Research Participants

Most research studies involving humans must be approved in advance by a committee - often called an Institutional Review Board (IRB) or an Institutional Ethics Committee (IEC).  IRBs are made up of scientists and doctors, as well as lay people from the local community. Before allowing a research study to go ahead, the IRB reviews it to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the importance of what may be learned.

IRBs use a special set of standards when evaluating a study that involves children. They look at the level of risk involved and the possibility of benefits. As the level of risk increases, so do the requirements that must be met for a study to go forward.

At the University of Louisville, we have two IRBs.  One deals with biomedical or clinical research.  The other deals with social, behavioral and education research.

Social, Behavioral, Educational Research can be defined as research that uses a variety of approaches including: surveys and questionnaires, interviews, direct observation, physiological manipulations and recording, descriptive methods, laboratory and field experiments, standardized tests, economic analyses, statistical modeling, customs of individual peoples and cultures, and evaluation. Most social and behavioral research is performed in schools.

Biomedical Research (Clinical) can be defined as research that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. Biomedical Research is often conducted using drugs or devices that have not been approved for use yet in the U.S. to see whether or not they are safe or work for the intended use.

The University of Louisville recognizes the importance of your decision to take part in a research study. Therefore, we want you to be educated in all the aspects of research before you decide to participate. It is important to consider the level of risk and compare it to any benefits when deciding whether or not to participate in human subject’s research. For more valuable information about participation, please see the attached brochure designed by The Office for Human Research Protections (OHRP) "Becoming a Research Volunteer: It's Your Decision".

If you are considering involvement in a research study, you should know that you have certain rights as a research participant.

Informed Consent

You are likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not you want to participate. This form itself should be coupled with a discussion of the research.

Generally, informed consent will involve a description of the following:

  • An explanation of the purpose of the research.
  • A description of what you will be asked to do and how long it will take should you participate and whether or not you will be compensated for your time.
  • A description of any risks involved in participating. These risks could be physical, psychological, social or criminal. The steps taken to minimize these risks should also be described.
  • A description of any benefits to you or to society as a whole.
  • The degree to which the information will be kept confidential.
  • Who to contact should you have questions about the research or about your rights as a participant.
  • A statement that you are free not to participate and can stop participating at any time.

Voluntary Participation

Any participation in a research study is completely voluntary. You are free to decline to participate for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a student, your teacher or professor cannot hold this against you when determining your grade. If you are receiving treatment, that treatment cannot be withheld if you do not agree to participate.  Whether or not you participate is entirely up to you.

You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

As described in the brochure, these are some questions that you should ask before you agree to participate in a research study:

  • Why is the research being done?
  • What will be done to me as part of the research?
  • How will I benefit from the research?
  • Could the research hurt me?
  • What will the researcher do with my information?
  • Will the research cost me anything?
  • Who pays if I'm unexpectedly injured in the study?
  • How long will the study last?
  • What happens if I decide to leave the study early?
  • Who should I call if I have a question about the research?

QUESTIONS/CONCERNS ABOUT A STUDY:

The Consent form you receive when you are invited to be a research subject includes some contact information if you have questions or concerns about the study.  You are encouraged to contact the researcher if you have questions.

QUESTIONS ABOUT RIGHTS AS A RESEARCH SUBJECT:

Call the office at (502)852-5188 or toll free at 1-800-334-UofL (8635). If calling toll free, when the operator answers, ask to be connected to extension 852-5188. You can discuss any questions about your rights as a research subject, in private, with a member of the IRB.

ANONYMOUS QUESTIONS/COMPLAINTS:

If you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call toll free at 1-877-852-1167. This is a 24 hour hot line answered by people who do not work at the University of Louisville.

Resources:

 

Background and Educational Materials on Human Research

Find a Clinical Trial Through Local Research Offices:

Clinical Trial Listings

Mental Health Research

Social and Behavioral Science Research