Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 6, June, 2018

Back Issues

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

Informed Consent Requirements Delayed

IRB and Informed Consent Requirements Delayed Again … p. 3
IRBs and Pregnant Women as Human Research Subjects … p. 6
IRBs and Exemption From Their Review … p. 8

FDA: IRB Noncompliance in Four Different Areas … p. 9
OHRP: IRB Continues to Explain How It Will Better Protect Subjects … p. 10
In Court: Defendants Claim That Study Was Vital and Should Continue … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRB and Informed Consent Requirements Delayed – Pt. 2 … p. 3

As we described last month, the delay in implementation of the new Common Rule for protecting human research subjects has been delayed … sort of. We continue here in this article with more of the federal explanation of what is delayed, and what isn’t.

We find at least some of this explanation to be moderately confusing. As a result, we have reformatted the quoted material from the FEDERAL REGISTER announcement about the new Common Rule to a greater extent than usual. Hopefully, it will make it easier to understand what is going on with the “old” pre-2018 requirements (especially for IRBs) versus the “new” 2018 Rule by separating various explanations.

In addition, we have also highlighted a considerable amount of material by underlining the points that we consider to be most important. We begin by continuing from where we left off last month, with the delayed Common Rule’s announcement about burden-reducing provisions for IRB members.


IRBs and Guidance on Pregnant Women as Study Subjects – Pt. 2 … p. 6

As we first described in last month’s HRR, the FDA is encouraging the inclusion of more pregnant females as human subjects in clinical trials. This appears to be due to at least two reasons.

First, due to special vulnerabilities, there is a scarcity of reliable experimental data about the effectiveness and safety of many pharmaceutical products when administered to pregnant women – including even commonly prescribed and otherwise approved products.

Second, again due to special considerations, pregnant women may react differently to both common and experimental products, yet the lack of reliable data means health care professionals simply may not be able to select the best solutions to medical problems without sufficient guidelines.

Hence, on April 9, FDA issued a new draft guidance useful for researchers and IRBs, titled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” We resume here where we left off last month, as follows.


IRBs and Exemption From Their Review – Pt. 3 … p. 8

We continue here with recommendations submitted to HHS by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) regarding “benign behavioral interventions.” Currently under review by HHS, these recommendations describe how such studies can be exempt from IRB review according to §___.104(d)(3)(i) in the new 2018 “Common Rule.”

These recommendations that would affect IRBs come in the form of a Question-and-Answer (Q&A) format. We resume here from where we left off last month with:

“7. Does the human subjects research involve means of collecting data limited to 1) verbal (oral) or written responses by the subject, 2) data entry by the subject, or 3) observation of the subject, including audiovisual recording?

(If no, [the research is] not exempt [from IRB review])” (“Attachment B – Recommendations on Benign Behavioral Interventions,” SACHRP letter, August 2, 2017; on the Web at