POLICY
It is the policy of Siena that research that has been disapproved by the Institutional Review Board (IRB) may not be conducted at Siena or by Siena faculty, staff, or students. However, investigators may appeal decisions made by the IRB that are in contention, including IRB decisions to disapprove, suspend, terminate, or stipulate modifications to submitted protocols and associated submission materials, including informed consent forms.
PROCEDURE
When the IRB disapproves, suspends, terminates, or stipulates modifications to submitted documentation, the investigator is notified of the action and rationale of the decision by written correspondence. If clarification of the written notice is needed, the investigator will be instructed to contact the IRB chair for further clarification.
Submission of Appeal: Investigators who disagree with an IRB decision and decide to enter into an appeals process should notify the IRB chair in writing by emailing irb@siena.edu. In this correspondence, the investigators should provide the rationale and supporting information/material that will aid the IRB in the review of the appeal.
Review Process:
- The IRB chair will, in consultation with at least 1 senior member of the IRB, review the appeal and respond in writing within 3 working days either reversing the IRB decision in favor of the appellant or referring the case for full board review. At that time, more information may be requested.
- The IRB chair will schedule the appeal for discussion at the next full (monthly) committee meeting. Investigators will be given the opportunity to attend that meeting to discuss their appeal and answer questions posed by the IRB.
The IRB will notify the investigator in writing of the IRB final decision within 24 hours of the meeting. In this notification, investigators will be informed they can direct additional unresolved questions, express concerns, as well as appeal the decision, to the Provost. - If investigators would like to appeal the IRB decision to the Provost, they are instructed to forward the following to the Provost: (a) original IRB decision letter, (b) appeals letter and supporting documents, (c) decision letter from IRB chair and (d) decision letter from IRB after the full convened meeting. The Provost may or may not request more information or an in-person meeting. Typically the Provost will respond with a decision within 5 working days.
The decision of the Provost is final. No further appeal to override the IRB decision may be made at Siena or any external entity.
(This policy was drafted in collaboration with and approved by the VPAA November 2019)