Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 4, April, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and HIPAA Review Exemption … p. 3
IRBs and Research on Prisoners … p. 4
IRBs and Certificates of Confidentiality … p. 5
IRBs and Human Gene Therapy Studies … p. 6
IRBs and Multisite Studies … p. 7
IRBs, Subject Safety, and COVID-19 … p. 7
Compliance Comment Deadlines & Notices … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: California 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 Use of HIPAA Review Exemption – #13 … p. 3
With this article, we near completion of our highlights’ presentation of an important set of recommendations for IRBs and researchers that is titled “Attachment B – Recommendations on the Interpretation and Application of §__104(d)(4) the ‘HIPAA Exemption’.”
These recommendations by the influential Secretary’s Advisory Committee on Human Research Protections (SACHRP) will likely lead to one or more new federal research compliance regulations or policies for researchers and research institutions to follow.
The current version of these SACHRP recommendations (now being reviewed by the Department of Health and Human Services (HHS)) is on the Web at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-december-12-2017/index.html).
IRBs and Research On Prisoners – #3 … p. 4
We continue here with our ongoing coverage of a disturbing development involving an IRB and research with prisoners.
As we have presented previously, the health care research component of the consumer advocacy group Public Citizen first made this situation public a few months ago, in late November. Public Citizen did this via an open letter to Admiral Brett Giroir, M.D., the Acting Commissioner of FDA.
This series of allegedly unethical research projects is described in the document 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, FDA, and Certificates Of Confidentiality
(CoCs) – #6 … p. 5
We continue here with CoCs and how IRBs should review their proposed or actual use in human subjects research.
In our last two articles in this area we have addressed the advice given by FDA on what informed consents should include – or not include – about the nature and use of any CoC that a researcher might use.
The relevant FDA guidance is titled “Certificates of Confidentiality [CoCs]: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” It is available on the Web at https://www.fda.gov/media/132966/download.