Individuals who take part in University research studies often receive payment for their participation as human subjects. University faculty and staff have a legal obligation to maintain confidentiality of those individuals. The payment process must maintain their confidentiality while meeting Internal Revenue Service (IRS) reporting requirements and also conform to the University's standard accounting and payment practices. Maintaining the confidentiality of human subjects must also be ensured when making payments to third parties that provide research-related services and/or products.
Exclusions
This policy does not affect the handling of payments to individuals participating in other (i.e., non-health or human subject related) research where privacy rights are not applicable.
This policy and procedures establish the payment process that University faculty and staff must use to ensure compliance with privacy and IRS regulations when making payments which are related to human subjects who take part in University research studies.
- Human Subject
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
- Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (See the Code of Federal Regulations Title 45 Part 46, Protection Of Human Subjects)
- Participants
- Individuals who attend a sponsored conference or symposium and who are eligible to receive expense reimbursement under the terms of the sponsored project agreement. These individuals cannot be paid for their participation. Such payments are paid as consultant fees or trainee stipends.
- Institutional Review Board (IRB)
- A Board whose members are appointed by the vice president for research. The Board and its staff are responsible, in conjunction with administrative officers of the University of Minnesota, for ensuring that University personnel and student researchers comply with applicable federal regulations and guidelines.
- IRB approval
- The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. (See the Code of Federal Regulations Title 45 Part 46, Protection Of Human Subjects)
- Minimal risk
- The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (See the Code of Federal Regulations Title 45 Part 46, Protection Of Human Subjects)
- Research
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (See the Code of Federal Regulations Title 45 Part 46, Protection Of Human Subjects)
- Sponsored Project
- An externally funded activity governed by specific terms and conditions. Sponsored projects must be separately budgeted and accounted for subject to terms of the sponsoring organization. Sponsored projects may include grants, contracts, and cooperative agreements for research, training, and other public service activities.
- Third Party
- Any person or vendor (external to the University) who receives payment for providing research-related services and/or products.
- Subject Payments
-
Cash and non-cash payments to inpatients, outpatients, human subjects, volunteers and donors for their participation and time commitment in a clinical trial or social science survey, etc.
-
RSPP-Research Subject Protection Program
- The department which serves as the administrative home for the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC). For more information see: http://www.research.umn.edu/subjects/index.cfm
- Protocol
- Plan of Study
- Principal Investigator
- Ensure confidentiality and proper protocol procedures are followed.
- Unit Administrator
-
Oversight
- Document Preparer
- Ensure confidentiality and accuracy.
- Certified Approver
- Approve and review payment documents for confidentiality and accuracy.
- Sponsored Projects Administration
- Approve Contracts for Professional Services over $2000.00 and review for confidentiality and accuracy.
- Disbursement Services
- Process payment documents. Monitor cash advances. Advise departments regarding standard University purchasing and payment processes.
- Amended:
- July 2008 - Updated to reflect rollout of Enterprise Financial System. CUFS forms were deleted, and EFS forms added.
- Amended:
- February 2004 - Added Frequently Asked Questions: Paying Human Subjects to appendices.
- Amended:
- January 2004 - Added Payment Affidavit for FFN Entry. Added FFN Approvers Tutorial.
- Effective:
- October 2002
-
To obtain a copy of a historical policy,
e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.
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