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Last updated: March 6, 2007

This project is partially supported by a Science Education Partnership Award (SEPA), 2R25 RR12329-07, from the National Center for Research Resources, National Institutes of Health (NIH).

 

Clinical Trials Protocol - A 'clinical trial' is when the research results move from the lab bench to testing on people. In the health and medical professions, biomedical researchers test new medicines, drugs, psychological theories, and other therapies. These researchers are required by law to follow specific procedures in order to safeguard the health of the participants in their study and to successfully test their hypothesis.

Clinical Trials Protocol are the rules researchers must follow. Here is a list of the most common steps:

1. All participants must have full knowledge of the trial (such as what the researchers want to find out, how long the study will take, if there will be any interventions or screenings, and if there is a "placebo-controlled" experiment).

2. All participants must know if there is any risk or benefit to the research.

3. If participants are over 18 years old, they must sign a consent form.

3. If participants are under 18 years old, they must sign an assent form. Their parents or guardians must sign a consent form.

The National Institutes of Health (NIH) has excellent web sites:

An Introduction to Clinical Trials: Choosing to participate in a clinical trial is an important personal decision. The frequently asked questions provide introductory information on What, Why, Where, and Who. Be sure to talk to your doctor, your family, and your friends about joining the trial.

Participation in Clinical Trials: For those considering participation in a clinical trial, here is important information to help you understand the role of the participant and the unique process of clinical trials.

Glossary of Clinical Trials Terms: This glossary was prepared to help the public become familiar with the most common terms used in clinical trials.

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