Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 12, December, 2019

Back Issues

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

Research on Preventing Pregnancy

IRBs and Research on Preventing Pregnancy … p. 3
IRBs and Use of “HIPAA Exemption” … p. 4
IRBs and Expanding Study Subject Eligibility … p. 5

IRBs, Postmarketing Studies, and New Trials … p. 6
IRBs and Fabry Disease Experiments … p. 7
Protecting Human Subjects and FDA … p. 8
Protecting Human Subjects Is Goal … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: California Physician … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Research Products
For Preventing Pregnancy – #2 … p. 3

We continue here with an IRB topic that we introduced last month (see November HRR, p. 6); namely, primary safety and efficacy issues in experiments with drugs that are designed to prevent pregnancy. As has been emphasized in the compliance field, both subject safety and study efficacy are important topics for IRB reviews.

As we also introduced last month with this topic, the relevant FDA guidance describes various human subject selection criteria and study design features that are just as relevant for IRB reviews.

We continue here with FDA recommendations on what to do to enhance the usefulness of subjects’ participation, and how to help ensure that their participation leads to valid results.


IRBs and Recommendations on
Use of “HIPAA Exemption” – #9 … p. 4

For IRBs, the “HIPAA Exemption” can save a lot of IRB resources for applicable types of “secondary research” that is not covered by the many restrictions contained in the Common Rule (e.g., see the September HRR, p. 7 and preceding related HRR articles).

However, it is also true that the “HIPAA Exemption” has many facets and IRBs must heed various requirements to appropriately skip protocol reviews.

This month, we continue with presentation of the “HIPAA Exemption” recommendations issued by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) for IRBs, researchers, and others. Last month, we introduced the recommendations’ section titled “Business Associates under the HIPAA Exemption” since it addresses one aspect of possible relationships that can exist between researchers and colleagues that affects IRBs.


IRBs and Expansion of Study
Subject Eligibility Criteria – #5 … p. 5

We continue here with more coverage of a recent guidance released by the FDA that is titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”

This guidance contains detailed recommendations on how researchers and IRBs can increase the diversity of human subject pools.

Subject diversity continues to be encouraged by FDA and the largest single funding source for human subject studies (i.e., the National Institutes of Health, or NIH).

Obviously, such subject diversity can significantly increase the probable applicability of study results.