All clinical research studies have guidelines to determine eligibility. The research physicians use very specific inclusion and exclusion criteria based on age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. A potential participant must meet these criteria before joining a clinical research study. These criteria help research physicians identify appropriate participants for the study.

If you and the person in your care choose to take part in a clinical research study:

• The person in your care may have access to an investigational drug that could potentially be beneficial to him or her.
• The person in your care will receive medical care and monitoring of his or her condition during the course of the research study.

You may both help others who have your disease or condition in the future by contributing to medical research.

Governmental regulatory agencies have strict and specific rules for conducting clinical research studies. For example, all clinical research studies must be approved and monitored by an ethics committee. Ethics committees must:

• Ensure that appropriate steps are taken to protect the rights, welfare, and anonymity of all people who voluntarily participate in clinical research studies.
• Review and approve the research study protocol, all written information provided to participants, and methods of recruitment of research physicians and participants.
• Monitor aspects of a clinical research study and prerequisite reporting of unexpected or unknown side effects.

A clinical research study follows a carefully controlled protocol, which is a plan that details what research physicians will do in that study. Researchers will also report the results of the study at scientific meetings, in medical journals, and to various government agencies. All participants' names remain confidential.

Anyone who is eligible and decides to participate in a clinical research study must first go through the Informed Consent process. In this process, the research study – its purpose, duration, required procedures, key contacts, and any possible benefits and risks – is explained in detail in an informed consent form, and all of your questions regarding study participation are answered by the research staff. This process ensures that you or the person in your care understand what participation involves. As a potential participant, you or the personal in your care must then decide whether or not you, he or she wants to enroll in the study. A participant's signature(s) and the date of his or her informed consent on this form make the form an important study document. Participants may withdraw from the research study at any time. Very often, a reason for withdrawal will be asked.

The staff of a clinical research study may include physicians and nurses, as well as social workers and other healthcare professionals. The clinical study staff checks the participant's health at the beginning of a research study, and monitors the participant throughout the study. The clinical study staff provides specific instructions for participation, and follows the research study protocol carefully in collaboration with the research staff. The procedures that the participant may receive depend on the research study protocol and on the disease or condition being researched.