You may already have experience with signing consent forms for other kinds of medical procedures, such as surgery, or for cancer treatments such as radiation or chemotherapy. However, informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process.
The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You can keep a copy and use it as an information resource throughout the course of the trial.
While informed consent documents do vary from place to place, they should communicate all of the information described below in language that you can understand, with some help from the research team (if needed). Even if your trial is not federally funded and therefore not governed by these regulations, you should know that any scientifically valid trial will provide an informed consent document that supplies the following information:
PURPOSE (Why is this clinical trial being done?)
DESCRIPTION OF PROCEDURES (What is involved in the trial?)
DURATION (How long will I be in the trial?)
RISKS (What are the risks of the trial?)
BENEFITS (Are there benefits to taking part?)
ALTERNATIVES TO PARTICIPATION (What are my options if I don’t participate?)
COSTS/ADDITIONAL EXPENSES (This section indicates whether participating in the trial will result in added costs to you or your insurance company. It also covers other cost issues, such as who will pay for emergency medical treatment in case of injury or illness, whether you will have to pay for drugs that become commercially available during the trial and whether or not you will receive payment for participating.)
PARTICIPANT’S RIGHTS (The document should specify that your participation is voluntary; you can choose not to take part or leave at any time without penalty or loss of benefits; and any new information that might affect your participation will be shared with you.)
CONTACT INFORMATION (Whom do I call if I have questions or problems?)
SUPPLEMENTAL INFORMATION (Where can I get more information?)
PATIENT SIGNATURE LINE After four years of work , the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research issued a detailed report that sets forth three principles underlying the ethical conduct of research. According to The Belmont Report:
- adequate information is provided to the prospective participants (generally, what a “reasonable person” would want to know to make a decision);
- prospective participants comprehend the information provided; and
- formal consent to enroll in the trial is given voluntarily by the patient.
While this process varies among different research institutions and clinical centers, you generally should expect the following:
An initial meeting during which a member (or members) of the research team provides you with the informed consent document and explains its content to you. This discussion may also include your oncologist (cancer specialist) and primary care doctor, as well as a nurse, social worker, patient representative, and/or staff psychologist. You may wish to bring along a family member or friend for support, and to help you keep track of the information presented. This information should be given logically and at a comfortable pace, with plenty of time allowed for you to consider it and ask questions.
Time to digest the information. It can be very difficult to absorb this information in one sitting, especially at a time of emotional distress. You should be given a copy of the document so that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors.
Assessment of your understanding. The research team should take some steps to ensure that you comprehend the information, either by having you fill out a questionnaire, asking you questions orally, or having you explain certain aspects of the trial in your own words. You also should alert team members to anything you do not understand. If you find that the document is written in words that are too difficult for you, don’t hesitate to let them know that.
Opportunities to ask questions. Both during the initial meeting and in follow-up discussion(s), you should be given the chance to ask questions and raise concerns. Keep asking questions until you have all the information you need to make your decision.
Continuing updates on new information. As the trial proceeds, the research team may discover new information that could affect your health, welfare, or willingness to remain in the study. They will share this with you and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information leads you to have doubts about continuing to participate.