Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 3, March, 2017

In This Issue

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

IRBs Will Have a New Consent Element to Assess in Reviews … p. 3
IRBs Have New Additional Consent Element to Review … p. 4
“Broad Informed Consent” Does Not Stay the Same in Final Rule … p. 6

IRBs Will Not Be Able to Waive Informed Consent … p. 7
IRBs and Basic Features of eIC … p. 8
FDA: Human Subject Safety Is Jeopardized … p. 9
OHRP: Researcher and Ineligible Subject … p. 10
In Court: Researcher’s “Cooperation” Refuted … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs Will Have a New Consent Element to Assess in Reviews … p. 3

IRB reviews of protocols often devote a considerable amount of effort to assessing informed consent components. The new regulations in the Common Rule now add new components to consent. In this article we focus on a new one for the collection of identifiable private information or biospecimens.

However, we first describe a structure of the Common Rule’s preamble that we shall assume readers will then know for any future HRR articles — if they don’t already. The preamble extends from page 7149 to page 7259 in the January 19 FEDERAL REGISTER in its usual 3-column small print format. The actual regulations then appear on pages 7259-7274.

The preamble contains 22 Sections numbered IXXII. In general, many Sections are divided into four Subsections: “A. Background and Pre-2018 Requirements,” “B. NPRM [previous Notice of Proposed Rulemaking] Proposals,” “C. Public Comments,” and “D. Response to Comments and Explanation of the Final Rule.”


IRBs Have New Additional Consent Elements to Review … p. 4

In addition to the new ninth element of informed consent that is required by the new final version of the Common Rule, as described in the preceding HRR article, there are also now nine additional elements of informed consent. These additional elements are optional, apply to various situations, and should not be confused with the required nine elements.

In the “pre-2018” human subjects protection regulations, as the preamble to the new Common Rule describes them, the number of required consent elements was eight. It is now nine. In the pre-2018 regulations, the number of additional optional elements was six. It is now also nine.

As we have noted previously, the earlier Notice of Proposed Rulemaking (NPRM) received over 2,100 comments from the public and the research compliance community. More specifically, proposals to add to, or modify, required informed consent elements also received numerous comments. If the number of said comments on consent does not seem large, we should keep in mind that we have witnessed entire regulation changes in the human subjects protection field sometimes receive less than 50 comments in total.


“Broad Consent” Does Not Stay the Same in Final Rule … p. 6

We begin here with coverage of a controversial section of the new Common Rule; namely, research with identifiable private information or biospecimens. We have chosen the following portions as the ones we believe to be among the most instructive.

D. Elements of Broad Consent for the Storage, Maintenance, and Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens (ç___.116(d))

1. Background and Pre-2018 Requirements Under the pre-2018 rule, if identifiers are removed from information and biospecimens such that the identity of the subject could not be readily ascertained by an investigator or associated with the information or biospecimens, then such information and biospecimens that have been collected for purposes other than the proposed research could be used without any requirement for informed consent. Similarly, under the HIPAA Privacy Rule, if data are de-identified or HIPAA identifiers do not accompany biospecimens, then the Privacy Rule does not apply.

When identifiers have not been removed, under the pre-2018 rule investigators were allowed in certain situations to obtain a consent that is broader than for a specific research study, such as for creating a research repository that involves obtaining biospecimens from living individuals for use in future research studies. In these cases, an IRB could determine that the original consent for the creation of the research repository satisfied the requirements of the Common Rule for the conduct of the future research, provided that the elements of consent continue to be satisfied for the future research (82 Fed. Reg. 7149-7274 at p.7216, January 19, underline emphasis added).