Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 10, October, 2017

In This Issue

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


IRB Compliance and Transition To New 2018 Common Rule … p. 4
IRBs and Automatic Issuance of Certificates of Confidentiality … p. 6
IRBs Have New Guidance For Meeting Minutes … p. 7

IRBs, Device Studies, and Safety/Efficacy for Subjects … p. 8
FDA: Researcher Pleads “Poor Documentation” … p. 9
OHRP: Complainant Says Consent Form Didn’t Explain Use of Genetic Data … p. 10
In Court: Violation of Subjects’ Privacy … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRB Compliance and Transition To
New 2018 Common Rule … p. 4

In early August, the influential Secretary’s Advisory Committee on Human Research Protections (or SACHRP) sent a series of six recommendations to Thomas Price, Secretary of the Department of Health and Human Services. These recommendations addressed key aspects of the controversial new 2018 Common Rule on protecting human subjects.

We present here the initial portion of one set of recommendations titled “Attachment A: Recommendations on Compliance Dates and Transition Provisions”– topics much on the mind of IRB members, researchers, and research administrators.

SACHRP Discusses Compliance Dates

“Final Rule §_.101(l) Compliance Dates and Transition Provisions

Section__.101(l) of the final rule addresses compliance dates and transition provisions. The entire language of §__.101(l) is as follows:
(l) Compliance dates and transition provisions:
(1) For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the CODE OF FEDERAL REGULATIONS.
(2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The compliance date for §__. 114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.

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IRBs and Automatic Issuance of
Certificates of Confidentiality … p. 6

Traditionally, “Certificates of Confidentiality” (or CoCs) have been issued by the National Institutes of Health (NIH) as a way to protect the confidentiality of sensitive data obtained from human subjects. Typically, researchers apply to NIH to have a CoC issued for his/her study(ies).

Usually, said research will already have received approval by the relevant Institutional Review Board (IRB) before an application is made for a CoC. However, it also has been possible for a researcher to seek a CoC from NIH if the IRB’s approval is pending and dependent only on NIH actually issuing the CoC.

As we have presented in past HRRs, CoCs shield the researcher, the institution, the research subject, and anyone else with access to sensitive, individually identifiable research data from liability and other risks associated with sensitive data (information on research subject drug use, etc.). Of course, there are exceptions.

Regardless, the typical CoC process has always involved the active seeking of a CoC by the researcher via an NIH CoC application procedure. However, that now has changed, and in a significant way.

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IRBs Have New Guidance For Meeting Minutes … p. 7

A joint guidance was issued in late September by the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) that expressly includes IRBs. The guidance is titled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.”

It is available from both agencies. OHRP’s link is posted at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html. FDA’s version is an Adobe pdf document and is on the Web at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM470154.pdf.

Since we prefer working with pdfs, we will be citing the FDA’s version. The two versions appear to be identical. The only minor variation we have seen is the fact that the FDA’s version lists references at the bottom of each relevant page, while OHRP’s version lists all references in order on the final page.

Law Requires Agencies to Harmonize Rules

The 13-page (pdf version) guidance is divided into the following four sections: I (Introduction), II (Background), III (Discussion), and IV (Additional Considerations). The “Discussion” section is subdivided into: A (Attendance at the IRB Meeting), B (Actions Taken by the IRB), C (The Vote on IRB Actions), D (Requiring Changes or Disapproving Research), and E (Controverted Issues and Their Resolution).

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