Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 5, May, 2018

Back Issues

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

Volume 33, No. 5, May, 2018 - back issues

IRBs and Guidance on Pregnant Women as Study Subjects … p. 4
IRB Minutes Covered in Agency Guidances … p. 5
IRBs and Exemption From Their Review … p. 6

IRBs and Investigational In Vitro Diagnostic (IVD) Studies … p. 7
In Congress: IRBs’ Involvement Is Crucial … p. 8
FDA: IRB Minutes Are Too Brief … p. 9

OHRP: University Admits Rule Violations … p. 10
In Court: Experiment at Heart of Multisite Lawsuit Was Federally Funded … p. 11
In Agencies & Organizations … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Guidance on Pregnant Women as Study Subjects – Pt. 1 … p. 4

For many years, IRBs have needed to heed the special federal regulations on the involvement of pregnant women and/or fetuses in clinical trials. For a variety of reasons, the risk-benefit ratio of whether or not to include such vulnerable subjects in experiments has posed special considerations for IRBs that review related protocols. The traditional IRB responsibilities, and special considerations, in this area of human subjects research is now changed somewhat as FDA pushes for more research involving pregnant women.

“FDA is announcing the availability of a draft guidance for industry entitled “˜Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.’ Currently, collections of safety data on prescription drugs and biological products used during pregnancy usually occurs after approval, and clinicians and patients must undertake a risk-benefit analysis for the use of such products in pregnant women with limited human safety information” (83 Fed. Reg. 15161-15162 at p. 15162, April 9, underline emphasis added).


IRB Minutes Covered in Joint Agency Guidances – Pt. 6 … p. 5

Of the two recent joint guidances on IRB minutes issued by FDA and OHRP, we are presenting portions of the FDA version. Note that this guidance presents practical and useful details on how IRBs should address a variety of topics in their minutes.

For example, in the present article we conclude FDA’s recommendations on how to address certain informed consent issues. We will conclude this article by beginning to discuss recommendations on what to do about research involving children in IRB minutes. We will conclude our presentation of the IRB minutes’ issues with children in next month’s installment on this topic.

First, however, we pick up where we left of with last month’s coverage of informed consent areas.

“Both OHRP and FDA regulations permit an IRB to waive the requirement that the subject or the subject’s LAR sign a written consent form if the IRB determines that certain criteria are met (45 CFR 46.117(c); 21 CFR 56.109(c) and (d)). We recommend that any such waiver of documentation of informed consent be documented in the minutes or other IRB record” (“Minutes of Institutional Review Board (IRB) Meetings – Guidance for Institutions and IRBs,” September, 2017, p. 6 of 13, underline emphasis added; on the Web at


IRBs and Exemption From Their Review – Pt. 2 … p. 6

We continue here with certain recommendations on protecting human subjects currently being considered by the Department of Health and Human Services (HHS). These particular recommendations regarding “benign behavioral interventions” were submitted to HHS by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) as part of a recommendation package for several human subject protection areas addressed by the committee.

In last month’s HRR we presented Part 1 of this coverage of studies that may be exempt from IRB review (see April HRR, p. 6). We resume here with more of the “Question and Answer” (Q&A) format used by the SACHRP on possible IRB review exemptions, beginning with Q&A #4.

“4. Does the nature of the research enable prospective agreement to participation by the subject; and, if so, is such prospective agreement required?

(If no, not exempt)” (“Attachment B – Recommendations on Benign Behavioral Interventions, SACHRP letter, August 2, 2017; on the Web at