Payment and Reimbursement to Study Participants

Pfizer’s policy is to promote cost neutrality for study participants so that study participation does not result in a financial burden for participants.

Payment and reimbursement to study participants must comply with all applicable local laws, regulations, tax requirements, and guidelines for the country or region in which the study is conducted. If applicable and required by local laws and regulations, changes to payment methods, amounts, or schedules that require a substantial amendment to the informed consent document must be submitted to and approved by the institutional review board/independent ethics committee prior to implementation.

Pfizer covers the cost of protocol-required treatments and procedures, unless otherwise specified in the protocol, clinical study agreement, or informed consent document. Payment and reimbursement to study participants, in accordance with regional and country requirements, must be based on consistent criteria (ie, offered for all study participants at a site or to study participants in the same treatment group at a site) as per the study budget.

Unless prohibited by local requirements, Pfizer offers reasonable payment for the time and effort and reimbursement of reasonable, study-related expenses for study participants of any age, as well as to parents, guardians, or caregivers of minor or incapacitated study participants. Parents, guardians, or caregivers accompanying a participant who has reached the age of majority must continue to receive payments and reimbursements while the participant remains in the study, as permitted by local laws and regulations.

Payments to study participants must be determined based on fair market value benchmarks in conjunction with protocol‑required activities, such as on-site visits, telehealth visits, eDiary completion, biopsies, etc. Participants can receive payment for sharing their data and/or medical device information (eg, Apple Watch data).

Items of nominal value are allowed as long as they are noncoercive and offered as a courtesy rather than as compensation for risk. Items of nominal value containing Pfizer or affiliate branding are permitted only for Pfizer Clinical Research Unit (PCRU) studies.

Payment and reimbursement must adhere to the following principles:

Based on consistent criteria (i.e., offered for all study participants in a country, at a site or to study participants in the same treatment group at a site) as per the study budget.
Reasonable expenses incurred by the study participant, parent, guardian, or caregiver (eg, parking, meals, hotel, travel, childcare, etc.) are reimbursed at the level they are incurred, or such direct costs of participation are defrayed or paid through use of other mechanisms, such as (i) transportation or meal vouchers, (ii) pre-paid gift cards, (iii) other in the amount of the average out-of-pocket expense expected to be incurred by a participant for a study visit.
Expenses may require receipts or other substantiation of expenditure by the study participant, parent, guardian, or caregiver, depending on local tax regulations.
Insurance cost-sharing obligations of study participants, including copayment, coinsurance, and deductible amounts, must only be reimbursed if specified criteria are met.
Consistent with the laws, regulations, tax requirements and guidelines of the country/region in which the study is conducted.
Expenses for protocol-required medication can be reimbursed, where allowed by local regulation.

Payment and reimbursement must not:

Be set at a level that is so high that it will result in undue influence that could compromise a prospective study participant’s evaluation of the risks of study participation or affect the voluntariness of his or her choices.
Be contingent on completion of the study by the study participant.
Be used to reimburse study participants, parents, guardians, or for their own lost wages, unless mandated by local requirements (eg, Portugal, Finland).
Be advertised in study participant recruitment materials in a manner that emphasizes payment or the amount to be paid (e.g., through use of large or bold type, or multiple references to payment per INV03-CT24-WI-GL01 Study Participant-Directed Recruitment Materials).
Be constructed in the form of a bonus for any purpose (eg, holiday, referral, study completion bonuses). Payment in the form of a bonus is permitted only for PCRU studies.
Be provided in the form of items of value (eg, video game console, iPhone).

Reasonable expenses incurred by the study participant directly as a result of participating in a study must be reimbursed so that qualified study participants may enroll without incurring any personal financial expenses to participate, to the extent permissible by applicable laws, regulations, and guidance. Details of anticipated expenses for which reimbursement will be made available must be included in the informed consent document as per CT05-GSOP Informed Consent Document or CT24-WI-GL07 Non-Interventional Study Informed Consent and Data Privacy, which must be submitted to and approved by the institutional review board/independent ethics committee before commencement of the study at the site.