Submit A Study For Initial Review
By law, the IRB can only grant approval to projects that comply with Basic Ethical Principles (see here). It is the responsibility of the principal investigator to ensure that applications are complete and make the case for compliance. The principal investigators (PIs) for all research involving human participants at Benedictine College must be faculty or staff. When students are involved as researchers, it is expected that they will be closely supervised by the PI on the project. It is expected that PIs will carefully review IRB applications that are completed by students before signing and submitting the applications.
Researchers should only submit applications (see here) once all research materials have been finalized, and those materials, including the consent form, must be submitted as appendices to the completed application. All materials should be sent via email to the Chair of the IRB (see here). The Chair will make an initial determination as to the completeness of the application and appropriate type of review.
If the study qualifies for exempt or expedited review, the application will be reviewed by the IRB Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. A research activity may be disapproved only after review by the full IRB.
Research covered by this policy that has been approved by the IRB 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.
Categories Of Action On Initial Review
As a result of its review, the IRB may decide to approve or disapprove the proposed research activity, or to specify modifications required to secure IRB approval of the research activity. In the case of full board review, these actions will be taken by a vote of a majority of the members present, except for those members present but unable to vote in accordance with the IRB's conflict of interest policies.
The IRB may make one of the following determinations as a result of its review of research submitted for initial review or for continuing review:
- Approval: The protocol and accompanying documents are approved as submitted. Approval will commence on the day the study is approved and expire within one year of the approval date. The IRB approval and expiration dates must be included on all informed consent/assent forms. Approvals are always considered conditional. The conditions for continued approval, and the time frame (if any) within which they must be met will be clearly stated in the approval letter. If the conditions of the approval are not met, approval may be withdrawn.
- Contingent Approval: This designation is reserved for projects whose proposals require minor changes or clarification prior to approval. Researchers are informed of the contingencies named by the Board, and are instructed that they may not begin data collection until they have responded in writing to the contingencies and have received final approval. The IRB Chair has the authority to determine whether the contingencies have been met; the researcher's response need not be reviewed by the full IRB. If the researcher fails to respond within 90 days, he or she must begin the application process anew. In the case of contingent approval, the expiration date of IRB approval will be based on the anniversary date of the initial IRB review. However, participants may not be recruited into the study until final approval has been issued.
- No Decision: This designation is reserved for projects whose proposals lack clarity or are missing significant required information or documents such as a consent form, questionnaire, or complete application form. Researchers are informed of the concerns named by the Board, and are given the opportunity to respond in writing to those concerns in time for the response to be considered at the next meeting of the full IRB. If the researcher fails to respond within 90 days, he or she must begin the application process anew.
- Disapproval: This designation is reserved for projects for which the IRB believes there may be unacceptable risk to the participants in the research. Researchers are informed in the Disapproval Letter of the concerns named by the Board, and are given the opportunity to respond in writing to those concerns in time for the response to be considered at the next meeting of the full IRB. If the researcher fails to respond within 90 days, he or she must begin the application process anew.
The IRB Chair will notify the Principal Investigator via email of the IRB’s decision within one week. If the research is being conducted by students, the lead student researcher will be copied on the email.
