Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 12, December, 2017

In This Issue

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

Volume 32, No 12

IRBs Have Special Role if Electronic Consent Is Used … p. 4
Single IRB (sIRB) Requirement Has Some Exceptions … p. 6
New Human Subject Forms for NIH and “Clinical Trials” … p. 7

IRBs Don’t Have to Put Everything in Minutes … p. 8
FDA: Researcher Fails to Follow His Own Approved Protocol … p. 9
OHRP: Institution Must Submit New Extensive Report on Alleged IRB Failures … p.10
In Court: Claim Is Made of Violating Federal Human Subjects Assurance Agreement … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs Have Special Role If Electronic Consent Is Used … p. 4

As we last presented in the September issue (see p. 5), electronic informed consent procedures are discussed in detail by an FDA guidance designed specifically for IRB members and select other groups. The guidance, formatted as a Question and Answer document (Q&A), is titled “Use of Electronic Informed Consent – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors” (underline emphasis added).

We resume where we left off in September; i.e., with the rest of Q6 (“How can electronic signatures be used to document eIC [electronic informed consent]”), as follows. Note that, for eIC to be considered fully and legally equivalent to handwritten signatures, eIC must comply with all of the requirements currently found in 21 CFR Part 11 (“Electronic Records; Electronic Signatures”).


Single IRB (sIRB) Requirement Does Have Some Exceptions … p. 6

In previous HRRs, we have presented the analysis of, and comments by, the Council on Government Relations (COGR) regarding the NIH’s new requirement for the use of single IRBs (sIRBs) for multisite studies. The deadline of January 25, 2018, is fast approaching. However,

“54. Are there exceptions to the NIH single IRB policy?

The NIH single IRB policy allows exceptions for domestic sites when review by a single IRB would be prohibited by a federal, tribal, or state law, regulation, or policy.

NIH will consider requests for other exceptions to the policy and will determine if there is adequate justification to grant an exception. Most exceptions are expected to be site-specific, that is, the exception to single IRB review will be made for a particular site, but all other sites conducting the same protocol will rely on the single IRB. NIH anticipates granting very few of these exception requests (March 16, underline emphases added; on the Web at


Human Subject Forms for NIH and “Clinical Trials” … p. 7

As we noted briefly last month in our “In Agencies & Organizations” section, several national groups have contacted NIH regarding its recent new description of what constitutes “clinical trials.” These groups include the Association of American Medical Colleges (AAMC), and their concerns include possible impacts on IRBs.

The Association of American Medical Colleges, Association of American Universities, Association of Public & Land-grant Universities and Council on Governmental Relations collectively represent hundreds of institutions that employ tens of thousands of researchers.

We write to convey the concerns of our members that the definition of clinical trial has been significantly expanded through the set of case studies1 recently published by NIH as a means to assist investigators in determining whether proposed research meets the NIH definition. The definition, issued in October 2014,2 is the foundation for several policies administered by NIH (Letter to NIH from AAMC etc., September 17, p. 1 of 7, emphasis added; on the Web at