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Informed Consent: What it Means to You

There are many research centers working closely with treatment centers across the United States and throughout the world. These centers play a crucial role in the prevention and treatment of many serious illnesses such as Alzheimer's Disease, cancer, diabetes, heart disease, and HIV/AIDS. Health professionals depend upon new information that comes from scientific research to learn better ways of treating diseases. In many cases, the goal of research is to determine if a new drug or medical procedure is more beneficial than the current standard.

Prior to participating in a study, you may be approached by one of the research staff at your treatment facility about a study that may be of interest to you, or you may come across a research project that is listed at the research center. If you are interested and eligible for the study, you and the research staff begin the process of informed consent.

Informed Consent - Not Just a Piece of Paper

Informed consent involves more than just signing a document. Informed consent is a process that includes on-going conversations between the potential participant and research staff regarding the clinical study to give you the opportunity to make an informed decision about participating in the research.

Informed consent helps ensure that the research is ethical and adheres to government standards. Informed consent is based on the ethical principle of respect for persons. Informed consent recognizes the importance of individual autonomy, the belief that individuals are able to make self-determined and rational decisions.

Elements of Informed Consent

There are four key elements to informed consent:

Communication: Information about the study is communicated to the potential research participant.

Comprehension: Refers to the ability of someone to understand what was explained. Individuals must have the opportunity to ask questions about the study and the informed consent document must be written in lay language, free of technical jargon. A research participant must be competent to give consent, or have an advocate assigned to them if unable to give consent.

Voluntariness: A person must also voluntarily agree to participate in a study. Individuals should not be coerced to participate or promised benefits unlikely to result from participation.

Consent: Individuals must authorize their participation in a study, usually in writing, by signing the informed consent form.

The Informed Consent Document

The consent form is a legal document designed to protect you and other participants by providing information about the study to enable you to make an informed choice. It also informs you of your rights as a research participant. Participation in any clinical study is voluntary, and even if you decide to participate in the study, but later change your mind for any reason, you are able to withdraw from the study.

To assist people considering participating in a study, the informed consent document should always include the following information about a research project:

Although reading the consent form may seem intimidating, it is important to take the time to understand what is being explained about the study. The research staff is knowledgeable and happy to answer any questions you may have about the study after reading the form. The informed consent process is designed to provide the information you need in making the right decision for you.

Prepared in partnership with Tiffanee Wright, MPH, Department of Bioethics, Case Western Reserve University.

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Last Reviewed: May 15, 2011

Patricia A Marshall, PhD Patricia A Marshall, PhD
Professor of Bioethics
School of Medicine
Case Western Reserve University