Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 7, July, 2016

In This Issue

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

V31 N07 In This Issue

IRBs, Informed Consent, and FDA Form 3926 for Access … p. 4
IRBs and Charging Human Subjects For Investigational Products … p. 5
IRBs MUST Use a Single IRB (“sIRB”) For NIH Multisite Human Studies … p. 6

In Congress: Group Says Bill Poses Unacceptable Risks for Study Subjects … p. 8
FDA: Researcher-Sponsor Fails to Secure Timely IRB Review of Study … p. 9
OHRP: Institution Investigated Even Though Its IRB Is Not THE IRB of Record … p. 10
In Court: Record Keeping Was Inadequate … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs, Informed Consent, and FDA Form 3926
for Access … p. 4

As noted in the previous article, this HRR article addresses the second of 3 new FDA guidances. This one is titled “Individual Patient Expanded Access Applications: Form FDA 3926.” The form is available:

… for licensed physicians to use for expanded access requests for individual patient INDs [Investigational New Drug Applications]. Individual patient expanded access allows for the use of an investigational new drug outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life threatening disease or condition when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

Form FDA 3926 provides a streamlined alternative for submitting an IND for use in cases of individual patient expanded access, including for emergency use. This guidance finalizes the draft guidance issued in February 2015 (81 Fed. Reg. 35776-35777, June 3, emphases added).


IRBs and Charging Subjects For Investigational
Products … p. 5

This article addresses the third and final guidance in FDA’s recent trio of final guidances. The first two, discussed in the previous two articles in this HRR issue, covered aspects of expanded access to experimental products for treatment use. The third guidance involves charging research subjects for the use of experimental products. However, note that one aspect of charging subjects also includes expanded access situations. All three guidances cover areas of importance to Institutional Review Boards (IRBs).

The guidance we highlight now is titled “Charging for Investigational Drugs Under an IND — Questions and Answers.” This guidance:

… provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug (IND) for the purpose of either clinical trials or expanded access for treatment use (81 Fed. Reg. 35779-35781 at p. 35779, June 3, emphasis added).


REQUIRED Use of Single IRB (sIRB) for
Multisite Studies … p. 6

It’s here. For a year and a half we have been following several developments, all of which were designed to establish a new policy for Institutional Review Boards (IRBs) involved with multisite studies. The mandate for just one IRB to review all sites involved in such experiments was a controversial part of the dozens of changes proposed to the Common Rule on the protection of human research subjects on September 8, 2015, in the FEDERAL REGISTER.

That proposed change for IRBs, and its related argument, is now largely moot. We present here, in its entirety (with some minor format editing), the new policy of the National Institutes of Health (NIH) on the required use of a “single IRB (sIRB)” in multisite studies, despite what IRBs might think of it.

The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multisite studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR part 46 (81 Fed. Reg. 40325-40331 at p. 40330, June 21, emphasis added).