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HRPP/IRB Newsletter
April 2024
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Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Learn more.]=
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Exciting eIRB+ System Updates
and Early Training Opportunities
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In April 2024, as part of the Office for Research’s commitment to enhancing and simplifying research processes and policies, we are thrilled to announce the launch of the eIRB+ version of our Institutional Review Board (IRB) submission system.
The updated system aims to enhance your experience and streamline the research proposal submission process by alleviating administrative burden and minimizing duplication of effort. eIRB+ uses branching logic and feedback from the Rutgers Research Community to create a more intuitive application and interface, as well as more efficient workflow.
To facilitate the learning curve and acclimation process, we have developed step-by-step Quick Guides to provide overviews, screenshots, and tips for the eIRB+ application. There are eIRB+ PDF Quick Guides for each of the initial submission types.
Attend a virtual eIRB+ Workshop to learn more about the updates to our submission platform and business processes.
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New CITI Refresher Process | |
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To alleviate the administrative burden on our researchers, we are pleased to announce a restructuring of the Collaborative Institutional Training Initiative (CITI) Refresher Course requirement, effective January 31, 2024.
The CITI Training are the required human research training modules at Rutgers University. The updated CITI requirement is as follows:
- Individuals required to complete a CITI Refresher can now choose five courses from the available offerings.
- Each course includes a quiz with a minimum pass rate of 80%, and upon completion, the CITI Refresher expiration period extends to every 4 years.
We believe these updates to CITI requirements and the updates via eIRB+ will streamline the research review process while maintaining our commitment to compliance.
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Office Hours and Upcoming Workshops | |
Conversion of Paper-based IRB Protocols to eIRB | |
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The deadline for converting paper-based IRB protocols (e.g., protocols approved outside of the eIRB system) is August 30, 2024.
We encourage you to begin the transition process at your earliest convenience by familiarizing yourself with the eIRB system, gathering pertinent paper-based study documents and information, and submitting your conversion prior to the deadline.
HRPP Compliance: Please note that any study that is not converted to the eIRB system by the August 30, 2024 deadline will be considered inactive and closed by the Human Research Protection Program (HRPP).
Once a paper study is closed by the HRPP, no research-related activity can continue without a new eIRB submission. Closed paper submissions cannot be reactivated.
If you have any questions or concerns, please email the HRPP/IRB office at IRBOffice@research.rutgers.edu using ‘Paper Conversion’ as the email subject. We also recommend signing up for a Paper Conversion Workshop.
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Demystify the IRB and Streamline Your Research: HRPP Outreach Available! | |
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Dear Deans and Department Chairs,
The Human Research Protection Program (HRPP) invites you to host a unit-specific outreach session during your upcoming meetings. We aim to:
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Demystify the IRB process: We can address common misconceptions, such as the volume we review, turnaround times, and the online submission process. We'll clarify any questions you or your faculty may have about IRB requirements and procedures.
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Share exciting eIRB updates: Get a sneak peek at our brand-new eIRB+ system launching in April 2024, designed to streamline the submission and review process for your research endeavors.
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Focus on specific departmental needs: Each session can be tailored to address your department's unique research challenges or to use case studies relevant to your specific field.
Ready to schedule an HRPP outreach session?
Contact us at IRBOffice@research.rutgers.edu to discuss specific topics, dates, and times that best suit your department meeting schedule.
We look forward to partnering with you to support your research success!
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We recently collaborated with the School of Criminal Justice in March 2024. Pictured from left to right:
Dr. Swapnali Chaudhari, Hila Berger, and Judy Kwak.
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Interested in Becoming an IRB Member? | |
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Do you (or someone you know) have an interest in biomedical or social science research?
Or do you know someone from the community that might be interested in serving as a community member on the Rutgers IRB?
Would you (or they) like to be involved with protecting the rights, safety, and welfare of individuals who volunteer to participate in research?
Please read more information online about IRB Membership or contact our Training and Communications Manager, Michelle Watkinson, CIP.
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Over the past several years, SMART IRB leadership has been working with the SMART IRB Harmonization Steering Committee, the National Center for Advancing Translational Sciences (NCATS), and other federal agency representatives, and members of the SMART IRB community to discuss possible changes to the current SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.
The proposed SMART IRB Reliance Agreement Version 3.0 is a significant amendment of the current SMART IRB Agreement. These changes are intended to:
- Address feedback from current and potential Participating Institutions,
- Fully reflect changes to IRB review requirements in the 2018 Common Rule, and
- Allow additional federal agencies to participate in the agreement.
The Executive Summary of the key changes can be found here.
There are no major concerns and once implemented, SMART IRB Agreement Version 3 will be utilized.
The IRB Reliance Team is happy to assist with any inquiries. Please contact us at IRBRelianceTeam@research.rutgers.edu.
