I.  PURPOSE / BACKGROUND

 
This policy and procedure establishes the payment process that University of Louisville faculty and staff must use to ensure compliance with subject privacy and IRS regulations when making payments related to human subjects who take part in University research studies.  The Internal Revenue Service (IRS) requires human subject payments aggregating $600 or more paid to an individual during a calendar year be reported on Form 1099-MISC, Miscellaneous Income.
 
Research relating to individuals and groups may involve the collection and storage of information that, if disclosed to third parties, could cause harm or distress to the subject.  Investigators should arrange to protect the confidentiality of such information by omitting information that might lead to the identification of individual subjects, limiting access to the information, anonymizing data, or other means.  During the process of obtaining informed consent, the investigator should tell the prospective subjects about the precautions that the investigator will take to protect confidentiality.
 
An investigator should inform prospective subjects of the limits to the ability of the investigator to ensure strict confidentiality and of the foreseeable adverse social consequences of breaches of confidentiality.  For example, some jurisdictions require the reporting to appropriate agencies of certain communicable diseases or evidence of child abuse or neglect.  Food and Drug Administration authorities and other federal agencies have the right to inspect clinical-trial records of drug or device studies.  A sponsor’s clinical-compliance audit staff may require and obtain access to confidential data.  The Institutional Review Board (IRB), IRB support staff, and University financial personnel may see clinical study and payment records as a part of the University’s oversight of research conducted by University faculty.  These and similar limits to the ability to maintain confidentiality should be anticipated and disclosed to prospective subjects.
 
If subjects get paid for participation in a project, parties providing compensation also need to be sensitive to concerns that the form of payment may contain information that would indicate to a third party a subject’s participation in a research project.  For example, there may be information on a request for payment that could constitute a confidentiality breach, because it could be apparent to the person processing the payment that the recipient of the check is a research subject.  While the possibility is remote, if the research is of a sensitive nature, this could lead to personal embarrassment, loss of employment and/or insurability.

II. DEFINITIONS

 
 Human Subject - a living individual about whom an investigator (whether professional or student) conducting research obtains:

• a. data through intervention or interaction with the individual, or  
• b. identifiable private information.

This person may or may not have an affiliation with the University of Louisville.
 
Institutional Review Board (IRB) - A Board whose members are appointed by the Senior Vice President for Research. The Board and its staff are responsible, in conjunction with administrative officers of the University of Louisville, for ensuring that University personnel and researchers comply with applicable federal regulations and guidelines.

Research - a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge. 
 
Subject Payments - cash and non-cash payments to individuals (subjects) for their participation and time commitment in a clinical trial or social science survey, etc.

III. POLICY

The University of Louisville payment process will maintain research subject confidentiality, to the extent possible under the law, while meeting Internal Revenue Service (IRS) reporting requirements and conform to the University's standard accounting and payment practices.  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 University and the investigator will also take steps to maintain the confidentiality of human subjects when making payments to third parties that provide research-related services and/or products.
 
An investigator may adhere to confidentiality safeguards in the conduct of a study but there is a significant risk of breach of confidentiality when payments to subjects are involved.  Therefore, the IRB requires that for payment purposes:

• a. any link between a subject and a particular protocol be coded, 
• b. only researchers and designated staff within the department sponsoring the study have access to the codes, 
• c. the study name NOT be included on any check or payment voucher or any other paperwork that may be seen by individuals outside of the sponsoring department, 
• d. payments made to human subjects who are also employees of the University are treated the same as nonaffiliated subjects. 

IV. PROCEDURE FOR POLICY

1. Prior to payment. 
   Confirm the individual receiving payment is a valid human subject at the time of the research participation and that IRB approval was current at the time of subject contact. 
2. Determine form of compensation and the correct form to use. 
   The form(s) needed to process the payment depends on what type of compensation is being issued or needed.  Use the list below as a general guide.  If a particular type of payment is not listed here, contact the Controller’s Office at 502-852-8237 for assistance. 
   When making Payments directly to human subjects choose one of the available options:  
• a. Request a petty cash account (to distribute cash to subjects on-site) VPF Petty Cash Fund Policy: 
• http://louisville.edu/vpf/controller/policiesprocedures/pettycash.pdf [adobe PDF]
• http://louisville.edu/vpf/forms/pettycshreq.pdf [adobe PDF] .
• b. Pay the subject by check (payment for participation and reimbursement for expenses).  Complete a Request for Disbursement form https://louisville.edu/vpf/forms/reqdisb.pdf [adobe PDF]. 
• c. Non-cash payments (i.e. gift certificates, T-shirts, etc.), when purchasing items to distribute to subjects, the vendors should be paid by: 
   i. Using the University's Purchasing Card 
   ii. Processing the vendor invoice.  
3. Complete the appropriate payment document while maintaining confidentiality.  It is required that the confidentiality of the study and the human subject(s) be maintained.  The only explanation that is required on the payment document is "Details are on file in department and available for audit."  Attachments identifying the Human subject(s) or the name of the Study should NOT accompany the payment document unless the check is being made payable to the subject.  Therefore, when completing the appropriate form(s) (Attachment A or B) requesting reimbursement or payment, include only the name and address of the payee, speed type, account, and amount. 
4. Complete the Human Subject Receipt for Compensation form.  Complete the University of Louisville Human Subject Receipt for Compensation form (use only for direct petty cash payment to participant) and Petty Cash Replenishment Form and retain the top portion of the form in the department with all study records. 
5. Obtain required approvals and forward payment document for processing.  Obtain appropriate signatures in the department and attach the bottom portion of the Human Subjects Payment Request form to the appropriate payment form and forward the documents to the Controller’s Office. 
6. Maintain payment records.  To protect the confidentiality of subjects, all details must be maintained in the departments. Departments are required to maintain proof of payments made to research subjects for both cash and non-cash payments. This can be in the form of a log or pre-numbered department receipts.  The recipient is required to sign the log or the receipt to indicate the payment was received. 
7. Making payments to a third party.
• a. Prior to payment -
  Confirm that expenses incurred and payments are in conjunction with a valid research project and that IRB approval was current at the time of the human subject participation. 
• b. Making payment - options available 
   i. The University Purchasing Card 
   ii. Process the vendor invoice.  
• c. Obtain required approvals and forward document for processing.  
8. Report total payments of $600 and over.  Generally, it is required that the confidentiality of the study and the human subjects be maintained.  Therefore, any information identifying the name or IRB number of the study must be excluded from the payment documents and any attachments.  All of the details should be maintained in the departmental files.
   One exception to this policy is as follows.  University departments are required to report on a W-9 form the names, addresses, social security numbers and total amount of payments made by the University to individual subjects that receive cumulative payments/value of $600 or more during a calendar year.  This information must be forwarded by mail to the Controller’s Office by December 31 every year.  Any single payment of $600 or more must be paid by check to the subject and all payee information must be reported to the Controller’s Office prior to request for disbursement. 

V.  ORGANIZATIONAL RESPONSIBILITIES

Principal Investigator – Ensures that confidentiality and proper protocol procedures are followed.

Unit Business Manager (UBM) - Oversight, approve and review payment documents for confidentiality and accuracy.

Document Preparer (Investigator or designee) - Ensures confidentiality and accuracy.

Grants Management or Office of Industry Contracts - Approve Contracts for Professional Services review and accuracy.

Financial Administration - Process payment documents.  Monitor cash advances.  Advise departments regarding standard University purchasing and payment processes.  
 
Subject:  Paying Human Subjects and Maintaining Confidentiality | Author: VPF & SVPR (HSPPO)  | Effective Date: 2-1-2005 | Revised Date: 5-21-2007