- Promulgated by: Research Administration and the Controller’s Office
Certain research projects involve human subjects. The involvement of human subjects in research projects is governed by federal, state and institutional regulations. Of particular importance in most of the types of human subject research conducted at North Carolina State University is the assurance of anonymity or in some cases the confidential maintenance of personal, identifiable information.
Anonymity means there is no record of the identity of the human subject in the research record and the recording of such identity in any means and for any purposes serves to compromise not only the integrity of the research project but possibly the safety and wellbeing of the research subject (in other words, you don’t have identifiers so there is no possible way you can disclose them). Confidentiality means the research (including administrative) record does contain some form of identifier that may or may not be readily associated with an individual but is collected most likely for follow-up, longitudinal study or other purposes and which will be protected with reasonable care to avoid improper disclosure (in other words, you have information but you don’t disclose it). Collection and maintenance of any identifiable characteristics of an individual human research subject is strongly discouraged by federal regulation * and by the North Carolina State University Institutional Review Board for the Protection of Human Subjects.
Incentive payments to prospective human subjects are not widely encouraged by North Carolina State University, and this position is supported by positions published by the federal government and other watchdog groups concerned with human rights. This lack of encouragement is because a strong mechanism to ensure the highest integrity in a study is to ensure that the subject population is not in any way compelled to participate other than through voluntary inclusion in a project with no expected unrelated benefit (other than those natural benefits which may accrue from the research findings in which they participated as a subject). However, most research studies are not significantly affected by de minimis incentive payments, and because of the effort involved and number of subjects needed for statistical significance, such payments are often necessary.
Guidelines on de minimis payments to human research subjects
De minimis payments to human research subjects in the form of gift cards or non-cash gifts are allowable expenditures when properly justified. Because the lack of identity of human research subjects (or the need for extra-ordinarily strict control of such information when it is collected) and because these payments are not compensation for services rendered, such payments will be recorded as research incentive payments. These “untraceable incentive payments” to any human subject for a given research project shall not exceed $25.00. In total, untraceable payments for all research projects to a single human subject for a calendar year shall not exceed $50.00 for a single project. Untraceable incentive payments may take the form of gift cards, cash payment, or other non-monetary compensation.
Procurement of Gift Cards for Incentive Payments to Research Subjects
Book keepers should use account code 53906 in procuring gift cards. When using the p-card, any transactions for gift cards must be supported by the assertions and certifications provided by the research coordinator and principal investigator as outlined later in this document. Only those studies with appropriate IRB approval are allowed to procure gift cards for the purposes of research incentive payments.
Internal Controls – Roles and Responsibilities
Those handling incentive payments, either in gift cards or non-cash gifts should develop a process for reconciling the amount of incentive payments delivered with the number of subjects receiving such payments. For example, if a principal investigator endeavors to give each human subject a gift card to a local merchant and anticipating 50 human research subjects procures $250.00 worth of $5.00 gift cards, the principal investigator should be able to readily identify that 50 human research subjects participated and received a $5.00 gift card. Systematically filing a copy of the receipt for the gift cards with a summary of the data collected and a copy of the advertisement that illustrates that the subjects will receive a gift card along with a distribution of how many incentive payments were distributed as asserted by the research coordinator and certified by the PI will provide a basis for documenting accountable adherence to the guidelines established in this guideline. The principal investigator is primarily responsible for maintaining these documents. The unit bookkeeper should maintain a copy of these documents in the official departmental procurement files.
For audit purposes, the research coordinators (those responsible for distributing gift cards) must assert in writing and the principal investigator of the study must certify in writing and the book keepers must maintain the assertion and certification on file that “x number of the gift cards were distributed to research subjects in the study entitled “XYZ” and this distribution is correct and consistent with the guidelines established for such human research incentive payments and relevant IRB approval.”
Research Administration will coordinate annually with the Controller’s office in identifying those projects that purport to distribute research incentive payments for purposes of assessing the reasonableness of charges posted against the Research Incentives account code.
* Federal regulations 45CFR46 with specific emphasis on 45CFR46.101 and 45CFR46.116.