The latest news from the Rutgers HRPP/IRB

HRPP/IRB Newsletter

May 2024

Contact the IRB

Contact IRB Reliance Team

Contact DRAFT Services

Contact Quality Assurance and Evaluation Team

Contact For ClinicalTrials.gov Support

Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Learn more.]=

eIRB+ System Enhancements Now Live!

We are thrilled to announce the launch of the eIRB+ version of our Institutional Review Board (IRB) submission system.

The refreshed eIRB+ system marks a significant milestone in our commitment to advancing research efficiency and compliance.

Now available for general use, the updated system enhances the investigator experience and streamlines 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.

Attend a virtual eIRB+ Workshop to learn more about the updates to our submission platform and business processes.

eIRB+ Workshop sessions offer a comprehensive walkthrough of updated features, step-by-step application tutorials, and an opportunity to address any questions you may have.

Open to all Rutgers faculty, staff, and students, our sessions have already attracted over 540 registrants across 60 sessions!

Register now on the Course Registration System to secure your spot in upcoming training sessions. Multiple sessions will be available weekly throughout each month/semester.

Simplified Submission Process

and Expanded Initial Application Options

Responding to valuable feedback from our research community, we've seamlessly integrated the protocol into the eIRB+ application.

The updated eIRB+ system introduces new initial submission types, providing increased flexibility and customization to accommodate a diverse array of research projects.

Our enhanced Consent and Waivers section now offers comprehensive guidance through help text, making it easier to navigate and complete appropriate waiver and consent requests.

Collaboration and document management is smoother and more efficient than ever in eIRB+, with a more intuitive new attachments section that populates at the end of the eIRB+ application.

eIRB+ PDF Quick Guides for each of the eIRB+ initial submission types are available. These step-by-step Quick Guides provide overviews, screenshots, and tips for the eIRB+ application.

eIRB+ PDF Quick Guides

New and Updated Features and Functionality within eIRB+

Enjoy Convenient Access to DRAFT Services Directly within the eIRB+ System

Upon request, the Document Revision And Feedback Team (DRAFT) provides study teams with comprehensive feedback on their IRB application and study documents prior to their submission for review by the IRB.

With the eIRB+ upgrade, this process is moving into eIRB+, thereby eliminating the need to request this service by sharing a folder in Box or OneDrive. You can now request this optional service prior to submitting your application to the IRB, simply by clicking the “Request DRAFT Services” button in the eIRB+ study workspace (under 'My Activities').

Reliance Made Easier Through An Improved Reliance Workflow in eIRB+

Research projects utilizing WCG IRB and Advarra are more effortlessly accommodated via the introduction of a new Commercial IRB submission type.

HURON IRB Exchange, which is a reliance agreement platform similar to SMART, provides enhanced functionality within eIRB+.

Built-in Local Context Supplement sections reduce the number of documents required in your collaborative research submission.

Reliance Agreement Options:

Rutgers University primarily utilizes SMART IRB Agreement (v1, v2) for multisite collaborative studies involving institutions within the SMART IRB network.

If an external site is not a Participating Institution of the SMART IRB network, the Rutgers Reliance Agreement will be utilized for collaborations involving Rutgers University and non-Rutgers institution(s).

The mission of the Document Review and Feedback Team (DRAFT) is to improve IRB submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices through pre-reviews and consultations.

Learn more about DRAFT.

Contact DRAFT

The Reliance Team provides subject matter expertise and consultations on the IRB requirements for collaborative research.

Learn more about Reliance.

Contact Reliance

Changes to CITI Refresher Course Requirements

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.

Automated Monitoring of CITI and COI

Requirements for CITI and eCOI are now automatically monitored within the eIRB+ system, facilitating quicker IRB review processes and issuance of Notices of Approval (NOAs).

Streamlined Departmental Review

The Department Review requirement for Rutgers Health schools is eliminated, with the exception of RWJBH studies.

To align with regulatory standards, a department notification is replacing this requirement.

No More 'Accept Participation Request'

To reduce administrative burden on researchers and to expedite the submission of their research to the IRB, researchers will now receive a notification when they are added to a study as an investigator.

Upcoming Events and Workshops

Rutgers Health Clinical Research Work Group Call

Monday, May 13, 2024

12:00 pm

As part of its work group series, the Clinical Trials Office (CTO) welcomes Hila Berger to discuss the eIRB+ rollout and other important updates from the Rutgers Human Research Protection Program (HRPP).

Hila Berger, MPH, CIP, CHC

Office for Research

Assistant Vice President for Research Regulatory Affairs

Join via Zoom

Reliance Workshop

Thursday, May 23, 2024

12:00 pm

The Human Research Protection Program's (HRPP) Reliance Workshop (IRB 104) will focus on understanding the IRB Reliance Mechanisms.

Researchers, faculty, and students are invited to learn more about our streamlined reliance processes for Single IRB (sIRB) and Administrative Review submissions to the IRB.

Virtual Institutional Review Board (IRB) Office Hours

DRAFT (Document Revision And Feedback Team) Services hosts IRB Office Hours weekly.

When:

Tuesdays, 1 – 1:30 pm (with IRB Reliance Team)
Thursdays, 10 – 10:30 am

Where: Zoom.

Office Hours Zoom Link | Passcode: 133269

More information on what to expect during Virtual IRB Office Hours.

Conversion of Paper-based IRB Protocols to eIRB+

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.

Demystify the IRB and Streamline Your Research: HRPP Outreach Available!

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:

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.
Share exciting eIRB+ updates: Get an introduction into our newly launched eIRB+ system, designed to streamline the submission and review process for your research endeavors.
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!

Interested in Becoming an IRB Member?

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.

Visit our webpage