Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 3, March, 2018

Back Issues

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

Volume 33, No. 3, March 2018


IRBs and Investigational In Vitro Diagnostic (IVD) Device Studies … p. 3
IRBs and Direct v. Indirect Costs … p. 5
IRB Guidances on Meeting Minutes … p. 6

IRBs and Protecting Subjects’ Privacy … p. 7
IRBs and Reimbursing Human Subjects … p. 8
IRBs and Extrapolating Adult Results … p. 8

FDA: Unnecessary Risks for Study Subject … p. 9
OHRP: Investigated Researcher Criticizes Federal Agency Officials … p. 10
In Court: Defending Researchers and University Try to End Lawsuit … p. 11
Compliance Conferences & Courses … p. 12

IRBs and Investigational In Vitro Diagnostic (IVD) Studies – Pt. 3 … p. 3

We continue here with presenting a portion of a recent FDA guidance designed specifically for IRB members and others involved with certain medical device experiments. The title of the guidance is “Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards” (emphasis added to title).

As we noted last month, this FDA guidance (in contrast to many others) is open for compliance community comments for a full 90 days. Comments are especially due by March 19 to help ensure that comments can be considered in shaping the future final version. In addition, and as is generally true, FDA also announced that comments can still be submitted at any time.

For more information on the guidance, and how to submit timely comments, contact FDA’s David Litwack of the Center for Devices and Radiological Health at 301-796-6697. The original announcement about the guidance appeared in the FEDERAL REGISTER of December 18, 2017, at 82 Fed. Reg. 60022.

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IRBs and Direct Versus Indirect Costs – Pt. 2 … p. 5

We continue here with a topic we introduced in the January HRR (p. 8) based on a recent NIH guidance issued specifically for IRBs. The issue of using direct vs. indirect costs from grant funds to support IRB activities has long been a contentious issue in the research compliance community.

This problem has become more pronounced over the years as more and more reviewing, reporting, and record keeping duties have been placed on many IRBs. The 80+ changes proposed for the existing Common Rule on the protection of human subjects has brought this challenge for IRBs even more to the forefront.

Finally, what has made this issue even more prominent is the recent push by NIH to have only one IRB be the IRB of record in multisite studies. Who pays for what when in such studies?

Hence, and due to continuing questions from IRBs and others in the compliance community, NIH recently released a compilation of its procedures regarding direct costs vs. indirect costs for IRBs. The compilation takes the form of a “Frequently Asked Questions” (FAQ) document addressing what can and cannot be treated as a direct IRB cost.

We resume where we left off in January; i.e., with FAQ #4, as follows.

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IRB Minutes Covered in Joint Agency Guidances – Pt. 4 … p. 6

We continue here with recent joint guidances on IRB meetings’ minutes issued by FDA and OHRP. Our previous installments were in the October 2017 HRR (p. 7 as Pt. 1), December 2017 (p. 8 as Pt. 2), and January 2018 (p. 6 as Pt. 3).

Of the two guidances, we have chosen to present portions of the FDA’s version. We resume our coverage with:

“B. Actions Taken by the IRB The minutes of IRB meetings must be in sufficient detail to show the actions taken by the IRB at the convened meeting (45 CFR 46.115 (a)(2); 21 CFR 56.115(a)(2)). OHRP and FDA interpret “˜actions taken by the IRB’ (also called “˜IRB actions’) to refer to any vote taken by the IRB related to a proposed research activity.

Accordingly, to be in sufficient detail to show actions taken by the IRB, the minutes must provide sufficient information to identify the research activities being reviewed and voted on by the IRB at that meeting (e.g., initial review of protocol title/protocol number).

The minutes should serve as a central repository for IRB actions on proposed research activities” (“Minutes of Institutional Review Board (IRB) Meetings – Guidance for Institutions and IRBs,” September, 2017, p. 5 of 13, underline emphases added; see https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM470154.pdf).

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