Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 9, September, 2019

Back Issues

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

Estimates of Federal Burden

IRBs and New Consent Alterations/Waivers … p. 3
IRBs and New Estimates of Federal Burden … p. 4
IRBs and Expanding Subject Eligibility … p. 5

IRBs and Which Regulations Apply Now … p. 6
IRBs and Use of “HIPAA Exemption” … p. 7
IRBs and What Doesn’t Have to Be Reviewed … p. 8
IRBs and Enrolling Younger Subjects … 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 New Informed Consent
Alterations/Waivers Possible – #4 … p. 3

With this article, we continue our coverage of a proposed FDA rule that would grant IRBs official leeway to alter – or even completely waive – their review of certain clinical trials. Rather than waiting until FDA’s said proposal, in whatever form, becomes final and mandatory for IRBs, we continue in our longstanding policy of informing IRBs ahead of time about such possible developments rather than waiting until the last moment.

As we have reported in our last three articles on this development, FDA is proposing to modify the current IRB regulations. It is currently reviewing comments from the research compliance community prior to issuing a final rule. There appears to be no question that this proposal will make it easier for IRBs to review studies that present “no more than minimal risk to human subjects.”


IRBs and New Estimates of Agency
Record Keeping Burden … p. 4

The Food and Drug Administration (FDA) is proposing to revise its long-standing record keeping and reporting requirements on IRB procedures, informed consent, and other aspects of human subject protections. This is of more than passing interest to IRBs, researchers, and others.

Why? For at least two reasons. First, because any such changes will clearly change “business as usual” for IRBs. Second, said changes may affect resource allocation and personnel time for affected institutions.

How? FDA’s new projected changes to the time required to follow regulations may encourage institutions to reduce resource allocations for IRBs … if we assume that FDA’s time estimates are correct regarding the impact on IRBs.


IRBs and Expansion of Study Subject Eligibility Criteria – #3 … 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.”

As we have discussed, this new guidance contains numerous recommendations on study design and human subject selection that are highly relevant for IRBs and researchers.

As we saw in last month’s HRR, the guidance’s section on “Inclusive Trial Practices” advises study sponsors to “adopt practices for determining eligibility criteria that will allow the clinical trial population to reflect the diversity of the patients who will be using the drug if the drug is approved.”