Subject Payments (CRC IRB)

Boston University
Charles River Campus IRB
Policies and Procedures

Title: Payments to Research Subjects
Date: September 23, 2014

Purpose

The purpose of this policy is to describe the process for reviewing payments to research subjects and to provide guidance on acceptable payment practices.

Policy

The Charles River Campus (CRC) IRB must review and approve payments made to research subjects. Investigators are required to include subject payment information in the IRB Application and in the Informed Consent Form

Payment may be in the form of cash, check, gift card, class credit, or other offering (gifts). The CRC IRB does not have any specific requirement in regards to the amount of payments or the form of payments.

Payment is not considered to be a benefit of participating in a research study.

Procedures

Payment to research subjects may occur in one of the four ways listed below:

  1. Reimbursement: Payments that are directly related to expenses that are incurred from participating in the research study. Examples include providing payment for transportation, parking, childcare, and meals.
  2. Compensation: Payments made to subjects for the time, effort, and inconvenience of participating in the study. Examples include providing payment for time away from work or for the length of time required for study participation.
  3. Gifts of appreciation: Small payments, gifts, gift certificates, or other tokens give to subjects to thank them for their time and effort.
  4. Incentives: Payments, gifts, gift certificates that are intentionally used to encourage enrolment, continued participation, and/or motivation to perform study procedures. Incentives exceed the value of reimbursement for costs and gifts of appreciation. Examples are “completion bonuses” or additional payments (bonuses) that are beyond expense reimbursements and are typically made as the study progresses. Any bonus for completion must be reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn.

The IRB will review the payment method and amount to determine that it meets the following criteria:

  • The amount of payment and the proposed method and timing of disbursement neither is coercive nor presents undue influence
  • Credit for payment accrues as the study progresses and is not contingent upon the participant completing the entire study
  • Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn
  • All information concerning payment, including the amount and schedule of payments, is included in the consent document
  • Coupons and /or discounts on the purchase of investigational drugs, devices, or services once the drug, device, or service is approved/commercially available may not be used

Note: If the investigator wants to impose a condition (e.g. completion of the survey or other study tasks) in order for the subject to receive compensation, the IRB will need to determine whether the time and effort required of the subject to complete the study procedure(s) justifies the condition.

Documentation of Payment

It is recommended that investigators document when payments are made to subjects. The QI Specialist in the QA/QI Program is available to assist investigators by creating tools and logs for study documentation purposes.

Payments to Children who are Research Subjects

For research involving children, the IRB will review the study to determine who (i.e. child subject, parent/guardian, or both) should receive the payment. In general, incentives should be provided to the child subject and compensation should be provided to the parent/guardian. The IRB will take into consideration the age and maturity of the child subject along with the circumstances of the study. The IRB will determine that the payment to the child subject is age appropriate.

Chance to Win

The IRB may approve chance to win methods if they meet the following criteria:

  • The study is not greater than minimal risk
  • All subjects are eligible
  • All subjects have an equal chance of winning
  • If a subject withdraws, they are still eligible for the lottery/drawing (unless conditions are required to be eligible for the chance to win)*The consent form must include the chances of winning
  • The value of the prize must be stated in the IRB Application and the consent form
  • The prize does not exert undue influence

*If the investigator wants to impose a condition (e.g. completion of the survey or other study tasks) before the subject is eligible for the chance to win, then the IRB) will need to determine whether the time and effort required of the subject to complete the study procedure(s) justifies the condition.

Class Credit

The IRB may approve the giving of course credit to students for study participation when the following criteria are met:

  • There is an alternative means of obtaining course credit for those students who do not want to participate in the research study
  • The alternative means must be comparable in terms of time, effort, and educational benefit. Examples of alternatives include participating in another research study, a short paper, special project, or short quizzes on additional readings.
  • Subjects must be informed that they can withdraw at any time and course credit will be prorated

Boston University Policies on Human Subjects Payments

Investigators are also required to comply with Boston University policies regarding human subjects payments. Information regarding University policies can be found at:

Title: Payments to Research Subjects

Author: Cynthia Monahan

Effective Date: September 23, 2014

Last Review/Update Date:

Revision #:

Approved: Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance

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