Federal regulations require that researchers minimize the possibility of coercion or undue influence in the process of recruiting and consenting research subjects (45 CFR 46.116). These must be avoided when compensating subjects for their participation in research.
Compensation refers to anything given to subjects as remuneration for the time and inconvenience of participation in research. Compensation can be monetary or non-monetary, and can be offered in a range of forms, including but not limited to cash, gift cards, vouchers, trinkets, course credit, and the opportunity to enter a drawing for a prize. Compensation is distinct from participant reimbursement, whereby researchers pay some or all of the subjects’ costs for participation - e.g. transportation, parking, lodging, etc.
For all research, the method and value of compensation must be appropriate for the subject population and the research activities. What constitutes “appropriate” compensation for any study is determined by consideration of the research activities, subject population, and the cultural/social/political context in which the research will take place. In other words, some forms, amounts and methods of compensation may be appropriate for some individuals or groups, but not others.
Compensation cannot be so great that it entices participants to engage in any activity to which they are averse, or to act against their better judgement. The following regulatory requirements and ethical principles must be considered when developing a compensation plan associated with any research protocol.
- Researchers must avoid coercion and undue influence. The following definitions have been adapted from the federal Office for Human Resource Protections (OHRP) guidance on minimizing the possibility of coercion or undue influence:
- Coercion. Compensation is considered coercive if it entails an overt or implicit threat of harm/negative consequence which could compel involuntary participation and/or compliance. For example, telling a prospective subject she will lose access to needed services if she does not participate in the research is coercive and would not be permitted.
- Undue influence. Compensation that includes an excessive or inappropriate reward or other overture may constitute undue influence. For example, offering college students $100 each to complete a 20 minute survey on illegal drug and alcohol use could be viewed as unduly influential because the amount could entice students to disclose information that they would not otherwise willfully disclose to strangers.
- When possible, investigators should pro-rate compensation – in other words, offer partial compensation for partial or incomplete participation in specific study activities or the study as a whole. Making receipt of compensation contingent upon completion of all study activities may constitute coercion or undue influence.
- Subjects participating in the same study and completing the same tasks should be compensated equitably. Variation in compensation is acceptable when it can be justified - for example, it is reasonable that compensation for subject populations in different countries may vary according to cultural customs.
- Because providing compensation may require the use of personally identifiable information - from email addresses used to email gift cards, to Social Security Numbers required for tax reporting purposes - the mechanics of compensating participants can contribute to risks associated with a loss of privacy or breach of confidentiality. Researchers should develop mechanisms for compensating subjects that reduces the exposure to these risks.
- In some cases, offering participants money or items of value may increase risk of harm to them. For example, giving cash to prisoners or smartphones to members of communities where that technology is largely unaffordable may increase the likelihood that the participants could become targets of theft or violence. Researchers must consider and take measures to prevent or mitigate the potential for such risks when developing a compensation plan.
- Compensation should be presented in the same manner as other information in the recruitment and consent materials. Presentation of compensation must not detract from important information participants need to consider in order to fully understand the study and assess the risks associated with participation.
- Compensation is not considered a benefit of research participation and must not be discussed as such.