The goal of clinical research is to determine if these treatment, prevention, and behavior approaches are safe and effective. People take part in clinical research for many reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. People with an illness or disease also take part to help others, but also to potentially access investigational treatments. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future.

Participation in clinical research typically follows this process.

Prescreening. As a potential participant, you will be screened prior to being enrolled into a clinical research study. Research personnel will explain the study in detail and obtain more information about you during the prescreening process to ensure you are a good fit for the research. It’s possible that further screening may occur following the informed consent process. 

Informed Consent. Informed consent is an essential part of participating in clinical research. It is the process of learning the key facts about the study before deciding whether to participate. Once you have had all your questions answered, and if you agree to participate, you may be asked to sign an informed consent form. Participants should take the time to review the informed consent document carefully and decide if participating in the study is right for them.

You will get a copy of the document to keep, which you can refer to as needed in the future. Also, note that informed consent is a continuous process that does not end with a signed document. You are encouraged to ask questions about your participation at any time—before, during, or after the study. The researchers will also provide you with any new information during the study if it could affect your willingness to participate.

Enrollment and Participation. Once you have enrolled, the study team will review the study procedures with you and schedule tests and other appointments. You will follow the trial procedures and report any issues or concerns to researchers. Remember, participating in a clinical study is completely voluntary and you can decide to stop at any time.

End of Study. Your participation in the study is complete. Researchers may provide participants with information about how they may find results once the study data is analyzed.

Protections are in place to ensure each study is as safe as possible. However, these methods of protection do not eliminate all possibility of risk. At UTD, an Institutional Review Board (IRB) reviews all research projects involving human participants. The IRB carefully reviews and monitors research to ensure that it is carried out legally and ethically.  Research studies involving human subjects cannot be started until the IRB has approved the study.

• An Institutional Review Board (IRB) is a committee that reviews and approves research involving human participants to protect their rights and welfare. Composed of diverse members, including scientists, non-scientists, ethicists, and community members, an IRB ensures a research study is designed ethically, and minimal unnecessary risk, and that participants are fully informed and protected throughout the process.
  
  The IRB has 4 main functions:
  
• Protect Human Subjects. The primary role of the IRB is to safeguard the rights and well-being of people involved in research studies.
• Ensure Ethical Conduct. UTD’s IRB reviews research plans to make sure they meet established ethical standards and comply with relevant laws and regulations.
• Minimize Risk. The IRB evaluates research proposals to ensure potential risk to participants is minimized.
• Verify Informed Consent. The IRB confirms that participants receive the necessary information about a study to make a voluntary and informed decision about participating in a study.

Informed consent is an essential part of participating in clinical research. It is the process of learning the key facts about study before deciding whether to participate.

If someone is interested in participating in a study, the research team may provide an informed consent document that includes details about the study, such as its purpose, how long it lasts, required procedures, potential risks, and whom to contact with questions or issues.

It is the responsibility of the research staff to help participants understand the information about the study and give them time to decide if they want to participate. Participants should feel comfortable asking questions and discussing with the research team any concerns they might have.

The process of informed consent does not end when someone signs the informed consent document. It is a process that continues with ongoing conversations between the research team and participants before, during, and after research participation. If someone decides they no longer want to participate in the study, they can withdraw at any time.