Understanding Clinical Trials

How are clinical trial volunteers protected?

The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and the benefits are as great as possible.

The IRB is involved to make sure that the study is performed ethically and that volunteers are protected.

Informed consent Informed consent is the process of learning the key facts about a clinical trial before you decide whether to participate.

These facts include:

• Why the research is being done.
• What the researchers want to accomplish.
• What will be done during the trial and for how long.
• What risks are involved in the trial.
• What benefits can be expected from the trial.
• What other treatments are available.
• The participant’s right to leave the trial at any time.

If a person is considering volunteering for a clinical trial, the Upstate research staff provide informed consent documents that include the details about the study. If English is not the person’s native language, the volunteer can ask for the consent documents in other languages. Volunteering for a clinical trial is an important decision. Therefore, volunteers are encouraged to ask questions about the study and the consent forms before they make a decision.

For more information, contact:

Phone: 315 464-5476
FAX: 315 464-5386

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