Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 12, December, 2016

In This Issue

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

Vol 31, No 12 December 2016

New IRB Responsibility and Its Related New Liability … p. 3
IRBs and Returning Research Results Back to Study Subjects … p. 4
IRBs and “Adaptive Designs” … p. 5

“Receiving” IRB Has Authority … p. 6
IRBs and Charging Human Subjects … p. 7
IRB Record Keeping Under Federal Review … p. 8
FDA: Compliance Violations to Be Remedied … p. 9
OHRP: Special IRB Requirements … p. 10
In Court: Researcher Blames Investigators … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

New IRB Responsibility and Its Related New Liability … p. 3

We continue this month with coverage of recent releases from NIH that will affect IRBs, individual researchers, and research institutions. The two releases consist of a Final Rule (“Clinical Trials Registration and Results Information Submission,” 81 Fed. Reg. 64982-65157) and the final version of a much shorter NIH policy (“NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information,” 81 Fed. Reg. 64922-64928).

Both were issued on September 21, and both become effective on January 18, 2017. The Final Rule, preceded by over 150 pages of explanations, adds an entire new Part 11 to 42 CFR.

Although the term “IRB” does not appear in the titles of either document, we caution IRBs that the new requirements will certainly affect them. For example, the Final Rule (including preamble, explanations, etc.) cites IRBs and their duties dozens of times.

However, the impact on IRBs will be indirect in that the documents do not change human subject protection regulations. Instead, the new requirements will make IRBs comply with numerous other types of activities related to gathering, reporting, and releasing the results of clinical trials — including results from studies with incomplete or negative outcomes.


IRBs and Returning Research Results Back
to Study Subjects … p. 4

In this article we continue coverage of Appendix B (“Return of Individual Research Results”) in recent recommendations submitted to the federal Department of Health and Human Services. The recommendations were developed by the Secretary’s Advisory Committee on Human Research Protections (aka SACHRP). The “return” in question means returning the research results back to the human subjects themselves who participated in the study.

Since the results return will usually affect the content of the study’s informed consent, this topic is a significant one for relevant IRBs. We resume here where we left off our discussion last month; namely, with SACHRP’s presentation of the “Ethical Foundation” of returning results to research subjects.

SACHRP would like to stress that the individual results do not have to be of clinical value to the subjects in order for return to be considered. Even if the results are not clinically relevant, the pure intellectual curiosity of the subjects is sufficient reason to return the results absent other reasons not to return them (SACHRP, Appendix B, July 21, emphasis is added; on the Web at


IRBs and Review of Protocols With “Adaptive Designs” … p. 5

A specific section of a recent FDA guidance addresses special IRB considerations for certain medical device studies. The guidance is titled “Adaptive Designs for Medical Device Clinical Studies.” It is the final version of an initial draft that was issued last year on May 18, 2015, and it includes revisions based on more than 150 comments that were submitted to FDA following release of the earlier draft.

Before we discuss particular IRB factors, we present a brief summary of the type of research in question.

This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success (81 Fed. Reg. 49230-49231 at p. 49230, July 27, emphasis added).