CFPR Informational Links:

• Contraception Information from the The National Women’s Health Information Center
• Contraception Information from Bedsider.org
• HIV Prevention Information from the Centers for Disease Control and Prevention
• Contraceptive Clinical Trials Network (CCTN)

Understanding Research

A clinical trial is a research study. The plan for a clinical trial is called a protocol. The protocol defines the type of study, how the study must be conducted, and who may participate. Some clinical trials may only require the completion a questionnaire; others may require that blood tests or certain medications; while still others may involve more extensive treatment. Study participants are given complete information about the type of clinical trial, what will be required, and what the potential risks and benefits might be. Clinical trials are not meant to take the place of the participant’s usual medical care, nor are they meant to conflict with any care she may currently be receiving. All clinical trials are conducted with the participant’s health care team.

Why join a clinical trial?

There are many reasons why people volunteer to become a part of a clinical trial. Some people volunteer because they may be helped by a new treatment or procedure. Still others join because they want to help in the discovery of new treatments, procedures, or medications that may help patients in the future. Without the help of people like you, progress to develop better disease treatments cannot be made. Regardless of the reason, the extra care and study drugs that are provided in a clinical study are at no additional cost to you.

How do I know if I am eligible to participate?

Each study has its own special set of standards that must be met before a person can participate. Trained research personnel carry out a screening process to determine which patients can fulfill these standards.

The questions that are usually asked include: age, weight, medical history, current medications, and history of medication reactions. For our family planning studies, we often also ask about your sexual history, periods, and birth control methods. In some cases, laboratory studies or a physical exam may need to be done to ensure that you have no medical problems that would prevent you from participating. If you qualify, you will be asked to participate in the study.

What are my rights and responsibilities?

At UPMC Magee-Womens Hospital, every clinical trial involving people must be reviewed and approved by the Institutional Review Board. Members of this committee, made up of both medical professionals and people from the community, review all aspects of the clinical trial before participants become involved. The purpose of this committee is to protect your rights and to prevent you from being harmed or exposed to unnecessary risks. The federal government and UPMC Magee-Womens Hospital Institutional Review Board require that all people participating in clinical trials completely understand the trial before they become involved in it. Each participant receives a consent form that outlines the purpose of the clinical trial as well as the risks and benefits. This consent form will clearly identify the frequency of tests and the visits involved as well as how long the trial is expected to last. It will also explain your rights and responsibilities.

The best time to ask questions and express any concerns that you might have is when the investigator reviews the consent form with you. If you do not understand any part of the study, do not agree to participate or sign the consent form until you receive the information you need. The consent form will specifically state that you can decide not to participate in the study or you can leave the study at any time, without penalty. No matter what you decide, whether to participate or not, your decision will not affect the care you would normally have received. You will be given a copy of the informed consent form to keep.