Institutional Review Board: How to Initiate a Review
Here are the steps to follow to initiate an IRB review of a research project:
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.
- For studies involving subjects likely to be vulnerable to coercion or undue influence, identify all appropriate protections in place for vulnerable subjects.
- 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.
- If the research involves collaboration, 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. The form also provides instructions on the order in which the proposal and any supplemental materials (e.g., questionnaires, informed consent notices) should be prepared.
3. Submit IRB Request for Review form, informed consent forms, and questionnaire surveys
Submit the completed IRB Request for Review form to firstname.lastname@example.org. Informed consent forms, recruitment advertisements, questionnaires/ surveys, and other study tools should also be included and be in final draft, free of typos. 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).
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 principal investigator shall communicate with the IRB when the research is completed and confirm that all agreed-upon protocols were followed. If any revisions to the study protocol, consent form, or any supporting materials are made, or new materials that may have human subject implications are added, The University of Portland IRB Study 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.