Steps for Submitting a Proposal
- Determine whether your project meets the definition of research. If it does meet the definition of research, continue to step 2. If your project does not meet the definition of research, you do not need to submit your project.
- Determine whether your study meets the criteria for Exempt, Expedited or Full Review. Download and fill out the appropriate forms. Make sure to consult the checklist at the end of the respective application to make sure you have all the appropriate documents (e.g. consent, debriefing, recruitment flyers etc.)
Send a paper copy of your proposal and all forms (make sure to have all signatures and all items on the proposal checklist) to the IRB office c/o Rhonda Prudhomme, Sterry 406. Make sure the NIH training certificates of all members of the research project are on file with the IRB. Any missing certificates will delay the review of your project. In addition, please email an electronic copy of your proposal and attached documents to Ann Koga at email@example.com and cc Rhonda Prudhomme firstname.lastname@example.org.
- Wait for the IRB decision. You may not begin your study until you have received IRB approval. Exempt and expedited proposals are accepted on a rotating basis. A decision will be rendered within 2 weeks. However, if a proposal is referred to a full board either because 1) the proposal does not meet the criteria for Exempt or Expedited or 2) the Chair or designee does not approve the proposal, the proposal will be referred to the next scheduled full board meeting.
- Decisions are made on one of three levels: Approved, Conditional Approval and Denied.
Approved: The reader or committee has determined from the information provided that the proposed study has met all ethical guidelines. The researcher may proceed with data collection. The chair of the IRB will notify the researcher via email, and an official letter will follow, containing the IRB research number.
Conditional Approval: The reader or committee has determined from the information provided that the proposed study has not met all the ethical guidelines but the adjustments are minor. The researcher will be notified via email of the changes that must be made, or of the information that was lacking. The researcher will work directly with her or his reader or, in the case of full-review, will be assigned a board member to whom the researcher must report. The researcher will be given one month to make the corrections and complete this process. However, research may not begin until approval has been granted. If this is not done or if the committee does not receive a request for an extension, the case will be closed and the researcher will be required to resubmit her or his full proposal. When the additional tasks have been completed, the reader will sign the proposal as approved. The researcher will be notified and the chair will send the official letter.
Denied: The reader or committee has determined from the information provided that the proposal is sufficiently lacking in its completeness or does not meet ethical standards. The researcher will be sent an email from the reader or the chair of the IRB listing the reasons for the denial. A follow-up letter will be sent. The researcher must resubmit her or his proposal in its entirety, along with a letter of explanation addressing the deficiencies of the proposal.