Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 2, February, 2016

In This Issue

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

V31 N02 In This Issue

New Exemption Category For IRB Protocol Reviews … p. 4
Subject Protection Changes Would “Seriously Impair IRBs” … p. 6
IRBs Alleged to Approve Unethical Experiments … p. 7

IRB Burdens Not Eased by Proposed Common Rule … p. 8
FDA: Enrolling Ineligible Subjects … p. 9
OHRP: Upgrading Protection Program … p. 10
In Court: Fighting Misconduct Charges … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

New Exemption Category For IRB Protocol Reviews … p. 4

We now present the third of four categories of research proposed to be exempt from the Common Rule and, hence, not need any Institutional Review Board review. We reported on the first two exemptions in previous articles (i.e., certain activities in “educational settings”– see January HRR “” and certain “demonstration projects” — see preceding article in this HRR).

The third exemption is yet another facet of the enormous Notice of Proposed Rulemaking (NPRM) issued in September of last year. We have listed the category title itself before, but we now proceed to the key details of this new exemption from IRB review, applying to:

iii. Research involving benign interventions in conjunction with the collection of data from an adult subject (NPRM at ç___.104(d)(3))

(1) NPRM Goal
The goal of this proposed new exemption for studies that involve benign interventions is to eliminate IRB review of these low-risk studies to reduce time and effort, allow IRBs to focus more
attention on research with higher risks or presenting other ethical challenges, and to enable this research to go forward (80 Fed. Reg. 53933-54061 at p. 53960, September 8, 2015, emphasis added).


Subject Protection Changes Would “Seriously
Impair IRBs” … p. 6

Among the many comments submitted in response to the Notice of Proposed Rulemaking (NPRM) on human subject protections are those sent in by the influential national Secretary’s Advisory Committee on Human Research Protections (SACHRP). The extent of their concerns (which supports HRR’s repeated calls for a longer comment period) can be seen in their cover letter to Health and Human Services.

The NPRM represents the first set of significant regulatory changes to the “˜Common Rule’ in almost 25 years. SACHRP appreciates the opportunity to provide comments on this important set
of proposals. SACHRP and its subcommittee members have taken this opportunity seriously and have spent hundreds of hours in efforts to understand the proposals, assess their ethical foundation, anticipate the consequences of the proposals for a range of stakeholders, and to craft the following responses and recommendations (letter from Jeffrey Botkin, M.D., SACHRP Chair, to Sylvia Burwell, HHS Secretary, January 5, emphases added; on the Web at


IRBs Alleged to Approve Unethical Experiments … p. 7

Although the recent Notice of Proposed Rulemaking (NPRM) containing numerous changes to the current Common Rule now dominates research compliance news, it is not the only development of interest. For example, the consumer rights activist group known as Public Citizen has accused a number of hospitals and health care training sites of conducting “highly unethical” research studies.

Once again, as we have presented in the past, Public Citizen says that many IRBs have approved certain studies that were blatantly unethical. In the most recent instance, Public Citizen’s Dr. Michael Carome, Director of Public Citizen’s Health Research Group, issued the following statement:

Two highly unethical clinical trials that have allowed first-year medical residents to work shifts of 28 consecutive hours or morenearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education (ACGME) for such residents — should be investigated (“Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts, Placing Them and Their Patients at Risk of Serious Harm,” November 19, 2015; on the Web at