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The Process of Informed Consent: What Does it Mean?

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 Alzhiemer'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 trial, 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 trial 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
Comprehension
Voluntariness
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 trial is voluntary, and even if you decide to participate in the trial, 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:

Purpose of the study
Procedures
Risks and benefits
Alternatives to participating
Confidentiality
Patients’ rights
Study contact information

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.

Questions You Should Ask About Participation in a Study

The following is a list of useful questions (provided by the National Cancer Institute) that you may want to explore with the research staff when considering participation in a clinical trial. Many of these questions may be addressed in the informed consent document.

The Study

What is the purpose of the study?
Why do researchers think the approach may be effective?
Who will sponsor the study?
Who has reviewed and approved the study?
How are study results and safety of participants being checked?
How long will the study last?
What will my responsibilities be if I participate? Whom can I speak with about questions I have during and after the trial? To find out the study results?
What steps will be taken to protect my privacy and the confidentiality of my medical records?

Possible Risks and Benefits

What are my possible short-term benefits?
What are my possible long-term benefits?
What are my short-term risks, such as side effects?
What are my possible long-term risks?
If I do not want to participate in the study, are there other options available to me?
How do the possible risks and benefits of this trial compare with those options?

Participation and Care

What kinds of therapies, procedures and /or tests will I have during the trial?
Will they hurt, and if so, how long?
How do the tests in the study comare with those I would have outside of the trial?
Will I be able to take my regular medications while in the clinical trial?
Where will I have my medical care?
Will I have to be hospitalized? If so, how often and for how long?
Who will be in charge of my care?
What type of follow-up care is part of the study?

Personal Issues

How could being in the study affect my daily life?
Can I talk to other people in the study?

Cost Issues

Will I have to pay for any part of the trial such as tests or the study drug?
If so, what will the charges likely be?
What is my health insurance likely to cover?
Who can help answer any questions from my insurance company or health plan?

No one, not even medical professionals, can predict whether the treatment under evaluation in the study will prove successful. This is a serious decision. Before agreeing to participate in a study, you should feel free to take the time to discuss the study with your doctor and trusted support members. Your doctor may be able to give you helpful information, but recognize that only you can decide if the study is right for you.

Source: National Cancer Institute - A Checklist of Questions to Ask the Research Team

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

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Last Reviewed: Apr 25, 2007

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