How to Initiate a Review | University of Portland

How to Initiate a Review

This website has been updated to reflect the Revised Common Rule, implemented on January 21, 2019.

1. Complete a narrative research proposal 

In most cases the proposal need not include an extensive literature review or references. However, the proposal must:

  • Identify a clear research hypothesis or study aims.
  • Demonstrate that the study design is appropriate to test the hypothesis or meet the study's aims.
  • Explain how the risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge that may reasonably be expected to result.
  • Identify criteria used to select or enroll research subjects.
  • Identify all appropriate protections in place for vulnerable subjects, particularly for studies involving subjects likely to be vulnerable to coercion or undue influence.
  • Identify procedures and protocols to ensure that informed consent is obtained from research subjects (or their legally authorized representative) when appropriate.
  • Demonstrate that procedures are in place to maximize subject privacy and confidentiality.
  • Provide procedures to ensure that all members of the research team understand and agree to be bound by the research protocol identified in the research proposal and stipulated by the IRB.

2. Complete the IRB Request for Review form 

The IRB Request for Review form asks for a brief summary of the research proposal and allows the IRB to determine which type of review is required. Investigators are responsible for providing all relevant information on the Request for Review form, as well as copies of any supplemental materials, such as questionnaires, confidentiality statements, consent forms, etc.

3. Submit the IRB Request for Review form with all supplemental materials

Submit the completed IRB Request for Review form by email to Informed consent forms, recruitment advertisements, questionnaires, surveys, and other study tools should also be included and be in final draft, free of typos and presented in a professional manner. The narrative research proposal need not be sent to the IRB unless it is specifically requested during the review process. The email address of origination must be the institutional UP email address of the principal investigator (or in the case of student research, the UP email address of the supervising faculty member.) A sample Request for Review form can provide further information to submit a comprehensive form. 

The IRB requires electronic submission (via email attachment) of all materials. An IRB designate will acknowledge receipt of the materials and inform the submitting party of the results of the review (including requests for additional information or modification of the research plan) as soon as is possible.

The IRB makes every attempt to respond to requests for review within 14 days of submission. However, during particularly busy periods, additional time may be necessary. 

4. Follow-up

If any revisions or additions to the study protocol, consent form, or any supporting materials are made, an IRB Continuing Review/Revision Form must be submitted. In its initial review of a proposal, the IRB will consider the extent of continuing review needed. All ongoing research projects subject to IRB review shall be reviewed at least annually. Upon request of the IRB, the principal investigator shall communicate with the IRB when the research is completed and confirm that all agreed-upon protocols were followed.

In addition, all records must be retained by the principal investigator in a secure fashion for three years after completion of the research. Records may include such items as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related correspondence concerning the use of human subjects. Unless otherwise stipulated by the IRB, records may be destroyed at the end of three years following the completion of the research project.