Information for Research Participants
The University of Montana Institutional Review Board (IRB) is responsible for ensuring the protections of the rights, welfare, and safety of individuals who participate in research conducted by UM faculty and students. Before a UM researcher can conduct a study with humans, the proposed research plan must be reviewed and approved by the UM IRB. If you are considering or have agreed to participate in a human research study, you may have questions about the process. This webpage provides important information for participants who are considering participating in research at the University of Montana.
University of Montana IRB Contact Information
- If you have any questions about the IRB review process or human research that are not answered below or feel that your rights as a participant have been violated, please contact the UM IRB at IRB@umontana.edu or 406-243-6672.
- If you have specific questions about a research study that you are considering joining or are an active participant in, the best person to contact is the Principal Investigator (PI) of the study. If you can’t reach the PI or want to discuss the study with someone else, contact the IRB at IRB@umontana.edu or 406-243-6672.
Pamphlets for Human Research Participants
The US Department of Health and Human Services (HHS) provides several useful informational pamphlets for human research participants in English and Spanish.
Also see below to answers to some frequently asked questions.
Frequently Asked Questions from Human Research Participants
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Human subject research is defined as any research project that involves living people and/or their private information. Some examples can include:
- Testing different educational practices in elementary schools
- A study on the impact of a medical device, such as a wearable glucose monitor for diabetic patients
- Observing how children interact with toys to study cognitive development
- Interviewing prisoners to understand factors that lead to criminal behavior
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An institutional review board (IRB) is a group of individuals tasked with overseeing and approving research with human subjects to ensure they are carried out ethically, safely, and in compliance with regulations.
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US federal policy mandates that an IRB must consist of at least five members of varying backgrounds, reflecting diversity in gender, expertise, race, and cultural backgrounds (i.e., the board must not be entirely made up of one gender or of one profession). An IRB must also have at least one scientist, one non-scientist (such as a social worker or lawyer), and one individual who is not affiliated with the institution.
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Many of the research studies conducted at the University of Montana are social-behavioral, rather than medical research. Social-behavioral research is concerned with human behavior such as actions or drivers of actions, emotions, or group interactions, involving topics such as marketing, politics, or psychology. It may also involve sensitive topics such as mental illness or trauma that may be uncomfortable for participants.
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Becoming a research participant is 100% voluntary, and you can discontinue participation in a study at any time. Before you agree to participate in a research study, you will receive an informed consent form containing information on the study, including risks and benefits to you and how your data will be used and protected. You do not have to sign until all your questions have been answered, and you can withdraw your participation at any time.
See here for some questions you can ask researchers before agreeing to participate in their study.
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The informed consent form given to you before you agree to participate will contain information on how your data will be used and protected. IRBs require researchers to have an appropriate plan to ensure data privacy, including a requirement to use secure, password-protected servers and to remove identifiers, if appropriate.
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Only those who need it to conduct or evaluate the study will see the information. This may include research assistants, graduate students, the IRB, funders, and governmental oversight agencies such as the FDA. The PI of the study will be able to tell you who will see your information and whether any identifiers (such as name, gender, or race) will be included.
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Any benefits to you will be outlined in the informed consent form. There may or may not be any benefits directly to you for participating in a research study, but it may result in information that will help people in the future.
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Any risks to you will be outlined in the informed consent form. Research procedures and experimental treatments may result in discomfort and negative side effects. Researchers may also ask questions that make you uncomfortable. The full risks and side effects may not be entirely known when you start the study, but the PI and research staff will tell you about any new risks that arise.
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You may withdraw your participation from a study at any time for any reason. You may or not be able to withdraw your data from the study once you have already started the study. Please refer to your informed consent form or ask the PI or the IRB if you have questions about withdrawing your data. You do not have to tell the PI and research staff the reason you withdraw from a study, but doing so may mean they will be able to help participants in similar situations in the future. Withdrawing from a study will not affect your relationship with the researcher or University of Montana. If you do not wish to inform the PI directly of your wish to withdraw, you can contact the IRB.