The purpose is to outline the policy and procedures for continuing review of human research.
Continuing Review of research is a review which is conducted after a project has received initial review and approval by the Institutional Review Board (IRB) or Exempt Review Committee.
According to federal regulations, continuing review of research must be conducted at intervals appropriate to the degree of risk to human subjects, but not less than once per year. An IRB shall also have authority to observe or have a third party observe the consent process and the research.
IRB or ERC approval of research is granted for one year only. If a project is expected to last longer than the one-year approval period, an investigator must apply for continuing review/renewal. Investigators are responsible for fulfilling requirements associated with continuing review in time for the IRB or ERC to carry out review prior to the expiration date of the current approval, as lapses in approval are not allowed. If a project’s approval expires, all research activities, including but not limited to recruitment, enrollment, study interventions/data collection, long-term follow-up AND data analysis, must cease. The only exception is where the investigator requests to continue the project because it is in the participants’ best interest (e.g., taking a study drug), and the IRB finds that it is in the best interest of individual participants to continue with such interventions or interactions.
Status reports are due for all approved expedited and full projects six -months from the date of approval (See Mandatory Reporting policy).
Marywood University’s IRB will determine which projects require more than annual review based on degree of risk and document that in 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.
Investigators may continue research activities only after final IRB or ERC approval is granted for the renewal submission.
Approval of Research
Closure or Withdrawal
Suspension or Termination
7/19/2013 - Updated