Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 10, October, 2019

Back Issues

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

Opioid Studies

IRBs and “Key Information” in Consent … p. 3
IRBs and Which Regulations Apply … p. 4
IRBs and Risks-Benefits in Opioid Studies … p. 5

IRBs and Risk Issues in New Protocols … p. 6
IRBs and Research With Neonates … p. 7
IRBs and Fabry Disease Experiments … p. 8
IRBs and Human Subject Privacy … 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 “Key Information” In Informed Consent – #2 … p. 3

With this article, we continue our coverage of an area vital to any IRB review; namely, the adequacy of the informed consent for the human subjects participating in an experiment. Our focus here is on new consent requirements being activated by the revised Common Rule on protecting human subjects.

The specific recommendations that we present originated with the federally-sponsored Secretary’s Advisory Committee on Human Research Protections (SACHRP).

As we introduced with our initial article on this topic last month (see pp. 1-2, September HRR), the SACHRP has responded to a series of six questions posed to it by the federal Office for Human Research Protections (OHRP).


IRBs and Which Regulations
Apply For How Long? – #6 … p. 4

We continue here with presenting highlights of a federal guidance for IRBs and others regarding how to “transition” to the requirements of the revised Common Rule. In previous articles in this series we have described important new changes to informed consent and other IRB matters, and how different compliance dates affect current and past IRB reviews (e.g., see last month’s September HRR installment on p. 6).

The relevant guidance from the federal Office for Human Research Protections (OHRP) is titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)) January 2019.”

We continue here where we left off last month. At that point, we introduced the topic of IRBs’ “continuing reviews” whereby OHRP advised that there are circumstances in which an institution may need or wish to conduct continuing IRB reviews even when the regulations do not require it. In such instances, OHRP states, there are two “Pathways” that an IRB can follow. We presented Pathway #1 last month.


IRBs and Risk-Benefit Issues in
Opioid Research Protocols – #1 … p. 5

As we’ve said more than once, the best time to influence a regulation is before it is a regulation. Hence, we devote this article to an ongoing federal discussion on what to do about the “Opioid Epidemic.”

We do not focus on public policy or treatment/control of the involved substances, but on the research and human subjects issues important to IRBs.

This is due to the fact that, inevitably, research protocols are going to be submitted to IRBs for review if they haven’t already. In such cases, the weighing of risk/benefit ratios in biomedical studies with human subjects may be even more challenging that with other less addictive drugs. This area is highly likely to become even more relevant in the future for IRBs and applicable researchers as well.