- Purpose of this document
- What is clinical research?
- Why do people choose to participate in research?
- What are the different types of clinical research?
- What are the risks and benefits of participating in research?
- What rights do I have?
- What are the possible financial costs?
- Who can participate in clinical research?
- What is randomization?
- What is informed consent?
- What else should I consider?
- How do researchers make sure that participants are safe?
- What kinds of results will come from the research?
- How can I enroll in clinical research?
- What kinds of questions should I ask the researcher?
- For more information on clinical research and clinical trials
What is informed consent?
Before you take part in a study, it is important to fully understand it and to understand what participation may be like. Researchers will help by providing an “informed consent” statement. This is a document that has detailed information about the study, including its length, the number of visits required, and the medical procedures and medications in which you will take part. The document also provides expected outcomes, potential benefits, possible risks, any available treatment alternatives, expenses, terms of confidentiality, and contact information for people you can call if you have questions or concerns. When needed, a translator may be provided.
Researchers will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement, getting all the information you need, and talking with staff and your family, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to participate voluntarily. You may still leave a study at any time and for any reason even after signing the informed consent document.
Sometimes, a potential participant may not be able to give informed consent because of memory problems or mental confusion. Someone else, usually a family member with a durable power of attorney, can give consent for that participant. That caregiver must be confident there is small risk to the participant, and that he or she would have agreed to consent if able to do so.