Approval of Research


Purpose

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

Definition

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.

Policy

Approval of research is valid for a maximum period of one year.

In its approval, Marywood University’s IRB or ERC will:

  • Determine which projects require more than annual review based on degree of risk and document it in its decision letters
  • Determine which projects need verification from sources other than the investigator that no material changes have occurred since previous review
  • Ensure prompt reporting to the IRB or ERC of proposed changes in a research activity
  • Ensure that changes during the approval period are not initiated without IRB or ERC review and approval except when necessary to eliminate apparent immediate hazards to the subject.

Approval of research does not signal the end of the investigator’s communications with the board or committee. Investigators are required to submit additional documentation throughout the life of a human research project, such as:

  • Report of status six-months after approval (IRB only; closure required if completed before six months)
  • Application for revisions to approved research (however minor they seem)
  • Report of unanticipated problems or serious adverse events in the project
  • Report of deviations or violations from the approved project
  • Application for annual renewal/continuing review prior to expiration if not complete
  • Closure report


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.

Review by Institution

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 [45 CFR 46.112].

Procedures

  1. Upon approval, an IRB or ERC staff member imprints documents which are part of the consent process (informed consent forms, parental permission forms, assent forms and scripts, recruitment scripts or email, and any advertisements) with Marywood University’s official IRB or ERC approval stamp and uploads the stamped copies into IRBNet. The staff member also creates and publishes an official approval letter in IRBNet.  
  2. The IRBNet system sends the Principal Investigator (PI) and all individuals who have been granted full project access an automated e-mail notification.
  3. The PI logs into IRBNet to access the official determination letter and stamped documents, which must be used in the implementation of the project.
  4. The approval letter communicates investigator responsibilities, reporting requirements, the approval date, the six-month status report due date (expedited and full projects only), and the expiration date for the research project.

  


Related Policies

  • Continuing Review
  • Closure or Withdrawal
  • Mandatory Reporting
  • Revisions to Approved Research
  • Suspension or Termination

 


History

06/13/2013 - Updated
07/19/2013 - Updated
12/10/2013 - Updated
06/13/2017 - Updated with regulatory language