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External Approvals

The Rutgers IRBs may also require approval from external departments within Rutgers, as applicable. These include:

  • Rutgers University Investigator Conflict of Interest Policy 90.2.5 requires that PIs and all personnel working on research projects, regardless of source of funding or lack thereof, disclose financial information that may reasonably be perceived to influence their work.

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  • Ethical concerns surrounding research utilizing human embryonic stem cells have necessitated regulations to guide the acceptable use of these materials. The National Academy of Sciences and the State of New Jersey require the formation of an Embryonic Stem Cell Research Oversight (ESCRO) Committee and approval prior to beginning work.

    Currently, human embryonic stem cell procedures are submitted as part of the IBC protocol form, and sent to ESCRO for review. Since all research with human materials must be reviewed by the IBC, this allows for a streamlined application process.

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  • For studies collaborating for other institutions.

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  • For studies involving EU residents or their data.

    Learn More (uec.rutgers.edu)

  • Authorization letters are required from research sites that are not affiliated with Rutgers University (e.g. schools). A letter of authorization/cooperation is a letter from the head of an organization/group granting you permission to carry out your research either at: their facility; with their employees; with their attendees or members; with their non-public or identifiable dataset, etc. Due to the individual nature with each organization’s authorization, the IRB doesn’t have any existing templates for letters of authorization.

    Site Authorization/Letters of Cooperation

    A letter of cooperation is a letter from the head of an organization/group granting you permission to carry out your research either at: their facility; with their employees; with their attendees or members; with their non-public or identifiable dataset, etc. 

    Each letter must include Investigator’s name, the title of the study, include details of the project to be conducted with the organization and spell out his/her explicit support of the intended project and/or authorization for the release of any data or private information for the research. In order for Investigators to start research at any site, investigators must have a letter of cooperation and forward this letter to the IRB BEFORE the commencement of any research activities.

    If the research site will not issue approval until the Investigator has obtained Rutgers IRB approval and provide them with a copy, please use a cover memo to include with your application indicating this issue.

    The IRB must be in receipt of each letter with original signature(s). Investigators may send the IRB an email containing a PDF of the actual letter, instead of a mailed hardcopy letter. The IRB will not accept any email correspondence in lieu of an actual authorization letter. Sorry, but, fax copies of this letter will not be accepted. Please retain a copy of any authorization for your records. The IRB is not responsible for misdirected snail mail or emails.

    Authorizations from Participating School Sites

    Research conducted in schools typically require approval for the investigator to conduct the project. It’s the Investigator’s responsibility to know what type of approval (i.e., District IRB, Board of Education, School District's Superintendent or School Principal approval, depending on the requirements of a particular school district) is required and to obtain approval before the commencement of research activities at that site(s).

    If the school site will not issue approval until the Investigator has obtained Rutgers IRB approval and provide them with a copy, please use a cover memo to include with your application indicating this issue.

    The school-based authorization letter to be obtained must state that the School’s Signatory Authority grants the investigator permission to carry out the research at their given school site with administration/other school employees, teachers and/or with students.

    The IRB must be in receipt of each letter with original signature(s). Investigators may send the IRB an email containing a PDF of the actual letter, instead of a mailed hardcopy letter. The IRB will not accept any email correspondence in lieu of an actual authorization letter. Sorry, but, fax copies of this letter will not be accepted. Please retain a copy of any authorization for your records. The IRB is not responsible for misdirected snail mail or emails.

  • Overview

    Performance Site approval documentation is required for all research involving any site below which includes systematic participant recruitment, research impacting site staff time, and/or research impacting site financial reimbursement.

    ***All research activity at a performance site cannot proceed until the PI receives approval from the Rutgers IRB and the performance site.

    Examples of Research Activities Requiring Performance Site Approval:

    1. Recruiting on-site

    2. Using hospital staff to provide a service

    3. Using hospital staff as study personnel

    4. Using a room

    5. Using equipment

    6. Accessing medical records (including chart reviews)

    Performance Site Approval Instructions

    A. Robert Wood Johnson University Hospital (RWJUH) (New Brunswick, NJ):

    1. Complete a Research Utilization Group (RUG) form Online Printable Form (Rutgers VPN required if accessing outside the Rutgers network). For questions email RUG Support.

    2. Submit your completed RUG Form online. It does not have to be approved before your eIRB request is submitted for review.

