Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 7, July, 2019

Back Issues

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

Broad Consent

IRBs and “Broad Consent” Concept … p. 3
IRBs and Which Regulations Apply … p. 4
IRBs and HIV Research With Children … p. 5

IRBs and Recommendations on Use of “HIPAA Exemption” … p. 6
IRBs and New Informed Consent Alterations
and Complete Waivers … p. 7
In Congress … p. 9
FDA Warning … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and New “Broad Consent” Concept – #5 … p. 3

We continue here with one of the most significant changes to informed consent in human subjects research in years; namely, the introduction of “broad consent” to the research compliance community.

As we have noted previously, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has released a document on this topic that is titled “Attachment C – Recommendations for Broad Consent Guidance.”

The recommendations explain the reasoning behind “broad consent” and how it is likely to be monitored by federal agencies and IRBs, based on the revised Common Rule (aka, the “2018 Requirements”).

We find the SACHRP’s descriptions of how earlier proposals on “broad consent” (e.g., in the original Notice of Proposed Rulemaking,” or NPRM) to be particularly instructive. Why? Because said descriptions make it easier to understand how to use – or not use – broad consent and to assist IRBs in reviewing this new type of consent.


Which IRB Regulations Apply, And for How Long? – #3 … p. 4

As we have presented previously, the federal Office for Protection from Research Risks (OHRP) recently issued a draft guidance to help IRBs and others to decide which version of federal regulations apply to their work (e.g., see April HRR, p. 3). Possible confusion is due to the recent finalization of the revised Common Rule on protecting human research subjects, or the “2018 Requirements.”

In particular, the “delay period” between July 19, 2018, and January 21, 2019 is the focus of OHRP’s guidance titled “The Revised Common Rule Compliance Date and Transition Provision.”

Of course, that “delay period” has come and gone. So why the guidance? The guidance remains relevant because of requirements for certain studies approved by IRBs in relation to that delay period.


IRBs and HIV Research With Children As the Subjects – #1 … p. 5

Children have long been recognized to constitute an especially vulnerable population of human research subjects. This is recognized in clinical trials and it is codified in special sections of the federal regulations on the protection of human subjects.

A recent finalized guidance from FDA contains recommendations for IRBs, researchers, and others active in planning, reviewing, and conducting a particular subset of pediatric research. That subset is research on pediatric HIV treatment. The guidance in question is titled “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment.”

This guidance is based on comments submitted to FDA after its release on May 14, 2018, of a previous draft version titled “Pediatric HIV Infection: Drug Development for Treatment.”