Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 8, August, 2017

In This Issue

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

In This Issue

IRBs and Electronic Informed Consent … p. 4
IRBs and Use of Electronic Records … p. 5
New Requirements on IRB Protocol Reviews … p. 7

FDA: Researcher Wonders — Was That Really My Study Plan? … p. 9
OHRP: Fellow Researchers Find Many Discrepancies in Study Data Where Misconduct Is Alleged … p. 10
In Court: Oregon Chosen By Researchers After Other States Decline to Participate … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs and Electronic Informed Consent … p. 4

As we last discussed in the March HRR, the use of “electronic informed consent” (eIC) forms and processes has been escalating in recent years. In this month’s coverage, we shall resume presenting selected Questions & Answers (Q&As) on this topic from a recent FDA guidance. FDA specifically notes that a primary audience for this guidance is comprised of the several thousand U.S. IRBs.

First, however, note that the FDA guidance has a brief cautionary reminder note to help our overall understanding of informed consent.

The term informed consent is often mistakenly viewed as synonymous with obtaining a handwritten signature from the subject or the subject’s legally authorized representative (LAR)5 on a written informed consent form.

[FN#5: Legally authorized representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research (45 CFR 46.102(c) and 21 CFR 50.3(l)) (“Use of Electronic Informed Consent–Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors,” December, 2016, p. 3 of 13; on the Web at RegulatoryInformation/Guidances/UCM436811.pdf).]


IRBs and Use of Electronic Records … p. 5

We continue here with coverage of a recent FDA guidance for IRBs and others on the growing use of electronic records. Just as for the increasing use of electronic informed consent (eIC) forms and processes, technology is changing many aspects of clinical trials and the protection of human subjects (see elsewhere in this HRR for details on eIC and IRBs).

The FDA guidance on electronic records is titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11–Questions and Answers [Q&As].” In last month’s HRR we presented some background information for this field. We now continue with examples of electronic records, especially records for IRBs and other research related entities.

Examples of electronic systems used in clinical investigations that are owned or managed by sponsors and other regulated entities (e.g., CROs, IRBs) include electronic case report forms (e CRFs), electronic data capture (EDC) systems, electronic trials master files (eTMFs), electronic Clinical Data Management System (eCDMS), electronic Clinical Trial Management System (eCT MS), Interactive Voice Response System (IVRS), Interactive Web Response System (IWRS), centralized, web-based electronic patient-reported outcomes (ePRO) portals, and electronic IRB human subject application systems (eIRBs). Requirements and recommendations for these systems are described in this section (guidance, June, p. 5 of 25, underline emphases added; on the Web at


New Requirements on IRB Protocol Reviews … p. 7

The new Common Rule for the protection of human subjects has a specific section on revised criteria for IRB approval of human subjects research. We present here that section on the new criteria, and we underscore the fact that some of the previous proposals in this area are not in the Final Rule. That is, not all of the proposals contained in the 2015 Notice of Proposed Rulemaking (NPRM) made it into the 2017 Final Rule.

“XI. Criteria for IRB Approval of Research (ç___.111)
A. Background and the Pre-2018 Requirements
The determinations that an IRB must make before it can approve a study were spelled out in the pre-2018 rule at ç___.111. These relate, among other things, to minimizing risks to subjects, determining that an appropriate relationship exists between risks and benefits, and ensuring the equitable selection of subjects. The regulations generally required all of these determinations to be made for any study that must undergo IRB review (82 Fed. Reg. 7149-7274 at page 7206, the emphasis is added).