Resubmitting Your Proposal for Review

  1. IRB approval is limited to one year after the date the project was last approved by the Institutional Review Board (IRB). For projects continuing or being initiated beyond that period of time, investigators must resubmit the application for review. Continuing projects must meet any new guidelines.

  2. Begin by checking to see whether your proposal addresses all of the information in the IRB application. Some requirements have changed over the years.

  3. Make sure your consent forms have all of the necessary elements.

  4. If the project includes deception or more than minimal risk**, the PI must provide a status report. Federal guidelines require this information in the status report.

    • The number of subjects accrued
    • A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review
    • A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review
    • Any relevant multi-center trial reports
    • Any other relevant information, especially information about risks associated with the research
    • A copy of the current informed consent document and any newly proposed consent document.

  5. Please send an e-mail to gagarrison@vassar.edu and tell her you would like to resubmit your proposal. Please state the title of your project and date of the most recent approval. Forward any necessary written materials to Ms. Garrison (e-mail is acceptable. She will make copies of all correspondence.) She will make copies of the proposal and send it to the IRB.

According to the federal guidelines, minimal risk means "the risk of harm anticipated is not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."