Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 9, September, 2018

Back Issues

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

Pregnant Women As Subjects

IRBs and Their Meeting Minutes … p. 3
IRBs and Pregnant Women As Subjects … p. 4
IRB Reviews That Are Not Needed … p. 5

Subject Protections and Acceptable Data … p. 6
IRBs and New “Broad Consent” … p. 7
In Congress: Senator Investigates OHRP … p. 8
FDA: Noncompliant IRB Is Replaced … p. 9
OHRP: Alleged IRB Reporting Failure … p. 10
In Court: Support for University Immunity … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRB Minutes Covered in Joint Agency Guidances – Pt. 9 … p. 3

As we have been presenting for several months, the current joint FDA and OHRP guidance on IRB meeting minutes issued a few months ago contains numerous specific recommendations for how to document IRB protocol reviews for various types of studies.

For example, we have already described the agencies’ latest advice on IRB minutes when medical device studies are involved, when emergency research is involved, and when expedited IRB reviews are relevant.

This month, we resume where we left off last month in our coverage of IRB minutes, with attention to problems and possible termination of IRB approval of a study.

The following presentation of IRB problems and noncompliance by researchers concludes our presentation of the joint OHRP/FDA guidance section titled “B. (Actions Taken by the IRB) 3. (Other IRB Regulatory Determinations and Review Responsibilities).


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

We continue here with advice for IRBs and others from the FDA as contained in its recent guidance titled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” This month, we present more of FDA’s recommendations on “Research-Related Risks” as they appear in the guidance’s “Section III – Ethical Considerations.”

We begin by resuming where we left off, where the FDA describes differences between research related risks and those risks not associated with the research. Risks not associated with the research are usually not a concern of IRBs.

At the conclusion of our article in the July issue, we presented FDA’s example of a study in which a researcher wished to measure the pharmacokinetics of a particular selective serotonin reuptake inhibitor (SSRI) during pregnancy. The researcher then enrolls pregnant women with a history of depression who are already being treated with the SSRI.


IRB Review Not Needed Before Seeking Funds – Pt. 2

As we described last month, the federal Office for Human Research Protections (OHRP) recently issued a series of three new draft guidances. Those guidances addressed three aspects of research with human subjects and IRB reviews of same. Those three aspects are: (1) reviewing protocols before seeking federal funding; (2) continuing IRB reviews; and (3) what research is covered by the human subject protection regulations.

With this article we conclude our highlights coverage of the new “2018 requirements” on eliminating the need for IRB reviews before seeking funds. We resume where we left off, noting that subsequent “certification” is still required before starting a covered study.

“Under no condition shall research covered by 45 CFR 46.103 be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB (45 CFR 46.103(d))” (“Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirement,” July 19, underline emphases added; available on the Web via‎.