Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 6, June, 2016

In This Issue

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

V31 N06 In This Issue

IRBs, Trial Design, and Safety of Human Subjects … p. 4
IRBs, Risks, and Human Factor Research … p. 5
IRBs and Electronic Health Record Data … p. 6

Study Says IRBs Approved a Clearly Unethical Experiment … p. 7
In Congress: Weaker Subject Protections … p. 8
FDA: Who Needs an IRB Review Anyway? … p. 9
OHRP: One IRB But Several Study Sites … p. 10
In Court: Where Did the Data Go? … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs, Trial Design, and the Safety of
Human Subjects … p. 4

We continue this month with our coverage of the CHAMPION PHOENIX studies, a project conducted at 153 institutions around the world, including 3 Veterans Affairs sites in the U.S. As we have described previously, the consumer advocacy group known as Public Citizen has urged that the federal Office for Human Research Protections (OHRP) and the VA investigate the alleged unethical and dangerously noncompliant CHAMPION PHOENIX human studies.

Public Citizen, a consumer advocacy organization with more than 400,000 members and supporters nationwide, hereby requests that the Office of Research Oversight (ORO) promptly conduct a compliance oversight investigation of the CHAMPION PHOENIX trial, which was conducted, in part, at Department of Veterans Affairs (VA) health care facilities (letter from Dr. Michael Carome, a Director of Public Citizen’s Health Research Group, to J. Thomas Puglisi, Ph.D., Chief Officer of VA’s Office of Research Oversight (ORO), January 7, p. 1 of 19, emphasis added; on the Web at


IRBs and Risks to Subjects In Human
Factor Research … p. 5

As we have discussed for the last two months, IRBs have particular responsibilities when reviewing “combination products” that involve human factor (HF) studies. One sign of IRB difficulties with such studies is the number of times that IRBs have contacted the Food and Drug Administration (FDA) with questions about IRB reviews of this type of research.

A basic feature of such studies is the nature of the research itself, since it can contain clues regarding possible human subject risks. We resume here where we left off last month (see May HRR, p. 6).

The HF study evaluates: (i) the ability of the user to perform critical tasks, and (ii) the ability of the user to understand the information in the packaging and labeling, such as product labels or instructions for use, that inform the user’s actions and that are critical to the safe and effective use of the combination product (e.g., product preparation, administration, maintenance and disposal, or what actions to take if an adverse reaction occurs). Both types of evaluations may be part of the HF Formative and HF Validation studies described below (“Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development,” February, pp. 3-4, emphases added; on the Web at


IRBs and Electronic Health Record Data … p. 6

The Food and Drug Administration (FDA) has issued a new draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations.”

The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations ….

In particular, the draft guidance provides recommendations on the following: (1) Deciding whether and how to use EHRs as a source of data in clinical investigations; (2) using EHRs that are
interoperable with electronic systems supporting clinical investigations; (3) ensuring that the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations meet FDA’s inspection, recordkeeping, and record retention requirements (81 Fed. Reg. 30540-30541, May 17, the emphasis is added).