Duration of Approval
All Full Board and Expedited studies must be periodically reviewed again at least annually. There are times when the risks associated with a particular project are such that continuing review should take place more frequently than annually. In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval (e.g., 3 or 6 months) or after a specified number of participants (e.g., after each participant or after 3 participants) are enrolled. The PI’s report must describe the observed effects of the research activities and/or how the participant(s) responded to the research interventions. Such a determination will be recorded in the IRB files (e.g., minutes), along with whether the reports will be reviewed by the full board or primary reviewer.
Appealing an IRB Decision
If the IRB makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the IRB Chair. The investigator should be prepared to present reasons that he/she believes that the proposed research is in compliance with College policy and federal regulations for the protection of human participants.
If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the IRB. In developing his/her appeal, the investigator is encouraged to seek the advice or opinion of an objective, qualified consultants to support the claim that the proposed research is in compliance with human participants policy and regulations.
The investigator must appear before the IRB to present his/her appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final determination on the proposed research. The Institutional official CAN overrule the IRB to disapprove a project, but CANNOT overrule the IRB to approve a project. Only the IRB can approve a project.
Negative decisions by the IRB may be appealed to the vice president for academic affairs on the grounds of a failure by the IRB to carry out a thorough and complete review in accordance with its stated procedures or on the grounds of a possible violation of the academic freedom of the investigator. Final appeal rests with the President.