• Complete the CITI training. All study personnel must successfully complete this training.
• Note: The Verification of Human Subjects Training Form (VOTF) section must include the test dates for all listed study personnel.
• Complete a Project Approval Form (PAF) or Project Review Form (PRF) and prepare relevant attachments (e.g., consent forms, recruitment materials, questionnaires, protocol, grant proposal, site authorization letters).
  • For projects involving Medical, Drug Testing, Genetics, etc., complete the PAF. If a project involves medical procedures which the Principal Investigator (PI) is not authorized to conduct, a Responsible Physician must be identified and is required to sign the PAF.
  • For projects involving Questionnaires, Video/Audio Tapes, Chart Reviews etc., complete the PRF.
• Note: PI is required to complete and sign form.
• Note: It is the direct responsibility of the PI to assure to the IRB that all other investigators (co-investigators, sub-investigators, involved statisticians or consultants) are aware of, and concur with, the project submission.
• Submit the PAF/PRF and attachments to the Department Head, Dean or comparable authority for review and signature.
• Submit the PAF/PRF and attachments to the Departmental Review Chair/Committee for review. The Chair must sign the PAF/PRF and indicate any recommended action.
• Note: The Department Head and Departmental Review Chair cannot sign the PRF if they are study personnel (this includes an Advisor on a student project). In this situation, it is advisable to contact HSPP for guidance.
• Submit PAF/PRF with attachments and signatures to the HSPP office for review.

HOW THE REVIEW PROCESS WORKS

• All projects are reviewed in the order in which they arrive at the HSPP office. If revisions are required, approval may be delayed.
• Once a project is received at HSPP, it is preliminarily classified as eligible for review under one of the following categories:
  1. Full Committee Review – human subjects at greater than minimal risk
     • Projects are preliminarily reviewed for completeness by a trained IRB staff member
     • If changes or clarifications are necessary, PI is contacted by memo, telephone, or email
     • Projects are assigned to the next available Committee agenda (Biomedical or Social/Behavioral Sciences)
     • Each Committee typically meets twice per month
     • After review, PI is notified in writing of the Committee's determination and if changes are required or issues need to be addressed
     • Approval letter is issued to the PI and the project may begin (with IRB approved consenting instruments if applicable)
     • A copy of approval letter is forwarded to the appropriate Departmental Review Chair
  2. Expedited Review – human subjects at minimal risk
     • Project is preliminarily reviewed for completeness by a trained IRB staff member
     • If changes or clarifications are necessary, PI is contacted by memo, telephone, or email
     • Project is presented for final review/approval by Chair of the appropriate Committee
     • Approval letter is sent to PI (with IRB approved consenting instruments, if applicable) and the project may begin
     • A copy of approval letter is forwarded to the appropriate Departmental Review Chair
  3. Exemption – human subjects at no risk/low risk
     • Project is reviewed by director
     • If changes are necessary, PI is contacted by telephone or email
     • When all documentation is complete, exemption letter is sent to PI (with IRB approved consenting instruments, if applicable) and the project may begin

ADDITIONAL PROCEDURES

Amendment

Any changes to the approved procedures, consent forms, or study documents requires review and approval prior to implementation. An Amendment Form, signed by the PI or Co-PI should include the nature of the change and rationale for the change. New or revised documents (i.e. consent forms, recruitment materials, etc.) are required to be submitted concurrently with the Amendment Form.

Adverse Event Report

Any adverse event, whether local or non-local, must be promptly reported to the HSPP or IRB. PI or Co-PI is required to submit the Study Related Problems Form detailing date/time of the event, project number, project title, whether local or non-local, subject I.D., description of the event, location, treatment if any, causality assessment, and whether local subjects or consent instruments are affected.

Protocol Deviation

Any deviation from protocol or protocol violation must be promptly reported to the IRB. PI or Co-PI must submit the Study Related Problems Form describing the deviation, outcome, and if applicable, action plan to avoid a re-occurence. This includes any unapproved activities that occurred or protocol approved activities that should have occurred , but did not.

Continuing Review

Continuing review is required for all Expedited and Full Committee projects, whether or not the project has actually begun. The due date for submitting continuing review information is based upon the expiration date noted in the project's approval letter.

Note: Continuing review may be conducted by the Full Committee or the Committee Chair, depending on the initial type of review and the current status of study.

Ending A Project

If the project is completed (including local data analysis), a PRF must be submitted by PI, or Co-PI.

Note: In the case of student projects, an Advisor is acceptable to officially conclude the project.

If the project was never started (no subjects consented to participate) and study will not be conducted, a PRF must be submitted to officially withdraw the project.