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Appointment of the Safety Officer



The Principal Investigator typically proposes an independent Safety Officer, usually a physician, with relevant study and disease specific expertise, and submits the individual's name for review and approval by the NIAMS Program Officer. NIAMS invites the individual to serve as a study's Safety Officer. The Safety Officer is appointed and receives the manual of operating procedures, which typically contains the study protocol and safety monitoring plan, before study enrollment begins.



II. Independence of the Safety Officer



To remain objective, the Safety Officer must maintain independence from the study. Accordingly, the Safety Officer should not be directly involved in the conduct of the study and should not have scientific, proprietary, financial or other interests that may affect independent decision-making.



Current collaborators of the Principal Investigator are not eligible. The letter of invitation to prospective Safety Officers should state the requirement of independence. In addition, potential Safety Officers must sign a Conflict of Interest Statement prior to the appointment. Annually, the NIAMS Program Officer will seek reconfirmation that no conflict of interest exists. Such a statement may also be required prior to each review.