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Institutional Review Board Submissions
  • New study submissions
    New studies must be submitted by the deadlines for inclusion at the scheduled IRB meetings. The new study Proposal Submission Application identifies what documents must be submitted for review. Be sure all consent and assent forms adhere to Informed Consent Requirements. Investigators must submit proof of human subjects training, taken within the last three years. If you do not have a current certificate, you may take the NIH on-line training .

    Investigators must submit a conflict of interest form.

    All studies must be approved by managers of the City unit(s) involved. A Unit Approval Form or a letter from the unit manager can be submitted.

    Please ensure that pages are numbered on all study documents for review.

    Expedited review

    The IRB, under Department policy, will review all new, non-exempt studies at a full IRB meeting. Follow-up reviews, continuing approval and minor revisions may be eligible for expedited review.

    Informed consent
    Except in very rare situations, participants in research must be informed that they are voluntarily being included in research. They must receive all pertinent information about that research and about their rights. Investigators should review and include all of the legally required information in an informed consent form.

    Waiver or alteration of informed consent and waiver of HIPAA authorization
    Federal regulations provide limited ability to perform human subjects research without written informed consent. An IRB may approve a waiver of HIPAA authorization under specific situations. Refer to the Summary Information Sheet for information on what waivers may be permitted by the IRB, and complete section 5 of the Proposal Submission Application, as appropriate. Be sure to provide justification for any requested waiver or alteration.

    When requesting waiver of parental consent for minors participating in research, it is strongly recommended that a third party opinion be obtained (from someone who advocates for children’s rights). The opinion should be from someone not involved in the project who carefully reviews the study requirements asked of the child and provides an opinion that the child is not placed at any additional risk by their participation without parental consent.

    Summary of Data Covered by HIPAA

  • Exemption from IRB review determination
    The IRB will make the exempt study determination. Requests for exempt study determination may be submitted with the new study application at any time. It is suggested that submissions be at least two weeks before an application deadline, so that investigators have time to make a full IRB study submission if the study is not determined exempt.

  • Revisions to an approved study
    Revisions to an Already Approved Study form.

  • Continuing review of an approved study

  • Closure report

  • Forms