Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 5, May, 2017

In This Issue

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

New Requirement For Public Posting Of Consent Forms … p. 4
NIH’s sIRB Requirement Scrutinized By COGR … p. 7
Want To Change Any Federal Regulations? … p. 8

Permission Not Needed To Charge For Study’s Drug … p. 8
FDA: Agency Says Sloppy Record Keeping Endangers Human Subjects … p. 9
OHRP: Alleged Failure To Get IRB Approval … p. 10
In Court: Study Is Shut Down By Agency … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … 14

New Requirement For Public Posting Of Consent Forms … p. 4

One of the controversial proposals in the past Notice of Proposed Rulemaking (NPRM) on changing the Common Rule on protecting human subjects was the public posting of informed consent forms. That is, the NPRM proposed that all IRB-approved informed consent forms in applicable studies (i.e., federally supported studies) must be posted on the Web for anyone to view.

The preamble to the new Common Rule’s description of the relevant existing requirement is quite brief.

H. Posting of Consent Forms (ç___.116(h))
1. Background and Pre-2018 Requirements
The pre-2018 rule did not have a requirement to post consent forms from clinical trials.
2. NPRM Proposal
The NPRM proposed a new provision that … require[d] that a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency be posted on a publicly available federal Web site that will be established as a repository for such consent forms. The name of the protocol and contact information would be required to be included with the submission of the consent form (82 Fed. Reg. 7149-7274 at p. 7227, January 19, emphases added).


NIH’s sIRB Requirement Scrutinized By COGR … p. 7

The Council on Governmental Relations (COGR) is a national group that advocates for research-related regulation policies that are affordable, workable, and reasonable. COGR is an association of over 190 research-intensive institutions in the U.S.

We have previously described parts of the COGR analysis of the new Common Rule on the protection of human subjects, including the Rule’s new requirement on the use of a single IRB (“sIRB”) for the review of clinical trials involving human subjects. We now present parts of COGR’s assessment of the new requirements by the National Institutes of Health (NIH) on the same topic; namely, the use of an sIRB in reviewing multisite studies.

The NIH requirement goes into effect sooner than the Common Rule’s effectiveness date of January 20, 2020. Instead, NIH’s requirement will go into effect on September 25 of this year.



Want To Change Any Federal Regulations? … p. 8

In a move that is likely to presage future actions by more federal agencies, the Environmental Protection Agency (EPA) is:

… seeking input on regulations that may be appropriate for repeal, replacement, or modification. Comments must be received by May 15, 2017 ….

On February 24, 2017, President Trump signed Executive Order 13777, “˜Enforcing the Regulatory Reform Agenda,’ which established a federal policy “˜to alleviate unnecessary regulatory burden‘ on the American people. Section 3(a) of the EO directs federal agencies to establish a Regulatory Reform Task Force (Task Force) to evaluate existing regulations and “˜make recommendations to the agency head regarding their repeal, replacement, or modification.’

The EO further asks that each Task Force “˜attempt to identify regulations that:
(i) Eliminate jobs, or inhibit job creation;
(ii) are outdated, unnecessary, or ineffective;
(iii) impose costs that exceed benefits …’ (82 Fed. Reg. 17793, April 13, emphases added).