Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 11, November, 2020

Back Issues

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

Infection Research with Children

IRBs and Infection Research With Children … p. 3
IRBs and Parental Permission for Children … p. 4
IRBs, COVID, and Developing New Drugs … p. 5

IRBs and “Live Case Presentations” … p. 6
IRBs and Research With Neonates … p. 7
IRBs and Research on Prisoners … p. 8
FDA Warning To: Houston, TX IRB … p. 9
In Court: Wade v. Oregon Health Sciences Univ. … p. 10
Compliance Comment Deadlines & Notices … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Infection Research With Children
as Subjects (#1) … p. 3

IRBs continue to face special challenges when reviewing protocols that involve children as the research subjects. One area that recently received attention from FDA is the participation of children in infection research.

The relevant new draft guidance is titled “Development of Anti-Infective Drug Products for the Pediatric Population.” As the following summary shows, this new guidance covers several topics of major importance for IRB reviews of any applicable studies.

The guidance addresses initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development (85 Fed. Reg. 39193, June 30).


IRBs and Parental Permission In Research
With Children (#1) … p. 4

IRBs have traditionally faced a number of challenges when reviewing protocols that involve the participation of children as the research subjects.

Both HHS regulations, and the separate ones for FDA-regulated products, contain specific directions for how informed consent is to be sought in such studies.

For example, an IRB may approve research that falls into three categories, and HHS must convene a panel of experts to review any proposed study that does not fit any of the three allowable conditions.

HHS is currently reviewing new recommendations for IRBs and researchers on particular aspects of research involving children. These recommendations were submitted to HHS in late 2018 and are still under review at HHS.


IRBs and Developing Drugs and Biologics
During COVID-19 (#5) … p. 5

In concluding last month’s article on highlights of FDA’s guidance titled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” we presented recommendations on clinical trial endpoints to use when designing relevant human subject studies. We refer applicable IRBs and researchers to pages 9-10 of that guidance for additional endpoint selection choices.

For the present article, we move on to the draft guidance’s section addressing a topic of equally immediate use to IRBs; namely, recommendations on ways to ensure the safety of human subjects, as follows:

“D. Safety Considerations
Sponsors of drugs to treat or prevent COVID-19 should consider the following:

• It is important to include a broad population of subjects in adequate and well-controlled clinical trials to generate a safety database that will best inform the safe use of the drug (guidance, May, p. 10; on the Web at