Compensation to Investigators in Clinical Studies
Effective December 1, 2016
1. Purpose & Scope
The purpose of this clinical and medical controlled document policy is to describe the requirements for compensation to investigators for work associated with the conduct of Pfizer-sponsored studies.
This policy applies to:
- Compensation to investigators for Pfizer-sponsored studies.
- Pfizer colleagues responsible for clinical research and development and medical affairs. This also includes those parties with whom Pfizer contracts (e.g., contract research organizations, vendors, or consultants) to perform such activities.
This policy does not apply to:
- Investigator-initiated research governed Pfizer Non-Sponsored Research.
- Clinical and research collaboration governed by Clinical and Research Collaborations.
- Compassionate use requests governed by Management of Requests for Compassionate Access.
- Pfizer Clinical Research Unit Investigators that are Pfizer employees. If the Pfizer Clinical Research Unit contracts an investigator to be principal investigator or sub-investigator in a particular study, the provisions in this policy apply.
2. Policy Statements
2.1 Compensation to Investigators
Pfizer compensates investigators for providing protocol-required services for Pfizer-sponsored studies.
Compensation must be:
- Fair, reasonable, and equitable to fair market value.
- Explicitly identified in the investigator contract and linked to their performing specific and necessary protocol-required services (e.g., medical procedures, collection of data).
- Specified in the informed consent that the investigator is being compensated by Pfizer.
Compensation must not be tied to the outcome of studies or include:
- Pfizer stock or stock options.
- Payments to physicians outside a study for referring subjects to investigators for entry into that study.
- Any services performed by an investigator outside of the study (e.g., consulting services, honoraria, speaking engagements). These must be documented in a separate agreement.
- Compensation for authorship of a primary publication about the results of the study.
- Advanced payments in the United States.