Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 5, May, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
FDA’s Advice for IRBs on the Coronavirus … p. 3
IRBs and Research on Prisoners … p. 4
IRBs and Charging Research Subjects … p. 5
IRBs and “Live Case Presentations” … p. 6
IRBs, NIH, and Dealing With COVID-19 … p. 7
IRBs and New Consent Alterations/Waivers … 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 FDA’s Advice on Coping With
Coronavirus … p. 3
As described in the preceding lead article in this HRR, the Coronavirus continues to impact human subjects research along with most activities. In addition to the guidance being provided to IRBs, researchers, and others by the federal Office for Human Research Protections (OHRP), FDA has similarly issued a new guidance for IRBs.
FDA’s new guidance is titled “FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards.” The FDA guidance, also cited by the more general OHRP guidance, contains a considerable amount of details of immediate use for IRBs.
Given the extent of FDA’s 16-page document, we shall present its key highlights in a series of consecutive articles. With this first installment, we begin with the “Background” section that includes a description of the types of virus-related problems that are impacting IRBs.
IRBs and Research On Prisoners – #4 … p. 4
We continue here with our coverage of an ongoing development involving human subjects, a drug developer, and the apparent absence of IRB approval for the controversial studies.
The research involved administration of an experimental drug to prisoners who allegedly did not realize what had happened to them. The drug involved was naltrexone, and it was allegedly administered in a manner not approved by the FDA.
Accordingly, the consumer advocacy group Public Citizen petitioned the FDA for the launch of an investigation, the halting of any further studies, and other corrective measures.
The document we are highlighting is titled “Company Tested Unapproved Implanted Drug on Louisiana Prisoners in Apparent Illegal Clinical Trial; FDA Must Investigate” (November 20, 2019; on the Web at https://www.citizen.org/news/company-tested-unapproved-implanted-drug-on-louisiana-prisoners-in-apparent-illegal-clinical-trial-fda-must-investigate/).
IRBs and Charging Subjects to Participate
in Research – #2 … p. 5
We continue here with an unusual topic for IRBs; namely, the issues involved with the increasing number of studies in which the human subjects are charged for their participation.
These types of studies pose atypical ethical issues for IRBs regarding the fairness and the appropriateness of any fees being charged to the human subjects.
The fact that such studies are increasing was acknowledged by the Secretary’s Committee on Human Research Protections (SACHRP) in their recent guidance titled “Attachment A- Charging Subjects for Clinical Trial Participation.”
As is customary for the SACHRP, this particular attachment was part of a letter of related recommendations for IRBs and researchers, submitted to the Department of Health and Human Services (HHS) by the SACHRP.