Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 5, May, 2016

In This Issue

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

V31 N05 In This Issue

IRB Members: Better Selection, Education, and Certification … p. 4
Investigation Requested for Large Scale Human Study … p. 5
IRBs, Risks, and Human Factor Studies … p. 6

IRBs, Consent, and FDA Flexibility … p. 7
Waiver of IRB Review Considered By Agency … p. 7
In Congress: Risks and Conflicts of Interest … p. 8
FDA: A Drug By Any Other Name … p. 9
OHRP: Regulatory Noncompliance Not Shown … p. 10
In Court: No “Missing” Data Found … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRB Members: Better Selection, Education,
and Certification … p. 4

We continue here with the influential Public Citizen group’s reaction to the September 2015 Notice of Proposed Rulemaking (NPRM) on protecting human subjects. Last month, we left off our coverage with the Citizen’s view that strongly disagreed with the opinion of the NPRM authors who stated that the proposed changes to the Common Rule would make Institutional Review Boards (IRBs) more efficient and better able to address human subject risks.

Not so, said Public Citizen, who then explained their reasoning on why the proposals would actually increase IRB burdens (see our April HRR, p. 3). This month, we begin our coverage of what Public Citizen believes should be addressed in future regulations.

Expertise of Many IRB Members Is Questionable, Says National Group

The Common Rule should include additional provisions to ensure that IRB members have appropriate knowledge and expertise regarding the research reviewed by the IRB …. Too often, IRB
members lack up-to-date knowledge and relevant expertise necessary for the IRB to make the determinations required for approval of research under Section __.111.

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Investigation Requested for Large Scale
Human Study … p. 5

We continue this month with our coverage of the CHAMPION PHOENIX studies conducted at 153 institutions around the world. As we quoted last month, the consumer advocacy group known as Public Citizen has charged that this study, including the trials conducted at three Veterans Affairs sites in the U.S., was unethical and exposed human subjects to unnecessary risks. Public Citizen has asked the VA’s Office of Inspector General to investigate these trials.

Before proceeding with highlights from the Public Citizen’s open letter sent earlier this year, note that the document had 65 footnotes citing various documents (e.g., professional journal articles, FDA publications, etc.) to support its statements. We refer our readers to the original letter those citations backing Public Citizen’s position. Its position is that:

The trial, as conducted at three VA health care facilities (Dallas VA Medical Center, Jesse Brown VA Medical Center, and VA Boston Healthcare System), was unethical and failed to satisfy the requirements of VA human subjects protection regulations at 38 C.F.R. Part 16 (letter from Dr. Michael Carome, Director of Public Citizen’s Health Research Group, to J. Thomas Puglisi, Ph.D., the Chief Officer of VA’s Office of Research Oversight (ORO), Jan. 7, p. 1 of 19, emphasis added; at http://www.citizen.org/documents/2297a.pdf).

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IRBs, Risks, and Human Factor (HF)
Experiments … p. 6

As we discussed last month (see April HRR, p. 7, “IRBs Have Same Major Role …”), IRBs have particular responsibilities when reviewing “combination products” that involve human factor (HF) studies. In fact, as a new FDA guidance points out, IRBs have contacted FDA with specific questions about their role when reviewing such studies.

For example, when responding to IRB inquiries on whether or not IRB review is even needed in such activities, FDA clearly states that:

Clinical studies regulated under 21 CFR Part 312 (IND requirements) or Part 812 (IDE requirements) and clinical studies intended to support an investigational or marketing application are subject to applicable requirements under 21 CFR Parts 50 and 56. See 21 CFR 50.1(a), 50.20, 56. 101(a), and 56.103. As used in this document, clinical study has the same meaning as investigation or clinical investigation as defined in Parts 50, 56, 312, and 812, as applicable (“Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development,” February, pp. 3-4, emphases added; on the Web at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-gen/documents/document/ucm484345.pdf).

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