The Rutgers Health Clinical Trials Office invites you to join them for the virtual NJ ACTS Special Lecture on Thursday, December 19th from Noon to 1:30 PM. 

Their speakers are Dr. Daniel Ford from Johns Hopkins and Dixie Thompson from the University of Utah. Dr. Ford and Ms. Thompson will speak to our Rutgers Health community about the resources available to us through the CTSA Trial Innovation Network (TIN). 

Part of the webinar will focus on resources available through the TIN when we (as Rutgers) serve as a coordinating site for multi-center clinical trials, and the other part will focus on additional resources and toolkits available to all study teams and investigators.  

This will be an incredibly valuable session for our clinical research community! Please note that registration is required.

Originally adopted in June 1964, the World Medical Association (WMA) recently released an update to the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants.

This is the eighth revision and first update since 2013.

As described in the article Declaration of Helsinki revised to modernize research ethics standards, "Several key revisions augment respect for individuals participating in medical research as partners and co-creators in the advancement of science and knowledge." 

These updates include:

• Replacing the term "subjects" with "participants" to emphasize a "meaningful engagement with potential and enrolled participants and their communities."
• New language that "calls on researchers to carefully consider how the benefits, risks and burdens of research are distributed."
• A paradigm shift in inclusion and exclusion criteria as it pertains to vulnerable populations. The WMA noted that "starting with a default of exclusion for all those in positions of vulnerability had resulted in enormous gaps in medical knowledge about certain populations." The changes in language related to vulnerable populations aims to address these disparities.
• Rewrites to the section on informed consent for biobanking. "Prior language failed to adequately address the growing risks and need for consent and privacy protections related to the increased use of stored personal data after trials... New language calls for free and informed consent for the collection, processing, storage and foreseeable secondary use of biological material and data and for ethics committee approval and monitoring of such databases and biobanks.”

Malica T. Dock, Assistant Director of the Institutional Review Board (IRB) Reliance Team within the Rutgers Human Research Protection Program (HRPP) and Institutional Review Board (IRB) presented, “Are You Leaving Money on the Table? Ensuring IRB Fees are Accounted for in a Single IRB (sIRB) World” at the 2024 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference in Seattle, WA. 

Her session took a deeper dive into the life cycle of research and explored when IRB fees should and could be recouped when an IRB serves as a single IRB or when it cedes review.

Andrea Dragan, MPH, CIP, Director of Quality Assurance and Evaluation within the Rutgers Human Research Protection Program (HRPP), contributed an article to the October/November 2024 Issue of the National Council of University Research Administrators (NCURA) online magazine.

Her article "The Alchemy of Auditing" outlines four steps a quality assurance and evaluation team can take to transform their compliance program and foster a partnership of compliance with its researchers.

Full article here (subscription to NCURA required).

Andrea also moderated Dr. Benjamin S. Wilfond’s poster abstract presentation, “The ENVISION study: Creating a values-oriented platform for informed consent” at the 2024 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference in Seattle, WA.

Kristen D. Krause, PhD, MPH, Institutional Review Board (IRB) Committee Member, Rutgers School of Public Health faculty and Deputy Director of the Center for Health, Identity, Behavior and Prevention Studies (CHIBPS) presented, “Robots in Disguise: When Your Participants are More Than Meets the Eye” at the 2024 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference in Seattle, WA. 

Drawing on lessons learned from case studies, her session offered strategies and resources for anticipating and responding to bots by identifying IRB and research (mis)steps, strategic and thoughtful safeguard moves, and interdepartmental routines for research compliance and bot prevention.

Doretha Walker, PhD, MPA, Community Institutional Review Board (IRB) Committee Member, presented, “Nurturing True Inclusion: Moving Beyond Tokenism to Actual Inclusion” at the 2024 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference in Seattle, WA.

Her session was geared towards human and animal research programs. It explored tokenism and lead a discussion into how venturing beyond the bounds of tokenism can lead to a broader range of thoughts, ideas, and opinions that can lead to sustainable and better solutions, as well as greater access to research communities and resources with and between organizations.

Michelle Watkinson, CIP, Training & Communications Manager within the Rutgers Human Research Protection Program (HRPP) and Institutional Review Board (IRB) presented, “Help! I Don’t Understand: Making the Consent Process and Form Meaningful Through Health Literacy and Adult Learning Theory” at the 2024 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference in Seattle, WA.

Her session proposed an alternate method to addressing the Belmont Report’s ethical principles of “respect for persons” and “justice” by addressing the barriers that exist for many people and communities which prevent them from participating in research. Through the integration of adult learning theory principles into informed consent procedures, this session offered insights into how to close health inequality gaps.