Beginning on October 1, 2021, four Full Board meetings now convene once a week on Wednesday afternoons at 1:00pm. One board is reserved as an ad-hoc committee, when necessary, and the other two boards review expedited submissions but currently do not have monthly meetings. In addition to the change of meeting dates, all boards have been renamed:
All board members have been emailed assignments to each of the new IRB boards. Please note that the above changes do not affect the Full Board Meeting submission deadline dates. Thank you again for your service on the IRB.
With Sincere Appreciation to Our Retiring Board Members
As your time on the Rutgers Institutional Review Board draws to a close, we wanted to express our sincere gratitude for your service. IRB service is one of the toughest volunteer roles at an Academic Medical Center. Thank you all for your contributions and the expertise you brought to our deliberations.
Marsha Bates 1994-2021
27 Years of Service
George Karp - 2001 -2021
20 Years of Service
Judy Flax 2005 -2021
16 Years of Service
COVID Study Pre-Review Services for Investigators Expanded
Good news. The IRB has expanded the COVID Study Pre-Review Services to include all types of studies.
The purpose of the Pre-Review process is to facilitate a complete submission for human subject studies by providing an optional Pre-Review Service to investigators prior to submitting new studies or substantial modifications to existing studies in eIRB.
The Pre-Review Team consists of experienced IRB members and Human Subjects Protection staff experienced with protocol review, criteria for IRB approval at 45CFR46, HIPAA Regulations at 45CFR46 Parts 160, 162, and 164, FDA Regulations at 21CFR50 and 56, the Rutgers HSPP Policies and Procedures, the Rutgers HSPP toolkit worksheets and checklists, as well as Rutgers University Policies and Procedures and NJ State Laws as they pertain to human subjects research.
The Pre-Review Team reviews the protocol and ancillary documents such as the consent form, recruitment materials, data collection forms and related documents to provide feedback and suggestions to the investigator for revisions or clarifications prior to submission in eIRB.
To take advantage of this service and begin the process please follow the instructions below.
For studies/modifications that have already been submitted please refer to Options for studies recommended for Pre-Review after submission in eIRB below
*Pre-Review Instructions:
- Upload the relevant documents in Rutgers OneDrive (see Rutgers OneDrive Instructions below).
- This Pre-Review should be done simultaneously as you work on the following:
- eIRB application (please do not submit the application or upload the documents until they have been pre-reviewed by the pre-review team and then finalized by you).
- If your research will be conducted on Robert Wood Johnson University Hospital (RWJUH) New Brunswick property or involve RWJUH New Brunswick patients, their data or biospecimens you must submit an application to the RWJUH Research Utilization Group (RUG).
- To access the RUG form, please visit our website under 'Performance Site Approval Forms': https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit .
- If your research will be conducted on University Hospital (UH) property or involve University Hospital patients, their data or biospecimens you must submit a UH Registration and Research Plan through the Office of Clinical Research Administration.
- Please refer to our website at https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit and view instructions under ‘Performance Site Approval Forms’ then under University Hospital.
- eCOI disclosures/CITI for the Principal Investigator and all research personnel
- Rutgers CITI training requirements can be found at https://research.rutgers.edu/researcher-support/research-compliance/research-integrity/collaborative-institutional-training . CITI training can be completed at https://about.citiprogram.org/en/homepage/
- eCOI - Please click the ‘Create financial disclosure certification in eCOI’ in the eIRB study workspace and select all study personnel.
- Any other required approvals applicable to your protocol such as Biosafety, Radiation Safety, Scientific Review Board, University Behavioral Health Care signoff, etc.
- Any contracts or agreements applicable to your protocol such as Clinical Trial Agreements, Data Use Agreements
- IRB Reliance Agreements, to accept another IRBs approval or for Rutgers to serve as the IRB of record for other sites involved in your research. For information regarding IRB Reliance Agreements please contact the IRB Reliance Administrator: IRBRelianceAdmin@ored.rutgers.edu
*Pre-Review Completed
- We will notify you via email once the pre-review is completed. Please keep in mind that this courtesy pre-review is intended to help expedite the approval process and the comments are recommendations - individual IRB members (who are faculty familiar with a variety of research) may have additional comments during the review process, after you submit your protocol through eIRB.
- Log into Rutgers OneDrive to review the comments and address as you deem appropriate.
- When your revisions are complete upload the final versions in eIRB before submitting your application.
*Options for studies recommended for Pre-Review after submission in eIRB:
Option 1:
- Withdraw the study in eIRB.
- Upload the protocol and relevant documents to OneDrive and share with the Pre-Review Team listed below.
- Once you are notified the Pre-Review is complete, address the comments/suggestions as you deem appropriate.
- The PI creates and submits a new application in eIRB and submits for IRB review.
Option 2:
- Allow the study/modification to proceed through the regular IRB process as submitted without pre-review
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HSPP Website Updates
Stay tuned for updates to the Website
