Research Involving Human Subjects

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Introduction

Appalachian State University has a responsibility and a requirement to maintain a specified level of confidentiality, and in some instances, total anonymity, in research involving the use of human subjects. In addition, it is important to maintain appropriate business practices in payments to these subjects. The University has set practices for handling various types of payments and the Internal Revenue Service (IRS) may require reporting of these payments. Payment is defined as any type of remuneration including, but not limited to: cash, gift certificates, or other items of value.

The University must obtain the subject’s name, Social Security number/Banner ID and address in order to conform to certain IRS reporting requirements. The informed consent document and process for research studies involving payment to human subjects must provide information to the subject regarding the need to disclose name, Social Security number/Banner ID, and address to the University for payment purposes.

Definitions

Definition phrase or word

Definition summary

Policy and Procedure Statements

Methods of Payment

Cash is one method for making payments of less than $100 to human subjects. Another option is the Research Subject Payment Form (XLS 25K). This method results in a check written through Accounts Payable. Due to the administrative costs of processing a check, this method can be chosen when payment amounts exceed $25, but is required for payments of $100 or more. The P-Card should not be used to purchase gift cards to pay human subjects. If gift cards are chosen as the method of payment for small amounts, they should be purchased through the normal Procurement Form process.

Rather than using personal funds, a cash advance by procurement up to $1000 is the preferred method to fund cash payments to subjects. (Procurements > $1000 must receive prior approval and should be submitted to Amy Roberts, Special Funds Accounting.) No more than 2 cash advances can be “open” at any time. Any remaining cash after the project is complete must be deposited within 24 hours to the Cashiers Office. If you are traveling for the project, the 24 hour period begins when you return. A cash advance clearing form must be submitted to Special Funds within 30 days along with Stipend Log #1 (portrait (DOC 32K)) or (landscape (DOC 36K)), or Stipend Log #2 (4 slips to a page (DOC 25K)).

Catagory 1: Confidential Studies

For studies where the University guarantees confidentiality and human subjects will be compensated, the University must obtain informed consent from the prospective research subject. The informed consent process would provide the prospective subject with information related to the reason for the need to provide the University with their name, Social Security number/Banner ID and address. Subjects who do not wish to have their confidential information shared with the University could have the option to waive receipt of any payment if they still wish to enroll in the study. If waiving receipt of payment violates the subject inclusion criteria for the study, the investigator may amend the form so that subjects who choose not to provide their name, Social Security number/Banner ID and address to the university may not enroll in the study.

Category 2: Total Anonymity

Some studies require total anonymity. The Principal Investigator (PI) must indicate to the Institutional Review Board (IRB) in the protocol application that subjects will be paid a nominal amount, how many subjects will be paid and why is it is important that total anonymity be maintained. In these instances, do not collect names or any other identifiers. The IRB will authorize payment using a form with the information that a certain dollar amount can be paid for a specified number of subjects and the period of time. This signed form should accompany all cash advance requests or reimbursements sent to Accounts Payable. (Only payments of less than $100 per occurrence may be made in cash to a human subject requiring anonymity. The total payments to any individual during a calendar year cannot exceed $599).