Paying Human Subjects and Maintaining Confidentiality and 1099 Reporting
Responsible University Officer(s):
- Associate Vice President and Controller
- Director of Accounting Services
- Director of Purchasing Services
This policy establishes guidelines and processes for paying Human Subjects who are involved in University research studies, complying with the legal obligation to maintain their confidentiality and the tax reporting requirements associated with these payments.
Departments must have an IRB approval on file prior to engaging and paying human subjects.
Individuals who take part in University research studies often receive payment for their involvement as human subjects. University faculty and staff have a legal obligation to maintain confidentiality of those individuals, whether issuing a payment to the individual or making payments to third parties that provide research-related services and/or products. The payment process must maintain their confidentiality, while meeting Internal Revenue Service (IRS) reporting requirements and conform with the University's standard accounting and payment practices.
Payments and Tax Reporting
IRS regulation requires the University to report payments to human subjects totaling $600 or more during a calendar year. University departments and/or PI’s must obtain a W9, including the human subject’s name, address and social security number when the cumulative payments over a calendar year equals or exceeds $600 (that are not paid or recorded in EFS using the standard disbursement process). This includes payments made via Single Payment Supplier Accounts, Zero Balance Accounts, and Contingent Accounts and through Cash Advances. This requirement does not conflict with HIPAA regulations. University faculty and staff must not include health or detailed information regarding the study in the payment documentation.
REASON FOR POLICY
To implement Board of Regents Policy: Research Involving Human Subjects. This policy and related procedures establish the payment process that University faculty and staff must use to comply with privacy and IRS regulations when making payments to human subjects who take part in University research studies.
|Primary Contact(s)||Sherrie Kutzler
|Sponsored project administration||Grant Administrator, SPA||Directory|
|Payment processing||University Financial Helplinefirstname.lastname@example.org|
|Human Subjects||Research Subjects Protection Programs||612-626-5654|
|Confidentiality issues||Office of the General Counsel||612-624-4100|
|Data Privacy/HIPAA||Privacy and Security Officeemail@example.com|
- Human Research Protection Program (HRPP)
- The department which serves as the administrative home for the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC).
- Human Subject
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 of a subject and/or information gathering 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).
- Human subject payments
- Cash and non-cash payments, including stipend, gift cards, or any type of remuneration or consideration to inpatients, outpatients, human subjects, volunteers and donors for their participation and time commitment in a clinical trial or social science survey, etc.
- 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)
- "Participants" are often confused with "human subjects." "Participants" are people who are taking part in sponsor-defined training or sponsor-supported conferences, who are eligible to receive expense reimbursement under the terms of the sponsored project agreement. Participants cannot be paid for their participation in these events, but can be reimbursed for legitimate and justifiable expenses
- Plan of Study approved by IRB
- 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
- For purposes of this policy, 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.
- Subject Payments
- See Human Subject Payments.
- Third Party
- Any person or supplier (external to the University) who receives payment for providing research-related services and/or products.
- Certified Approver
- Review and approve payment documents for confidentiality, accuracy and compliance with policy.
- Disbursement Services
- Approve and monitor cash advance requests. Develops and maintains policies and procedures associated with payment processing. Manages the pay cycle which generates payments processed by departments/clusters. Reviews payment activity, obtains payee information from departments and issues 1099 MISC for reportable payments as required.
- Document Preparer
- Ensure confidentiality and accuracy of payment documentation. Completes documentation in accordance with University policies and procedures.
- Principal Investigator
- Ensure confidentiality and proper protocol procedures are followed.
- Ensures compliance to policy and collection of required data.
- Sponsored Projects Administration
- Assist in negotiation of grant,contract terms and conditions in accordance with Regents policies, laws, guidelines and interpretation of federal regulations, such as OMB Uniform Guidance. Develop and maintain policies and procedures in accordance with the regulations. Establish sponsored project accounts in the University's accounting system and assign the appropriate function codes.
- Unit Administrator
- Oversight of departmental activities.
- Ensures awareness and compliance to policy.
- Board of Regents Policy: Research Involving Human Subjects
- Federal Policy for the Protection of Human Subjects: (45 Code of Federal Regulations, Part 46)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA) website
- June 2017 - Added pre-paid debit card related procedure and forms. Modified existing procedure: Paying Human Subjects Directly and FAQ to include this payment option.
- December 2014 - Reference to A-21 changed to OMB Uniform Guidance in Responsibilities.
- September 2012 - Comprehensive Review. Minor revision in multiple sections and procedure for clarification.
- July 2008 - Updated to reflect rollout of Enterprise Financial System. CUFS forms were deleted, and EFS forms added.
- February 2004 - Added Frequently Asked Questions: Paying Human Subjects to appendices.
- January 2004 - Added Payment Affidavit for FFN Entry. Added FFN Approvers Tutorial.
- October 2002