained in an attachment that is one of a series of four separate attachments, each addressing a different topic, that are now under consideration by the Secretary of Health and Human Services. Many SACHRP recommendations end up in regulations and/or in HHS policies that affect IRB research reviews.

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IRBs and New Exemptions From Required Review – Pt. 3 … p. 6

We continue here with more of the explanations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP) regarding the new exemptions from IRB review contained in the revised Common Rule (aka the “2018 Requirements”).

As we noted last month, SACHRP points out that the number of exemptions from subject protection regulations (and the related need for IRB reviews) has been increased to eight in the new Common Rule.

In addition, the wording and interpretation of exemption Categories 1 and 2 have been modified, although they have retained their primary areas of
focus.

We ended last month’s article on this topic by presenting SACHRP’s discussion and recommendations to IRBs regarding the changes to Exempt Category 1. We resume now with SACHRP’s recommendations on Exempt Category 2 as addressed by the newly revised Common Rule (or “2018 Rule”).

Part of these recommendations contain Questions and Answers (Q&As).

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