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Investigator Resources

Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM - 4:30 PM

Definition

  • Clinical Trial (NIH): A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Registration

Consent Form Requirements

Additional Information

For investigators who will collect specimens from human subjects (including blood draws), the research must be submitted to the Institutional Biosafety Committee (IBC), which is done by the Principal Investigator through BioRAFT. 

This process will ensure that the research meets the requirements of the Occupational Safety and Health Bloodborne Pathogens plan, spill/exposure planning, disinfection and other biosafety concerns. This review process is an additional layer/perspective to the IRB review and focuses on the researcher and laboratory safety angles. 

With questions, please contact the Biosafety Program at biosafety@umd.edu. 

For assistance with participant payments or questions about the materials below, please contact your business office.

For all studies involving human research subjects, an approved IRB protocol is required. An MOU between the department, College, and Controller’s Office must be executed, and a copy of the IRB approval, and consent form must be kept on file with the MOU. 

NOTE: per the State of Maryland regulations, PCards cannot be used to purchase gift cards directly. (This includes using gift card companies like Gifthub and Tango.) Disbursement of cash directly to participants via Venmo, PayPal, Zelle, etc., is not allowable at this point. Questions about the matrix below or other compensation/incentives solutions can be directed to the human subjects working group at HSWG-Admin@umd.edu. 

Research Participant Payment MOU

Reimbursement of Human Subject Participant Incentives

This form may be used to assist in documenting reimbursement of allowable human subject participant incentives. It is designed to be supporting documentation included with itemized receipts for incentives purchased to acknowledge human subjects who participated in a research study as a group. Examples are groups of student participants in K-12 school classrooms.

This form should be completed before the research study visit occurs, and must be acknowledged with an original signature by the school or organization. Please attach the completed form along with original itemized receipts for allowable items purchased to accounts payable. For meal purchases provided as incentives, a list of attendee names or class roster must also be attached.

Please remember that this form is to be used as supporting documentation to ORIGINAL itemized receipts as required by the State of Maryland.

International Participant Payment

The recommended payment method for international research participants is Tango.  Researchers are encouraged to contact their Department’s Business Office to set up a Purchase Order for Tango gift cards. 

For assistance with international participant payments, you may also email the Human Subject Payment Working Group at hswg-admin@umd.edu. 

Participant Receipt Forms

Research Match aims to serve as an effective, useful and complementary recruitment tool that will help connect willing volunteers with researchers who are searching for appropriate volunteers to be placed in their clinical and other health related research studies.  This resource is provided at no cost and is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program.

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