Human Subject Compensation - Disbursements
Start here to get an overview of human subject compensation and the various payment options for clinical research and trial participants.
IRB
Individuals who take part in University research studies often receive payment for their involvement as human subjects. The Institutional Review Board (IRB) reviews and approves proposed payments for anyone participating in human subject research as part of the protocol review process. The process for paying research participants depends on the circumstances of the study, the method in which you are distributing funds, and the amount of the payment.
Types of Payments to Human Subjects
Compensation is the payment to a human subject for their time and effort for participating in a study and can be in the form of a UC San Diego issued a check, cash, and gift card. Compensation is subject to IRS income reporting and all forms are considered compensation (as the type of payment does not determine IRS filing requirement).
Reimbursement is the payment to a human subject to claim out-of-pocket expenses incurred as a result of participating in a study such as study-related travel, gas, non-business mileage (medical/move rate), lodging, and meals.[1] Reimbursement can be in the form of a check or ACH. As approved on a study-by-study basis, airfare expenses can be prepaid by UC San Diego Travel (airfare only) rather than requiring reimbursement. US Citizens and Resident Aliens’ reimbursement for out-of-pocket expenses are not subject to IRS income reporting. Non Resident Alien reimbursements for out-of-pocket expense are reportable to the IRS, please refer to the Non-Resident Alien section under the Income Tax Reporting Requirements tab below.
Method of Payments
The following options are available for Trial Administrators:
Mileage expenses are paid at the medical rate of 20 cents/mile.
Definitions and Resources
Clinical Trial: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of 21 CFR 58, regarding nonclinical laboratory studies. The terms clinical study, clinical trial, and clinical investigation are deemed to be synonymous for purposes of this Manual.
Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity (ICH 1.16).
Conflict of Interest: A convergence of an investigator's private interests with his or her research interests, such that an independent observer might reasonably question whether the investigator's professional actions or decisions are improperly influenced by considerations of personal financial gain.
Human Research Protection Program (HRPP): The department which serves as the administrative home for the Institutional Review Board (IRB).
Human subject: As defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]. As defined by FDA regulations, “human subject” means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient [21 CFR 50.3(g), 21 CFR 56.102(e)]. A human subject includes an individual on whose specimen a medical device is used [21 CFR 812.3(p)].
Institutional Review Board (IRB): Research at UCSD using a human subject must be approved by the Institutional Review Board (IRB. ) which is an independent committee that protects the rights and well-being of research subjects. As part of the protocol and informed consent process, the IRB reviews all aspects of compensation and reimbursement made to a human subject including amount, proposed distribution method, timing, and if a human subject is either a UCSD student or employee.
IRB approval: The determination of the IRB that the human subjects 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.
Investigator: An individual who actually conducts human subjects research, i.e., under whose immediate direction the test article or research procedure is administered or performed upon, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team (21 CFR).
Participants: 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.
Protocol: Plan of Study approved by IRB.
Research: 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.
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.
Policy Statement/Considerations
Institution Review Board (IRB)
Research at UCSD using a human subject must be approved by the Institutional Review Board (IRB) which is an independent committee that protects the rights and well-being of research subjects. As part of the protocol and informed consent process, the IRB reviews all aspects of compensation and reimbursement made to a human subject including amount, proposed distribution method, timing, and if a human subject is either a UCSD student or employee.
The IRB’s approval is limited to the payment and protection of a human subject. The IRB does not have the authority to override IRS/UCSD policy. If there is a need to have a human subject paid in a manner inconsistent with UCSD policies and procedures, contact the IRB Office to ascertain if an exception can be made.
Before payment can be initiated, Principal investigators must renew their IRB approvals annually. The continuation of research after expiration of IRB approval is a violation of the regulations [21 CFR 56.103(a)]. If the IRB has not reviewed and approved a research study by the study’s current expiration date, i.e., IRB approval has expired, research activities should stop. No new subjects may be enrolled in the study.
