May 1, 2018: Proposal for 6-month Delay for Implementation of Revised Common Rule

On April 20, 2018, the Department of Health and Human Services and 15 other federal departments and agencies proposed a rule to delay both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). The Interim Final Rule initially announced a delay until July 19, 2018, and the new, proposed rule would delay by a further 6 months to January 21, 2019. This is intended to give institutions additional time to prepare to implement the revisions. Before January 21, 2019, institutions must comply with the pre-2018 Common Rule, except for these three proposed allowances, which are intended to reduce burden on regulated entities:

  1. Entities may use the 2018 definition of “research,” which deems certain activities not to be research,
  2. No annual continuing review is needed for certain categories of research, and
  3. Institutional review boards (IRBs) are not required to review grant applications related to research.

Comments on the proposal will be accepted until midnight EST on May 21, 2018, on the Federal eRulemaking Portal or through regular mail. To use the portal, search for “83 FR 17595” and click the box “Comment Now!”

CTSA-PCORnet Webinar: A Central IRB Approach


The webinar copresented on March 2, 2016, by the Clinical and Translational Science Awards (CTSA) program and PCORnet is available as a video and slideset.

Petra Kaufmann, MD, MSc
Director, Office of Rare Diseases Research and Division of Clinical Innovation
National Center for Advancing Translational Sciences
National Institutes of Health

Rachael Fleurence, PhD
Program Director, CER Methods and Infrastructure Program
Patient-Centered Outcomes Research Institute

Sabune J. Winkler, JD
Director, Regulatory Affairs Operations
Harvard Catalyst

Webinar details:
March 2, 2016
3pm - 4pm ET
To join the WebEx, click here: http://bit.ly/1TGRTFS
Call-in number: 1-855-244-8681
Access code: 737 807 582

Modernizing the Common Rule for the 21st Century


The New England Journal of Medicine today published a perspective by NIH Deputy Directory Kathy L. Hudson, PhD, and NIH Director Francis S. Collins, MD, PhD, in which they outline the major reforms proposed for regulations governing the ethical conduct of research involving humans, known as the Common Rule (45 CFR 46, Subpart A).

The proposed changes are meant to enhance respect for research participants, calibrate oversight to level of risk, simplify consent documents, streamline IRB review, increase privacy and security safeguards, and facilitate broad participation in research.

“These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist.”

The NIH is encouraging all stakeholders—the public, researchers, and patients—to closely review the proposed changes and participate in the comment process by the December 7, 2015, deadline.

For more information on the proposed revisions:

Grand Rounds Presentation, Kathy Hudson (video)

Department of Health and Human Services' website on the NPRM 

OHRP Webinars on the NPRM

Living Textbook Chapter: Informed Consent: Emerging Issues and Controversies

CTTI Releases New Tools to Help Organizations Implement Central IRBs


The Clinical Trials Transformation Initiative (CTTI) has released new recommendations encouraging adoption of a central institutional review board (IRB) model for multicenter clinical trials. The recommendations are based on results from its Central IRB Advancement Project. Along with the recommendations, CTTI offers tools, including evaluation checklists and an IRB authorization agreement template, to help organizations implement a central IRB model.

Read the complete announcement on the CTTI blog.


Grand Rounds (4-25-2014): CTTI’s Central IRB Advancement Project

Update:

Archived video and slides from the April 25 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.


This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives”) will be presented by Cynthia Hahn and Petra Kaufmann, MD, MSc, team leaders for the Clinical Trials Transformation Initiative’s Central IRB Advancement Project. Ms. Hahn is vice president of Clinical Research & Regulatory Affairs for the Feinstein Institute for Medical Research. Dr. Kaufmann is director of the Office of Clinical Research for the National Institute of Neurological Disorders and Stroke.

CTTI’s Central IRB Advancement Project is a follow-up to its previous Central IRB Project that conducted expert and stakeholder interviews to produce considerations and recommendations for central IRB adoption. The current project will take additional steps in encouraging the implementation of these recommendations and addressing remaining barriers to further advance the use of central IRBs for multicenter clinical trials. Expected deliverables include tools and best practices for researchers, sponsors, sites, and IRBs.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 25. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.