Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 7, July, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and Developing Drugs and Biologics During COVID-19 … p. 4
IRBs and “Re-Consent” of Human Research Subjects … p. 5
IRBs and Expansion of Study Subject Eligibility Criteria … p. 6
IRBs and COVID Restrictions on Research and Study Protocols … p. 7
Compliance Comment Deadlines & Notices … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: Florida 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 Developing Drugs and Biologics
During COVID-19 – #1 … p. 4
The research compliance spotlight has focused recently on various ways that COVID-19 is affecting research and reviews of said research by IRBs. One aspect of this emphasis has been the findings by FDA and other agencies on how COVID-19 is affecting human subject recruitment and retention in general, problems with higher subject dropout rates due to virus fears, and other challenges for researchers and IRBs alike.
However, the study of the coronavirus itself poses numerous challenges for research compliance professionals as well. Recommendations on topics to heed for IRB members in such research can be found in a new guidance published by FDA.
Although the term “Institutional Review Board” does not appear in the title of this particular guidance, we found it sufficiently full of relevant compliance areas for IRBs. The guidance is titled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention” (May).
IRBs and “Re-Consent” of Human
Research Subjects – #6 … p. 5
We continue here with the new recommendations for IRBs from the influential Secretary’s Advisory Commission on Human Research Protections (or SACHRP) regarding informed consent. We resume with the SACHRP’s advice on “re-consent.”
This issue has always been a challenging one for IRBs. However, the coronavirus has heightened interest in it because of the changing nature of some studies due to the advent of COVID-19 and what it means to certain subjects already enrolled in applicable studies.
Setting aside the virus for a moment, though, we note that the issue of “re-consent” is relevant for any research with human subjects when new information becomes available during a clinical trial.
This recent advice for IRBs and researchers is contained in a SACHRP document titled “Attachment A – New Information Provided to Previously Enrolled Research Subjects” (March 11; on the Web at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/april-7-2020-attachment-a/index.html).
IRBs and Expansion of Study Subject
Eligibility Criteria – #8 … p. 6
We continue here with our coverage of an FDA guidance that is part of a number of such guidances for IRBs and researchers on how to make studies relevant for more population groups.
The guidance is titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”
We resume with the final portions of the guidance’s section titled “Broadening Eligibility Criteria and Encouraging Recruitment for Clinical Trials of Investigational Drugs Intended to Treat Rare Diseases or Conditions,” as follows:
“Sponsors should therefore consider the following approaches (and others as appropriate) to broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and improve the enrollment and retention of participants with rare diseases: [see below for specifics]” (guidance, June, 2019, p. 9; on the Web at https://www.fda.gov/media/127712/download).