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Compensation to Human Research Subjects in Clinical Studies
Effective September 3, 2013
1. Purpose & Scope
The purpose of this clinical and medical controlled document (CMCD) policy is to describe the requirements for the fair compensation of the subject (including both patients and healthy volunteer subjects) during the conduct of Pfizer-sponsored studies. The term policy will be used throughout the remainder of this CMCD policy.
This policy applies to:
- Pfizer colleagues who are involved in activities related to the policy, as well as to those parties with whom Pfizer contracts (e.g., contract research organizations, vendors or consultants) to perform such activities, unless Pfizer has agreed that such parties may follow their own processes with respect to these activities.
This policy does not apply to:
- Investigator-Initiated Research which is governed by CT25-GSOP Investigator-Initiated Research.
2. Policy Statements
It is Pfizer policy that subjects may be compensated for their participation in Pfizer-sponsored 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 conducted and must not improperly influence a subject’s 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. Compensation may also include direct payment of expenses by Pfizer, contract research organizations, vendors, or consultants. In studies involving healthy volunteer subjects (eg., Phase 1 or Pfizer Consumer Healthcare (PCH)), 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 minors who participate in studies must 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 must be:
- Reviewed and approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and developed based on consistent criteria (i.e. offered for all subjects in a country, at a site or to subjects in the same treatment group at a site). Variation at the individual subject level is not permitted. The nature and amount of compensation to subjects must be disclosed in the documentation of the voluntary informed consent. Any compensation to potential subjects must reflect local financial conditions so as to avoid unduly influencing enrollment decisions.
- Reimbursed based on the subjects’ anticipated expenses incurred during participation in a study (e.g., parking, meals, travel). This includes any travel arrangements made by Pfizer, contract research organizations, vendors, or consultants, on behalf of the subject and/or paid directly to a travel provider, on behalf of the subject, by Pfizer, contract research organizations, vendors, or consultants. Details of anticipated expenses will be included in the informed consent.
- Prorated (e.g., per visit) and not 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.
Note that Pfizer generally covers the cost of protocol-required treatments and procedures supplied during Pfizer-sponsored studies and arranges for medical care for any physical injury or illness that occurs as a direct result of taking part in a Pfizer-sponsored study. Pfizer reimburses this medical care at no expense to the subject.
Research and Development (R&D) Legal provides guidance for any request of post-study care, which includes treatment or other benefits of tangible value provided to a subject after their participation in a study ends.
The clinical lead or equivalent is responsible for assessing whether compensation to subjects is appropriate for studies that they sponsor or conduct, in consultation with the outsourcing lead 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.
For studies conducted in a Pfizer Clinical Research Unit (PCRU), the compensation to human research subjects is assessed and developed by PCRU staff, in line with SOP CRU-R02-LSOP, Calculation and Payment of Subject Compensation at the PCRU.
2.3. Trial Master File
- The Document Owner Group is responsible for submitting Trial Master File (TMF) required documents to the TMF in accordance with the authoritative source for TMF information.
- For non-interventional studies, follow applicable document filing requirements.