IRB Policies and Procedures

Incentives in Research

Purpose

The purpose is to describe the policies for incentives or other rewards used in research involving human subjects.

Definitions

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

Coercion is an overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.

Incentives are payments, compensation or other rewards given to human subjects as motivation to participate in research and granted in either monetary (cash, check, gift card, voucher, etc.) or non-monetary format (gift, promotional item, course credit, etc.).

Pro rate is to divide something in a proportional way, based on time.

A research raffle, lottery or drawing (interchangeable terms) occurs when subjects are offered a chance to win a prize or something of value in return for their participation as subjects in a research activity.

Undue influence is an offer of excessive or inappropriate compensation or other overture in order to obtain compliance

Policy

Investigators may pay or otherwise reward human subjects for participating in research studies. However, they must not consider such payments or rewards as benefits that subjects would weight against risks when making a decision about whether to participate. Instead, investigators should consider them as incentives for time, effort, travel, minor discomfort or inconvenience. Investigators frequently use incentives when the benefit of study participation is otherwise remote or non-existent.

Information concerning payment of human research subjects, including its amount, nature, and disbursement schedule, is subject to initial and continuing review by the Institutional Review Board (IRB) or Exempt Review Committee (ERC). Investigators must keep the ethical principle of justice in mind when formulating an appropriate incentive or payment schedule.

Ethical Considerations for Incentives or Other Payments

Incentives or other payments:

  • Must be reasonable and considerate of the time, complexity (procedural type and number), and inconvenience of participation
  • Must NOT be based on the risks of participation
  • Must NOT coerce or present undue influence for initial or continued participation in the study; values should not be so high as to unduly induce subjects to participate or stay enrolled when they would have otherwise withdrawn
    • When involving multiple or complex visits, pro rate payments according to a fee schedule; create a plan to compensate withdrawing subjects for time and effort already invested
    • When involving vulnerable populations or international settings, consider whether small gifts or incentives have greater impact due to a particular population's culture or economic situation, and clarify this context in the application
  • Must include information on alternate, equitable ways to earn course credits when participating subjects are university students who are going to be offered credit

Research Raffles/Lotteries

The Commonwealth of Pennsylvania considers all forms of gambling to be illegal unless specifically accepted by law. Raffles or lotteries used in the context of providing incentives to human research subjects may be permitted under some circumstances. The IRB or ERC will determine, on a case-by-case basis, whether raffles or lotteries may be used to recruit research subjects.

When used in research involving human subjects, raffles pose several challenges about which investigators must be aware:

  1. Jurisdiction: Investigators must be aware of potential subjects’ locations at the time of participation in the research. Raffles are illegal in some locations (e.g., state of Florida). In others, licensing may be required. It is the investigator’s responsibility to follow the laws of a winners’ jurisdiction, whether state and/or local. The informed consent process needs to include language informing potential subjects that raffle payments may be “void where prohibited.”
  2. Subject Identity: Investigators must design research procedures in ways that protect privacy or preserve anonymity of responses. When no identifiers will be collected for the research itself, but an investigator will offer raffle entry afterward, the method of entry should not compromise privacy or anonymity.

    Examples:

    1. Web-based Survey Platforms: Investigators may achieve response anonymity on most survey platforms by disabling collection of IP address and by using one survey link for all subjects, so long as no other identifying information is being collected. They also must consider not asking for an email address or other identifiers for the raffle in the main survey itself. Investigators can ask subjects entering the raffle to email them separately, outside of the survey platform, or they can set up two surveys – one for the main survey responses, and the second for the raffle entry only (see Creating an Anonymized Raffle in Qualtrics). In such protocols, the email, which is often an identifier, may not be associated with specific survey responses.
    2. Paper-based Surveys: When distributing and collecting paper surveys, investigators should consider collecting raffle entries in a separate manner, such as having slips of paper with contact information to place in a raffle entry envelope or box, so that the email address and any other identifying information will not be associated with specific survey responses.

Marywood University's Fiscal Affairs Policy

Marywood University has legal and fiduciary responsibilities to properly account for all payments made to individuals, whether employees, students, vendors, or research subjects. Responsibility for financial management of funded human subject research rests with Fiscal Affairs (FA), with oversight by the Principal Investigator (PI) and Advisor, as applicable. Individuals in these roles should clearly understand the financial authority and institutional obligations as outlined by the FA Office. Investigators will need to give the FA Office identifying information about participating subjects, but the FA Office will keep this information confidential.

  • Marywood University’s fiscal policies do not apply if investigators will pay subjects out of their own funds.
  • Marywood University’s fiscal policies do apply if investigators will pay subjects out of funds awarded through a grant, contract or other award (i.e. Graduate Research Award, Research Initiation Funds, Professional Development Award, etc.). Investigators must submit specific documentation to FA for all participating subjects.

For one-time payments $25.00 or under:

  • List of participating subjects' printed names
  • Participating subjects' signatures (Note: If subjects can only make their mark, e.g. as an "X," the signature of a Marywood affiliated witness must be provided for each X.)

For multiple payments in a calendar year, or for payments over $25.00:

  • List of participating subjects' names
  • Completed and signed IRS W-9 forms

For an aggregate payment to a single subject of $600 or more during a given year, IRS Form 1099 must be submitted to FA for that individual. It is the investigator’s responsibility to know whether or not a subject is required to submit this form. Please contact the FA Department for further information.

For studies receiving funds through the FA Office, the informed consent process needs to include language informing potential subjects about any requirements, such as – “Payments or rewards for research participation may be considered taxable income. The University requires tracking of anything paid to you for reporting purposes. This may include your name, contact information, and social security number. This information will be kept separate from research data.”

Types of Payment through Fiscal Affairs

  • Cash payment
  • Check payment
  • Gift cards

Incentives for Children participating in Research

Regardless of the funding source, where children will be involved in research, investigators must make payments directly to the parent(s) or guardian(s). Investigators need to consider not only the actual value of an incentive, but the perceived value. For instance, a child might believe an older model gaming device to be a desirable incentive for participating in a study with high risks, even though the investigator may feel that the incentive would be relatively inexpensive based on the procedures involved.


History

10/05/2021: Updated formatting, definitions and some content (ethical considerations and raffles)