Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 11, November, 2019

Back Issues

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

Research With Neonates

IRBs and Expanding Eligibility for Subjects … p. 3
IRBs and Research With Neonates … p. 4
IRBs and Which Regulations Apply … p. 5

IRBs and Research on Preventing Pregnancy … p. 6
IRBs and “Live Case Presentations” … p. 7
IRBs and Fabry Disease Experiments … p. 8
IRBs and Research With Prisoners … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: California Physician … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Expansion of Study Subject
Eligibility Criteria – #4 … p. 3

We continue here with more coverage of a recent guidance released by the FDA titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.” This new guidance contains numerous recommendations on study design and human subject selection that are highly relevant for IRBs and affected researchers.

As we last saw in the September HRR (p. 5), this guidance’s section on “Trial Design and Methodological Approaches” began by describing how researchers could vary their human subject populations by minimizing exclusion criteria.

This is especially important when young or elderly subjects may be involved, since it poses additional considerations for IRBs that review relevant protocols.


IRBs and Research With Neonates – #2 … p. 4

We continue here with recommendations for IRBs and researchers regarding an area of human subjects research that poses special challenges. The research in question involves studies with neonates.

We resume here where we left off last month; namely, with more details on the kinds of studies that could be determined by IRBs to have been conducted prior to launching any neonatal studies on the same experimental materials. This would be one way to minimize safety concerns with neonates, as follows.

“Leveraging knowledge and data obtained from adult, preclinical, and other pediatric studies coupled with innovative quantitative approaches can help predict neonatal doses and optimal clinical trial designs.


IRBs and Which Regulations
Apply For How Long – #7 … p. 5

We continue here with highlights from a guidance issued by the federal Office for Human Research Protections (OHRP). This guidance addresses an area that we find somewhat confusing; namely, what should IRBs do about protocols approved before the revised Common Rule (aka “2018 Requirements”) went into effect, or during the “delay period” before said Rule became effective, or after the Rule became effective?

The relevant guidance from the federal Office for Human Research Protections (OHRP) is titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)) January 2019.”

We resume our coverage by briefly repeating what the guidance says about consent forms and what happens when a current study (i.e., one previously approved by an IRB) is “transitioned” to be governed by the new “2018 Requirements.”