Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 34, No. 1, January, 2019

Back Issues

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

Informed Consent Waivers

IRBs and Informed Consent Waivers … p. 3
IRBs and “Master Protocol” Studies … p. 4
IRBs and Exempt “Activities” … p. 5

IRBs and “Broad Consent” … p. 6
IRBs and Subject Risks in IVD Studies … 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 Have New Informed Consent Alterations/Waivers Possible – Pt. 2 … p. 3

We continue here with a significant proposal by FDA on informed consent regulations and allowing IRBs to alter informed consent elements or, in certain circumstances, even to waive its need altogether. Obviously, such a change would permit IRBs, researchers, and FDA staff to save much needed time, and to potentially make it easier to recruit and enroll otherwise hesitant research subjects who might find such documents daunting in some cases.

The recent FDA announcement was made on November 15, 2018, in the FEDERAL REGISTER. FDA set their comment deadline for this proposal for January 14, 2019, as we noted in last month’s initial HRR article on this development. However, on December 20, 2018, FDA issued an extension of that comment deadline to February 13 (83 Fed. Reg. 65322). The extension was due to one request for said extension.

Below we resume our coverage where we left off in last month’s HRR, as follows.

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New Procedures for IRBs in “Master Protocol” Studies – Pt. 2 … p. 4

As we first presented in last month’s HRR (see pp. 1-2), human subject studies using “master protocols” pose significant challenges for IRBs and researchers who use such experimental designs. Those challenges include research subject safety issues, as well as subject selection, enrollment, and retention issues that are relevant for IRB reviews of applicable protocols.

The new FDA guidance on these special types of human subject studies points out that:

“… a master protocol is defined as a protocol designed with multiple substudies, which may have different objectives and involves coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure” (“Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics,” September, 2018, p. 3 of 12; on the Web at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm621817.pdf).

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IRBs and Activities That Don’t Have to Be Reviewed – Pt. 2 … p. 5

We continue here with our coverage of a new guidance issued by the federal Office for Human Research Protections (OHRP) titled “Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements.” As noted in last month’s HRR, the main reason why the guidance is so useful for IRBs and researchers alike is that it describes in detail the activities that do not require IRB review. The potential savings in IRB personnel time and resources for the relevant “public health surveillance activities” would appear to be self-explanatory.

Public health surveillance activities are deemed not to be research because HHS recognizes that the requirements of 45 CFR part 46 should not impede a public health authority’s ability to accomplish its mandated mission to protect and maintain the health and welfare of the population(s) for which it is responsible” (guidance, page 4 of 10; on the Web at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/activities-deemed-not-to-be-research-public-health-surveillance-guidance/index.html).¹

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