Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 7, July, 2017

In This Issue

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

Vol. 32, No. 7, July 7, 2017

When IRBs Do Not Have to Conduct Continuing Reviews … p. 4
IRBs Have New Guidance on the Use Of Electronic Records and Signatures … p. 6
Human Subjects Data-Sharing Is Proposed By Major Agency … p. 7

In Congress: National Group Says Bills Pose Unjustified Risks for Human Subjects … p. 8
FDA: Researcher Did Not Understand Own Protocol … p. 9
OHRP: Alleged Mistreatment of Human Research Subjects … p. 10
In Court: Lawsuit Examines IRB Approval … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

When IRBs Do Not Have to Conduct Continuing Reviews … p. 4

As we described in last month’s lead HRR article, some aspects of continuing reviews by IRBs have been modified by the new Common Rule. We noted at the conclusion of that article that continuing reviews have been eliminated for most research that is eligible for expedited review.

In addition, the final rule states at ç___.109 (f)(1)(ii) that continuing review is not required for research reviewed in accordance with the limited IRB review procedure described in ç___.104 (d)(2)(iii), ç___.104(d)(3)(i)(C), ç___.104(d)(7), or ç___.104(d)(8).

[In contrast with the previously proposed Common Rule,] The final rule does not require investigators to provide annual confirmation to the IRB that such research is ongoing and that no changes have been made that would require the IRB to conduct continuing review. Institutions that choose to require some accounting of ongoing research not subject to continuing review have significant flexibility in how they implement their own requirements.

Note that under the final rule, investigators would still have the current obligations to report various developments (such as unanticipated problems or proposed changes to the study) to the IRB (82 Fed. Reg. 7149-7274 at p. 7205, January 19, emphases added).


IRBs Have New Guidance On Electronic Records/Signatures … p. 6

The FDA has issued a new draft guidance that is titled “Use of Electronic Records and Signatures in Clinical Investigations Under 21 CFR Part 11″”Questions and Answers.”

The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products.

The draft guidance expands upon recommendations in the guidance for industry entitled “˜Part 11, Electronic Records, Electronic Signatures””Scope and Application,’ issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations (82 Fed. Reg. 28277-28279 at page 28277, June 21, emphasis added).


Human Subjects Data-Sharing Is Proposed By Major Agency … p. 7

Comments are due by July 21 on a Request for Information (RFI) regarding the NIH’s National Institute on Alcohol Abuse and Alcoholism’s (NIAAA’s) “Initiative for Collecting, Archiving, and Sharing Individual-Level Human Subjects Data” (emphasis is added to title).

NIAAA seeks public comments on a proposed data-sharing initiative to create a repository of all future NIAAA-funded studies that include human subjects. With such an initiative, all NIAAA-funded researchers would be expected to make individual-level data obtained from NIAAA-funded human subjects research available to the general research community.

Access to individual-level data from humansubject studies has numerous advantages …. Secondary data analysis of existing datasets offers a low-cost, high-yield approach for further investigation. Researchers can pose and test new and creative research hypotheses that go beyond those of the initial studies …. (“Request for Information,” Notice No. NOT-AA-17-005, emphases added; on the Web at