We are thrilled to share updates regarding the Rutgers eIRB submission system. In late Spring 2024, we will be launching eIRB+, a revised version of our current eIRB platform, to enhance your experience and streamline the research proposal submission process.

Currently, a select group of researchers and administrative staff are actively beta-testing the updated eIRB+ application. This group will utilize the system to submit research proposals and monitor the workflow of their submissions. The valuable feedback collected during this User Acceptance Testing (UAT) phase will be crucial in identifying areas for improvement before the official release.

Rest assured, any insights gained from the UAT will be used to fine-tune the eIRB+ application, ensuring a seamless experience for all researchers. We are committed to providing you with a robust and user-friendly platform.

In the coming weeks, we look forward to sharing more details about the new system, including eIRB+ Workshop sessions. These sessions will offer you an opportunity to familiarize yourself with the updated features and address any queries you may have.

We appreciate your ongoing support and collaboration in making these enhancements to our research infrastructure. Stay tuned for further updates and thank you for being a valued part of the Rutgers research community.

Please also visit the revised Human Research Protection Program (HRPP) | Rutgers Research website. 

A notice was sent out by the Research Regulatory Affairs unit at the Rutgers Office for Research in December 2023 to Principal Investigators of IRB protocols that were approved outside of the eIRB system.

The deadline for converting these studies, often referred to as paper-based protocols, is August 30, 2024.

Transitioning these protocols to eIRB will streamline and improve the efficiency of the IRB protocol management process and provide you with a user-friendly platform to submit, manage, and track your protocols. 

Key Highlights of the Transition: 

• eIRB System Benefits: The eIRB system offers several advantages, including enhanced accessibility, real-time monitoring, improved compliance, and centralized data management. This transition aligns with the evolving needs of researchers and regulatory requirements and our recent AAHRPP accreditation. 

• Support for Transition: The IRB team is committed to supporting you throughout this process. We will assist in drafting your applications in the eIRB system and guide you through the electronic submission process. Once the applications are drafted, you will have the opportunity to review and verify the information within a week.  

• We will also provide Information Sessions and comprehensive training resources to support the migration of your studies.

Transition Timeline: 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 August 30, 2024 deadline. 

To register for a “Paper Conversion Session”, please visit crs.research.rutgers.edu, the Research Course Registration System. When there, please click on “IRB/eIRB” to find a Paper Conversion Session that fits your schedule. 

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 immediate questions or concerns, please feel free to reach out to the HRPP/IRB office at IRBOffice@research.rutgers.edu using ‘Paper Conversion’ as the email subject.

Nakia Yumor, MS, BS, is an unaffiliated community member who has joined the Rutgers IRB as a member. Ms. Yumor has expertise in Public Health (Healthcare Policy development), is a Certified Medical Assistant in OB/GYN-Reproductive Health (specialization in infertility & miscarriages), and has worked on vaccine & oncology research. We welcome Ms. Yumor to the IRB and look forward to working with her. 

Interested in Being a Featured IRB Member

in a Future Newsletter?

Share your background, interests, and area(s) of expertise by being a featured board member in an upcoming issue of the HRPP/IRB Bulletin

Please contact Claribel Vega or Angela Cartmell-McGlynn.

New Registration Process

for eIRB Workshops

The Rutgers Human Research Protection Program (HRPP) and Institutional Review Board (IRB) is pleased to announce that registration for eIRB Virtual Training Workshops is now completed directly via the Research Course Registration System (CRS). CRS provides each registrant with an instantaneous email confirmation along with the session’s Zoom link and calendar event invite.

eIRB workshops are offered through March 2024, with additional 2024 dates forthcoming. These workshops are designed to provide a step-by-step tutorial on using the electronic submission system known as eIRB and offer a Q&A session. They are open to all Rutgers faculty, staff, and students.

To obtain session dates/times and register for a workshop, please visit the Research Course Registration System. 

Registration is required to secure your spot, and you'll receive the Zoom meeting link from the CRS system.

For more information, please visit “eIRB Workshops” under HRPP/IRB Educational Resources. 

Education Items

HHS Finalizes New Provisions to Enhance Integrated Care and Confidentiality for Patients with Substance Use Conditions

(HHS Press Release). Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes. 

Report: Best Practices for Using, Teaching Generative AI in Research (Inside Higher Ed). Guidance from Cornell University identifies how artificial intelligence tools should be applied to research, with guidance on navigating the shortcomings of generative AI. The report, “Generative AI in Academic Research: Perspectives and Cultural Norms,” was published Dec. 15 and highlights best practices in the current landscape, how university policies impact the Cornell community and considerations for other faculty members or researchers navigating the new tech tools. 

Democratizing the future of AI R&D: NSF to launch National AI Research Resource pilot (NSF News). Today, the U.S. National Science Foundation and collaborating agencies launched the National Artificial Intelligence Research Resource (NAIRR) pilot, a first step towards realizing the vision for a shared research infrastructure that will strengthen and democratize access to critical resources necessary to power responsible AI discovery and innovation. Partnering with 10 other federal agencies as well as 25 private sector, nonprofit and philanthropic organizations, the NAIRR pilot will provide access to advanced computing, datasets, models, software, training and user support to U.S.-based researchers and educators.

FDA Revises Draft Guidance on Remote Regulatory Assessments (Bloomberg Law). The FDA revised a draft guidance Thursday on its use of regulatory remote assessments and its process for facilitating evaluations outside of the Covid-19 public health emergency. Remote regulatory assessments are tools the Food and Drug Administration introduced in response to the pandemic to provide continued oversight of the regulated industry while responding to Covid-19 guidelines. The examinations pertain to FDA-regulated establishments and their records. They are conducted entirely remotely and used to mitigate risk, meet critical public health needs, and help maximize compliance of regulated products, according to the agency.