Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 9, September, 2017

In This Issue

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


IRBs and Charging Human Subjects for Investigational Drugs … p. 4
IRBs and the Use of Electronic Informed Consent … p. 5
Exemptions to Human Subjects Regulations … p. 6

Eliminating the Need for IRB Review of Grant Applications … p. 8
FDA: Researcher “Overlooks” Own Protocol … p. 9
OHRP: Building on Allegedly Flawed Studies … p. 10
In Court: Sign This Voluntary Consent Form or Kiss Your Sports Goodbye … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs and Charging Subjects For Investigational Drugs … p. 4

We continue here with an area we last covered in the May HRR; namely, the current requirements from FDA on charging research subjects for the use of investigational drugs. As we have discussed previously, this area addresses a responsibility of IRBs, since it can influence subject recruitment, enrollment, and retention. In addition, it can affect the welfare of subjects, a prime concern of IRBs and researchers.

We previously presented most of the Answer to the Question and Answer (Q&A) listed as Q10 in the FDA guidance (“Q10: If a sponsor’s own approved drug is used as a concomitant therapy for an approved use during a clinical trial intended to evaluate another drug, should the sponsor obtain authorization to charge for the drug used as concomitant therapy?”) (“Charging for Investigational Drugs Under an IND–Questions and Answers,” June, 2016, p. 5 of 8; on the Web at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm351264.pdf).

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IRBs and Electronic Informed Consent … p. 5

We continue here with our coverage of the new Question & Answer (Q&A) guidance issued by FDA on the use of electronic informed consent (eIC) forms and processes. As we noted in last month’s HRR (see p. 4), IRBs are a prime audience for this guidance.

We begin here with where we left off last month; namely, with the rest of the answer to Q3 (“How and when should questions from [human] subjects be answered?”). We then continue with more Q&As.

Subjects should be given a description of how and when they will receive answers to their questions, and they must be provided information on how to contact an appropriate individual for pertinent questions about the research and their rights and whom to contact in the event that they sustain a research-related injury (45 CFR 46.116(a) (7) and 21 CFR 50.25(a)(7)) (“Use of Electronic Informed Consent; Questions and Answers–Guidance for Institutional Review Boards, Investigators, and Sponsors,” December, 2016, p. 6 of 13, emphasis added to title; on the Web at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf).

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Exemptions to Human Subjects Regulations … p. 6

The new 2018 Common Rule addresses the issue of exemptions from the requirements of the Subparts B, C, and D of 45 CFR 46 regarding research with fetuses, pregnant women, and neonates; prisoners; and children, respectively, as follows:

“V. Exempt Research (§___.104)
A. Applicability of Exemptions to Subparts B, C, and D

1. Background and Pre-2018 Requirements In the pre-2018 rule, the application of the exemptions to research under subparts B, C, and D was specified through footnote 1, which stated that the exemptions do not apply to research involving prisoners, and are also limited in their application to research involving children.

Regarding the latter issue, the pre-2018 exemption at §___.101(b)(2) for research involving educational tests, survey or interview procedures or observations of public behavior did not apply to subpart D (i.e., such research did not qualify for this exemption), except for research involving educational tests, or observations of public behavior when the investigator does not participate in the activities being observed. The pre-2018 exemptions did apply to subpart B (82 Fed. Reg. 7149-7274 at p. 7181, January 19, underline emphases added).

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