Paying Human Subjects                                                    UPPS No. 02.02.06 (NEW)

                                                                                                Issue No. 1
                                                                                                Effective Date: 08/14/2008
                                                                                                Review: November 1 E4Y
                                                                                                                                                           

01.       POLICY STATEMENT

01.01  The purpose of this policy is to prescribe the policies and procedures for paying human subjects involved in external and internal sponsored programs at Texas State University-San Marcos. This policy applies to all sponsored programs, regardless of the source of funds. 

 

02.       DEFINITIONS

02.01  Human subject – 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.

02.02  Independent contractor – An individual who is compensated for performing a service for the University and who does not have an employee relationship with the University.

02.03  Intervention – both physical procedures by which data are gathered 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. 

02.04  Private information – 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)

02.05  Institutional Review Board (IRB) – A Board whose members are appointed by the Associate Vice President for Research. The Board and its staff are responsible, in conjunction with administrative officers of the University, for ensuring that university personnel and student researchers comply with applicable federal regulations and guidelines.

02.06  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)

02.07  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)

02.08  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. (See the Code of Federal Regulations Title 45 Part 46, Protection of Human Subjects)

02.09  Sponsored Project – an externally or internally-funded activity governed by specific terms and conditions. Sponsored projects must be separately budgeted and accounted for in accordance with terms of the sponsoring organization and Texas State. Sponsored projects may include grants, contracts, and cooperative agreements for research, training, and other public service activities.

02.10  Subject Payments – Payments made to inpatients, outpatients, human subjects, volunteers and donors for their participation and time commitment in a clinical trial or social science survey, etc.

02.11  Protocol - Plan of Study

 

03.       POLICIES & PROCEDURES

03.01  Federal regulations which deal with human subjects are applicable only to sponsored programs funded with federal monies, in accordance with the Code of Federal Regulations, Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). This federal regulation applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.  Texas State has elected to apply this federal regulation to all sponsored programs so as to assure protection of human subjects in all sponsored programs. 

 03.02 Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from the confidentiality aspects of this policy: 

a.   Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: 1) research on regular and special education instructional strategies, or 2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

b.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: 1) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and 2) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

 

c.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph b. 2) of this section, if: 1) the human subjects are elected or appointed public officials or candidates for public office; or 2) federal statute requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

d.   Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

 

e.   Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: 1) Public benefit or service programs; 2) procedures for obtaining benefits or services under those programs; 3) possible changes in or alternatives to those programs or procedures; or 4) possible changes in methods or levels of payment for benefits or services under those programs.

 

f.    Taste and food quality evaluation and consumer acceptance studies, 1) if wholesome foods without additives are consumed or 2) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

 

03.03  The University may pay human subjects participating in any sponsored program by check, electronic deposit, gift certificate, or cash. When a department or school handles cash in providing payments to human subjects and participants, funds must be secured and handled in accordance with the principles established for cash custodians.

 

03.04  A Principal Investigator (PI) or other university employee may not pay human subjects from personal or other funds and later request reimbursement.

 

03.05 Payments will not be made without adequate documentation and approval, as described later in this policy. 

 

03.06  The University will maintain the names of human subjects in confidence unless exempted under section 03.02 of this policy. The only explanation that is required on the payment document is: "Details are on file and available for audit in the department". Attachments identifying the name or nature of the study should NOT accompany the payment document. 

 

03.07  Prohibited Payments – Certain payments are prohibited from being made for human subjects participating in a university-sponsored research program. These are:

 

a.   International Participants – Payments cannot be made to research participants who are international visitors (such as F-1 or J-1 students) because these individuals cannot work as independent contractors in the United States. Also, many international visitors are prohibited from receiving compensation from any entity other than their sponsor.

 

b.   Employees, graduate students, or undergraduate students who are funded by the research grant to which the cost of the human subject payments will be charged. The University cannot pay these employees as independent contractors because of the possible conflict of interest and internal control issues.

 

03.08  Texas State Employees – To obtain payment to human subjects who are Texas State employees, an individual personnel action (PCR) form must be processed in accordance with regular university procedures for compensating employees. Any payment to an employee is subject to employee deductions, such as federal tax withholding and retirement deduction.

           

When subjects are university employees, payments for work as human subjects are made through the University's Payroll Office. Payments are included in the next regularly scheduled paycheck for the employee who has served as a human subject in a research project. All applicable taxes will be withheld at the time of payment in accordance with Internal Revenue Service regulations.

 

03.09  Payment Requests.

 

a.   Payments as Contractors – Individuals who are not Texas State employees being paid as human subjects are regarded as “independent contractors”. To obtain payment by check or direct deposit to individual human subjects who are not employees of Texas State, follow the steps detailed below:

 

1)   Complete a Vendor Maintenance form (Form FS-01) to set the individual up as a vendor in the system.

2)   Complete a Payment Request. [The form can be accessed via the web at http://www.txstate.edu/gao/ap/forms.html.]

 

b.   To obtain a single payment for multiple human subjects, a single Payment Request form may be utilized. A list must be attached to the Payment Request form, with the following information for each individual to be paid: 

 

1)   Printed name of human subject;

2)   Dollar amount of funds to be paid to each human subject;

3)   Social Security Number of each human subject is needed if the amount to be paid exceeds $100.00; and

4)   Mailing address of human subject.

