Compensation to Investigators in Clinical Studies
1. Purpose
This policy addresses payment to investigators and/or their institutions for work associated with the conduct of clinical studies.
2. Scope
This policy applies to all Pfizer colleagues and to those parties with whom Pfizer contracts (e.g., Contract Research Organizations [CROs] , vendors, contractors) who are involved in managing compensation to investigators in clinical studies. It applies to compensation to investigators for all Pfizer-sponsored studies. Investigator-initiated Research (IIR) studies are out of scope of this policy.
3. Policy
This policy sets forth minimum standards with regard to compensation of investigators in Pfizer-sponsored studies and implements the US Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. The policy does not relieve investigators of their responsibility to address potential financial and other conflicts of interest with their institution, Pfizer, and/or the Institutional Review Board/Independent Ethics Committee (IRB/IEC) responsible for review of the clinical study.
Compensation to an investigator must comply with the following policies:
- Pfizerýs Global Policy on Interactions with Healthcare Professionals
- Corporate Policy #202, Anti-Bribery and Anti-Corruption , Corporate Procedure #115, International Anti-Bribery and Anti-Corruption Procedure
- For studies sponsored by Worldwide Research & Development: Research & Development SOP #201, Research & Development Transactions Involving Healthcare Professionals and Government Officials of Non-US Jurisdictions
Pfizer compensates investigators for their work in conducting Pfizer-sponsored clinical studies and for providing protocol-required services to Pfizer related to those studies. Such compensation must be fair, reasonable, and equitable to fair market value for such work. The rate of compensation may take into account factors such as required procedures, time commitment, study complexity, and locale.
Any compensation to investigators as part of the clinical study must be explicitly identified in the clinical study budget. Any services performed by an investigator outside of the clinical study (e.g., consulting services or speaking engagements) may not be included as part of the study budget and must be documented in a separate agreement.
Pfizer shall not provide financial compensation to investigators for the conduct of clinical studies in the form of consulting agreements or honoraria. Financial compensation for consulting or other services related to the study or the research program and not directly related to investigator study conduct is acceptable, but must be appropriately documented and must also adhere to the Research & Development SOP #201, Research & Development Transactions Involving Healthcare Professionals and Government Officials of Non-US Jurisdictions.
Pfizer has the following additional requirements for compensation to clinical investigators:
- The financial compensation to investigators and their institutions must be linked to their performing specific and necessary services (e.g., medical procedures, collection of data).
- Notice of the financial relationship between Pfizer and the investigator/institution must be disclosed to study subjects in the informed consent. Such disclosure must consist of a statement such as the following: "The investigator or his/her institution is receiving compensation from the study sponsor for the investigator's participation in this clinical study."
- The financial compensation must be specified in a written contract describing the nature of the research services and the basis of payment.
- The financial compensation must be reasonable relative to compensation for similar clinical studies sponsored by the pharmaceutical/biotechnology industry in the country where the research is conducted. It may include reimbursement for reasonable travel, lodging, and meal expenses when clinical investigators or their staff must travel to meetings for a clinical study. Venue and circumstances for the meeting must be appropriate for the purposes of the meeting.
Financial compensation to investigators and their institutions or other clinical study personnel shall not:
- Be tied to the outcome of clinical studies.
- Include Pfizer stock or stock options.
- Include payments to physicians outside a clinical study for referring subjects to investigators for entry into that clinical study.
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Include special incentives such as enrollment bonuses, awards, or gift certificates that are designed to reward the achievement of subject enrollment goals within a specified time period.
- Should enrollment in a study be particularly challenging, Pfizer may compensate investigators, their institutions, or other clinical study personnel for extra recruiting expenses to enroll appropriate subjects. For example, compensation may cover such expenses as additional advertising costs.
Investigators or their immediate families shall not have direct ownership interest in the specific pharmaceutical product being studied. This provision does not preclude direct ownership of Pfizer stock.
Pfizer may publicly disclose compensation to investigators in clinical studies.
4. Responsibilities
The Study Manager, in conjunction with the Clinical Operations Lead (COL) (where assigned) and the Contracts & Outsourcing (C&O) Lead, is responsible for compliance with this policy. If a country-validated fair market value range of per-subject costs has been established for a particular study, all compensation rates outside that range must be justified, approved by senior management from Study Management and the relevant Business Unit, including Finance and documented (e.g., email). The C&O Lead is available for consultation when exceptions to compensation rates are being considered by project teams.
Waiver requests to this policy must be requested according to the ADM01 — Standard Operating Procedure Development and Management, Including SOP Training, Waivers and Deviations SOP and may not be implemented without written approval of senior management and R&D Legal.
