Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 11, November, 2016

In This Issue

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

Human Research Report - Vol. 31, No. 11, Nov. 2016

“sIRB” Members Will Need Multiple Skills … p. 3
Returning Subjects’ Data Back to Them May Increase “Public Trust” of Research … p. 4
IRBs’ Views v. Researchers and Others … p. 5

IRBs Have Choices When Taking Over … p. 6
IRBs and Subject Risks in Combination Studies … p. 7
Major Human Subject Protection Changes … p. 8
FDA: Devil Is in Details for Noncompliant PI … p. 9
OHRP: Some Allegations About IRBs Untrue … p. 10
In Court: Researcher’s Lawsuit Against University Cannot Stop Investigation … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

“sIRB” Members Will Need Multiple Skills … p. 3

Given the number of recent notices from the National Institutes of Health (NIH) regarding its new requirement for a single Institutional Review Board (sIRB) for multisite clinical trials, it seems clear that NIH recognizes that such a change will not be an easy one. As we have discussed, a majority of IRBs and institutions are against it.

However, NIH has not changed its mind and plans to make the change effective next year, on May 25, 2017. Therefore, we continue to present aspects of that new requirement to assist IRBs and others to plan how they can implement the requirement.

We continue here where we left off last month on input from the research compliance community on the many types of capabilities that an sIRB will have to develop and/or maintain, such as:

• Mechanisms in place to assess the experience and qualifications of site investigators and study staff, including whether they are in good standing with state board and other licensing authorities and have a good record of compliance with all laws and regulations.

Other factors to be considered in this assessment would include financial conflicts of interest, research workload, and training in research ethics and the responsible conduct of research (“Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research,” 81 Fed. Reg. 40325-40331 at p. 40327, June 21, emphases added).


Returning Subjects’ Data Back to Them May
Increase “Public Trust” of Research … p. 4

On July 21 the Secretary’s Advisory Committee on Human Research Protections (SACHRP) submitted recommendations to Health and Human Services on “Minimal Risk Informed Consent Models” (Appendix A) and the “Return of Individual Research Results” (Appendix B) back to human subjects.

In this article we continue coverage of Appendix B. The privacy of research subjects, the determination of who can see their data and when, and other aspects of data return can easily affect the review of relevant protocols by Institutional Review Boards (IRBs). Data return can also become a primary component of adequate informed consent forms.

Last month we presented SACHRP’s discussion of the three types of individual results; namely, “baseline findings,” “in-study findings,” and “end-of-study findings” (see October HRR, p. 3). For the present article, we examine the subsequent section of the SACHRP’s Appendix B recommendations which is titled “Timing of “˜Return of Individual Results.’ ”

When to Return Individual Data to Subjects

Another factor is the timing of the return of individual results to the subjects, in regards to when they are returned rather than when they are collected. Above [in last month’s HRR] we classified individual results as being baseline, in-study, or end-of-study findings, depending on when they were collected. In any of these categories, the findings might be returned to the subject immediately, or might be returned after a certain amount of time or a given milepost (such as the end of the study) has been reached.


IRBs’ Views v. Researchers and Others … p. 5

In recent HRRs we have presented the views of various research compliance community populations on the enormous changes to the Common Rule on the protection of human subjects proposed on September 8, 2015, in the FEDERAL REGISTER. Those discussions, especially those contrasting the views of Institutional Review Board (IRB) members with the opinions of individual researchers and others, give us useful insights into different perspectives.

However, if we step back a bit and examine overall trends, we may get a better estimate of what is likely to happen to the more than 80 changes proposed for the Common Rule. We believe that the likelihood of the changes becoming final depends a good deal on the sociopolitical power and influence of the different groups to be affected by the proposed changes.

In addition, of course, the future impact of the proposed changes, especially on IRBs and research institutions, will depend a good deal on what they do about the proposals. Obviously, submitting comments to the government is one step toward influencing the eventual outcome. It is, however, only one step. More may be achieved by lobbying with regulators.

Majority Are Against the sIRB Concept

In any event, the overall analysis of the Common Rule public comments, as conducted by the Council on Governmental Relations (COGR) and the Association of Public and Land-Grant Universities (APLU), presents a very useful overview of said comments (also see our August HRR, pp. 1-3). We begin by addressing the COGR/APLU analysis of the controversial Common Rule proposal for a single IRB (or sIRB) for multisite studies.