Human Research Report

Protecting Researchers and Research Subjects

Vol. 31, No. 3, March, 2016

In This Issue

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

V31 N03 In This Issue

Proposal: No Need for IRB Review of Education Activities … p. 4
IRBs Need Not Review Normal Program Improvement Efforts … p. 6
Proposal on Human Subjects Needs Complete Revision … p. 8

FDA: Researcher Provides No Proof of IRB Approval of Study … p. 9
OHRP: Heightened Focus Placed on Continuing Education for IRB Members … p. 10
In Court: Researcher Makes Allegations of University Bias as Part of His Defense … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

Proposal: No Need for IRB Review of
Education Activities … p. 4

One of the major exceptions to Institutional Review Board (IRB) reviews contained in the recent Notice of Proposed Rulemaking (NPRM) on protecting human research subjects involves the area of educational research. In last month’s HRR we briefly cited this as one of several exception areas (see p. 3 in that issue). We now take this opportunity to present more details, including the background reasoning of the NPRM’s authors. The NPRM covers a number of activities that, up to now, have often caused IRB confusion and increased IRB review burdens.

Educators, behavioral and social scientists, and many others have long criticized the existing Common Rule on protecting human subjects as unduly burdensome and largely irrelevant for many educational activities. The key issue, of course, is whether or not the activities actually constitute “human research” in the sense intended by the Common Rule.

A related issue, often brought up by those claiming that much educational “research” should not be covered by the Common Rule, is whether or not such education-related activities involve sufficient risks to warrant Common Rule protections.


IRBs Need Not Review Normal Program
Improvement Efforts … p. 6

We have devoted considerable space in the last few HRR issues to the NPRM section proposed for the Common Rule that is referred to as covering “excluded” types of research. We continue here with more of that same significant proposal by presenting the overall picture of what the category means.

The NPRM creates a new section in the regulations referred to as “˜exclusions.’ This section outlines eleven specific types of activities that will be outside the scope of the regulations. These
activities will therefore not have to satisfy any regulatory requirements, nor is it expected (unlike exempt research) that they will undergo any type of review process to determine this status.

The exclusions will eliminate uncertainty regarding some activities that are not research, and identify some activities that arguably might be judged to be research, but whose contribution to
public welfare is so imperative that they should proceed without having to satisfy the regulatory requirements. The exclusions also identify certain research activities that are sufficiently low-risk and nonintrusive that the protections provided by the regulations are an unnecessary use of time and resources, whereas the potential benefits of the research are substantial (80 Fed. Reg. 53933-54061 at p. 53946, September 8, 2015, emphases added).


Proposal on Human Subjects Needs
Complete Revision … p. 8

As reactions to the massive and confusing recent proposed changes to the Common Rule become more numerous, we find yet another large group that is recommending that those proposals be withdrawn and dropped and/or revised. The proposals, of course, are those of the September 8, 2015, federal Notice of Proposed Rulemaking (NPRM) that we have been discussing since the October 2015 HRR.

In this article we present some of the views on the NPRM as they have been expressed by a group that we have followed for years; namely, the consumer advocacy group known as Public Citizen. In particular, we have often presented the views of Public Citizen’s Director of the Health Research Group, Dr. Michael Carome. We have found, and continue to find, his views particularly useful for the human subject research compliance community due to his past experience as a member of the federal Office for Human Research Protections (OHRP).

Although not listed as an author on this particular public comment letter, he has authored many similar ethical and regulatory critiques of problematic human subject studies that we have covered previously, such as the SUPPORT, TOP, and FIRST studies.