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Compensation to Subjects:
• Shall be reviewed and approved by an Institutional Review Board (IRB) or and Independent Ethics Committee (IEC).
• Shall be based on subjects’ time, nature of the procedures, and/or anticipated (or actual) expenses incurred during participation in a clinical trial (e.g., parking, travel, lodging expenses, baby-sitting costs).
• Shall be prorated (e.g., per visit) and not wholly contingent on completion of the trial by the subject.
• May include incentives of minimal value (e.g., phone cards with a monetary value of $10).
• The nature and amount of compensation or any other benefit should be consistent with the principle of voluntary informed consent.
• Subjects are free to withdraw from a trial at any time without penalty or loss of benefits to which they are otherwise entitled.
• The nature and amount of compensation to research subjects shall be disclosed in the informed consent form.
• For each individual clinical trial, the clinical team is responsible for developing a compensation structure for subjects that is tied to expenses relevant to the trial (e.g., time, travel costs, nature of procedures) and is not at a level that would be considered coercive. In that regard, given that the appropriateness of compensation depends on the patient population for a given clinical trial, the compensation structure for subjects for each clinical trial will be reviewed by an IRB or IEC, as it is best qualified to assess the appropriateness of a given compensation scheme to a particular pool of research participants.
• Pfizer generally assumes the cost of all investigational products supplied during clinical trials it sponsors. In addition, Pfizer will arrange for medical care for any physical injury or illness that occurs as a direct result of taking part in a company-sponsored clinical trial. This medical care is provided at no expense to the research subject.