Human Research Report

Protecting Researchers and Research Subjects

Vol. 33, No. 1, January, 2018

In This Issue

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

In this Issue - Vol. 33, No. 1, January, 2018

IRB Reviews When eICs Are Used in Human Subjects Research … p. 4
IRB Meeting Minutes and Joint Federal Agency Guidance … p. 6
IRBs and More Pediatric Research … p. 7

IRBs and Reimbursement of Device Costs … p. 7
IRBs and Direct v. Indirect Costs … p. 8
IRB Reporting Requirements Up for Renewal … p. 8
FDA: Researcher Pleads Ignorance … p. 9
OHRP: Researcher Wants to File Complaint … p. 10
In Court: Violation of Constitutional Right? … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRB Reviews When eICs Are Used in Experiments … p. 4

In concluding last month’s article on IRBs and FDA’s current electronic informed consent (eIC) requirements, we presented the FDA guidance’s policy on HIPAA and research subjects’ privacy – a key IRB review component. In particular, we ended with the guidance’s Question 10 on how to help ensure the “privacy, security, and confidentiality” of the electronic system that includes the eIC.

We present here the FDA’s related notation on regulatory applicability for Question 10.

[FN #15: The HHS Office for Civil Rights (OCR) administers and enforces the HIPAA Privacy Rule, which protects the privacy of individually identifiable health information and establishes an array of individual rights with respect to health information; the Security Rule, which sets national standards for protecting the security of electronic protected health information; and the Breach Notification Rule, which requires covered entities and business associates to provide notification following a breach of unsecured protected health information.

Additional information about the HIPAA Rules is available on OCR’s Web site at:] (guidance, December, 2016, p. 10 of 13, underline emphases added; on the Web at


IRB Meeting Minutes and Joint Agency Guidance … p. 6

We concluded last month’s article on the recent joint HHS/FDA guidance on IRB meeting minutes by noting that IRB members can “attend” a meeting via an “alternative mechanism.” That term refers to meeting, for example, via a telephone or video conference. We resume our coverage of the IRB minutes guidance with the following.

An IRB may choose to appoint alternate members who may substitute for primary members for an entire meeting (e.g., when the primary member is not able to attend the meeting), or at any time during a meeting (e.g., when the primary member is not able to attend the whole meeting, or when the primary member has a conflicting interest and is recused from review of a particular study).

When an alternate member replaces a primary member at a convened meeting, the minutes must include the name of the alternate member in attendance (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). When an alternate member substitutes for a primary member due to a conflicting interest, the minutes should identify the name of the primary member for whom the alternate member is substituting, and state that this is the reason for the substitution (“Minutes of Institutional Review Board (IRB) Meetings – Guidance for Institutions and IRBs,” September, 2017, p. 4 of 13, emphases added; on the Web at


IRBs May Have to Brush Up On Research With Children … p. 7

Changes are being considered by NIH for human subject experiments that involve children as the subjects. On December 1, 2017, NIH issued a notice about the current status of such developments that were put in place by the 21st Century Cures Act – enacted on December 13, 2016. That Act:

… includes new provisions requiring NIH to address the consideration of age as an inclusion variable in research involving human subjects, to identify the criteria for justification for any age-related exclusions in NIH research, and to provide data on the age of participants in clinical research studies.

Furthermore, the Act requires NIH to convene a workshop of experts on pediatric and older populations to provide input on these issues, and taking account input received through the workshop, the NIH Director is charged with deciding whether any changes to NIH inclusion policies are needed (“Notice of Intent to Revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects,” NIH Notice NOT-OD-18-008, December 1, 2016, emphases added; on the Web at