Investigator Resources

• Consult the ADA/504 Coordinator's Office to connect to services and information related to all aspects of accessibility.
• For research website accessibility, see this page on Electronic Information and Technology Accessibility.
• Contact Communication Access Services to request services such as ASL interpreters.

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

• Clinical trials must be registered at clinicaltrials.gov prior to collecting data from human  subjects if the researcher wants to submit a manuscript of their study to the journal.
• To register a study, see the Clinicaltrials.gov Registration Guidance (PDF)

Consent Form Requirements

• The Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. More information about these requirements can be found here:
• Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))
• NIH - Posting Clinical Trial Informed Consent Forms

Additional Information

• NIH's Clinical Trial Requirements for Grants and Contracts
• NIH's Policy on the Dissemination of NIH-Funded Clinical Trial Information

• UMD Data Classification Standards
• Understanding the University Data Classification Standards
• UMD Software Approved by DIT Security
• UMD Software NOT Recommended for Use by DIT Security
• UMD Research Related Tools and Security Capability
• Google Drive vs. Box: Which Cloud Storage is Best for You?
• Electronic File Shredding Resources
• Secure File Storage and Data Backup Options
• PERVADE Data Ethics Decision Support Tool: This tool is designed for academic data science researchers to understand ethical data use considering the contexts and of tools data collection, the awareness and expectations of data subjects, decisions made about storage, analysis, and sharing, and the researcher's own positionality. The tool walks the user through those factors and refers to resources to help make informed choices in data research.

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 mailto:biosafety@umd.edu. 

• OHRP's List of Educational Resources for Investigators
• Choose your own adventure in Research Administration
• International Research: Compilation of European GDPR Guidances
• NIH Decision Tool: Am I Doing Human Subjects Research?
• NIH: Human Subjects Research Infographic
• NIH: Research Involving Private Information or Biospecimens Flowchart
• Studying Trauma: Indirect Effects on Researchers and Self - and Strategies for Addressing Them
• Managing Secondary Trauma in Social Science Research (PDF)
• Participant Education and Resources
• Hair me out: Recommendations to increase inclusion in research using EEG
• A Brief Guide to Conducting Research in Schools

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

• Research Payment Guidelines (PDF)
• Research Participant Documentation Exception (PDF)
• Research Participant Payment Solutions Matrix (PDF)
• Participant Payment Flashcard - Cash Payments (PDF)

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

• Guidelines for Research Participant Payment MOU (PDF)
• Research Participant Payment MOU Form (PDF)

Reimbursement of Human Subject Participant Incentives

• Participant Incentives Reimbursement Form (PDF)

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

• Receipt Form - $100 or Less (.docx)
• Receipt Form - Greater than $100 (.docx)

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.

• UMD Research Policies
• IRRoC: Integrated Research Resources on Campus
• UMD Libraries Research Resources
• Faculty Separation Checklist (PDF)
• UMD Disclosure Office (inTERP)
• REDCap at UMD
  • REDCap (Research Electronic Data Capture) is available to all faculty, staff, and students at the University of Maryland, College Park through the University of Maryland Baltimore’s Institute for Clinical & Translational Research (ICTR).
  • REDCap is a secure, web-based platform designed for building and managing online surveys and databases—ideal for collecting research data. This expanded access empowers the UMD community to easily collect and manage data securely, engage in multi-site collaboration, and export data to common statistical packages, with support provided by the UMB REDCap team.
  • To learn more, please visit the REDCap - Institute for Clinical & Translational Research (ICTR) website or contact the UMB REDCap team at redcap@umaryland.edu.