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All Things ClinicalTrials.gov | |
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Good Cause Extension: Clinical Trial Results Delayed Submission
Applicable Clinical Trials (ACTs) and NIH-funded clinical trials are required to officially submit results to clinicaltrials.gov no later than one year after the study’s Primary Completion Date.
However, a Responsible Party (RP) may request an extension of the deadline for submitting clinical trial results information for good cause (see criteria of “good cause" in section III).
A request of Good Cause Extension (GCE) can be submitted via the ClinicalTrials.gov Protocol Registration System (PRS) prior to the date of the submission deadline, and must include:
- A description of the reason(s) why results information cannot be provided according to deadline, and
- An estimated date for submission of results information.
Once the request is reviewed, the NIH will issue a determination via the PRS (“PRS notification”) to the RP. There are 3 outcomes of a GCE request:
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Granted: NIH granted the new deadline as requested, and the RP has until the extended date to submit clinical trial results information.
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Granted with modification: NIH identified a submission deadline that is earlier than the requested submission date. In this instance, the RP must either (1) submit clinical trial results information by the submission deadline identified in the PRS notification, or (2) appeal the NIH-identified earlier deadline.
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Denied: NIH determined that GCE request did not constitute “good cause”. As a result, the RP must either (1) submit clinical trial results information by the later of the date on which clinical trial results information would otherwise be due or 30 calendar days after the date that the PRS notification was issued by NIH, or (2) submit an appeal.
The appeal must be submitted no later than 30 calendar days after the date that the PRS notification was issued by NIH. Appeals should be submitted via PRS.
NIH-funded awardees should take into considerations that any GCE request could impact other aspects of the contract or grant award. Communicating with your grants manager or contracting officer is strongly encouraged.
For detailed information on the application process, as well as what can be considered a good cause for extension, please read the up-to-date Good Cause Extension Request Process and Criteria.
For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
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All Things Quality Assurance & Evaluation | |
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Highlighting Routine Post Approval Monitoring (PAM) Reviews
One of the primary purposes of our Quality Assurance and Evaluation Team (QA&E) is to provide post-approval monitoring (PAM) to all research professionals at Rutgers. Any human-subjects research protocol at Rutgers University, whether approved through exempt, expedited or full board review, is eligible for a PAM review.
One type of review regularly conducted by the QA&E team are Routine reviews, which are randomly selected from the active study research portfolio in eIRB. A brief highlight of the Routine Review process:
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Purpose: Routine Reviews are completed to ensure that the research study is being conducted as described in the approved protocol and that the rights and welfare of participants are being adequately protected.
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Benefit for researchers: Researchers are provided an opportunity to ask questions and receive information about regulations and issues regarding the protection of human subjects.
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Misconception: Routine reviews are not designed to “catch individuals doing something wrong”; rather, they are meant to verify that research is being conducted as approved.
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What If...: If a QA&E staff reviewer finds an instance of non-compliance, we recognize that it may be a result of lack of understanding of roles and responsibilities or the regulations, and/or inadequate training of staff. Our goal is always to provide feedback and solutions to lead to better outcomes for both human subjects and the research teams themselves.
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In the End...: An exit interview will be held to discuss any findings and to answer any questions. During this time, discrepancies or issues to resolve will be discussed and clarified before creation of the final report.
For assistance please contact:
Andrea Dragan, Quality Assurance and Evaluation Director
andrea.dragan@rutgers.edu
Barbara LoDico, Quality Improvement Senior Analyst
barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
smithk6@research.rutgers.edu
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Please note, some articles linked below may require a subscription to view.
Top Federal Drug Agency Cites Marijuana And Psychedelics Research Efforts To Justify Congressional Funding (Marijuana Moment). A top federal drug agency is promoting its efforts to support studies into psychedelics, cannabis and harm reduction programs that it says helps to justify funding levels proposed under the president’s new budget plan. The National Institute on Drug Abuse (NIDA)—which would be renamed the National Institute on Drugs and Addiction under President Joe Biden’s 2025 Fiscal Year budget request—published an overview of various initiatives that would be expanded in the coming year.
How Science Sleuths Track Down Bad Research (Wall Street Journal). Scientific images offer a rare glimpse of raw data: millions of pixels tidily presented alongside the text of a paper. Common types of images include photographs of tissue slices and cells. Researchers say no two tissue samples taken from different animals should ever look the same under a microscope, nor should two different cell cultures. When they do, that is a red flag.
It’s More Important than Ever to Invest in Research Communication (Inside Higher Ed). Communication is part of the problem. Journals, conferences and other forms of academic communication are set up for scholars to share findings with their peers. While conversation among experts remains essential to the production of knowledge, it is poorly suited for dissemination to broader audiences. Policy makers, business leaders and individuals lack the time or proficiency to parse long research papers. This means cutting-edge insights in fields from medicine to public policy can lie dormant in journals few people ever read. The inaccessibility of research dovetails with the perception that higher education is overly complex.
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