Continuing Review


Purpose

The purpose is to outline the policy and procedures for continuing review of human research.

Definition

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.

Policy

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 (of private, identifiable information), must cease (see Closure Policy for definitions related to identifiable data). 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.

Procedures

  1. Investigators wishing to extend research activities beyond the one-year approval period submit an Application for Continuing Review/Renewal form to the IRB or ERC.
  2. If activities involve data analysis, only the application is needed. If recruitment or enrollment will continue, clean copies of documents which are part of the consent process (e.g., informed consent forms, parental consent forms, assent forms and scripts, recruitment scripts, and any advertisements) are required, since they will need to be stamped with a new approval period. Any changes should be described, and additional documentation attached (as applicable).
  3. If research was originally reviewed under an exempt or expedited procedure, the review category remains the same, assuming that no substantial changes are proposed. If research was originally full, the annual review qualifies for expedited status if it meets the criteria set forth under expedited category 8 (45 CFR 46.110 (a) list).IRBNet sends an automated e-mail message to the PI and sponsor to remind them of expiration dates. These are generated and sent at 90 days, 60 days, 30 days, and 10 days prior to expiration, as well as one day after. In addition, expiration dates are found in the IRBNet system, on stamped documents which are part of the consent process, as well as on approval letters.
  4. While IRB or ERC staff members attempt to send personal courtesy reminders to investigators about upcoming expiration dates whenever possible, it is ultimately the investigator's responsibility to monitor his/her project's expiration date, and to apply for continuing review/renewal in a timely fashion if a study is to persist.

 


Related Policies

Approval of Research
Closure or Withdrawal
Mandatory Reporting
Suspension or Termination


History

7/19/2013 - Updated
10/24/2014 - Updated (Identifiable data)