Participating in UofL Research
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.
The U.S. Office for Human Research Protections (OHRP) has developed resources for you to learn about participating in research and making informed decision. Visit their "About Research Participation" page. Participants can also view the OHRP brochure "Becoming a Research Volunteer: It's Your Decision".
People considering involvement in a research study should know that they have certain rights as a research participant. More information below. For more information on children participating in research, please see this page.
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.
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).
- 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.
Background and Educational Materials on Human Research
- CenterWatch: Background Information on Clinical Research
- NIH Clinical Center: Participate in Clinical Studies
- NIH Senior Health: Participating in Clinical Trials
- NIH Senior Health: Participating in Clinical Trials
- National Cancer Institute: Protecting Participants in Clinical Trials: Links to NCI Materials
- Dana Farber Cancer Institute: Entering a Clinical Trial: Is It Right for You?
- Association of American Universities: About University Research
Find a Clinical Trial Through Local Research Offices
- Norton Healthcare Office of Research Administration (NHORA)
- Brown Cancer Center Clinical Trials (JGBCC)
- University of Louisville Clinical Trials Unit
Additional Clinical Trial Listings
- AIDsinfo Clinical Trials
- Alpha-1 Foundation: Participate in Research Programs
- ALS Association: The ALS Association Active Research Projects Searchable Database
- American Lung Association: Research
- Asthma and Allergy Foundation of America: Clinical Trials Research Center
- ClinicalTrials.gov: List of Clinical Trials
- The Leukemia & Lymphoma Society Clinical Trial Service
- National Alopecia Areata Foundation: Research Announcements
- National Breast Cancer Coalition: Breast Cancer Research Initiative
- National Cancer Institute: Search for Clinical Trials
- National Health Council Membership Roster: Links to web sites of more than 115 Council members, most of which include information on research studies
- Yale Cancer Center Trials
- Research Studies at Yale
- Yale Center for Clinical Investigation
- National Institute of Mental Health: A Participants Guide to Mental Health Clinical Research