Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 10, October, 2018

Back Issues

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

New “Broad Consent” Option

When Continuing IRB Reviews Not Needed … p. 3
IRBs and Guidance on Pregnant Subjects … p. 4
IRBs and New “Broad Consent” Option … p. 5

IRBs and New Meeting Minutes Guidance … p. 6
IRBs and Subject Risks in IVD 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

Conditions When Continuing IRB Review Not Needed – Pt. 2 … p. 3

With this article we conclude our coverage of one of three guidances recently issued by the federal Office for Human Research Protections (OHRP). This particular guidance addresses when continuing IRB reviews are not needed, under certain circumstances.

Of the other two guidances, we concluded our coverage of “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements” with our September HRR. We will present the remaining guidance titled “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements” in the near future.

We now resume our coverage of the continuing IRB review topic where we left off last month on pages 1-2.

Changes to Continuing IRB Review

Research for Which Continuing Review Is Not Required

For the categories of research described below, unless the IRB determines otherwise, continuing review is not required. If the 2018 Requirements indicate that continuing review is not required for a study and the IRB does not determine otherwise, the IRB does not need to document that fact.


IRBs and Guidance on Pregnant Women as Study Subjects – Pt. 5 … p. 4

We continue here with our coverage of a recent FDA guidance titled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” As noted previously, the guidance contains a significant amount of information for IRBs and researchers.

The guidance signifies a change in federal and compliance community involvement with such vulnerable subjects. For example, as presented in last month’s HRR, the guidance’s section titled “C. General Guidelines for Including Pregnant Women in Clinical Trials” describes the circumstances in which FDA considers it ethically justifiable to include pregnant women in clinical trials (see September HRR, page 4).

In the present article, we conclude that section and move on to other key features of such research.

Studies With Pregnant Subjects
Can Be Ethically Justified

Last month we ended with a presentation of such research in the “postmarketing setting.” We resume our coverage with FDA’s opinion that such trials are also ethical in the following circumstances:

“In the premarketing setting (i.e., investigational drugs)


IRBs and the New “Broad Consent” Concept – Pt. 2 … p. 5

One of the new features in protecting human subjects is the concept and implementation of “broad consent.” We have been excerpting key portions of recommendations on broad consent as issued by the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

As we have often reported in the past, recommendations by the SACHRP frequently end up as new regulations and/or policies by federal agencies on the protection of human research subjects.

The SACHRP’s current recommendations on broad consent were released as “Attachment C – Recommendations for Broad Consent Guidance.” This document was one of several attached to a cover letter submitted to the Department of Health and Human Services.

Importantly, this attachment was issued with awareness of, and in concert with, the now final Common Rule on the protection of human subjects.

With this article, we resume coverage where we left off last month on this topic (see September HRR, page 7).