Payment and Reimbursement to Study Participants

Pfizer offers reasonable payment for the time and effort to participate in a study. In addition, Pfizer may offer reasonable payment to parents, guardians, or caregivers of minor children or incapacitated study participants.

Pfizer generally covers the cost of protocol-required treatments and procedures. Pfizer covers the cost for medical treatment for any injury or illness that occurs as a direct result of taking part in a Pfizer-sponsored study at no cost to the study participant.

Pfizer does not use any exculpatory language in informed consent documents that will prohibit a study participant from obtaining appropriate payment for research injuries.

Nominal gifts for study participation are allowed as long as the item does not display Pfizer (or affiliate) branding. For example, in studies involving minor children, a small, age-appropriate gift or gift certificate may be provided to the child.

Payment and reimbursement must be:

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.
Planned to cover reasonable expenses incurred due to study participation so that participants do not incur personal financial expenses to participate, to the extent permissible by applicable laws, regulations, and guidance. This may include expenses incurred by parents, guardians, or caregivers of minor children or incapacitated study participants, as appropriate given the circumstances of the study.
Consistent with the laws, regulations, tax requirements and guidelines of the country/region in which the study is conducted.
Disclosed in the informed consent document as per CT05-GSOP Informed Consent Document, CT45-GSOP Interventional Studies with Minimal Risk, or CT24-WI-GL07 Non-Interventional Study Informed Consent and Data Privacy, including the methods, amounts and schedule of any payment provided.
Reviewed and approved by an institutional review board/independent ethics committee (IRB/IEC) before commencement of the study at the site; any change in the methods, amounts, and/or schedule of payment must be submitted as an informed consent document update for review and approval by the IRB/IEC before the change is implemented.

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 caretakers for their own lost wages.
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).

Anticipated reasonable expenses incurred by the study participant directly as a result of participating in a study may be covered 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, CT45-GSOP or CT24-WI-GL07 which must be submitted to and approved by the IRB/IEC before commencement of the study at the site. All such payment and reimbursement must adhere to the following principles:

Reasonable expenses incurred by the study participant, parent, guardian, or caregiver (e.g., 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 not be reimbursed.
Consistent with the laws, regulations, tax requirements and guidelines of the country/region in which the study is conducted.