Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 4, April, 2019

Back Issues

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

Which Regulations Apply?

IRBs and Which Regulations Apply? … p. 3
IRBs and Research With Human Specimens … p. 4
IRBs and New Exemptions From Review … p. 5

IRBs and Activities Not Needing Review … p. 6
IRBs and Risks of In Vitro Research … p. 7
IRBs and Human Subject Eligibility … 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

Which IRB Regulations Apply, And For How Long? – Pt. 2 … p. 3

We continue here with highlights from a recent guidance issued by the federal Office for Human Research Protections (OHRP). The new draft guidance is titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”

As we pointed out in our previous article on this guidance, this new guidance for IRBs, researchers, and institutions explains the benefits – and potential burdens – of “transitioning” certain studies.

That is, many studies that have been approved under the pre-2018 revised Common Rule on protecting human subjects can be “transitioned” to fall under the requirements of the new Rule, if one so desires.

There are advantages of doing so, including applicability of new exemptions of certain research from IRB review and other requirements. However, there are possible disadvantages too, such as more stringent informed consent requirements for certain types of human studies.


IRBs and Research With Human Specimens – Pt. 3 … p. 4

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 (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 area, that are now under consideration by the Secretary of Health and Human Services (HHS).

Last month in the HRR we completed an overview of informed consent aspects relevant for IRBs that review studies involving human specimens. We also presented FAQ #s 1 and 2 from the SACHRP’s recommendations. We now present FAQ #3 below.


IRBs and New Exemptions From Required Review – Pt. 4 … p. 5

With this article we conclude our presentation of explanations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP) on the new exemptions from IRB review contained in the now revised Common Rule.

As we noted last month, SACHRP points out that the number of exemptions from subject protection regulations (and the need for IRB reviews) has been increased to eight in the new revised Common Rule.

In addition, Categories 1 and 2 have been modified. We ended last month’s article on this topic by presenting SACHRP’s initial discussion and recommendations to IRBs regarding the changes to Exempt Category 2. Note that we covered implications for IRBs regarding Exempt Category 1 in the January HRR (see pp. 1-2). We resume now with the conclusion of SACHRP’s recommendations for the interpretation and use of Exempt Category 2.