Confidential Subject Information
On occasion an investigator might feel that it is a breach of a research subject’s privacy to collect their SSN/ITIN; however, UCSD is obligated by law to collect and report a human subjects’ income. The IRS receives the recipient’s name, identification number, street address and total income from UCSD. The information provided to the IRS neither identifies the recipient as a study participant nor the purpose of the payment.
As there are privacy and confidentiality issues, the department is responsible for maintaining a human subjects’ information. As the W-9 contains the person’s SSN/ITIN and other potentially sensitive data, it should be protected. The best way to safeguard sensitive data is to securely transmit the W-9 to Disbursements and not retain a copy in the departmental file.
Accounting for Payments
Review the current practice of expensing up-front purchases (cards) for a federally sponsored study as most awards indicate that these costs can only be expended to federally funded studies once payment has been distributed to the human subject.
Clinical Trial Payment Coordinator Responsibilities
Review the Clinical Trial Payment Coordinator Responsibilities document (PDF).
Income Tax Reporting Requirements
To fulfill UCSD’s tax reporting responsibilities, UCSD is required to obtain the subject's SSN if they will be paid $600 or more in a calendar year to report compensation on IRS Form 1099-MISC. If cumulative payments to a human subject will total $600 or more in one calendar year, the first payment of the calendar year will require a W-9 for U.S. Citizens and Resident Aliens.
Human subject participants should consult with their tax advisor regarding reporting requirements.
Compensation to human subjects who are UCSD employees is subject to the procedures and payment will be reported on Form W-2.
Non-Resident Alien
All Non-Resident Aliens receiving payments of any amount should be paid via direct payment through MyPayments. Non-resident aliens receiving compensation are required to complete a GLACIER record prior to receiving payment as federal and state tax withholdings apply.
Compensation in Confidential Studies
In certain circumstances, research studies are performed in which the privacy of the subject must be protected and the confidentiality of the data[1] maintained. If the study has been determined to be confidential, the procedures for cash, gift cards, and other non-checks are as follows as these forms of compensation can be processed for up to $600 to any one subject in a calendar year:
- Because the study is confidential, it is unnecessary to identify the name of the subject as is for non-confidential studies; an identifying code must be assigned to each subject
- A listing of these codes, along with the dollar amounts paid to each must be attached to (Certification of Cash Payment to Human Subjects)
- A cross-reference of the coded identification, including the subject’s name, amount received, and date, must be maintained by the Principal Investigator for a period of three years following the submission of the final financial report, unless the terms of the award provide for a different period
- This information is required to be available upon the request of internal/external and the Internal Revenue Service (IRS)
Total payments to any one subject during the course of a study totaling $600 or more in a calendar year must be paid via direct payment, issued in the form of a check or ACH. Information required for these payments include the subject's name, address, and SSN (submit W-9). This information will be reported to the IRS, and Form 1099-MISC, will be sent to the payee at the end of the calendar year in which the payment(s) were made.
[1] The investigator maintains the confidentiality of the data as this is not required by the IRS.
Required Forms
To request a Human Subject Express Card, fill out the following form:
If a payee meets the tax requirements of payment issued in a calendar year totaling $600.00 or more, then fill out the following new secure form for income tax reporting:
- Human Subject Compensation Record (OnBase)
Suggested Forms
Below are suggested forms to utilize for internal record keeping, these forms were previously required by Disbursements & Travel for reconciliation and certification. Disbursements & Travel no longer requires departments to submit this information to us. Departments are responsible for the continued maintenance of financial records and are subject to audits by the Audit & Management Advisory Service (AMAS) team and General Accounting.
Human Subject Gift Cards
Cash Advances
- Certification of Payment to Human Subject (PDF)
- Participant Log Sheet (PDF)
- Return of Human Subject Cash Advance Funds (PDF)
Human Subject Designated Procurement Card