Investigator Support and Resources
Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM - 4:30 PM
- What are Waivers? (PDF)
- What is Deception? (PDF)
- Example Waiver of Parental Consent (College Students) (PDF)
- Preventing Bots and Imposter Participants in Research (PDF)
- MTurk Tip Sheet for Researchers (PDF)
- IRB Investigator Handbook (PDF)
- UMD Research Policies
- IRRoC: Integrated Research Resources on Campus
- Faculty Separation Checklist (PDF)
- Institutional Biosafety Committee: 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.
- UMD Libraries Research Resources
- Accessibility 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.
- Letters of Organizational Support
- If collaborating with an outside entity such as a nursing home, school, community center, or other organization to conduct the research, specifically if data collection will be done in-person at that location, researchers must provide documentation of support from the organization indicating that the organization is aware of and supports the research activities.
- Letters of support should be provided on institutional letterhead, if possible.
- Documentation of support can be provided via email. However, the documentation must originate from an official organization email address and include the approving individual's title within the organization. Personal email correspondence is not accepted.
- Translations
- If you anticipate that your study may enroll non-English speaking participants, you must indicate in the IRB Application that non-English speakers will be enrolled, and the IRB must approve this request before you can enroll non-English speakers.
- Also, please clarify who will be conducting the consent process/translating the consent form, their qualifications for doing so (e.g. native speaker, professional translator) and how this person will communicate with non-English speakers.
- Copies of both English and non-English language versions of participant-facing materials (e.g. recruitment, consent, survey/interview questions) must be submitted and approved by the IRB before their use with participants.
- Email Communication Requirements
- UMD policy states that email sent by UMD personnel must be sent using an approved UMD institutional email system. All IRB materials should list either the PI's UMD email address or a shared UMD email account for the lab/project.
- UMD Policy on Email Communication
- Instructions for Creating a Shared UMD Email Account
- OHRP's List of Educational Resources for Investigators
- Choose your own adventure in Research Administration
- "Informing Consent: A Study on Privacy and Consent in Internet Research" (PDF)
- International Research: Compilation of European GDPR Guidance
- NIH Decision Tool: Am I Doing Human Subjects Research?
- NIH Clinical Trials - "Doing Human Subjects Research? Changing NIH Policies May Impact You" (.pptx)
- 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
- Electronic File Shredding Resources (PDF)
- Google Drive vs. Box: Which Cloud Storage is Best for You?
- Online Survey Research Guidance (PDF)
- Storing and Transmitting Human Subject Data
- Research Data Ownership in the Cloud: Google Drive and Dropbox (PDF)
- UMD Data Classification Standards
- UMD Software Approved by DIT Security
- UMD Research Related Tools and Security Capability
NIH Clinical Trial Definition – Updated January 7, 2019
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. In addition, this is required by many peer-reviewed journals if an investigator is planning to submit a manuscript to that journal.
Clinicaltrials.gov Registration Guidance (PDF)
More information about the clinical trial requirements for grants and contracts can be found here:
The revised Common Rule also 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
In addition, informed consent documents for clinical trials are required to include a specific statement relating to the posting of clinical trial information at ClinicalTrials.gov. For more information please visit: NIH's Policy on the Dissemination of NIH-Funded Clinical Trial Information.
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.
Participant Payment Forms and Guidance:
Guidelines for Reimbursement of Human Subject Participant Incentives Form:
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.
Participant Receipt Forms:
- Receipt Form - $100 or Less (.docx)
- Receipt Form - Greater than $100 (.docx)
Research Participant Support Payments:
Research Participant Payment Solutions Matrix Info:
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.
Research Participant Payment Solutions Matrix
Participant Incentives Reimbursement Form
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.