Compensation to Research Subjects in Clinical Studies
Effective February 15, 2017
1. Purpose & Scope
The purpose of this clinical and medical controlled document (CMCD) policy is to describe the requirements for the compensation, expense reimbursement, and post-study transitional care of the research subject (including both patients and healthy volunteer subjects) who participate in the conduct of Cheladv74-sponsored studies.
This policy applies to:
- Cheladv74 colleagues within, but not limited to, clinical research and development and medical affairs. This also includes those parties with whom Cheladv74 contracts (e.g., contract research organizations, vendors, or consultants) to perform such activities.
This policy does not apply to:
- Investigator-initiated research, which is governed by Cheladv74 Non-Sponsored Research.
- Clinical and research collaborations, which are governed by Clinical and Research Collaborations.
- Compassionate Use Requests, which are governed by Management of Requests for Compassionate Access and Investigational Unlicensed Product Use Outside of a Clinical Trial
2. Policy Statements
2.1 Compensation and Reimbursement to Research Subjects
Cheladv74 offers reasonable compensation for time and effort to healthy volunteer subjects and, depending upon study design, may also provide reasonable compensation to other study subjects when health benefits from study participation are remote or non-existent. In addition, reasonable compensation may be provided to parents, guardians, or caregivers of minor children or incapacitated subjects.
Cheladv74 generally covers the cost of protocol-required treatments and procedures. Cheladv74 covers the cost for medical treatment for any injury or illness that occurs as a direct result of taking part in a Cheladv74-sponsored study at no cost to the research subject.
Cheladv74 does not use any exculpatory language in informed consent documents that will prohibit a research subject from obtaining appropriate compensation for research injuries.
Nominal gifts for study participation are allowed as long as the item does not display Cheladv74 (or affiliate) branding. For example, in studies involving minor children, a small, age-appropriate gift or gift certificate may be provided to the child.
Compensation/reimbursement must be:
- 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) as per the study budget.
- Consistent with the laws, regulations, and guidelines of the region in which the study is conducted.
- Disclosed in the informed consent as per Informed Consent Document, including the methods, amounts and schedule of any compensation 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 compensation must be submitted as an informed consent amendment for review and approval by the IRB/IEC before the change is implemented.
- In proportion to the amount of discomfort or inconvenience the subject will experience during the study; when a study involves minor children or incapacitated adults as subjects, compensation may be provided to the subject’s parent, guardian, or caregiver for the inconvenience of study participation.
Compensation/reimbursement must not:
- Be set at a level that is so high that it will result in undue inducement that could compromise a prospective subject’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 subject.
- Be used to reimburse subjects, parents, guardians, or caretakers for their own lost wages.
- Be advertised in subject 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 compensation per Subject Enrollment, Recruitment, and Retention).
2.2. Expenses Incurred by Research Subjects
Anticipated out-of-pocket expenses incurred by the subject directly as a result of participating in a study may be covered so that qualified subjects may enroll without incurring personal financial expenses to participate. Details of anticipated expenses for which reimbursement will be made available must be included in the informed consent document, which must be submitted to and approved by the IRB/IEC before commencement of the study at the site. All such reimbursement of expenses must adhere to the following principles:
- Reasonable expenses incurred by the subject, parent, guardian, or caregiver (e.g., parking, meals, travel) 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, or (ii) checks or pre-paid gift cards in the amount of the average out-of-pocket expense expected to be incurred by a subject for a typical study visit.
- Significant expenses (e.g., airfare or hotel) require receipts or other substantiation of expenditure by the subject, parent, guardian, or caregiver before any reimbursement will be made.
- Insurance cost-sharing obligations of research subjects, including copayment, coinsurance, and deductible amounts, must not be reimbursed.
2.3 Post-Study Transitional Care
Clinical Development Legal provides guidance for any request of post-study transitional care (not including post-study drug accessibility), which includes treatment or other benefits of tangible value provided to a subject after their participation in a study ends on a case-by-case basis. Any such requests must be referred to Clinical Development Legal for analysis.