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Written by Andrea Mirin

 

Both in the course of designing studies and as an IRB, questions arise that lead us to contemplate what may be “best practices” or “best ethical practices” for appropriately recruiting participants. One area of frequent discussion, particularly as an IRB, is related to the “honoraria”[1] or “incentives”[2] that are offered. While the amounts offered for a particular participant group are guided by “Fair Market Value,” we should also consider if when the compensation for participation is offered, under ethical principles, may be construed as an “unjust inducement.”

Unlike clinical trials (at least later stage clinical trials) which may hold out some potential benefit to a participant, human factors studies (a majority of which are simulated studies), will likely have no direct benefit to the participant (Since frequently user groups are those who may or will use a device, their participation and feedback may influence the end-product, which, at least arguably, is a down-stream potential benefit, however, we tend to recognize no direct benefit to a research participant). Furthermore, while human factors studies are frequently required by regulatory authorities, many also may fall under a category of “market research.” Regardless, securing participation of user groups are essential for human factors studies. To secure participation, we rely on “incentives” – namely, monetary incentives.

While this is standard practice, we have a responsibility to consider if an “incentive” may cross a line to become an “unjust inducement.” While there is no per se bright-line test, we should consider if a monetary offer may influence a participant to participate in a study or do something which they may otherwise would have chosen not to do. This leads to an interesting question: When is it the appropriate time to offer an incentive in order to recruit participants – particularly during the screening process?

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One line of thought is that it may be most appropriate to inform an individual who has already committed to participating in the study that they will receive an “honoraria” for their time. The reality is, however, that it may be hard to secure participants if individuals are unaware of any potential compensation for their time (There is a reason that we refer to these payments as “incentives.”). Practically speaking, we may be more likely to find a participant (or at least have a potential participant answer screening questions) if there is an anticipated benefit. For practical purposes, incentives provide a means of bargaining. Here we have a tension between the ethical principles of autonomy, which respects an individual’s rights to make decisions, including a “bargaining” for their time and the principle of beneficence, where we look to protect a research participant from unjust inducement. We need to ask ourselves, in each specific case, does the timing of when we mention the incentive potentially affect the ultimate decision of an individual to participate and/or does it unduly influence them to make a decision that they otherwise would not have made.

An example where we observed this tension was in a screener that went through a process of asking screening questions, offered an incentive, asked an individual if they wished to participate, and then said that the participant was required to do one more action to participate in the study. While there was debate of whether or not the action required was significant, we felt that the mention of the incentive should have come after asking if the participant was willing to perform the action. This way, there was no question whether the incentive, or the amount of the incentive, influenced the individual’s decision to participate in the study.

In the course of discussion, it was mentioned that most people who participate in human factors research are savvy to the offer of incentives. Regardless, it was determined that to offer an incentive, and then ask for an additional action (beyond participating in the study) could potentially influence someone to take an action they may otherwise have chosen not to do. By simply discussing the incentive after the person agreed to the action, questions of inducement were eliminated.

The discussion also included a second line of thought: namely, what about when incentives are offered initially (in order to promote interest in participation)? Would this influence participant decision-making? It was acknowledged that without the incentive, practically, it may be hard if not impossible to secure the appropriate user groups for studies. If the amount of the incentive is known upfront, then an individual can make informed decisions related to their interest in participating in the study as well.

Ultimately, it may be ethical (and indeed necessary for the promotion of research) to state that a study includes honoraria upfront (prior to screening). Similarly, it is ethical to mention any honoraria after a participant has committed to participating in a study. The issue of the timing of the offer of honoraria really should be considered if or when it may influence someone to do something or to participate in a study that they may otherwise would have chosen not to do. For example (and for confidentiality purposes this is completely hypothetical), what if an individual was required to cut their hair to participate in the study? If a monetary incentive is offered, and then an individual is immediately asked if he/she would be willing to cut his/her hair to participate, the offer of money (or the amount) could be undue influence. What if that individual really did not want to cut his/her hair, but the offer of the amount of money shaded the decision-making process. Conversely, if an individual states that they would be willing to cut his/her hair prior to be an offered an amount of money to participate in the study, there are less ethical concerns. While it is foreseeable that the individual anticipates receiving some amount for taking part in a study, clearly the amount being offered is not influencing his/her decision making (vis-à-vis cutting his/her hair).   To this end, separation between a discussion of money (or other external benefits) and the specifics related to what the participant is required to do should help keep an ethical balance, particularly in human factors studies.


[1] “A payment for a service … on which custom or propriety forbids a price to be set.” http://www.merriam-webster.com/dictionary/honorarium.

[2] “Something that incites or has a tendency to incite to determination or action.” (Simple definition: something that encourages a person to do something…) http://www.merriam-webster.com/dictionary/incentive.