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Policy on Compensation to Human Research Subjects in Clinical Studies

1. Purpose

This policy describes Pfizer standards for the fair compensation of human research subjects (including both patients and healthy volunteers) during the conduct of clinical trials/clinical studies sponsored by Pfizer.

2. Scope

This policy applies globally to all Pfizer-sponsored studies. This SOP applies to Pfizer colleagues within Worldwide Development (WWD), Safety and Risk Management (SRM), Worldwide Regulatory Affairs and Quality Assurance (WRAQA), Worldwide Medical, and the Pfizer Country Organizations (PCOs – Medical, Regulatory, Safety) in Worldwide Pharmaceutical Operations. It also applies to those parties with which Pfizer contracts (e.g., Contract Research Organizations (CROs) or consultants) who are involved in Pfizer-sponsored studies.

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3. Policy

It is the policy of Pfizer to compensate human research subjects fairly for their participation in clinical studies and to ensure that such compensation does not improperly influence their decision to participate.

Subjects often participate in clinical studies because they want access to an investigational therapy. In those cases, compensation may be provided to reimburse out-of-pocket expenses associated with participating in the study so that qualified subjects may enroll without incurring personal financial expenses to participate. In other cases such as Phase I studies in healthy volunteers and in studies with strict eligibility requirements, onerous testing procedures or the need to have subjects stay overnight (e.g. for observation, or to control their diet or dosing), additional monetary or non-monetary compensation may be acceptable to facilitate enrollment of qualified study subjects. Pfizer recognizes that compensation to human research subjects should be structured so that subjects are not unduly influenced by such offers of compensation.

To that end, compensation of study subjects shall be:

• Reviewed and approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). The nature and amount of compensation to research subjects shall be disclosed in the documentation of the voluntary informed consent.
• Based on subjects’ time, nature of the procedures, and/or anticipated (or actual) expenses incurred during participation in a clinical study (e.g., parking, travel, lodging expenses, baby-sitting costs). Compensation may include incentives of minimal value (e.g., phone cards with a monetary value of $20 or less).
• Prorated (e.g., per visit) and not wholly contingent on completion of the study by the subject. Subjects must be free to withdraw from a study at any time without penalty or loss of benefits to which they are otherwise entitled.
• Structured to take into account any special circumstances of the relevant population that is recruited for the study. For example, compensation of subjects in a pediatric study, other than for reimbursement of out-of-pocket expenses, may be inappropriate since it is the subject’s parent or guardian who would both receive the compensation and provide the informed consent. Similarly, within indigent communities, any compensation to potential subjects should reflect local financial conditions so as to avoid unduly influencing enrollment decisions.

Note that Pfizer generally covers the cost of protocol-required study-specific treatments and procedures supplied during clinical studies it sponsors and arranges for medical care for any physical injury or illness that occurs as a direct result of taking part in a Pfizer-sponsored clinical study. Pfizer reimburses this medical care at no expense to the subject.

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4. Responsibilities

The study team is responsible for assessing whether compensation to subjects is appropriate for studies that they sponsor or conduct and for developing a compensation structure that consistent with this policy. Final approval of compensation and any changes to compensation of subjects is up to the relevant IRB/IEC overseeing the study.

Exceptions to this policy may not be made without written approval of senior management and Legal.