Guidelines on Compensating Research Subjects
What is Compensation in regards to Human Subjects Research?
Compensation refers to the predetermined form of payment provided to research subjects for their participation in the research investigation. Possible forms of compensation include but are not limited to: travel reimbursement, electronic gift cards, and cash. Small compensatory measures are permitted as long as the incentive is not coercive in nature.Compensation is relative to the population to which it is being provided to. For example, providing pediatric patients fifty dollars may be coercive; however, providing the same amount for adults may not be. It should be noted that compensation is not synonymous with reimbursement. Reimbursement refers to researchers paying for the subject’s cost of participation whether that be transportation or housing during the course of study. Compensation, however, is anything given to the subject to acknowledge their participation in the study.
Benefits vs Compensation
Compensation within a study is not considered a benefit of participation. A benefit of participation refers to outcomes of the study such as providing the participant with more clinical testing opportunities as well as treatments for their condition. However, compensation refers to a form of payment for participating in the study that is not related to the study’s results.
Essentially, compensation is payment for the efforts that participants take in order to be a part of the study whereas benefits are the advantages that the subject gains from the trial itself such as increased knowledge. Investigators should be careful when communicating information about benefits and compensations to potential participants to avoid coercion or undue influence.
Best Practices for Disclosing a Plan to Compensate Participants
When researchers submit their research protocol to the Institutional Review Board (IRB), they must also disclose and detail their plans on participant compensation. It is recommended that researchers include “a detailed account of the terms of payment, including a description of the conditions under which a subject would receive partial or no payment (e.g., what will happen if he or she withdraws part way through the research or the investigator removes a subject from the study for medical or non-compliance reasons). Payment may be prorated for the time of participation in the study rather than delayed until study completion because the latter could unduly influence a subject’s decision to exercise his or her right to withdraw at any time.” (HHS gov).
Elements of a Compensation Plan
The following elements should be implemented in a compensation plan:
- Explanation for how participants will be
- The amount and the form of
- How the researcher will distribute the compensation to
- The collection of any participant identifiable information during the distribution
- Circumstances wherein the participants may or may not be
- Circumstances wherein the participants may be partially
- For studies that extend over the course of several sessions or days, consideration of prorating the compensation.
Potential for Coercion
Coercion refers to the implication of harm or negative consequences which compels involuntary participation or compliance. Subjects must make informed, independent decisions regarding their participation in the study without being fearful of loss of rights and services. The IRB will also look at the tasks that the participants will perform and determine if the incentive correlates to the difficulty and effort needed to be put behind the task.
Potential for Undue Influence
Undue influence refers to compensation that includes an excessive or inappropriate reward. The known medical benefits for participating in the study should be stated clearly without any exaggerations. This could potentially put participants in a position where they are likely to participate just for the sake of the reward without acknowledging their risk and contributions to the study. Thus, participants may enroll in the study without considering risk, thus not making an informed, independent decision rather one that is clouded with the primary thought of compensation.
The IRB, when examining the protocol for review, may restrict the level of financial or non-financial incentives while also looking at exactly how this information will be conveyed to participants. The level of compensation or reimbursement is relative to the requirements of participating in research and to the population.
If the compensation for a subject’s participation in a clinical investigation exceeds $600 or more during a calendar year, the subject will be required to report to the IRS using the IRS Form 1099-MISC (Miscellaneous Income) in Box 3 of Income for a United States Resident. To have proper documentation for tax obligations, investigators must obtain the following from subjects: participant’s name, mailing address, Taxpayer Identification Number (TIN) or Social Security Number (SSN), or Individual Taxpayer Identification Number (ITIN). The principal investigator may also request that participants complete the IRS Form W-9 (Request for Taxpayer Identification Number and Certification).
For a Non-Resident Alien, all payments made in the calendar year must be reported on Form 1042-S, (Foreign Person’s U.S. Source Income Subject to Withholdings) and may be subjectable to a 30% federal income tax withholding.
ClinCard at Rutgers
RBHS (Rutgers Biomedical and Health Sciences) utilizes Greenphie’s ClinCard as a way for investigators to provide compensation for research participation. ClinCard is a reloadable debit card system and is the preferred form of compensation at Rutgers. To learn more about the ClinCard, please visit the following link: https://njacts.rbhs.rutgers.edu/clinical-trials-office/solutions/clincard/