General Ethical Principles
A primary principle in human participants research is that a participant's decision to become involved in the research must be voluntary and free of undue influence or coercion, including potential undue influence through payments or rewards for participation. On a practical level, it is probably impossible for an IRB to determine what amount of money or type of reward would unduly influence a particular individual to accept a given degree of risk. Although our society generally accepts the premise that those assuming risk deserve reward, the application of this rule in establishing payment for participants in biomedical and behavioral experiments is still being debated. The appropriateness of proposed payments is therefore a matter each IRB must address for each study.
Clear cases of coercion (e.g., actual threats) are readily identifiable; it is more difficult to recognize undue inducement. An offer too good to refuse is essentially coercive (or "undue"). Undue inducements may be troublesome because: (1) offers that are too attractive may blind prospective participants to the risks or impair their ability to exercise proper judgment; and (2) they may prompt participants to lie or conceal information that, if known, would disqualify them from enrolling or continuing as participants in a research project.
When determining the appropriate level of remuneration, the principal investigator (PI) should take into consideration the participants' medical, employment, and educational status, as well as their financial, emotional, and community resources. These considerations should be applied regardless of the form of payment, which may be offered by cash, gift card, gift (e.g., t-shirt or book), entry into a drawing, travel or child care reimbursement, course credit, or no-cost services or treatment.
Record Keeping and Payment Process When University Funds are Involved
Following approval of a study protocol by the IRB, the PI will need to work with the Office of Business Operations (OBO) and/or the Office of Research and Sponsored Programs (RSP, for externally funded projects) to set up the participant payment process, if the study involves direct payments to individuals from university funds. The appropriate process will depend on which type of compensation is planned and the dollar value of the compensation.
I. If individual payments to participants will not exceed $75 AND any recurring payments to individuals will not exceed $599 in any one year, investigators may choose to pay participants by cash, gifts or gift cards, or entry into a drawing. If the PI wants to pay cash to participants, or purchase gift cards to use for participant compensation, a cash advance should be requested by contacting the Office of Business Operations. Purchase of gift cards with personal money for which the PI then requests reimbursement is acceptable, but not encouraged, particularly if the exact number of participants is not certain. The PI should not request that University checks be issued to pay participants because doing so requires that participant identity and contact information be revealed to others outside of the research team, which is not required for payments under the $75 individual - $599 annual threshold. If the PI wants to provide a gift, those should be purchased using standard departmental processes for doing so, and then provided to the participants after they complete the study task for which they are receiving payment.
When requesting a cash advance or reimbursement for purchase of gift cards, the cash advance or reimbursement form must be accompanied by the IRB approval letter and the page from the IRB application that documents the number of planned participants. Investigators will not be limited to payments for the exact number of participants originally planned. The number may vary over the course of the study, but if significant changes to the sample size or a new sample population should be necessary, the PI must send an email to the IRB Administrator requesting approval for a study modification before proceeding further.
Investigators are cautioned to use appropriate financial tracking procedures when managing participant payment processes. If cash or gift cards are lost or stolen, the PI will be required to reimburse the university for the loss. In addition, in all cases, including anonymous studies, the PI must maintain a tracking list or spreadsheet with individual code numbers and payments to ensure that no one individual receives a total of $599 or more, which would require following the procedures listed below. If the study is not anonymous, the PI must also keep a master list linking code numbers and individual participant names and contact information, which must be kept in a password protected computer and/or locked filing cabinet. The tracking spreadsheet or other documentation with study and individual code numbers must be kept indefinitely to allow for an audit of expenditures if required. If the PI is a student, the tracking spreadsheet and master list must be turned over to the student’s advisor for storage long-term.
II. If individual payments will exceed $75 OR any recurring payments to individuals may exceed a total of $599, investigators may choose to pay participants by university check, gifts or gift cards, or entry into a drawing. The use of cash payments is not allowed for these studies.
If compensation is by gift or gift card, the researchers must record the individual’s name, UNI ID# (if applicable), address, and signature at the time of payment, using the OBO Acknowledgement of Payment Receipt form. The PI then retains this information in a confidential manner, except that a copy of all signed forms must be sent to OBO at the end of the study. If the compensation is by university check, participant name, ID, and contact information must be provided to OBO on a Request for Payment form and then checks will be issued.
As above, the PI must maintain a tracking spreadsheet of individual and study code numbers and payments to track how much individual participants are being paid for the study. The PI must also keep a master list linking code numbers and individual names, which must be kept in a password protected computer and/or locked filing cabinet. Tracking information must be retained per the record retention policy and schedule. These items should be kept for the length of time identified for Request for Payments in order to allow for an audit of expenditure documentation if necessary.
In the event a PI wishes to propose a study that may include compensation that will go over the $75 - $599 thresholds, and will be either anonymous or include a waiver of consent signatures, the PI must request special approval for this in the IRB application. It is likely the request will only be approved if providing signatures will pose a significant risk to participants, compensation is strongly indicated for study success, and the study benefits are expected to be quite high. The IRB will also confer with OBO before approving such a request.
UNI Employees and Students as Study Participants
In the event the participants are employees or students at UNI, regardless of the value or type of compensation, all names and contact information and UNI ID# of participants who elect to receive compensation must be provided to OBO, so that the dollar amount (or value) can be included in the individual’s tax statements as required by the IRS. Participant signatures will also be required for any payments made over the $75 - $599 thresholds. This policy is applicable even if the actual payments to UNI employees or students come from another organization and UNI is just a co-sponsor of the study in some way (e.g., someone at UNI is a co-investigator). Again, a special request can be made for a waiver of this policy, but significant justification will be necessary for approval.
Informed Consent about Payments
In those studies where names, contact information and UNI ID# (but not their research data) must be submitted to OBO (all university employees and students, and all non-employees who are eligible to receive an individual payment exceeding $75 and/or receive more than $599 in one year, either in one study or through multiple studies), the participants must be informed about this policy during the consent process, and that they will receive a tax form from the university at the end of the year. They must also be informed that the business office has careful procedures in place to keep such information confidential, and that they may elect not to receive payments if they prefer not to have their identifying information provided to anyone outside the research team.
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