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A Guide to Understanding Informed Consent
 
If you and your physician have found a clinical trial that is of interest to you and for which you are eligible (that is, you meet requirements such as age, treatment history, overall health, and others), you will need information in order to make a decision about whether to participate in the trial. Making a decision about participating in a research study involves understanding the potential risks and benefits as well as your rights and responsibilities. The presentation and discussion of these important issues are part of the process called informed consent. This guide will tell you what to expect during the informed consent process, explain its importance to clinical research participants, and describe how it fits into a larger system that protects the welfare of people who take part in clinical trials.
 
 
Introduction
 
A Definition of Informed Consent
 
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.
 
The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial's purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.
 
 
Safeguards
 
Informed Consent and the Larger System of Protections
 
Informed consent for clinical trials is just one part of a larger system in place to safeguard people who want to help researchers evaluate new practices that may improve treatment, supportive care, screening, and prevention, while perhaps benefiting from these new methods. This system ensures that clinical trials are conducted ethically, without undue risk to participants. What follows are links to some of the resources that contribute to this system of protections.
 
Institutional Review Boards
 
Institutions have an Institutional Review Board (IRB) made up of medical specialists, nurses, social workers, medical ethicists, and patient advocates. The IRB reviews all clinical trial protocols and approves only those that address medically important questions in a scientifically and ethically responsible manner. It also reviews all informed consent documents to make sure that they provide clear and complete information for those who may wish to take part.
 
Regulatory Guidelines and Law
 
You may find additional information on the Regulatory Guidelines and Law on the Research Ethics Office of the McGill University Health Centre https://muhc.ca/cae/research-ethics
 
Ombudsman
 
The MUHC has three ombudsman to assist patients and their families by investigating and helping to resolve complaints. Acting as a resource to staff, the ombudsman are available to help those who may have questions about patients' rights or need advice to help resolve a conflict. The patient complaint system is governed by Québec law, which is available here.
 
 
The ombudsman may be reached at:
 
Montreal General and Montreal Neurological Hospitals     (514) 934-8306
 
The Montreal Children's Hospital                                       (514) 934-1934, local 22223
 
Royal Victoria Hospital and Montreal Chest Institute          (514) 934-1934, local 35655
 
                                            
What to Expect
 
What Should I Expect During the Informed Consent Process?
 
According to The Belmont Report, the informed consent process relies on three principles:
  • adequate information is provided (generally, what a "reasonable person" would want to know to make a decision);
  • participants comprehend the information; and
  • consent is given voluntarily.
 
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. 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. You may be given a video, audiotape, or even interactive computer programs to help you better understand the information in the consent document.
If your child (under age 18) is the one who will participate in the clinical trial, you will go through this process on his or her behalf. More and more frequently, children over the age of 6 are being asked to give their "assent" to participation as well. If this is the case, you will be asked to give permission for your child to take part in the assent process. During this process, a child or teenager is provided with a form that explains, in concrete and age-appropriate terms, the purpose of the research, what they will be asked to do, and what procedures they will undergo. Usually, a nurse or other heath professional also explains the information and gives the child a chance to ask questions. Then they are asked to indicate their assent either by signing the form or making a mark in a specific place.
  • 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 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.
 
Other Useful Tips
  • Keep a copy of the informed consent document as a helpful resource for the duration of the trial. Ask for a copy if one isn't offered to you. You may also request a copy of the protocol (full study plan).
  • According to Federal regulations, no informed consent document may include any language that asks or appears to ask you to waive your legal rights, or that releases or appears to release the investigator, the sponsor, or the institution from liability for negligence.
  • If you cannot understand the forms you are signing, don't be afraid to let someone know that you are having trouble. If you have difficulties reading the document at first, try not to get upset. Many people feel anxious about reading and signing documents and communicating with physicians. Just take your time and ask for help when you need it.
 
The Web site of the National Cancer Institute (http://www.cancer.gov)