Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 1, January, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and Charging Research Subjects … p. 3
IRBs and Research On Prisoners … p. 4
IRBs and Use of HIPAA Exemption … p. 5
IRBs and “Live Case Presentations” … p. 6
IRBs and Certificates of Confidentiality … p. 7
IRBs and New NIH Requirements … p. 8
IRBs and Study Results Database … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: California Researcher … 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 Charging Subjects To Participate
in Studies – #1 … p. 3
The primary influential national group on protecting human subjects has issued a new set of recommendations for use by IRBs, researchers, and others. The group is the “Secretary’s Advisory Committee on Human Research Protections” (SACHRP). Their latest advisory document is titled “Considerations Surrounding Charging Subjects to Participate in Clinical Trials.”
This latest SACHRP guidance was enclosed as an “Attachment A” to a letter sent to Alex Azar, Secretary of Health and Human Services, on November 20, 2019. This new set of recommendations could be viewed as a companion work to the SACHRP recommendations released earlier that was titled “Attachment A – Addressing Ethical Concerns – Offers of Payment to Research Participants” (September 30; on the Web at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-september-30-2019/index.html).
IRBs and Research On Prisoners – #1 … p. 4
So far, no lawsuit has been filed, as far as we know. Therefore, the series of articles that we start this month does not appear in our traditional “In Court” section. Nor has the situation yet led to a “Warning Letter” being issued by the FDA. Hence, similarly, these articles do not appear in our “Warning Letters” section.
However, the IRB and research compliance issues involved certainly warrant our attention by the HRR. The ethical and regulatory issues in question center on research with prisoners, the longstanding required elements of informed consent, and whether or not an IRB review is required for any proposed human subjects research.
We will present key portions of relevant documents in future issues of the HRR. In the meantime we present here the highlights of a recent press release from the nationally-based consumer advocacy group known as Public Citizen, as follows below.
IRBs and Use of HIPAA Review Exemption – #10 … p. 5
As we have been describing, the revised “Common Rule” on protecting human subjects has produced dozens of major changes for IRBs and their protocol reviews. One significant example is the new “HIPAA Exemption” on waiving IRB reviews.
However, as we’ve also seen, there are a number of qualifications to the “HIPAA Exemption.” Hence, we present here another in the advice series issued by the influential Secretary’s Advisory Committee on Human Research Protections (aka SACHRP).
This particular SACHRP series was initially released a little over a year ago, and we continue to examine and present their ongoing recommendations in this and other human subject protection areas.