Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 8, August, 2016

In This Issue

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

V31 N08 In This Issue

IRBs, Institutional Liability, and New IRB Review Mandate by NIH … p. 4
IRBs and Possible Steps to Help With IRB Reviews … p. 5
Stop Changing So Many Human Subject Regs! … p. 6

In Congress: Patients Would Be Turned Into “Guinea Pigs” … p. 8
FDA: IRB Members Must Retake Regulatory Training Course … p. 9
OHRP: University Investigated Even Though Its IRB Is NOT the IRB “of Record” … p. 10
In Court: Researcher Says Others Lied … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs, Institutional Liability, And New Review Mandate … p. 4

Despite the concerns expressed by many Institutional Review Boards (IRBs) and their parent institutions, the National Institutes of Health (NIH) still intends to force all NIH-funded multisite studies to use only one IRB (“sIRB”) to review said studies. As an initial guide to help IRBs implement this new requirement, see elsewhere in this HRR for a summary of a recent notice in their NIH GUIDE regarding the establishment of sIRBs.

Some commenters have urged NIH to wait on its own requirement for sIRBs until the many changes proposed for the Common Rule are ironed out. Instead, here is what NIH said about that same issue, after describing some objections of IRBs to the new requirement:

However, other commenters praised the NIH for addressing the single IRB issue in the absence of an updated Common Rule. Finally, a few commenters discussed how the policy could be harmonized with other federal policies. One commenter recommended that the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) provide guidance to support the policy’s stance on duplicative IRB review (81 Fed. Reg. 40325-40331 at p. 40326, June 21, emphasis added).


IRBs and Possible Steps to Help With sIRB Reviews … p. 5

Assuming that the National Institute of Health’s (NIH’s) new mandate on using only a single IRB (“sIRB”) for multisite studies becomes a reality (despite the widespread objections by Institutional Review Boards (IRBs) and their parent institutions), many new policies and procedures will be required for implementation. Elsewhere in this HRR we present some preliminary guidance from NIH on this sweeping mandate, but much, much more will be needed to assist IRBs to adopt this new requirement.

However, we do have a resource from the Food and Drug Administration (FDA) that may be of use to IRBs. The resource is titled “Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.” It remains FDA’s current advice on this issue.

While transferring oversight between IRBs is not the same thing as establishing an sIRB for multisite studies, we believe that there are useful tips in that FDA guidance to help with sIRB operations. For example, we present here the guidance’s advice on one aspect of the legal establishment of IRB oversight that may be of use. This excerpt resumes from where we left off our coverage in the October, 2014, HRR.


Stop Changing So Many Human Subjects Regs! … p. 6

A major challenge has been raised against making any of the more than 80 modifications proposed for the existing Common Rule on the protection of human research subjects. As we have been discussing, that proposal, in the form of a federal Notice of Proposed Rulemaking (NPRM), was issued in the FEDERAL REGISTER on September 8 of last year. Over 2,000 comments were later submitted to the federal Department of Health and Human Services (HHS).

A significant amount of those public comments were negative, including those that recommended that the entire complex, 140,000-word+ NPRM be wholly shelved, rewritten, and released again later in a better organized format. Such comments also recommended that the proposals be issued in separate content sections, in view of the immense financial and administrative impact the changes to the Common Rule would have on so many researchers, research institutions, and Institutional Review Boards (IRBs).

Another Key Group Says “Stop the Changes!”

Yet another powerful, nationally respected group has added its voice to the chorus seeking that all the far-reaching proposed changes to the Common Rule be put on hold. That group is the National Academies of Science, Engineering and Medicine’s Committee on Federal Research Regulations and Reporting Requirements. The recommendation to halt the headlong federal rush to change the Common Rule is contained in the committee’s new and second 282-page report titled “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century.”