Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 11, November, 2017

In This Issue

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

V 32 No 11 In this Issue

IRBs and Proposed Changes to Final 2018 Common Rule … p. 3
IRBs, Alleged Compliance Violations, and Protection for Potential Whistleblowers … p. 5
IRBs and Exemption from Their Protocol Reviews … p. 7

FDA: Researcher Fails to Follow His Own Approved Protocol … p. 9
OHRP: Federal Agency Requires University to Launch Investigation … p. 10
In Court: Declaration of Helsinki and Protection of Human Research Subjects
Cited in Lawsuit Against University … p. 11

In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs and Proposed Changes to
Final 2018 Common Rule … p. 3

We continue here with presenting highlights of major new recommendations submitted to the Department of Health and Human Services (HHS) by the influential Secretary’s Advisory Committee on Human Research Protections (SACHRP).

The recent six sets of recommendations (“Attachments A-F”) were submitted to HHS on August 2. With this HRR article, we conclude our coverage of “Attachment A: Recommendations on Compliance Dates and Transition Provisions.” This set of recommendations was developed SACRHP’s Subpart A Subcommittee (SAS).

All Main IRB Regulations Targeted for Change

SACHRP’s charge to the Subpart A Subcommittee (SAS) is to review and assess all provisions of subpart A of 45 CFR part 46 (HHS’ codification of the Federal Policy for the Protection of Human Subjects, also known as the Common Rule) and relevant Office for Human Research Protections (OHRP) guidance documents, and based on this review and ongoing assessment, to develop recommendations for consideration by SACHRP in three categories: (1) recommendations on interpretation of subpart A provisions, (2) recommendations for development of new, or modification of existing, OHRP guidance; and (3) recommendations for possible revision of subpart A.


IRBs, Alleged Compliance Violations, and
Protection for Potential Whistleblowers … p. 5

A new report recommends that the federal Office for Human Research Protections (OHRP) should take specific steps, not now in place, to offer protection to whistleblowers who allege violations of human subject protection regulations. The report is titled “OHRP Should Inform Potential Complainants of How They Can Seek Whistleblower Protections.” The report was issued by the Office of Inspector General (or OIG)
of the Department of Health and Human Services (or HHS), and is based on an examination of OHRP investigations of allegations of human subject protections noncompliance between 2000 and 2015.

One of the reasons for releasing the report, according to OIG, is something OIG discovered during its past evaluation of the compliance enforcement activities conducted by OHRP. That evaluation led to a previous OIG report titled “OHRP Generally Conducted its Compliance Activities Independently, But Changes Would Strengthen its Independence” (OEI-01-15-00350). What did OIG discover then, according
to the more recent report?

We found evidence of a fear of reprisal in four of the five closed for-cause compliance evaluations that we reviewed” (OEI-01-15-00351, September, p. 1 of 7, emphases added;


IRBs and Exemption from Their Protocol Reviews … p. 7

We continue here with our coverage of one of the most discussed sections of the 2018 Common Rule; namely, the exemption of certain research protocols from IRB review. As we noted last month, the previous proposal in the NPRM (Notice of Proposed Rulemaking) included the development and use of an “exemption determination” tool or process to be used to make such decisions.

Since this issue has obvious implications for IRBs, we will continue to discuss the pros and cons of how to make such an “exemption determination.” We resume where we left off last month with:

4. Response to Comments and Explanation of the Final Rule: Exemption Determination

The final rule does not adopt the NPRM proposal at this time. Therefore, the final rule does not require that exemption determinations be documented, as had been proposed in the NPRM, and continues to permit flexibility in how exemption determinations are made.

We recognize it was difficult [for the compliance community] to provide detailed feedback in the absence of an exemption decision tool to evaluate. However, we continue to believe that a well-designed, tested, and validated exemption decision tool could offer an expedient mechanism for determining whether research studies are exempt (82 Fed. Reg. 7149-7274 at p. 7184, January 19, emphases added).