Compensation

The procedures for paying human subjects are outlined below. The IRB will review all compensation to ensure that payments do not cause undue influence or coercion. Please refer to cash advance for more information about payment procedures.

• Procedures for Paying Human Subjects
• Acknowledgement of Receipt/ Research Cash Advance system

Approved methods of payment to participants are listed below. See Procedures for paying human subject for complete details.

1. Cash payments given directly to the participants.
2. Certificates or gift cards given directly to the participants
3. Electronic gift cards sent electronically directly to the participant or from a third-party vendor (i.e. amazon)

Do not use gift cards that have activation fees

Providing financial compensation and/or incentives to research subjects in exchange for their participation is a common and, in general, acceptable practice. The specifics of each protocol will influence the determination of much financial incentive a research subjects should receive and/or what a research subject should receive compensation for.

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.

Non-monetary compensation and/or incentives (e.g., extra credit for students, access to services or programs) are an acceptable practice but should not be 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)).

In studies 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)).

Employees may enroll in research protocols approved by the IRB as long as the compensation and/or incentives offered to potential participants who are employees are be designed to minimize the possibility of coercion or undue influence with additional considerations and safeguards in place. Employees, (e.g., full-time, part-time, temporary, visiting, student employee appointments, etc.) may be recruited for research participation; however, an employee may not be required to participate in research as a condition of employment. An employee’s decision about research participation may not affect (favorably or unfavorably) performance evaluations, career advancement, or other employment-related decisions made by peers or supervisors. Thus, researchers and Texas State University’s IRB must be cautious about the potential for coercion or undue influence of any compensation and/ or incentive offered.

University faculty and staff have a legal obligation to maintain the confidentiality of individuals who have received financial or non-financial incentives, whether issuing a payment to the individual or sharing confidential information to third parties that provide research-related services and/or products. Investigators must ensure that information identifying the human participants or name of the study are excluded from the payment documents and any attachments.

See Procedures for Paying Human Subjects(link) for more information.

• Do not include title/purpose/project description on any incentive payment documents.
• Compensation details are considered sensitive personal information that should be kept separate from the primary research data set.

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. 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. It is the responsibility of the researchers to ensure that any renumeration is not so high that it creates an “undue influence” or offer undue inducement that could compromise or “coerce” a prospective subject’s examination and evaluation of the risks or affect the voluntariness of their choices. The IRB reviews all renumeration for the potential for coercion or undue influence and the need to protect confidentiality for their employers.

Guidelines and considerations for Coercion/ Undue influence include but are not limited to:

• 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 or because of the relationship to the researcher.

Researchers need to determine whether their use of a drawing for a chance to win a prize constitutes a lottery. Lotteries are illegal because they are considered “gambling” under Texas Penal Code Chapter 47.

A "lottery" is defined as any scheme or procedure whereby one or more prizes are distributed by chance among persons who have paid or promised consideration for a chance to win anything of value, whether such scheme or procedure is called a pool, lottery, raffle, gift, gift enterprise, sale, policy game, or some other name.

Given the possible implications to researchers using drawings as a form of compensation or an incentive to participate in research, here is a framework for the acceptable use of drawings in human research at TXST:

1. The compensation is appropriate when it is not large enough to be considered an inducement (undue influence).
2. The participant is not told that entry or eligibility for the drawing is conditioned on completing the study. This means that everyone is eligible for the drawing upon providing consent to participate in the study and cannot be told they must complete the study
3. The time, effort, and inconvenience of the participant cannot be substantial. Substantial time and effort is determined on a case by case basis and considers the procedures involved such as what is asked of the participant and the amount of time involved.
4. This approach is not limited to exempt research.

Participants should also be informed of the odds of winning, number of prizes, how winners are chosen and notified.