Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 2, February, 2019

Back Issues

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

New Review Exemptions

IRBs and New Review Exemptions … p. 3
IRBs and Continuing Reviews … p. 4
IRBs and Exempt “Activities” … p. 5

IRBs and Subject Risks in IVD Studies … p. 6
IRBs and “Broad Consent” … p. 7
In Congress … p. 8
FDA Warning … p. 9
OHRP Determination … 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 New Exemptions From Required Review – Pt. 2 … p. 3

We continue here with more of the explanations from the Secretary’s advisory Committee on Human Research Protections (SACHRP) regarding the new exemptions from IRB review contained in the newly revised Common Rule (aka the “2018 Requirements”).

As we noted last month, SACHRP points out that the number of exemptions from IRB review and related human subject protection requirements has been expanded to eight. In addition, most of the exemptions’ wordings and meanings have been altered.

We ended last month’s article on this topic by presenting SACHRP’s examples of “educational settings,” since Exempt Category 1 addresses research in such settings. We continue this month with more of SACHRP’s “Questions and Answers” (Q&As) on how to determine whether a particular type of research is covered by the new exemptions and what IRBs and/or researchers should do when it is or is not covered.

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IRBs and What to Do About Continuing Reviews – Pt. 1 … p. 4

In addition to the OHRP guidance presented on pp. 1-2 of this HRR on compliance dates for IRBs and others regarding the newly revised Common Rule, OHRP has also issued another guidance titled “2018 Requirements FAQs – IRB Review.” This guidance addresses the status of continuing IRB reviews in light of the new Revised Common Rule. The guidance is constructed as a “FAQ” (i.e., “Frequently Asked Questions”) document, as follows:

[Q] How should IRBs approach the continuing review of research that remains active beyond long-term follow-up or data analysis, but that is eligible for expedited review under categories 8(b) or 9 of the 1998 OHRP Expedited Review List in light of the new provision at §46.109(f)(1)(i) of the [now final] 2018 Requirements, which eliminates the requirement for such continuing review unless an IRB determines otherwise?” (guidance, January 16; on the Web at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html).

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IRBs and Activities That Don’t Have to Be Reviewed – Pt. 3 … p. 5

We continue here with our coverage of a new draft guidance issued by the federal Office for Human Research Protections (OHRP) titled “Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements.”

This guidance is part of OHRP’s series of new guidances, all being developed because of new requirements contained in the revised Common Rule. As described in last month’s HRR, the main focus of the new guidance is on determining whether or not a public health surveillance activity is deemed to be research.

If such a determination is made – and there are many such activities to consider – the activity would be judged as nonresearch and therefore exempt from IRB review and related human subject protection requirements.

We shall begin where we left off in last month’s article; namely, with discussion of the types of activities that could be determined to be exempt.

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