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IRB

For Research Participants

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

Image of Marie Mount Hall at the University of Maryland
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Research Compliance Institutional Review Board (IRB)

For Research Participants

KUALI-IRB LAUNCH (1/5):

Kuali-IRB is LIVE for new projects and transitions! For more information, see the Transition to Kuali-IRB page.

Why Participate in Research?

Research is when investigators conduct a study to answer questions to learn more about a problem or answer a question. Other words that describe research include project, protocol, survey, experiment, or clinical trial.

Medical research studies try to test if a treatment is safe and effective or determine how to prevent an illness. Social and behavioral research studies find out how people behave and why and can include questionnaires, interviews, or focus groups to understand opinions and beliefs. Most of the research conducted at UMCP is social and behavioral.

People may want to participate in research because it advances knowledge, understanding, and can lead to important new discoveries. 

How Are Participants Protected?

At UMD, all research involving human participants is required to be reviewed and approved by the UMD Institutional Review Board (IRB). The IRB reviews research to ensure that it is well-planned and conducted in an ethical way.

The IRB protects your rights and welfare before and during the research. One way they do this is by making sure the risks are as limited as they can be and that you are informed of them before you decide to participate. The IRB also reviews research studies while they are ongoing to make sure volunteers are protected.

As a research participant, you have the right to know:

  • What the research study is about
  • What you will be asked to do as part of the research
  • How much time the research will take
  • What the investigators hope to learn from the study
  • Whether you will benefit from participating in the study
  • Any risks or other discomforts that may happen if you participate
  • How your information will be kept confidential or if it will be shared
  • Who you can contact with questions or problems because of participating

You also have the right to:

  • Ask questions before you decide to participate and after you agree to participate
  • Say no if you do not want to participate
  • Change your mind about participating after you have agreed to participate
  • Stop participating at any time
  • Receive a copy of the consent form or information sheet
  • Have enough time to read the consent form and have the study explained to you in detail
  • Be treated with respect, including respect for your decision to participate, stop participating, or not participate at all

Participant Responsibilities

It is also important to understand your responsibilities as a participant. Participants should:

  • Read the whole consent form and ask the study team or Principal Investigator (PI) any questions
  • Know when and where participation will take place
  • Consider the possible benefits to you (if any) and risks of being in the study
  • Talk to the study team or PI if you want to stop being in the study
  • Contact the PI, the UMD HRPO, or OHRP with any complaints or concerns about being in the study (see the Participant Concerns section for more information)
  • Let the PI know if you have any problems related to the study
  • Keep a copy of the consent form for your records

Participant Concerns

Research Team

If you have questions or concerns about the research, you should start by contacting the research team.

Contact the Research Team if:

  • You would like to ask questions before deciding to participate in a project
  • You would like to enroll in a project
  • You have questions about any forms or documents provided by researchers
  • You have questions about how the research is conducted
  • You have questions about compensation or payment
  • You believe you have a research-related injury
  • You have concerns or a complaint about the research
  • You would like to withdraw from the research

The name of the Principal Investigator and their contact information can be found on the consent form, usually in the “Right to Withdraw and Questions” section.

UMD Human Research Protection Office (HRPO)

If you have concerns or complaints about your rights as a research participant, are unable to resolve your concerns with the research team, or would like to discuss concerns/complaints with someone other than the researcher, you can contact the UMD Human Research Protection Office.

Email: irb@umd.edu

Phone: 301-405-4212

Address:

Institutional Review Board

University of Maryland

1204 Marie Mount Hall

7814 Regents Drive

College Park, MD 20742

Office for Human Research Protections

If after contacting the Research Team and the UMD HRPO you do not feel that your concern has been adequately addressed, you may contact the Office for Human Research Protection (OHRP). OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46), also known as the Common Rule. In carrying out this responsibility, OHRP reviews complaints involving human subjects research that fall under their oversight.

For more information about OHRP’s oversight responsibilities and information you need to know before you start a complaint, please see this OHRP page.

Participant Education and Resources

  • Participant Outreach and Participant Rights Flyers (PDF): The UMD HRPO has created two educational flyers to inform participants of their rights. We encourage researchers to hang these flyers in their research labs, include it in course syllabi, or distribute it to participants whenever possible.
  • Office of Human Research Protection (OHRP) website: This website has more information and resources for learning about being a research participant.
  • OHRP Informational Videos: These videos for participants provide basic information about research, including videos about social and behavioral research to help you decide whether you want to participate in research. These videos are available in both English and Spanish.
  • OHRP List of Questions: This is a list of questions that you can ask when meeting with the investigator and study team to discuss participating in a research study.
  • How Are You Protected - AAHRPP Accreditation (PDF): UMD’s Human Research Protection Program (HRPP) is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). This brochure describes how AAHRPP accreditation protects participants.
  • Are You Thinking About Being in a Research Study? (PDF): The CITI Program has created a document that describes important aspects of the research, like the informed consent process and what is expected of you after you have agreed to participate in a research study.
  • Opportunities to Participate in Research: University of Maryland researchers offer opportunities to the campus and the surrounding community to participate in research studies. These opportunities are posted regularly on this page.
  • AAHRPP Resources: This page has additional background and educational information on research, as well as listings of clinical trials, information about children and research, and social and behavioral science research.
  • Certificates of Confidentiality: This page from the National Institutes of Health describes what information is protected by a Certificate of Confidentiality, which some studies have to prohibit researchers from having to release sensitive, identifiable information in any legal action.
  • The Belmont Report: This report details the basic ethical principles and guidelines for human subject research in the United States.
  • The Nuremberg Code: This is a set of ethical research principles developed as a result of World War II war crime trials.
  • The Declaration of Helsinki: This is a set of ethical principles issued by the World Medical Association, expanding principles from the Nuremberg code.