For Research Participants
Participant Rights & Resources
The Texas Christian University (TCU) Research Compliance Office is responsible by Federal Law for ensuring the protection of the rights, welfare, and well-being of participants involved in research studies conducted by TCU faculty, students, and staff. If you are a participant, you may contact the IRB with a question or concern.
One way this is accomplished is by having all research studies reviewed by an Institutional Review Board (IRB). The IRB carefully reviews and monitors research to ensure that is carried out legally and ethically. Research studies cannot be started until the IRB has approved the study.
Every research participant has the following rights:
- To be treated with respect, including respect for your decision whether or not you wish to enroll in, continue in, or stop being in a study.
- To choose to stop being in a study at any time.
- To be given time to ask questions, and to be told whom you can contact if you have any more questions.
- To be given a copy of the consent after you have signed it.
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 can volunteer to be a research participant?
Anyone can volunteer. People who volunteer for research come from all walks of life. Volunteers can be healthy or they may have a specific condition. Volunteers can be younger or older adults as well as children. Everyone, regardless or gender, age, or ethnicity may volunteer for research.
Can children participate in research too?
Yes, children can participate in research studies. However, there are additional protections for children. For example, the parent(s) or legal guardian(s) must provide their permission for the child to participate. In addition, if a child is old enough to understand what the study is about, the child may also be asked to give his/her agreement or assent to participant in the research.
What rights do I have as a participant?
It is your decision whether or not you want to participate. In most cases you do not have to decide right away. You have the right to make this decision without any pressure. There will not be any consequences if you refuse. To help you make an informed decision, you have the right to receive information about the study. Information will almost always be given to you in writing (written study information is called an “informed consent form” or “study information sheet”). The information must always be in a language you can understand. If you do not understand something, the study team must explain it for you in a way that you can understand. You have the right to ask questions at any time and to have your questions answered. If you decide to participate, you will be asked to sign and date the informed consent form if the study is not exempt from this requirement. In many cases, a signature is not required because the research is low risk and your signature may be the only thing linking you to the research. You also have the right to leave the research at any time. If you leave the research, your decision will not affect your relationship with TCU or any rights or benefits to which you are otherwise entitled. You simply need to tell the research staff that you have changed your mind.
How do I protect my rights if I participate?
The most important thing to do is take an active role and communicate with the study team before, during and after the research. You should always ask questions if you are not clear about something, if you are curious about something, or if it seems like the research plan is different from what you were told. You have a right to have your questions answered. Take your time making decisions about whether or not to participate. You should seek the advice of trusted family members, friends or healthcare professionals before and during the research. If you feel uncomfortable with what you are doing, or if you think you might be experiencing changes in your health (whether good or bad), let the study team know. Always keep in mind that participation in research is voluntary. If you feel like you are being pressured to join or stay in a study, you can always say no. You can leave the research at any time for any reason, and you do not have to explain your decision. You can also contact our office with questions about your rights, or any problems or complaints about your experience with research at TCU.
Learning about research participation can be challenging. There are many resources that can help you make the best decisions for you and your loved ones. The following resources can help you answer common questions, and suggest other questions you may want to ask if you are considering participating in a research study:
Office of Human Research Protection
- What is Medical Research? (YouTube- English)
- ¿Qué es la investigación científica? (YouTube – Español)
- Deciding to Participate in Clinical Trials (YouTube – English)
- ¿Qué son los ensayos clínicos? (YouTube – Español)
Food and Drug Administration (FDA)
National Institutes of Health
U.S. Department of Health and Human Services
US Ethical Codes & Regulations
- 45 CFR 46
- Revision of the Common Rule
- 21 CFR 50
- 21 CFR 56
- Belmont Report
- Office for Human Research Protections (OHRP)
This information is heavily borrowed from Northwestern University IRB.