The purpose is to outline the policy and procedures for approval of human research.
Approval of research is the determination of the Institutional Review Board (IRB) or Exempt Review Committee (ERC) that the research has been reviewed and may be conducted within the constraints set forth by the IRB/ERC and by other institutional and federal requirements.
Approval of research is valid for a maximum period of one year.
Marywood University’s IRB will determine which projects require more than annual review based on degree of risk and document that in its decision letters. In addition, the IRB will determine which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review.
Approval of research does not signal the end of the investigator’s relationship with the board or committee. Investigators are required to submit additional documentation throughout the life of a human research project, such as:
Please see our Mandatory Reporting, Continuing Review and Closure policies for further information.
Expiration of Approval and Continuing Review
IRB and ERC approval expires one year from the approval date. Status reports are due for all approved expedited and full projects six -months from the date of approval. A final report is due on or prior to the expiration date for all types of review, unless the PI applies for continuing review
If research will continue beyond the one year approval period, the investigator must apply to the appropriate board for continuing review prior to the expiration date. This is true for all categories of research: full, expedited and exempt. Please see our Continuing Review policy for further information.
Research covered by this policy that has been approved by the IRB or ERC may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by the IRB or ERC.
06/13/2013 - Updated
07/19/2013 - Updated
12/10/2013 - Updated