 

c.   Approvals

 

1)   The preparer of the Payment Request must obtain written approval of the account manager (or designee) on the form.

2)   Externally Sponsored Programs – The approved Payment Request should be forwarded to the Assistant Vice President for Research for their review, to assure that the expenditure is being made in accordance with sponsor requirements.

3)   Internal Research Enhancement Program (REP) grants – The approved Payment Request should be forwarded to the Assistant Vice President for Research for their review.  The PI (or account manager) must assure that the expenditure to the human subjects is being made in accordance with provisions of the REP award.

 

d.   The completed and approved Payment Request should be forwarded to Accounts Payable for processing of the payments. All payments will be mailed or sent via electronic means in accordance with standard university procedures. Allow 10 working days for processing.

 

e.   Request for purchase of gift cards or certificates should follow the Purchasing guidelines by processing a Purchase Requisition.  University employees may not use P-cards to purchase gift cards or certificates.

 

f.    Requests for cash advances must come from the PI of the grant, even if the request is for another person working on the research project.  Texas State requires a three week lead time to process a cash advance request and PIs are required to return any unspent funds.  The PI will maintain a log of payments to study participants.  Administrative personnel for the department conducting the research or study must reconcile the research payments and verify that all appropriate information has been collected. To obtain a cash advance for payment to human subjects who are not employees of Texas State, follow the steps detailed below:

 

1)   In addition to a Payment Request form, a Cash Advance Application must be submitted containing the following information:

 

(a) purpose of the advance;

(b) date advance needed;

(c) person responsible for funds;

(d) security to be provided for funds;

(e) approval of unit administrator (chair, director);

(f) approval of the principal investigator, where sponsored project funds are involved;

(g) externally sponsored programs – approval of the Assistant Vice President for Research.

(h) internal Research Enhancement Program grants – approval of the Assistant Vice President for Research

04.       RESPONSIBILITIES

04.01  Principal Investigator – has the following responsibilities with regard to making payments to human subjects through Texas State:

a.   Select participants in accordance with university policies.

b.   Verify the employee or non-employee status of the participant.

c.   Verify that the participant is a U.S. citizen.

 

d.   Secure a completed copy of IRS form W-9, including social security number and valid mailing address for the participant. Texas State should always try to get participants to sign acknowledging receipt of funds, where even if the subject is, for example, a vagrant, interviewed on the street, etc. Therefore, the PI should keep on file a copy of the intake form described in this policy.

 

e.   Report to the University Tax Specialist any payment to an individual during the tax year that cumulatively exceeds $600.00

 

f.    Prepare a payment request form. The PI must keep on file a spreadsheet with lists of participants and have on file the intake forms for the participants and the completed W-9’s. 

 

g.   Ensure confidentiality and proper protocol procedures are followed, in accordance with federal and state regulations and university policies (Refer to UPPS 02.02.03, Protection of Human Research Subjects).

04.02  Unit Administrator (Chair, Director) – Oversight

04.03  Document Preparer – Ensure confidentiality and accuracy

04.04  Certified Approver – Approve and review payment documents for confidentiality and accuracy

04.05  Assistant Vice President for Research – Review Payment Requests, Cash Advance Requests and PCR’s being processed to compensate human subjects, to assure compliance with external and internal funding source requirements.   

04.06  General Accounting Accounts Payable – has the following responsibilities:

a.   Processing payments to human subjects participating in a research study.

1)   Process Payment Requests and advise departments or schools regarding standard University payment processes. Review the Payment Requests for completeness.

2)   Process payments for human subject participants in lump sum to the PI, or when applicable, process individual payments to participants.

 

b.   Processing Cash Advances

1)   Process Cash Advance and advise departments or schools regarding standard University processes. Review Cash Advance form for completeness.

c.   Gift Cards or Certificates

1)   A Non Purchase Order (NPO) is not appropriate for payment processing for gift cards or certificates. Return to account manager.   

04.07  Purchasing

a.   Process purchase requisitions for gift cards or certificates.

1)   Follow same procedures for processing purchase requisitions.

2)   Additional approval is needed from Office of Sponsored Programs prior to processing.

 

b.   P-Card purchase is NOT an appropriate purchasing method for gift cards or certificates. Contact account manager for resolution.

 

04.08  Tax Specialist – File a 1099-MISC with the Internal Revenue Service to report the payments as taxable compensation if payments to a participant exceed $600.00 (from all sources) in any one calendar year.

05.       REVIEWERS OF THIS UPPS

05.01  Reviewers of this UPPS include the following:

 
Position                                                         Date
 
Assistant Vice President for Research    Nov. 1 E4Y
& Director of Federal Relations                                                           
 
Associate Vice President,                          Nov. 1 E4Y
Financial Services    
 
06.       CERTIFICATION STATEMENT                        

 

This UPPS has been approved by the following individuals in their official capacities and represents Texas State policy and procedure from the date of this document until superseded.

 

Assistant Vice President for Research & Director of Federal Relations; senior reviewer of this UPPS

Associate Vice President for Research & Federal Relations

Provost and Vice President for Academic Affairs

President