Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 6, June, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and Reviews During a Pandemic … p. 3
IRBs and “Re-Consent” of Human Subjects … p. 4
IRBs and Research on Prisoners … p. 5
IRBs and Expansion of Subject Eligibility … p. 6
IRBs and Reviews By a “Single IRB” … 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
IRB Protocol Reviews and Dealing With
Coronavirus Pandemic – #2 … p. 3
We resume here with more IRB issues related to the coronavirus pandemic and recommendations on how to deal with it.
As we introduced last month, the federal Office for Human Research Protections (OHRP) has released some recommendations for IRBs on what to do regarding various aspects of the pandemic.
For example, the longstanding protections afforded to human research subjects by a Certificate of Confidentiality (CoC) do not preclude law enforcement agencies from seeking research subject identity and other information (see April HRR, pp. 1-2).
Similarly, it is reported, the need to report COVID-19 cases is not barred by the existence of a CoC.
We resume here with OHRP’s advice to researchers and their IRBs stating that study personnel may change some procedures even without prior IRB approval.
IRBs and “Re-Consent” of Human
Research Subjects – #5 … p. 4
The Secretary’s Advisory Commission on Human Research Protections (SACHRP) has issued new recommendations for IRBs. Normally, such an event would warrant a lead article in the HRR.
However, as is distressingly obvious, these are not normal times. Hence, our two preceding HRR articles this month cover new developments affecting IRBs due to the coronavirus.
Nevertheless, since the SACHRP’s recommendations are designed to assist IRBs in an increasingly complex research compliance environment, we will present the SACHRP’s advice accordingly.
This month, we begin coverage of the SACHRP’s recommendations that were submitted on April 7 to Alex Azar, Secretary of the Department of Health and Human Services (HHS). As explained in the SACHRP cover letter, these recommendations are primarily for IRBs and affected researchers.
IRBs and Research On Prisoners – #5 … p. 5
We continue here with our coverage of drug experiments with prisoners. The experiments apparently were conducted without IRB approval. The drug involved was naltrexone, and it was allegedly administered in a manner and format not approved by the FDA.
The consumer advocacy group Public Citizen (PC) petitioned the FDA to halt any further studies.
Picking up where we left off in last month’s HRR (see p. 3), we resume with PC’s quote from the company press release by BioCorRx explaining the objectives of their experiment.
“Goal: Help those suffering and to illustrate the cost benefit of using the BioCorRx Recovery Program in lieu of incarceration of an individual for 6 months (including difficult to calculate costs of lost wages, cost to families, children without parent home, etc.) ….” (“Company Tested Unapproved Implanted Drug on Louisiana Prisoners in Apparent Illegal Clinical Trial; FDA Must Investigate,” November 20, 2019, p. 3; 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/).