Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 4, April, 2016

In This Issue

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

V31 N04 In This Issue

IRB Failures Show That System Is “Broken” … p. 3
Changes May Not Help Research Subjects … p. 4
IRBs Not Given Enough Risk Information … p. 5

IRBs Accused of Approving Unethical Study … p. 6
Just One IRB in Charge is Fine With Group … p. 7
IRBs’ Major Role in “Human Factors” Study … p. 7
In Congress: Bill Could Weaken Protections … p. 8
FDA: Researcher Doesn’t File FDA Application … p. 9
OHRP: New Education for IRB Members … p. 10
In Court: Researcher Says Data Were Lost … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRB Failures Are Sign That Protection System
Is “Broken” … p. 3

We continue here with highlights from the influential Public Citizen group’s reaction to the NPRM on protecting human subjects. See our previous article (March HRR, p. 8) describing the initial responses of Public Citizen, as it objects to much (although certainly not all) of the numerous proposed changes to the Common Rule on protecting human subjects. We continue now with Public Citizen’s additional point:

(5) Throughout the NPRM’s preamble, there are multiple uses of the term “participants” when referring to “human subjects.” We believe that the regulatory term “human subject” should be used throughout the preamble of any subsequent NPRM or final rule because (a) the term “participants” fails to capture the uniquely vulnerable status of human subjects involved in research relative to the many other people who participate in human subjects research study, such as investigators and sponsors …. (letter to Jerry Menikoff, M.D., J.D., OHRP Director, from Public Citizen’s Drs. Sidney Wolfe and Sarah Sorscher, January 6, p. 2 of 28, emphasis is added; on the Web at


Changes May Not Improve Research Subject
Protections … p. 4

We will continue to present research compliance public comments as they become available regarding the huge Notice of Proposed Rulemaking (NPRM) on protecting human research subjects. We now present the views of two influential groups that we have not yet discussed. These groups are the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU). In their comments on the NPRM, “Federal Policy for the Protection of Human Subjects,” Docket ID HHS-OPHS-0008, they remind the government that:

… AAU and APLU together represent most of the major public and private research universities in the United States, all of which are engaged in human subject research affected by the proposed rule. Many of our members will submit detailed institutional responses to the NPRM, based on their own experiences and expertise. As associations representing institutions that perform a broad range of research involving human subjects, we focus our response primarily on areas of considerable consensus and concern to our institutions (letter to Jerry Menikoff, M.D., J.D., Director of the federal Office for Human Research Protections (OHRP), from Hunter Rawlings (President, AAU) and Peter McPherson (President, APLU), December 23, 2015, page 1 of 15, emphases added; on the Web at


IRBs Are Not Given Enough Information to
Mitigate Risks … p. 5

As we first reported in our February HRR, the consumer advocacy group known as Public Citizen and the American Medical Student Association have called for the investigation of two studies referred to as “˜iCOMPARE” and “FIRST.” Those studies, conducted at numerous sites throughout the country, were defined by the two groups as:

highly unethical clinical trials that have allowed first year medical residents to work shifts of 28 consecutive hours or more — nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Education (ACGME) — for such residents …. (“Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts, Placing Them and Their Patients at Risk of Serious Harm,” Public Citizen, Nov. 19, 2015, emphases added; on the Web at

As those groups also noted in press releases and in a complaint letter to the federal Office for Human Research Protections (OHRP), the trials could never have started if the ACGME hadn’t issued a special waiver for the participating institutions to ignore the usual working guidelines for residents.