    3. Once approved by the RWJUH RUG Committee, attach your approved RUG Form to your eIRB submission and ensure RWJUH is listed as a site for your study in eIRB.

    B. University Hospital (UHNJ) (Newark, NJ) (affiliated with the New Jersey Medical School (NJMS))

    1. Determine if your study requires “University Hospital Registration” and/or “NJMS Office of Clinical Research Administration (OCRA)" review.

    2. If yes, your study must have both of the following included in eIRB: (a) Add "University Hospital" as a performance site in your eIRB application. (b) Your "OCRA confirmation email" should be attached with your eIRB submission to provide proof of registration and/or review.

    ***Please note that University Hospital will not provide final approval for a study until after it has been approved by the IRB. You will be directed in the confirmation e-mail from NJMS-OCRA to forward your IRB approval notice once received, so that the UH registration/approval process can be completed.

    C. University Behavioral HealthCare (UBHC) (Various Locations in New Jersey)

    1. Please contact UBHC for a copy of their UBHC Human Subject Research Form and obtain site approval from UBHC before submitting your study to the Rutgers IRB.

    2. Complete the following actions when you submit your study in eIRB.

      1. Add UBHC as a research site.

      2. Attach your approved UBHC Human Subject Research Form in your eIRB submission.

  • The National Institutes of Health requires an Institutional Biosafety Committee for any organization that receives federal funding to perform work with recombinant or synthetic nucleic molecules. The committee must approve all work with the following materials, and provide oversight to biosafety related research at Rutgers University. The Institutional Biosafety Committee reviews and approves all research at Rutgers.

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  • Cancer-related research involving human subjects at the Cancer Institute of  New Jersey (CINJ) submitted to the IRB require CINJ Scientific Review Board (SRB) approval before being eligible to receive IRB Approval.

    The Scientific Review Board (SRB) of the Cancer Institute of New Jersey (CINJ) is the institutional body charged with Protocol Review and Monitoring. The SRB oversees the scientific aspects of cancer-related research involving human subjects at the Cancer Institute of  New Jersey (CINJ).  The SRB focuses on the scientific merit of cancer-related research involving human subjects at CINJ. The function of the SRB is complementary to that of the Rutgers/RWJMS Institutional Review Board (IRB), but it does not duplicate or overlap the responsibilities of the IRB, which focuses on the protection of human subjects.

    All cancer-related protocols involving a University/RWJMS faculty member or a CINJ member requires review and approval by the CINJ SRB, as mandated by the Dean of the Robert Wood Johnson Medical School (RWJMS).

    The specific objectives of the SRB are as follows:

    • Review the scientific merit of cancer-related research involving human subjects at CINJ.
    • Review of amendments that are deemed to be significant to the scientific conduct and/or progress of the trial before IRB submission.
    • Foster the development of innovative, collaborative, and scientifically sound studies, which focus on the prevention, detection, diagnosis, or treatment of cancer.
    • Provide a standard format for submission and review.
    • Review of trials identified by Human Research Oversight Committee (HROC) as having low accrual, significant toxicities or significant protocol violations.
    • Close a trial when an accrual rate is judged too low to allow the aims of the trial to be completed within a reasonable period of time or if the scientific integrity of the trial is compromised due to the lack of adherence to the research design and methods of the protocol.

    CINJ SRB Form Instructions

    Please complete the following steps to submit your SRB application in the Oncore website.

    1. Access the Online Collaborative Research Environment (ONCORE) website. If you don’t have access to Oncore, please contact Yifang Zhou (CINJ).
    2. Once logged in, place your cursor over the tab ePRMS and click ‘Submission Console’.
    3. Look for the "Create Submission" section, on the left side of your screen, click the button for ‘Initial Review’.  Begin entering information pertaining to your study.  Please leave the protocol no. field blank, this will be entered by our in-house staff.
    4. After all requested and applicable information is entered, click ‘save’.  An expanded version of the page will appear; the system will prompt you to provide additional information such as study team, study sites, sponsor and research documents. 
    5. Review your information and make sure that you have entered as much information as possible, once done, click ‘submit’.  This will send your application to the SRB coordinator to begin the review process.

    CINJ SRB Help

    Contact the CINJ Office of Human Research Services

     

  • Other approvals may be required as applicable to your specific study. The IRB Office will alert you to any other requirements.

Need Help?

The PI should follow up with the external department to coordinate and manage the Non-IRB Approval process.