Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 6, June, 2017

In This Issue

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

New IRB Expedited Review Requirements in Final Rule … p. 3
IRBs and Privacy Boards Both In New NIH Requirements … p. 4
Changes to IRB Steps In Approving Research … p. 6

Human Subject Inclusion and Exclusion Factors Are Studied … p. 8
FDA: Agency Says Researcher Failed to Protect Study Subjects … p. 9
OHRP: Researcher Accused of Misconduct And Failing to Protect Study Subjects … p. 10
In Court: Individual IRB Members Are Sued … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

New IRB Expedited Review Requirements in Final Rule … p. 3

The following excerpt presents Section X of the Final Common Rule’s preamble on changed expedited IRB review requirements (found at §___.110). This excerpt contains the primary requirements, minus a few minor notes.

A. Background and Pre-2018 Requirements

Under the pre-2018 rule, a research study could receive expedited review if the research activities to be conducted appear on the list of activities published by the Secretary of HHS that are eligible for such review and was found by the reviewer(s) to involve no more than minimal risk.

Under an expedited review procedure, the review could be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among the members of the IRB. Research that was eligible for expedited review required continuing review at least annually” (82 Fed. Reg. 7149-7274 at page 7206, emphasis added).


IRBs and Privacy Boards Are Both in New NIH Requirement … p. 4

As we described last month, the Council on Governmental Relations (or COGR) is an association of over 190 research-intensive institutions in the U.S. COGR has analyzed the upcoming requirements by the National Institutes of Health (NIH) on the use of one single IRB (“sIRB”) in the review of multisite studies. As a reminder, note that the requirement goes into effect soon, on September 25.

We continue here with key portions of the COGR’s analysis of NIH’s “Frequently Asked Questions” (or FAQs), that COGR submitted to NIH for NIH’s consideration. Any COGR comments appear in blue italics.

“6. The NIH single IRB policy states that it applies to domestic ‘NIH-funded multi-site studies.’ What does ‘NIH-funded multi-site studies’ mean?

[Answer] For the NIH single IRB policy, ‘NIH-funded multi-site studies’ means that the same protocol involving non-exempt human subjects research is being conducted at more than one site and is being wholly or partially funded by NIH (“NIH Single IRB Policy FAQs for Extramural Community: Policy Background and General Requirements,” March 16, p. 2; on the Web at


Changes to IRB Steps In Approving Research … p. 6

The new Common Rule’s preamble explains the upcoming changes to the criteria for IRB approval of research, as follows: ….

B. NPRM [Notice of Proposed Rulemaking] Proposals

The NPRM proposed a number of changes regarding the criteria for IRB approval of research, including (1) creating a new form of IRB review for activities relating to storing or maintaining data and biospecimens for later secondary use; (2) revising two of the existing criteria for approval of research that have special considerations related to the involvement of vulnerable populations and for privacy and confidentiality of data provisions; and (3) adding a provision about plans to review the return of individual results to participants.

The first set of changes concerned updating the IRB review criteria for research activities relating to storing or maintaining information and biospecimens, and to the secondary use of such information and biospecimens.

Paragraph (a)(9)(i) of proposed §___.111 would have applied to a proposed exemption at §___. 104(f)(1) for storing or maintaining biospecimens or identifiable private information for use in secondary research.

This provision would have eliminated the need for an IRB to make the usual determinations about such an activity. Instead, the IRB would have been required to determine that the procedures for obtaining broad consent to storing or maintaining the biospecimens or information were appropriate, and met the standards included in the introductory paragraph of §___.116 (82 Fed. Reg. 7149-7274 at pp. 7206-7207, emphases added).