Human Subjects/Institutional Review Board (IRB)

General Guidelines

All YSU faculty, students, and staff who are involved with human subjects research must complete training through the CITI Program.
New investigators should consider beginning the online training course up to two weeks prior to the submission of an IRB Protocol or grant application, and prior to beginning the planned research project. Once the investigator has completed the training course and the appropriate protocol form, please submit an electronic copy to the committee (email: YSUIRB@ysu.eduAND one hard copy with original signatures to the Office of Research Services in Melnick, Room 2101 Hall. You must not recruit participants or begin your project in any way prior to the approval of your project.

Protocol Completion*

  1. To determine which form to use, review the following instructions, and answer the exempt screening questions:
    OR-IRB01 Instructions for Claim of Exemption*

  2. If all answers are "NO", please complete the Claim of Exemption Form:
    OR-IRB02 Claim of Exemption Form*

  3. If any answer is "YES", the review must be by the IRB Committee and the investigator(s) must complete the full/expedited protocol form:
    OR-IRB03 Full & Expedited Form*

  4. Informed Consent. A template for informed consent guidance may be found at the location below. From 45 CFR Part 46, the following Checklist of Elements* may also be useful for review.
    OR-IRB04 Informed Consent Template*

  5. Modifications or Amendments: If a project requires an amendment or revision, please complete the following form:
    OR-IRB05 Amendment & Modification*

  6. Adverse Events: If problems or difficulties are encountered which could affect the safety or welfare of the subjects during the course of a research project, the PI must communicate the issue to the IRB through submittal of the following form:
    OR-IRB06 Adverse Protocol Report*

  7. Continuing Review: Research which is not exempted (expedited and full IRB-approved projects) must undergo continuing review if research activities will continue beyond one year of the date provided on the original IRB approval letter. The following form must be completed and submitted at least two weeks prior to the annual approval date:
    OR-IRB07 Continuing Review Form*

  8. Handbook:
    OR-IRB08 IRB Regs and Procedures*