Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 8, August, 2019

Back Issues

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

Eligibility Criteria

IRBs and Human Subject Eligibility Criteria … p. 3
IRBs and Activities Not Considered Research … p. 4
IRBs and New “Broad Consent” Concept … p. 5

IRBs and Which Regulations Apply Now … p. 6
IRBs and Use of “HIPAA Exemption” … p. 7
IRBs and Enrolling Younger Subjects … p. 8
In Congress: IRB Regulations & Ethics … 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 Expansion of Study Subject
Eligibility Criteria – #2 … p. 3

As we introduced last month, the FDA has released a new guidance titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.” The new guidance addresses numerous topics highly relevant for IRBs and researchers.

We resume here where we left off, where the guidance points out that many potential research subjects are excluded from experiments due to worries over human subject safety.

In addition to protecting participant safety, the exclusion of certain patients on multiple medications or with multiple comorbidities is sometimes intended to avoid noise in the safety data.


IRBs and Activities Not Considered
as Research – #2 … p. 4

With this article we conclude our presentation of a topic that we introduced in the May HRR. That area concerns several types of research that we do not often cover in HRR. The area in question deals with experiments that are not biomedical or behavioral in nature. Such studies cover professional disciplines that do not frequently appear in our “In Court” or “In Congress” features either.

Said disciplines can include basic science (chemistry, biology, physiology, etc.), education, sociology, psychology, political science, economics, journalism, and other endeavors seldom associated with personal injury, malpractice, misconduct, or violation of Constitutional rights of human subjects.

Nevertheless, such areas certainly can pose threats to personal or group privacy, reputations, livelihoods, and other important aspects of human activity. Hence, some federal human subject protection regulations do apply, and affected IRBs need to heed the relevant regulations.


IRBs and New “Broad Consent”
Concept – #6 … p. 5

We continue here with presenting key elements of the new “broad consent” feature of the newly revised Common Rule. As we have noted previously, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) released a document on this topic titled “Attachment C – Recommendations for Broad Consent Guidance.”

This was part of a series of SACHRP recommendations for IRBs and researchers (see past HRRs).

Before proceeding, note that “broad consent” is not – so far – being used in a particularly wide sense for multiple types of human studies. That is, it is being implemented with specific regards to the storage, maintenance, and possible use of “identifiable information” and “biospecimens.”

We resume here where we left off last month (see July HRR, p. 3) with a special SACHRP reminder about a human subject’s possible consent.