The IRB process includes the following steps:
Main Page Content
For student investigators, the IRB application is completed under the guidance of the student's faculty advisor. The student's advisor is responsible for guiding the student investigator in the development of the research plan as well as the conduct of the research project. The faculty advisor will refine the project and should help the student investigator determine the expected level of review (exempt, expedited, or full board review). Please note that the final determination of review category will be made by the IRB. The advisor also assists students in a design to maximize the benefits and minimize the risks involved in the research, and assure the ethical conduct of the project. Student proposals require a faculty advisor's signature for submission.
For faculty and staff investigators, the IRB applicant is responsible for completing the proposal application on their own or with the help of the IRB staff.
The College at Brockports IRB staff is available to assistant all applicants, whether by e-mail, in person, or over the phone.
2. Application submitted to IRB for review
The IRB staff will conduct a pre-review of all applications before it is eligible for further levels of review by the review board. If a study is exempt, IRB staff will review and approve it. If a study does not qualify as human subjects research, IRB staff will determine this and no further approval is required. (The IRB office can provide a letter stating that the study does not meet the parameters for human subject research.)
3. IRB review outcomes
The IRB will notify the researcher with one of the following once the application has been reviewed:
- Approval - the application is complete, the risks to subjects are minimal/minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
- Revisions/Clarifications Needed - the application is complete but there are issues/changes that must be addressed before the project can begin. Once a satisfactory response to these contingencies is received and approved by the IRB, the review is complete.
- Incomplete review - applications that are found to have deficiencies (risk to subjects, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. The researcher is sent an e-mail listing the concerns that must be addressed for approval to proceed. The researcher's response is reviewed by the IRB and will be approved or deferred until all issues are addressed satisfactorily.
- Non-Approval - Applications that are found to have risks that outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted as designed. Institutional administrative officials may not override this decision.
4. Conduct of research and reporting
Once the application is approved, the researcher may begin recruiting subjects and conducting study procedures. However, the researcher must inform the IRB office if any of the following occurs:
- Modifications and Amendments to the approved protocol (changes to the original submitted study must be reviewed and approved by the IRB before they are implemented)
- Adverse Events/Effects and Unanticipated Problems involving risks to subjects or others (the IRB must be notified immediately if any undue harms result from the study)
- Complaints Regarding Human Subjects Research (the IRB must be notified immediately if any complaints, either from the subjects or the study staff, are made regarding the research study)
- Breach of Confidentiality (If any personal/confidential data has been inappropriately disclosed by any member of the study staff, the IRB must be notified immediately)
5. Status Report (Continuation or Closeout)
Prior to the expiration of a study, the IRB will require submission of a continuation form to assess the study's progress or a close-out form when the study is completed. For student projects, either the student or the faculty advisor may submit the final report.