Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 8, August, 2020

Back Issues

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

Reviews of “Expanded Access” Protocols

IRBs, FDA, and Reviews of “Expanded Access” Protocols … p. 4
IRBs and COVID Restrictions on Research and Study Protocols … p. 5
IRBs and Expansion of Study Subject Eligibility Criteria … p. 6

IRBs and Certificates of Confidentiality … p. 7
Compliance Comment Deadlines & Notices … p. 8
In Congress: Research Regulations & Ethics … 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, FDA, and Reviews of “Expanded Access”
Protocols – #2 … p. 4

With this article we conclude presenting the highlights of FDA’s recent COVID-related guidance titled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency: Guidance for IRBs and Clinical Investigators.”

As is obvious from the title, the guidance contains practical advice for IRBs on the specific topic of “expanded access requests.” Such requests typically come from health care practitioners who wish to use an investigational product as a potential treatment for a patient.

This is in contrast to situations where researchers seek to administer an investigational product to a human research subject.

We resume here where we left off last month, with the following final excerpt from the guidance’s section titled “III. Recommendations on IRB Procedures and Factors to Consider for Individual Patient Expanded Access Requests.”


IRBs and COVID Restrictions on Research
and Study Protocols – #2 … p. 5

We continue here with the recent listing of “Frequently Asked Questions” (FAQs) titled “Human Subjects FAQs,” as issued by the widely respected Council on Government Regulations (or COGR). These recommendations and observations of “best practices” now in use by institutions throughout the country contain useful tips for IRBs.

We resume with more excerpts from COGR’s FAQ #1 titled “What criteria are institutions using to determine what clinical trials will be allowed to continue while COVID restrictions are in place?”

In all cases, the safety of the study subject is paramount, and the study sponsor and investigator (in consultation with the reviewing IRB as appropriate and required), must determine for each particular study that the participant’s ‘safety, welfare and rights is best served by continuing a study participant in the trial as per the protocol or by discontinuing the administration or use of the investigational product or even participation in the trial’ (“FAQs,” May 4, Version 1.0; on the Web at ON HUMAN SUBJECTS for REC final may 4 2020.pdf).


IRBs and Expansion of Study Subject Eligibility
Criteria – #9 … p. 6

We continue in this article with our coverage of the FDA guidance titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”

This guidance directly addresses several IRB protocol review areas, with a primary focus on human subject selection and retention of subjects once they are enrolled in clinical trials.

We resume with the final portions of the guidance’s section titled “Inclusion of Clinically Relevant Populations.” This portion of the guidance cites existing FDA documents of particular importance to IRBs and researchers.

This type of guidance document addressing experimental design, subject safety, and other topics continues to be useful for IRBs and researchers, regardless of the COVID-19 crisis.