Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 10, October, 2020

Back Issues

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

COVID Restrictions on Research

IRBs and COVID Restrictions on Research and Study Protocols … p. 4
IRBs and Developing Drugs During COVID … p. 5
IRBs, COVID, and Special Statistical Considerations … p. 6

IRBs and FDA’s Advice on Coping … p. 7
IRBs and Human Subject Privacy And Data Confidentiality … p. 8
Compliance Comment Deadlines & Notices … p. 9
FDA Warning To: Texas Physician … p. 10
In Court: Wade v. Oregon Health Sciences Univ. … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and COVID Restrictions on Research
and Study Protocols – #3 … p. 4

COVID-19 is continuing to change human subjects research in many ways, and to alter the operations of institutions and their IRBs that review such studies.

One effort designed to assist affected IRBs, researchers, and institutions is being spearheaded by the Council on Governmental Relations (or COGR).

We continue this month with a topic we introduced in the July HRR; namely, how institutions around the country are dealing with COVID impacts and how those experiences might help others involved in human subjects research.

The relevant new document by COGR is titled “Research Ethics & Compliance Committee – Human Subjects FAQs.” The document uses a “Frequently Asked Questions” (FAQ) format to offer practical examples of how IRBs and others are addressing the many COVID-caused challenges for human research projects throughout the country.


IRBs and Developing Drugs and Biologics
During COVID-19 (#4) … p. 5

We continue here with the FDA’s recent advice to researchers and others (e.g., IRBs) on conducting most types of human research involving drugs and biological products related to COVID-19. The guidance is titled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention” (see

This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2).

However, the recommendations and processes described in the guidance are expected to assist the Agency more broadly in its continued efforts to assist sponsors in the clinical development of drugs for the treatment of COVID-19 beyond the termination of the COVID-19 public health emergency and reflect the Agency’s current thinking on this issue (85 Fed. Reg. 29949-29951 at p. 29951, May 19).


IRBs and COVID: Statistical Considerations
in Studies – #2 … p. 6

We continue here with an area that we addressed last month that we do not often cover for IRBs and researchers. That area involves the use of statistics to help interpret the significance of experimental results in human studies.

The accuracy and appropriateness of whatever statistics a researcher might use has a direct bearing on the meaningfulness of his/her results.

By extension, the same characteristics of the statistics may impact whether or not any human subject risks were worth the subject’s participation in a study.

Since the safety and well-being of subjects are paramount responsibilities of IRBs, the area of statistics therefore is relevant for IRBs.

Hence, in this COVID crisis, the FDA has issued a new guidance titled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”