- South Africa
- Hong Kong
- New Zealand
- Czech Republic
- United Kingdom
Compensation to Human Research Subjects in Clinical Studies
This policy describes Pfizer standards for the fair compensation of human research subjects (including both patients and healthy volunteer subjects) during the conduct of clinical studies sponsored by Pfizer.
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 human research subjects in clinical studies. It applies to compensation for human research subjects for all Pfizer-sponsored studies. Investigator-initiated Research (IIR) studies are out of scope of this policy.
It is the policy of Pfizer that research subjects may be compensated for their participation in clinical studies. Compensation amount and the method and timing of disbursement must be consistent with the laws, regulations, and guidelines of the region in which the study is being conducted and must not improperly influence a research subjectýs decision to participate.
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 studies where participants will likely receive no medical benefit (e.g., Phase I studies) reasonable compensation for time and effort is permitted. Excessive compensation may cause subjects to undertake risks or discomforts that they otherwise would not assume.
Compensation of minor subjects who participate in clinical studies should be given additional consideration. Parents or guardians who incur expenses for travel, parking and childcare for siblings may receive compensation for those expenses. However, such compensation must not become an improper incentive to enroll the minor.
Compensation of study subjects-patients shall be:
- Reviewed and approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and offered for all subjects in the cohort (i.e., not specific to an individual). The nature and amount of compensation to research subjects shall be disclosed in the documentation of the voluntary informed consent. Any compensation to potential subjects should reflect local financial conditions so as to avoid unduly influencing enrollment decisions.
- May be reimbursed based on the subjects' anticipated expenses incurred during participation in a clinical study (e.g., parking, meals, travel).
- For Phase 1 studies involving healthy volunteer subjects, reasonable compensation for time and effort involved with the study.
- Prorated (e.g., per visit) and not contingent on completion of the study by the research subject. Research subjects must be free to withdraw from a study at any time without penalty or loss of benefits to which they are otherwise entitled.
Note that Pfizer generally covers the cost of protocol-required 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.
Seek guidance from R&D Legal should any post-study care be required or requested, which includes treatment or other benefits of tangible value provided to a subject after the subjectýs participation in a clinical study ends.
The clinical lead is responsible for assessing whether compensation to subjects is appropriate for studies that they sponsor or conduct, in consultation with Contracts and Outsourcing (C&O) and R&D Legal as necessary, and for developing a compensation structure that is 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.
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.