Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 4, April, 2017

In This Issue

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

IRBs Have Explanations for New Consent Changes … p. 4
More Informed Consent Changes Explained in New Common Rule … p. 6
IRBs Have Tips in Guidance On Using NIH’s sIRB Approach … p. 8

FDA: Three Years Is Probably a Long Time To Wait to File Adverse Event Report … p. 9
OHRP: Research Subject Eventually Dies In Study That Included Ineligible Subject … p. 10
In Court: Panel Concludes That There Were Numerous Instances of Research
Misconduct, Including in Publications … p. 11

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

IRBs Have Explanations For New Consent Changes … p. 4

As we continue our coverage of informed consent changes contained in the new Common Rule, we pick up where the preceding HRR article ends. That is, as is true for much of the FEDERAL REGISTER’S preamble to the actual Common Rule regulations, the following format is used to describe the new regulation modifications:

(1) “Background and Pre-2018 Requirements,”
(2) “NPRM” [previous Notice of Proposed Rulemaking],
(3) “Public Comments,” and (4) “Response to Comments and Explanation of the Final Rule.”
Since we presented sections 1-3 in the preceding

HRR article, we resume here with section 4:

4. Response to Comments and Explanation of the Final Rule: General Requirements for Informed Consent
Before addressing how the general requirements for informed consent proposed in the NPRM have been adopted and altered in the final rule, it is important to note that the structure for this regulatory text has been altered. In the pre-2018 rule, the general requirements were included in an unnumbered introductory paragraph (82 Fed. Reg. 7149-7274 at p. 7212, January 19, 2017, underline emphasis added).


More Informed Consent Changes Explained in New Common Rule … p. 6

The preceding article in this HRR concluded with an explanation of the “body” versus “appendix” informed consent issue and how it is handled in the new Common Rule. We continue here with the preamble’s subsequent explanation of the new informed consent requirement on the importance and need for a new concise and understandable beginning for informed consent forms.

In particular, the final rule imposes a new requirement (set forth in ç___.116(a)(5)(i)) that the informed consent begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.

This provision further requires that this beginning portion of the informed consent must be organized and presented in a way that facilitates comprehension. This requirement applies to all informed consents, except for broad consents obtained pursuant to ç___.116(d), which may warrant a different presentation (82 Fed. Reg. 7149-7274 at p. 7213, January 19, emphases added).


IRBs Have Tips in Guidance On Using NIH’s sIRB Approach … p. 8

We continue this month with more key sections of a current FDA guidance for IRBs and others that we last discussed in the January HRR. That guidance is titled “Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.”

As we have suggested in past HRRs, we believe that elements of this existing guideline (now in effect for almost three years), contain useful tips for the upcoming requirements for the use of a single IRB (sIRB) to review multisite experiments. This is in contrast to the traditional, and still in use, approach whereby local IRBs review the protocols for multisite studies that are held in their particular locations.

As we noted last month, the new version of the Common Rule on the protection of human subjects has extended the deadline for the government-wide requirements for sIRBs to January 20, 2020. This is considerably later than the January 18, 2018, implementation date for the rest of the Common Rule.

However, the separate NIH requirement for sIRB reviews is still set to become effective on September 25 (extended beyond the original effective date of May 25). The NIH requirement will apply to all NIH-funded studies. Since NIH is the largest single funding source for human subjects research, NIH’s requirement is expected to have a major impact.