Human Research Report

Protecting Researchers and Research Subjects

Vol. 30, No. 10, October, 2015

In This Issue

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

V30 N10 In This Issue

Extending the Common Rule to All Studies … p. 3
Mandatory Use of Central IRBs Proposed … p. 4
IRBs and “Standard of Care” Studies … p. 5
IRBs, INDs, and Reporting Requirements … p. 6

IRBs and “Foreseeable Risks” for Subjects … p. 7
FDA: Enrolling Ineligible Research Subjects … p. 8
OHRP: No Evidence of Inadequate Consent … p. 9
In Court: Panel Concludes that Researcher
        Committed Fraud to Get More Grants … p. 10
In Congress: Allegation that Bill Would
        Support More Conflicts of Interest … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

Extending the Common Rule To All Applicable Studies … p. 3

As noted in the previous article about the major changes being proposed for the Common Rule, one of the biggest changes is extension of the Common Rule requirements to all applicable human subjects studies, regardless of funding source. We begin this discussion with reference to the current Common Rule requirements, as presented in the recent federal proposal in the September 8 FEDERAL REGISTER.

b. Current Rule
The Common Rule applies to all research in- volving human subjects that is conducted or sup- ported by a Federal department or agency that has adopted the policy (ç .101(a)).

c. ANPRM [2011 Advance Notice of Proposed Rulemaking] Discussion
The ANPRM discussed the possibility of the Common Rule applying to all studies, regardless of funding source, that are conducted by a U.S. institution that receives some federal funding for human subjects research from a Common Rule (80 Fed. Reg. 53933-54061 at p. 53989, emphasis added).


Common Rule Changes Include Mandatory Use
of Central IRB … p. 4

As we continue our coverage of the recent major proposal to revise human subject protection regulations, we turn to a controversial topic that we have addressed previously. That topic is the mandated requirement to use ONE Institutional Review Board (IRB) to review protocols of multisite studies. This requirement was proposed in the 2011 Advance Notice of Proposed Rulemaking (ANPRM) and again separately in a proposal by the National Institutes of Health (NIH) late last year. In the recent NPRM, the government states:

These issues attracted a large number of comments to the 2011 ANPRM, and revealed nearly evenly divided perspectives. Investigators and disease advocacy groups tended to favor the single IRB review requirement. IRB and institutional representatives tended to be opposed to the possible requirement, though many indicated single IRB review should be encouraged(80 Fed. Reg. 53933-54061 at page 53983, emphasis added).


IRBs and Draft Guidance on “Standard of Care” Studies … p. 5

As discussed elsewhere in this HRR and in past HRRs, the topics of “standard of care” and “reasonably foreseeable risks” continue to pose problems for Institutional Review Boards and researchers. The core challenges are the problems posed by insufficient explanations in informed consent of all risks, especially when more than one “standard of care” is studied.

Even more complicated are the problems posed by randomized placebo-controlled trials, despite the traditional view that such trial designs represent the “gold standard” for truly assessing efficacy while still protecting human research subjects.

We have presented and will continue to present opposing views on these issues, including those of leading consumer and patient advocacy groups such as Public Citizen. However, we now switch to a federal office proposal released on October 24 of last year that became the focus of much of these discussions. In turn, that proposed guidance was based in large part on a public meeting held by the Office for Human Research Protections (OHRP).