Research Participant FAQ and Resources

Different types of research projects can involve people. Investigators conduct these research projects to answer questions and gain knowledge that they hope will benefit society.

Investigators may do things to research participants with their agreement, or investigators may ask participants to do specific activities and obtain information from them to answer research questions. Research involving human participants must follow specific rules created by the US government to ensure that research participants are treated with dignity and respect, and that the research causes minimal harm.

A research participant is an individual who participates in a research study. Information (or data) is collected from or about the individual participant to help answer the question under study. Research participants may also be referred to as study volunteers.

Each study has its own set of criteria to determine who is eligible to participate. Eligibility depends on the research questions being asked and may include restrictions based on age, behaviors, health, or other factors. Before you enroll in a study, researchers may ask questions to determine if you are eligible to participate.

According to the National Institutes of Health, clinical trials are research studies that are aimed at evaluating a medical, surgical, or behavioral intervention in humans participating in the studies. They are the primary way that researchers find out if a new treatment, like a drug or diet or medical device, is safe and effective in people.

The principal investigator or PI is the individual responsible for the planning and conduct of a research study. At UT, this person is usually a faculty member.

UT’s Human Research Protection Program and Institutional Review Board oversee all research activities involving human participants that are conducted by faculty, students, and staff at the university. The HRPP and the IRB work together to ensure that the rights, safety, and welfare of participants are protected and that UT researchers comply with all applicable federal and state laws and regulations.

Research at UT is designed to benefit society. While most research does not directly benefit the participant, most people participate based on the possibility of helping themselves or others in the future.

The researcher will usually provide you with the information listed below. Information may vary depending on the type of study.

• Why the study is being done
• Why you are being asked to participate
• How long your participation will last
• What will happen during the research process
• Any expected risks or benefits you might experience
• Any expected costs to you
• What you can do instead of participating
• Reasons you might be asked to leave the research
• Whom you can contact for questions about the research and your rights as a research participant
• Whether your information will be used in future research
• Your option to withdraw from the study at any time without any penalty and without having to give a reason

You will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given the opportunity to ask questions about the study. This process is called informed consent. Before beginning the study, you need to agree to participate (that is, provide your consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary depending on what is being studied. All the activities you will complete will be described to you during the consent process.

Members of the research team and, when appropriate, others who have permission to see your records will know that you are participating in research. If other people will have permission to see your research records, they will be listed in the informed consent for the study. Otherwise, information about your participation is kept confidential unless you choose to tell someone.

Research studies involving humans must be approved and monitored by UT’s Human Research Protection Program and Institutional Review Board. The IRB confirms the following points about each study involving humans:

• There is a good reason to conduct the study.
• The risks related to participating are the least possible.
• The risks related to participating are reasonable given the knowledge that will be gained from conducting the study.
• The plan for selecting participants is equitable (that is, everyone who is eligible has an equal chance to participate).
• Participants will be provided enough information about the study, in an understandable manner, to make an informed decision about participation.

Some studies offer payment to participants; others do not. If payment is provided, it is usually only enough to cover expenses related to participation, such as parking, transportation costs, or time, and should not be enough to convince you to take risks that you normally would not take. If the study offers payment, the arrangement and amount will be explained in the informed consent process.

If you leave before the end of the study, check the consent form and confirm with the research team about compensation.

Your participation contributes to UT’s research mission to make life and lives better by finding new information and creating new solutions to societal or scientific problems. While most research may not have a direct benefit to you as a participant, it is intended to advance scientific progress and benefit society.

Your participation in research is voluntary. You always have the right to leave the research at any time and for any reason, and you do not have to explain your decision to stop participating.

The consent form will outline what is involved in participating in the study and will let you know what to expect when the study ends. If you want to see the results from the study, you should ask the investigator about this before you enroll.

Please contact the principal investigator who is listed on the consent form. You can also contact the Human Research Protection Program at [email protected] or 865-974-7697 if you have questions about a study or your rights as research participant.