Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 34, No. 6, June, 2019
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and Research With Human Specimens … p. 3
IRBs and Use of “HIPPA Exemption” … p. 4
IRBs and “Rare” Diseases and Conditions … p. 5
IRBs and Multiple IRBs and Rereviews … p. 6
IRBs and New “Broad Consent” Concept … p. 7
In Congress … p. 8
Noncompliance Complaints … p. 9
FDA Warning … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12
IRBs and Research With Human Specimens – #4 … p. 3
We continue here with a particular aspect of informed consent and IRB reviews of consent forms as they are addressed in one set of recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Those recommendations are contained in the document titled “Attachment C – FAQs [Frequently Asked Questions], Recommendations, and Glossary: Informed Consent and Research Use of Biospecimens and Associated Data.”
This SACHRP document is one of a series of four separate attachments, each addressing a different topic, that are now under consideration by the Secretary of Health and Human Services (HHS) for possible future regulations and/policy changes.
Last month, in the April HRR, we presented highlights of FAQ #3. In the present article, we present the initial portions of the next FAQ #4, as follows below.
IRBs and Recommendations on Use of “HIPAA Exemption” – #5 … p. 4
With this article we continue our presentation of explanations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP) regarding the new exemptions from IRB review contained in the newly revised Common Rule on human subjects.
This series of articles contains highlights from the SACHRP recommendations regarding HIPAA and IRBs. We resume where we left off last month on the different aspects of IRB reviews regarding private human subject information when the HIPAA exemption from IRB review may apply.
“Therefore, in the role prescribed for IRBs or Privacy Boards under 45 C.F.R. § 164.512(i) – a more limited role than convened IRB review – IRBs and Privacy Boards will serve as crucial gatekeepers of the HIPAA Exemption.
IRBs and Many Not-So-Rare Diseases and Conditions – #2 … p. 5
As we noted in last month’s article on this topic for IRBs, the term “rare” diseases is a misnomer, given the actual prevalence of such maladies. See p. 4 of our May issue for more background on the use of “natural history” studies on rare diseases, including special provisions for informed consent.
In the present article, we present other key portions of the FDA’s recently released guidance on this topic titled “Rare Diseases: Natural History Studies for Drug Development,” as follows.
“The focus of this guidance is rare diseases; however, the recommendations in the guidance may be applicable to drug development for nonrare diseases” (“Rare Diseases: Natural History Studies for Drug Development,” March, p. 1; on the Web at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-diseases-natural-history-studies-drug-development).