Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 1, January, 2017

In This Issue

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

Vol 32, No. 1 January 2017

IRBs and Single IRB Review: Multiple Considerations Apply … p. 3
IRBs and Cluster Randomized Studies … p. 4
IRBs and Returning Results to Study Subjects … p. 5

IRBs and sIRBs: Tips From FDA Guidance … p. 6
IRB Violations and Agency’s “Blind Eye” To Violations Is Alleged … p. 7
In Congress: Health Care Bill Includes Research … p. 8
FDA: Failure to Report Study Subject Problem … p. 9
OHRP: Agency Rejects IRB Violation Charge … p. 10
In Court: Researcher’s Misconduct Is Pervasive … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs and Single IRB Review: Multiple Considerations … p. 3

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) has submitted new recommendations as attachments to a letter dated November 2, 2016. The recommendations were submitted to the Department of Health and Human Services.

The recommendations on human subject protections cover the following five areas: (1) “Initial Considerations for Single IRB Review: Points to Consider” (Attachment A, emphasis added); (2) “Recommendations on Regulatory Issues in Cluster Randomized Studies” (Attachment B); (3) “Recommendations on Benchmarking” (Attachment C); (4) “Recommendations on Revisions to “˜NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules’ ” (Attachment D); and (5) “Recommendations on OHRP/FDA draft guidance “˜Institutional Review Board (IRB) Written Procedures Guidance for Institutions and IRBs’ ” (Attachment E).

Much on the Shoulders of IRB Members

As we have been discussing for over a year, the issue of only one IRB serving as the “IRB of record” for multisite studies continues to cause concern. This is especially true for those where such a decision is mandatory, as will be true for NIH-funded studies starting this coming May unless NIH delays implementation of its new “Single IRB” (sIRB) policy.


IRBs and Recommendations On Cluster Randomized Studies … p. 4

We introduce in this article our initial examination of the second of five sets of new recommendations by the Secretary’s Advisory Committee on Human Research Protections (SACHRP); namely, the set titled “Recommendations on Regulatory Issues in Cluster Randomized Studies (Appendix B).” See the preceding article in this HRR for how these recommendations are likely to impact IRBs, researchers, and research institutions.

The central defining feature of a cluster randomized trial (CRT) is that randomization occurs on a group level rather than an individual level. In a traditional randomized clinical trial, subjects are randomized sequentially as each subject is identified and then enrolled in the study. In contrast, in a CRT the randomization occurs as a function of being a member of a group.

In addition, there can be several layers of groupings as well, for instance by school district, school, and class, or by health care facility, medical provider, and each medical providers’ patients (“Recommendations on Regulatory …,” November 2, 2016, p. 4 of 44, emphases added; on the Web at


IRBs and Types of Results to Be Returned to the Subjects … p. 5

In this article we continue our coverage of Appendix B (“Return of Individual Research Results”) in recent recommendations issued by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The “return” in question means returning research results back to the human subjects.

Whether or not a researcher opts to return results back to the subjects is a crucial issue for IRBs. Not only will the decision affect informed consent documents and procedures, it can have a major effect on the risks for research subjects.

Accordingly, we resume here where we left off our discussion last month with a final note by SACHRP on risks for human subjects.

Finally, if researchers retain contact information, or maintain records in an identifiable form so that they can return individual results, this increases the risks to subjects of data breaches and
unauthorized disclosures (SACHRP, Appendix B, July 21, emphasis added; on the Web at