Human Research Report

Protecting Researchers and Research Subjects

Vol. 32, No. 2, February, 2017

In This Issue

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

Single IRB Reviews and New Final “Common Rule” … p. 4
IRBs and Increasing Interest In Using Electronic Consents … p. 5
IRBs and Charging Research Subjects … p. 6

IRBs and Data Required By Clinical Trials Registration … p. 7
IRBs and Privacy of Human Research Subjects’ Results … p. 8
FDA: Bothersome Details for Researcher … p. 9
OHRP: Researcher Failures and Misconduct … p. 10
In Court: Misconduct Even During Hearing … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

Single IRB Reviews and New Final “Common Rule” … p. 4

As described in the preceding lead article in this HRR, the topic of single IRB reviews (or “sIRB” reviews) of multisite (or “cooperative”) studies is a major one for IRBs. The National Institutes of Health (NIH) has promised to publish guidances on the many challenges of sIRB reviews prior to the NIH’s effective date of its new sIRB policy on September 25.

In addition, as described in last month’s HRR (p. 3), the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has submitted sIRB recommendations to Health and Human Services (HHS).

Apparently in recognition of the many implementation problems with an sIRB approach, the recent final Federal Policy for the Protection of Human Subjects (“Common Rule”) made a special announcement about the regulations’ effective date. The effective date for the many Common Rule changes will be on January 19, 2018. The compliance date for the overall rule will be the same; i.e., January 19, 2018.

However, out of all the changes to the Common Rule, only one component has a much later compliance date. That component, as one might guess, is the section on single IRB review of multisite (“cooperative”) studies. The compliance date for those regulations (to be found at §___.114(b) of the HHS final rule), will be two years later, on January 20, 2020.

TOP ▲

IRBs and Increasing Interest In Using Electronic Consents … p. 5

We continue here with a topic we first covered last month; i.e., the release by the federal Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) of a revised version of a guidance on electronic informed consent (“eIC”).

Last month we presented the two specific Q&As from the guidance that addressed IRB issues directly. This month, we begin coverage of the other more basic Q&As that affect IRBs, researchers, and sponsors.

For the purposes of this guidance, electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent” (“Use of Electronic Informed Consent: Questions and Answers — Guidance for Institutional Review Boards, Investigators, and Sponsors, December, 2016; on the Web at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf).

TOP ▲

IRBs Must Be Familiar With Policy On Charging Subjects … p. 6

We continue here with a topic that we last covered in the December 2016 HRR (p. 7); namely, the role of IRBs when sponsors or sponsor-researchers want to charge research subjects for administration of an experimental drug. If such a financial charge is levied against research subjects, any involved IRB would be well-advised to be familiar with the FDA’s guidance on this topic, to help ensure the welfare of the study subjects.

We present here information from the guidance’s Q&As that we have not covered previously. For example:

“Q1: How much time does FDA have to review and respond to a request to charge for an investigational drug?
A1: The provision in 21 CFR 312.8 does not specify a time frame for FDA to respond to a request to charge for an investigational drug. However, FDA intends to respond to charging requests within 30 days of receipt when possible (“Charging for Investigational Drugs Under an IND — Questions and Answers,” July, 2016, p. 7 of 8; on the Web at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm351264.pdf).

TOP ▲