FAQs for Research Participants

Human subjects research is research that involves people. Investigators do research to answer questions and gain knowledge that they hope will benefit society. Investigators may do things to research participants with their agreement or ask participants to do specific activities and obtain information from them to answer research questions. Human subjects research must follow specific rules about the treatment of humans that have been created by the U.S. Federal Government. This ensures that research participants are treated with dignity and respect, and that the research causes minimal harm.

A research participant is an individual that participates in research. Information (or ‘data’) is collected from or about the individual to help answer the question under study.  Sometimes research participants are referred to as human subjects, research subjects, or study volunteers.

Each study has its own set of criteria to determine who is eligible to participate. Eligibility depends on the research question(s) being asked and may include restrictions based on age, behaviors, health, or other factors.

Before enrolling 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 interventions in human subjects. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people.

The Principal Investigator (PI) is the individual responsible for the planning and conduct of a research study. At the University of Tennessee, Knoxville this person is usually a faculty member.

The Human Research Protection Program (HRPP) and the Institutional Review Board (IRB) oversee all research activities involving human subjects 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 human research subjects are protected, and that University researchers comply with all applicable federal and state laws/regulations related to human subjects research.

It is the process of informing potential study participants about what is involved in taking part in a research study, and if they are interested, having them officially agree to participate. Typically, this process includes:

• Asking the potential participant to review written study information
• Giving the potential participant time to review the information and consider participation (taking it home to discuss with others if desired)
• Giving the potential participant time to discuss the information in the consent form with researchers and to ask them questions about the study

Note that as a participant in a study, your decision to participate is voluntary and you may change your mind at any time. 

Depending on the type of study, as a participant you may be asked to sign a consent form or you may be asked to give consent verbally or by checking a box online. The researcher should always give you the option to keep, save, or print a copy of the consent document.

Under Tennessee State Law, children under the age of 18 are generally not allowed to consent for themselves and parent permission for them to participate in a study may be required. In this case, the study team will also ask the child whether they want to participate in the study. This process is called obtaining assent from the child.

Research 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 give you the information listed below. This may change 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.
• Who 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 anytime 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 (i.e. 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. Other people who have permission to see your research records will be listed in the informed consent for the study, if applicable. Otherwise, information about your participation is kept confidential unless you choose to tell someone.

Research studies involving humans must be approved and monitored by The University of Tennessee, Knoxville’s Institutional Review Board (IRB). The IRB confirms that:

• 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 (meaning that 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

Not all studies offer participants payment for participating, but some studies do. Information about payment will be explained in the informed consent process. 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 you leave before the end of the research, please check your consent form and confirm with the research team about compensation.

Researchers are searching for new information and new answers to societal or scientific problems. Most research may not have a direct benefit to you as a research participant, however, it is intended to contribute to 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 (PI) that is listed on the consent form. You may also contact the Human Research Protection Program (HRPP) if you have questions about a study or your rights as research participant. You may contact us by phone (865) 974-7697 or email: utkirb@utk.edu