The Rutgers HSPP/IRB’s Pre-Review is a process 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 process begins when the IRB receives a request for Pre-Review or a Pre-Review is recommended by HSPP/IRB Staff.
Investigators requesting or being recommended for Pre-Review must follow the Pre-Review Instructions for Researchers.
The process ends when the investigator has been notified by the Pre-Review Team the pre-review is complete, provided with instructions to address the comments/suggestions as they deem applicable and submit the revised study/modification documents in eIRB.
The Pre-Review process and suggestions are optional:
- It is not required that investigators utilize the Pre-Review process however it is strongly recommended.
- The Pre-Review Team comments are suggestions and are not mandatory prior to submission in eIRB.
Pre-Review Instructions for Researchers
These instructions are to facilitate a timely IRB review for all human subjects studies (including those researching the COVID-19 pandemic). These instructions apply to all studies: biomedical, clinical trials, social-behavioral, and humanities human subjects research. These instructions detail the steps to be taken by researchers to initiate a pre-review. The pre-review is intended to provide feedback on fundamental aspects of the research and is to take place prior to submission in eIRB.
For studies recommended for pre-review after submission in eIRB, please see below.
The pre-review is conducted by highly knowledgeable IRB and HSPP staff, as well as key members of the University’s several IRBs (e.g., the IRB Chairs).
In your pre-review submission, you should include documents relevant to the human subjects part of your research, such as: consent forms, description of recruitment, local context supplements, data excel files, surveys/questionnaires, and recruitment materials.
- To begin the process, please upload the relevant documents as Word documents in Rutgers One Drive or Rutgers Box.com.
- See Rutgers OneDrive or Rutgers.Box.com instructions below.
- Share the folder with all pre-review team members listed below:
- Send an email to Pre-Review Team Members (listed above) alerting them of your pre-review service submission.
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 online 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@research.rutgers.edu
- Withdraw the study in eIRB.
- Upload the protocol and relevant documents to Rutgers OneDrive or Rutgers Box.com 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.
- Allow the study/modification to proceed through the regular IRB process as submitted without pre-review
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.