Research is collaboration between researchers and patient volunteers. Participating in a research study gives you an opportunity to take an active role in your own health care and gain access to innovative new drugs or procedures not yet available to the general public. You may also be helping others who may have similar health conditions.
Informed Consent ProcessBefore you enroll in a research study, you will engage in the process of informed consent. The goal of this process is to provide potential participants with all of the information that they need to make the decision about whether or not to participate in a clinical trial. During the consent process, you will review the informed consent document to learn the purpose, risks, and benefits of the research, expected length of time for participation, and a description of all the procedures that will be completed during enrollment on the clinical trial. You will have an opportunity to ask the study team questions about anything they do not understand before making their decision. If you agree to participate, you will sign the form before starting the formal screening process. Informed consent is a voluntary agreement to participate in research. Giving consent is not a contract; participants may leave a study at any time.
Screening ProcessIt is important to understand that every study has guidelines for who can or cannot take part. These guidelines describe characteristics that must be shared by all who participate, such as disease type, age, gender, medical history and current health status. These criteria are evaluated through a screening process, which ensures safety for participants and meaningful research outcomes. The screening process could include a review of your medical record, and you may be required to undergo additional testing. Screening potential participants helps us determine if you are the right person for the study—and helps you decide if this is the right study for you.
Additional InformationAs a participant in a research study you will have responsibilities. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study-related instructions given to you. You also might be expected to go in for many more visits than non-participants. Therefore, you may have extra costs, such as parking, babysitting and time off work.
Every research study is different and can range in complexity; some studies may only require a simple questionnaire, while others may involve surgical procedures. It is important to review all of the study details and compare with the other options available to you before deciding that participating in research is right for you. We encourage you to take all of the time that you need, and share and review the study details with your family, friends, and doctors to help you decide if you would like to volunteer. Visit Know Your Rights for more information on your rights as a study participant.
If you have study-specific questions, you can contact the study team at any time for more information.
There are a number of additional resources available online to help you find out more:
- National Cancer Institute: Clinical Trials Information
- CenterWatch: Patient Resources
- ClinicalTrials.com: Study Participant Information
- ClinicalTrials.gov: About Clinical Studies
- FDA - Clinical Trials: What Patients Need to Know
- Medline Plus: Clinical Trials
- National Institutes of Health (NIH) - Clinical Research Trials and You