Following full or expedited review of a protocol by the IRB, the Chairman corresponds with the Investigator regarding the decision of the IRB (approval, disapproval and deferral). Letters are sent to Investigators within five working days of a decision. If the IRB votes to disapprove a research activity, it shall include in its written notification a statement of the reasons for the decision and give the investigator an opportunity to respond in writing and in person at a convened meeting of the IRB. All Investigators are informed of OHRP policies as outlined in the FWA filed with OHRP by providing them with a copy of the FWA document with the application form and periodic mailings. Compliance with IRB, OHRP and FDA regulations and guidelines is expected from Principal and collaborating investigators. In the approval letter, investigators are instructed to inform the office of the IRB, in writing, of all changes in protocols prior to their implementation, and terminations, should they occur prior to the renewal due date.

Investigators may appeal to the IRB, in writing, documenting the reasons for the appeal. These will be addressed to the Chair of the IRB and discussed at a convened meeting. Based on the Investigator's response, the IRB may approve or disapprove the protocol, or require additional information or changes, in which case voting will be deferred pending receipt of the Investigator's response. The IRB can vote to allow the IRB Chair to approve the protocol when the IRB requirements have been satisfactorily met, or require full board review at the next convened meeting. The outcomes will be communicated to the investigator in writing by the Chair of the IRB. No Institutional official or other Institutional committee may override the decisions of the IRB to disapprove a study. However, the Institution may prevent the performance of a study approved by the IRB.

Investigators may bring forth any concerns or suggestions they have regarding the functions of the Institutional Review Board or the protection of human research subjects to the IRB itself, their department head, or the Senior Vice President of Medical Affairs. Investigators are invited to IRB meetings to present their new protocols, and they may also address concerns and issues directly with IRB members at that time.

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