Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 12, December, 2018

Back Issues

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

Guidance on Pregnant Women as Human Research Subjects

IRBs and Guidance on Pregnant Women as Human Research Subjects … p. 3
IRBs and Subject Risks in IVD Studies … p. 4
IRBs and Informed Consent Waivers and Alterations … p. 5

IRBs and Activities That Don’t Need Review … 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 Guidance on Pregnant Women as Study Subjects – Pt. 7 … p. 3

With this article, we conclude our coverage of the recent FDA guidance titled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” As noted previously, the guidance contains a significant amount of information for IRBs and researchers. We resume where we left off last month with:

“Sponsors should consider whether any of the following situations apply in determining when to enroll pregnant women in the drug development process.

    • If there are limited safety data or other approved (i.e., safe and effective) treatments are available: In this situation, it may be more appropriate to complete phase 3 clinical trials in a nonpregnant population before enrolling pregnant women and exposing them to the investigational drug
    • If there are limited therapeutic options: In these situations, the risk-benefit considerations may favor enrollment of pregnant women in earlier phase trials
    • If there are safety data for a drug that has been studied previously for other indications or populations: In these situations, the risk-benefit considerations may favor enrollment of pregnant women in earlier phase trials” (guidance, April, p. 9 of 11; on the Web at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM603873.pdf).

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IRBs and Risks of Investigational In Vitro Diagnostic Studies – Pt. 8 … p. 4

We continue here with presenting key portions of FDA’s current guidance on the special human subject risks associated with certain studies. The guidance is titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards.”

In concluding our article last month, we began presenting human subject risks in this area along with accompanying research design features aimed at reducing such risks. We resume with FDA’s cautionary note in its “Study Enrollment” section that:

“Misclassification of subjects due to erroneous investigational IVD results can lead to treatment that might unnecessarily expose them to toxicities or suboptimal treatment” (guidance, December 18, 2017, page 10 of 23; on the Web at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM589083.pdf).

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IRBs and Informed Consent Waivers and Alterations – Pt. 1 … p. 5

FDA is proposing to change its regulations on the requirement to obtain informed consent from human subjects in certain types of studies. Before proceeding with our presentation of this significant time-saving
procedure for IRBs and researchers, note that FDA is accepting comments on their proposal until January 14, 2019. More information is available from FDA’s Janet Norden at 301-796-1127.

“A. Purpose of the Proposed Rule

The purpose of this proposed rule is to implement the statutory changes made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 3024 of the Cures Act (Pub. L. 114–255) to allow for a waiver or alteration of informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects” (83 Fed. Reg. 57378-57386 at p. 57379, November 15).

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