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Office for Human Subject Protection
Office of the Vice President for Research

IRB Submission Checklist

In accordance with OHSP Policy 502: Types of RSRB Submissions, reference the following checklist of information/documents for inclusion in your study submission to the Research Subjects Review Board (RSRB, the University of Rochester’s Institutional Review Board [IRB]). You can also save a PDF version of this guidance for your records.

Download the submission checklist

 

Submission requirements checklist

Basic information
  • Study protocol and any applicable site-specific supplements and/or addendums
    • A site-specific protocol supplement maybe be required if the sponsor provided protocol does not provide specific information about the conduct of the research at the University. Specifically, to address how subjects will be recruited and consented, if non-English speaking subjects will be recruited and if not, what is the rationale for excluding, etc.
  • Study team members
  • Funding sources
  • Research locations (i.e., non-University locations [e.g., Rochester City School District] and University of Rochester-affiliated sites [e.g., Highland Hospital, FF Thompson] where research activities will be conducted by University faculty/staff or by University faculty/staff in collaboration with non-University staff)
  • ClinicalTrials.gov registration number, if applicable
Study and local site documents
  • All consent, permission, and assent forms, as applicable
    • All consent, permission, and assent forms should be submitted with the first page on University letterhead.
    • For studies undergoing review by an External IRB, ensure all consent and permission forms have been edited to include local, site-specific information. Minimally this includes local site contact information and template University language (e.g., HIPAA authorization and compensation for injury). For additional information, see the Relying Consent Language Reference.
    • For multi-site research undergoing single IRB review where the RSRB is the Reviewing IRB, include all model consent forms that will be distributed for use at participating sites on the study submission under the Study-Related Documents. For participating site submissions, ensure all consent and permission forms have been edited to include local, site-specific information.
  • All recruitment materials (i.e., all direct advertising materials that may been seen/heard by potential subjects), as applicable
    • For studies undergoing review by an External IRB, ensure all recruitment materials have been edited to include local, site-specific information (as appropriate).
    • For multi-site research undergoing single IRB review where the RSRB is the Reviewing IRB, include all model recruitment materials that will be distributed for use at participating sites on the study submission under the Study-Related Documents. For participating site submissions, ensure all recruitment materials have been edited to include local, site-specific information (as appropriate).
  • All study measures that will be completed by, or include questions that will be asked to, subjects (e.g., surveys/questionnaires, interview/focus group scripts, behavioral assessments, diaries)
    • If the research involves a secondary analysis, include a data collection sheet that identifies all data points that will be collected
  • All supplemental educational materials that will be provided to potential or enrolled subjects, including any instructions/information sheets (e.g., concerning drug administration)
  • Certificate of Confidentiality (CoC), if applicable, for research funded via a mechanism other than the National Institute of Health (NIH). Translator Declaration, if applicable (for additional information, reference our Enrolling Non-English Speaking Subjects page).
Ancillary review documents
Drug details (if applicable)
  • Drug name
  • Package insert or investigators brochure
  • Drug management and accountability plan, if not included in the study protocol
  • Randomization plan, if applicable and not included in the study protocol
  • Sample of drug label
  • Temperature log (for storage location)
  • If the study is being conducted under an IND (Investigational New Drug):
    • IND number, IND holder
    • Verification from the FDA (or sponsor) of the IND
    • If the local PI is the IND holder, documentation of required IND training via the CTSI Office of Regulatory Support
Device details (if applicable)
  • Device name
  • Manufacturers brochure/device instructions
  • Device management and accountability plan, if not included in the study protocol
  • Randomization plan, if applicable and not included in the study protocol
  • If the study is being conducted under an IDE (Investigational Device Exemption)/HDE (Humanitarian Device Exemption):
    • IDE/HDE number, IDE/HDE holder
    • Verification from the FDA (or sponsor) of the IDE/HDE
  • If the local PI is the IDE holder, documentation of required IDE training via the CTSI Office of Regulatory Support
Important note about file types

To facilitate reviews, limit document uploads to Microsoft Word files, when feasible. DO NOT upload Rich Text or Publisher Files. When Microsoft Word files are unavailable, PDF files may be used.

If you have questions about what types of files can be uploaded, contact your IRB Coordinator.

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