Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 5, May, 2019

Back Issues

Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.

Research on Rare Diseases

IRBs and Research With Human Specimens … p. 3
IRBs and Research on Rare Diseases … p. 4
IRBs and Use of “HIPAA Exemption” … p. 5

IRBs and Risks of In Vitro Research … p. 6
IRBs and Enrolling Younger Study Subjects … p. 7
IRBs and Activities Not Needing Review … p. 8
In Congress … 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 IRBs as it is addressed in one set of recommendations from the Secretary’s Advisory Committee on Human Research Protections (or 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).

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.


IRBs and Many Not-So-Rare Diseases and Conditions – #1 … p. 4

With this article we begin a short series of articles on a special human subjects area that – in our opinion – does not often receive the kind of attention from IRBs, researchers, and research entities that it merits.

That area concerns rare diseases. Perhaps this is due to the use of the word “rare.” While specific rare diseases and conditions may not affect a large number of patients and human subjects on their own, FDA points out that the overall numbers of people with rare diseases is quite substantial. Hence, we believe that this area is worthy of more consideration by the research compliance community.

“There are approximately 7,000 recognized rare diseases. Individually, rare diseases affect a small number of people, but collectively rare diseases affect about 1 in 10 people in the United States[!] Most rare diseases have no approved therapies and thus present a significant unmet public health need” (84 Fed. Reg. 11111-11112 at p. 11112, March 25).


IRBs and Recommendations on Use of “HIPAA Exemption” – #4 … p. 5

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 Common Rule (aka the “2018 Requirements”).

As we have noted before, the SACHRP’s recommendations on human subject protections – and on IRB operations in particular – continue to be one of the most useful resources available for IRBs.

In our view, this is due largely to the facts that SACHRP discussions and recommendations usually:
(1) go far beyond the often sparse wording of federal regulations to include actual practical examples and protocol review details for IRBs’ benefit; (2) are based on significant input from professionals with viewpoints from different disciplines around the country representing multiple institutions and organizations; and (3) often end up as actual regulations – or at least influence eventual regulations – and are therefore unusually relevant for IRBs.