Research Participant Payment Process

Procedure Administrator: Assistant Provost

Authority:Effective Date: December 17, 2012

Index Cross-References: I-52.5: Committee on the Protection of Human Subjects

Procedure File Number: 1097

Approved By: Dr. Herman J. Saatkamp, Jr., President

Richard Stockton College of NJ balances its responsibility to maintain confidentiality of information about human research subjects with record keeping requirements of the State of New Jersey, grantor agencies, and the Internal Revenue Service. In studies that involve human subjects, College procedure requires that the Institutional Review Board (IRB) be initially involved in a review of the study procedures (in compliance with federal regulations 45 CFR Part 46, see
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) to determine risks to subjects and to assure that consent documents contain an adequate description of the procedures, as well as the risks and benefits that might result from participation in the study. It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of an investigation. Payment to research subjects for participation in studies is not considered a benefit, but rather as a recruitment incentive or as compensation for their participation. The amount and schedule of all payments should be presented to the IRB at the time of initial review.

These procedures cover payments to confidential and to anonymous research study
participants.

Fiscal Responsibilities

Having gained approval for compliance with the requirements of the IRB, the research
investigator is responsible for:
• Safeguarding the cash/gifts prior to distribution
• Issuing individual payments to study participants
• Maintaining appropriate documentation for each participant payment made
• Reconciling advanced or replenished funds within 3 days unless otherwise mandated
• Signing Certification of payments to Research Participants

The security of undisbursed cash or cash-equivalents is of utmost concern. Funds should
be kept safe in a locked cabinet in an office securely locked at night.

Guidelines for Compensation to Research Participants

There are no hard and fast rules about how much participants should or should not be paid. Participants should be paid enough to make up for their time and trouble, but not so much that their decision to volunteer or continue in a study is influenced by the amount being offered. Subjects should not see research participation as a way to make a living or regularly supplement their income. Large payments can suggest this possibility and can be coercive.

Undue inducement is to be avoided. “Undue inducement” may be seen as inducement so high that were it not for the amount of the inducement, the participant would not enter the study, or the participant would withdraw from the study early, given his or her better judgment. Payment should not be entirely contingent upon the participant completing the entire study, as that may be coercive. Rather, payment should be structured to accrue as the study progresses.

Payment types are limited to cash. Researchers must collect Participant Receipts and must maintain a Participant Payment Log for all research participants. Both the Research Participant Payment (RPP) Log and the Research Participant Receipt Form (RPRF) link payments to individuals for reasons of fiscal accountability, while maintaining confidentiality of the research participants.

These documents should be identified as confidential and will be processed in a prescribed manner ensuring names and contact information, if included, are not imaged and access to documentation restricted to ensure confidentiality.

Payments to Research Participants

All research participants receiving compensation are required to complete a Research Participant Receipt Form (RPRF). RPRFs are considered confidential and are handled only by researchers connected to the Project and who have been identified in the IRB review as compliant. Documentation will be handled according to confidentiality requirements in a secure, locked place.

Research participants should be informed that information collected allows the College to meet government reporting obligations and precautions are in place to keep their information secure. Participants may be given the opportunity to participate without receiving payment if they do not wish to provide identifying information. Research participants must sign an RPRF at the time they actually receive their cash payment. The informed consent form must state the amount of compensation to be received.

Confidentiality of Research Participant Identifying Information

In many cases, the research participant is guaranteed confidentiality if they participate in the study. As such, the RPP log and RPRF, which identify research participant(s) or the name of the study, should be kept secure by the research investigator and should NOT be distributed with any payment reconciliation documents to other College departments.

A person designated by the Controller will complete the Collaborative Institutional Training Initiatives (CITI) training on “Privacy and Confidentiality” in order to review participants’ names and log books. The Bursar’s Office will receive a Certification from the research investigator that he/she is maintaining the necessary documentation for the period of time required by law in the event of an audit.

Documentation of Research Investigator Certification

The certification should be signed by the Principal Investigator (PI) and include the total amount of research participant fees paid, total number of research participants paid, for a stated period of time. The document should certify that research participants were each paid appropriately and according to protocol approved by the IRB and that signed RPRFs were obtained. Additionally, the research investigator should certify that details pertaining to research participant disbursements (i.e., payee name and other personally identifiable information) are securely filed and available for audit, if necessary. See the Research Investigator Certification of Participant Payments template for research investigator certification.

The research investigator needs to maintain this documentation for seven years after the final financial and technical reports have been sent, according to State of New Jersey record retention policy.

Payment details to research participants will not be available centrally. As a result, research investigators are required to report the names, addresses, social security numbers and total amount of payments made by the College to individual participants who receive cumulative payments/value of $600 or more during a calendar year. This information must be forwarded to the Controller’s Office by December 31st every year.

If a research participant’s total compensation from Stockton accumulates to equal or exceed $600 in one calendar year, Stockton is required to issue an IRS Form 1099, Miscellaneous Income. If a research participant’s total compensation equals or exceeds $600, the researcher must have the research participant complete an IRS W-9 form prior to the participant receiving the payment that exceeds $600 and identify an address and social security number, so that Stockton can issue a 1099. Payments made to research participants should be reported in Box 3 of Form 1099-MISC, as other income.

Anonymous Research

In limited circumstances where completely anonymous research participation is necessary, the following provision permits a modification/exception to the above
documentation and reporting requirements. To qualify for this exception, the research investigator must have written approval/acknowledgement from the IRB and each anonymous research participant must be paid no more than $75. In this case the research investigator would not be required to maintain normal identifying information for payments, such as recipient name, address, telephone number, or signature of receipt. However, the research investigator must maintain some form of documentation in support of these payments to anonymous participants. It is essential that the research investigator sufficiently document the completion of participation by the research subject, and the payment of Stockton funds for that participation. Examples of proper documentation alternatives would include a unique participant identifier specific to the recipient of Stockton funds and a log maintained showing that, for instance, there are 20 completed surveys to support 20 disbursements of funds.

Obtaining Petty Cash for Research Participant Payments

Please see the College’s Petty Cash Funds Procedure for making payments to research participants. The Controller should be contacted for assistance on petty cash advances that exceed current thresholds.
Questions regarding implementing the requirements while maintaining confidentiality requirements for the IRB:
• Office of Grants Development or
• Chair, Institutional Review Board