When thinking about influence/coercion guidelines, here are some things you might keep in mind:
- Time commitment – in terms of a per hour rate for financial gain
- Level of inconvenience – given the structure of the protocol, how difficult it is to comply or participate
- Targeted population’s existing resources – if these were bankers vs. homeless vs. being on food stamps vs. moderate income families, etc.
- Level of risks involved – invasive procedures, level of confidentiality risks, experimental drugs, etc.
- Level of influence – does the person feel obligated to participate given what is offered
Paying research subjects in exchange for their participation is a common and, in general, acceptable practice. However, difficult questions must be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment – their time, inconvenience, discomfort, or other considerations. Texas State University’s IRB is sensitive to whether any aspect of the proposed remuneration will cause undue influence, thus interfering with the potential subject’s ability to give voluntary informed consent.
Remuneration for participation in research should be just and fair. However, the specifics of each protocol will influence how those determinations are made. Researchers and Texas State University’s IRB need to be familiar with the study population and the context of the research in order to make reasonable judgments about how compensation might affect participation. Wherever the remuneration is set, it will influence the decisions of some more than others. In particular, it will be more important to those for whom it will make a significant financial difference. Thus, IRBs should be cautious that payments are not so high that they create an “undue influence” or offer undue inducement that could compromise a prospective subject’s examination and evaluation of the risks or affect the voluntariness of his or her choices.
Information submitted to Texas State University’s IRB should indicate and justify proposed levels and purposes of remuneration, which also should be clearly stated in the accompanying consent forms.
The consent process should 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 noncompliance reasons).
In studies of considerable duration or that involve multiple interactions or interventions, it is recommended that payment 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. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions, there might be payment after every two sessions.
in certain circumstances. Non-monetary incentives (e.g., extra credit for students, access to services or programs) also can create undue influence on a potential subject’s decision about research participation.
Researchers and Texas State University’s IRB should ensure that non-financial incentives are not so great as to diminish the voluntariness of consent or cloud someone’s appreciation of risks or potential benefits that might be gained from participating in a study (45 CFR 46.116). Moreover, it must be clear that choosing to not participate will not adversely affect an individual’s relationship with the institution or its staff or the provision of services in any way (e.g., loss of credits or access to programs) (45 CFR 46.116(a)(8)).
Overt coercion (e.g., threatening loss of services or access to programs to which the potential subjects are otherwise entitled) is never appropriate. However, it might be permissible to provide incentives to participate that do not constitute undue influence. Using enrollment incentives to recruit subjects may be ethically permissible as long as it is determined that, although incentives may be a factor in a subject’s decision to participate, they have not served to unduly influence the subject to participate. To make this determination, Texas State University’s IRB may ask for clarification about who the subject population will be, what incentives are being offered, and the conditions under which the offer will be made.
Participation of students in research must be voluntary. Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation or research is a course requirement, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. Students must not be penalized for refusing to participate in research (45 CFR 46.116(a)(8)).
Texas State University utilizes a so-called “student subject pool” known as SONA to identify students who might be willing to participate in research, even when the exact nature of the research to be conducted has not yet been determined. Extra credits or other rewards are often offered as an incentive to encourage participation. Students who sign up have not legally consented to participate in a research study since they have not been provided with sufficient information concerning the exact study in which they would participate. Thus, signing up to be in a subject pool is only a first and preliminary step by which individuals can indicate their willingness to be considered for research participation. The student must also provide informed consent, once he or she is being considered for a specific study (45 CFR 46.116). Furthermore, individuals in the pool must be free to decline participation in any available research projects without penalty (45 CFR 46.116(a)(8)).
The issues involving employees as research subjects are essentially identical to those involving students as research subjects: that is, researchers and Texas State University’s IRB must be cautious about the potential for coercion or undue influence and the need to protect confidentiality for their employers.
Employee participation raises questions about the ability of employees to exercise free choice, for example, because of the possibility that a decision to participate could affect performance evaluations or job advancement, even if it is only the employee’s perception that this is the case. In the case of coercion, refusal to participate might result in a loss of benefits (e.g., salary increases, time off). In the case of undue influence, a decision to participate could result in a job promotion. Employees are likely to view their employers as authority figures to whom they must show deference, which could undermine the freedom of their choice.