The choice to become part of a research study is often motivated by more than a personal desire for the latest medical advances. Participation is an act of service. Participants are the most important ingredient in the study and play the most vital role in advancing medical knowledge that could benefit millions of people.

Taking part in a research study offers potential benefits and may pose some risks not associated with standard medical care using FDA-approved drugs, medical devices, vaccines and other biological agents. It’s important that participants look at all aspects of the study, including life-style changes or time requirements, to determine if participation is realistic. Remember, there is no obligation to stay in a clinical trial once enrolled – a participant has the right to leave a study at any time.

Pros and Cons

By choosing to take part in a research study, you may gain access to new and promising medical advances before they are widely available. In many cases, the study sponsor covers the cost of drugs, medical devices, more frequent interaction with medical professionals and additional tests to monitor your overall health. Some study sponsors also reimburse participants for their time and travel. Please keep in mind that there is no guarantee a research drug, medical device or treatment option will provide better results than current methods of diagnosis and treatment. Ask questions and read all information provided before deciding whether a research study is right for you.

Informed Consent

Every person who chooses to be a participant in a clinical trial must give his or her informed consent, meaning that they fully understand the potential benefits and risks, as well as all requirements of the trials. If English is not the participant's native language, the consent document needs to be translated in a language understandable to the participant and the consent interview needs to be conducted in the participant's native language. The participant is provided with a consent form that must be signed before the participant can take part in the trial. The consent form describes study participant's rights, and includes details about the study, such as its purpose, duration, required procedures and key contacts. It also identifies the risks and potential benefits. The signed document ensures each participant has voluntarily chosen to participate and accepts the conditions of the trial. During the trial, the informed consent process means the participant will continue to receive information. The consent form document is for the participant's protection. It is not a contract and the participant is free to withdraw from the study at any time.

Each SIMR-affiliated study is approved for safety through the Sutter Health Central Institutional Review Committee and is carefully monitored to ensure the highest standards of participant safety are rigorously maintained.

For more information about clinical trials, see clinical trials in our health information section. The NIH Web site amd www.clinicaltrials.gov also offers extensive information.