Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 9, September, 2016

In This Issue

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

V31 N09 In This Issue

Stop the Changes to Human Subjects Rule! … p. 3
New IRB Recommendations Contain Informed Consent Models … p. 4
IRBs, Subject Privacy, and Data Releases … p. 5

NIH Requirement on One IRB … p. 6
IRB Regulations Are Target Of Requested Comments … p. 7
In Congress: Changing IRBs’ Role … p. 8
FDA: Researcher Fails to Follow Own Plan … p. 9
OHRP: It Wasn’t Our IRB! … p. 10
In Court: Researcher Tries to Discredit Others … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 13

Stop the Changes to Human Subjects Rule! … p. 3

Last month we presented two major recommendations recently posed by the prestigious National Academies in a new report that included the protection of human research subjects (see August HRR, pp. 6-7). That 282-page Academies’ report is titled “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century” (see

One of the two recommendations (#9.2) is to withdraw the massive number of changes proposed for the existing Common Rule on the protection of human subjects! Instead, the National Academies recommends the formation of a new national commission to study the many complex issues on human subjects currently faced by Institutional Review Boards (IRBs).

These recommendations are in stark contrast to the reputedly eager government rush to institute widespread changes to the Common Rule before the end of the Obama Administration.


New IRB Recommendations Contain Informed
Consent Models … p. 4

On July 21, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) submitted two recommendations to Sylvia Burwell, the Secretary of Health and Human Services (HHS). The recommendations were made in the usual format of separate attachments to a brief cover letter. The two attachments are: (1) “Attachment A: Minimal Risk Informed Consent Models,” and (2) “Attachment B: Return of Individual Research Results.”

As in the past we present SACHRP recommendations because they often lead to actual federal regulations and/or agency policy changes influencing Institutional Review Boards (IRBs), research compliance professionals, and researchers. In this article we focus on Attachment A. We cover highlights of Attachment B in the following article in this HRR.

The model documents below were written to provide examples of informed consent forms that would be appropriate in the context of minimal risk research and reflect the goal of reducing the length and complexity of the consent forms used for non-exempt minimal risk research activities (Attachment A, p. 1, emphasis added; on the Web at


IRBs, Subject Privacy, and Data Releases … p. 5

As noted in the previous article, this article covers the second topic addressed by the Secretary’s Advisory Committee on Human Research Protections (or SACHRP) in its recent letter to Sylvia Burwell, Secretary of Health and Human Services (HHS). The second topic, contained in the letter’s Appendix B, is titled “Return of Individual Research Results.”

We find this topic to be significantly more complex than the one discussed in Attachment A, although Attachment A does cover a number of different recommendations for Institutional Review Boards (IRBs) on various informed consent options. The second area in Appendix B of returning research results more widely than in the past extends far beyond the more singular concept of informed consent.

There is currently significant attention to the distribution of final study data and results, both to the subjects who participated in the research and to the public at large. SACHRP has determined that there are four aspects of returning research results to subjects and releasing the results publicly, with overlap of the concepts along a spectrum:

• Return of incidental findings to subjects
• Return of individual study results to subjects
• Return of general study results to subjects
[and] • Public release of study data (Appendix B, July 21, emphases added; on the Web at