Adult students in class

Institutional Review Board

Submitting an IRB Proposal

  1. To determine whether the proposal needs to undergo full IRB review, expedited IRB review or exempt IRB Review, consult “Is my project research?,” flowchart and policies and guidelines. After reviewing the flowchart, if you are still unsure as to how to proceed, please contact the chair of the IRB Committee to ask for clarification.
  2. Fill out, print and sign the appropriate forms and attach them to the front of your proposal.
  3. Include the following elements in your proposal:
    • Statement of the research question
    • Description of the research methods
    • Description of the research setting and duration of the study
    • Description of sampling procedures and demographics of the participants
    • Description of plans to maintain participants’ confidentiality and anonymity Explanation of how you will keep your data under lock and key for a period of three years
    • Description of any potential risks to participants
    • Description of plans to ensure informed consent, including plans to communicate with participants whose first language is not English
    • Letters of informed consent to participants, guardians (if applicable), and agency or site administrator(s). Letters to non-English speakers must be translated into the appropriate language. Letters to children must be in age-appropriate language.
    • Data collection instruments must be accompanied by permission to use any copyrighted materials or documentation that the instruments are available for public use.
    • Bibliography of secondary sources consulted in the development of the proposal
    • De-briefing statement or description of plans to share the results of the research with participants and agency or site administrator(s)
  4. Submit one hard copy of the completed proposal and attached forms to the IRB Chair before or on the submission due date (see IRB Dates).
  5. Once your proposal is approved, the IRB chair will notify you and email you an electronic file containing the signed approval page. You may then begin your research.
  6. If you modify the research project during the study, consult with the principal investigator. If he or she deems the modifications significant, you must submit a Research Modification Form (exempt, expedited, or full review) to the IRB.
  7. In cases of full or expedited IRB proposals, IRB approval will remain in force for no more than 12 months after the date of review. If you require additional time to complete the study, submit a Study Renewal/Continuation Form.
  8. If there are any unanticipated adverse effects as a result of your research, stop the project immediately and inform the IRB. Submit a Report of Unanticipated Problem or Serious Adverse Event form to the IRB and await the IRB’s decision before resuming any research activity.
  9. When the research is complete, submit a Research Completion Form to the IRB.

 

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