Federal regulations have been created to protect the well-being and rights of volunteers in biomedical research. These regulations (Title 45 Code of Federal Regulations Part 46 or 45 CFR 46) say no investigator may involve anyone as a subject in research without getting that person’s informed consent, either directly or from the person’s legal representative.
A researcher must ask you to sign a written informed consent form in which you agree to take part in a certain study. The form contains a description of the study, possible risks, and benefits of the research. The director of the research must prepare the form and an IRB must approve it. The researcher must then go over this form with you and get your permission to enter you into the study.
Having a mental disorder does not necessarily mean that a person cannot understand and see the value and risks of taking part in research. Most people, therefore, who enter research studies on mental disorders can provide informed consent. Additional guidelines and safeguards exist for patients who are not able to give their permission with full understanding. In those cases consent is obtained both from the participant and the legally authorized representative.
Informed consent is not a one-time event, but a continuing process. Throughout a study, the research team must continue to provide information about participating in the study. They must respond to any questions you have about the research and inform you if any new risks are identified. You may, at any time, reappraise your decision to take part in the project and withdraw your consent. It is advisable to discuss any concerns with the director of the study.
Every informed consent form developed by an investigator and submitted to an IRB for approval must include eight basic parts. These parts are:
- A statement that the study involves research and that tells what its goals are, how long the research will last, and what methods will be used.
- A description of any reasonably foreseeable risks or discomforts you could experience as a result of the research.
- A description of any benefits that the research may be reasonably expected to yield to you or to others.
- A description of alternative courses of treatment, or therapies, if any, which might help you.
- A statement describing how the researcher will protect the confidentiality, or privacy, of your medical records.
- For research in which risk is somewhat more likely than you would expect in routine health care, an explanation and description of the availability of compensation or medical treatments if injury occurs.
- The name and phone number of the person to contact about the research and your rights, and whom to contact in case the research causes an injury.
- A statement that your taking part in the research is voluntary, and that if you change your mind, or quit later on, you will not be penalized in any way, or lose any benefits you have coming to you.
The informed consent process must include the following items when they apply to you:
- A statement that the particular treatment or method used may not work as planned and may be risky for you.
- The reasons why the investigator might have to drop you from the study without asking you first.
- A list of any extra charges you may have to pay to take part in the research.
- A description of what would happen if you decide to drop out of the study, and what the researcher will do to make sure you keep receiving appropriate treatment if you do drop out.
- A statement that you will be told of any important results of the research which may help you to decide whether to continue taking part in the study.
- Approximately how many subjects are in the study.
Clinical researchers try to write informed consent forms that are brief and understandable by people without scientific or medical training. Even so, some informed consent forms appear long and complicated. Thus, it is important that you are given the opportunity to read the form thoroughly, perhaps discuss it with a family member or a trusted friend, and raise any questions you have with the investigator. We hope you will feel comfortable talking to the investigator or other members of the research team and asking questions until you are satisfied that you understand the informed consent form.
Some investigators prepare additional material to help research subjects understand the contents of an informed consent form. These might include, for example, a videotape that describes the illness under study, the research project, and the methods it will use. There may be a short quiz you can take to help identify issues you wish to discuss further with the researcher. You may be able to complete such a quiz at home at your convenience. If these ideas sound useful, ask the director of the research if these or similar items are available. You can ask for a copy of the protocol to take home to discuss with family members, your physicians and others.