How to Read a Consent Form
Mary Jane Attridge and research coordinator Michele Barnard review a consent form
by Pamela Andrews
Self-help books, from "How to Be an Effective Parent" to "How to Make a Million Dollars," are some of the most popular items found in book stores. As a potential participant in clinical research, here are some guidelines about "How to Read a Consent Form" because giving informed consent is the first step to actually participating in a study.
After learning the basic information about a particular trial, and if you fit the participation requirements, and decide to join, you will be asked to read and sign a document, called an informed consent form (ICF), with detailed information that describes the trial process. You may request a sample copy of the consent form ahead of time so you have time to read it, to think about the information and to discuss it with a family member or friend. Because research consent forms are often many pages long, they can, at first, appear overwhelming and hard to understand. But if you remember the old adage, "How do you eat an elephant? One bite at a time," you should have no trouble reading and understanding a consent form.
The first step in navigating a consent form is to know it is written according to a "recipe" or template requiring specific information. The information is listed section by section, so reading one part at a time is like taking one bite of the elephant and chewing on it before going on to the next. The required sections of the form will explain the following information:
- PURPOSE: Goals of the trial such as "... to learn whether medicine XYZ will slow the progression of Parkinson's disease." This section will include basic information about the treatment or medication that is being tested in the trial.
- PROCEDURES: This section tells you how many clinic visits will be required and what will happen at each visit (physical exams, obtaining blood samples, etc), as well as how often you will take the study medicine and for how long. Frequently, there also is a chart or table that summarizes this information.
- RISKS AND DISCOMFORTS: Known risks and possible side effects of the medicine or treatment must be stated even if the chances of experiencing them are small.
- BENEFITS: No benefits can be promised or guaranteed from participation in a clinical trial. Possible benefits can be mentioned, however, including that by participating, you may contribute new information that could help other people in the future.
- ALTERNATIVES: Other treatments may be available and you may choose not to participate in the trial.
- CONFIDENTIALITY: The data collected in the study will be coded and not identified with your name.
- CONTACT INFORMATION: Used to aid in communicating with the research staff.
When reading a research consent form, it is helpful to mark or underline specific information, such as how many times you will go to the clinic, and to write notes or questions in the margin. Having a family member read the form, too, can be helpful to them as well as to you.
When you feel you understand the information in the consent form and have had a chance to ask questions about the study, you are ready to sign it with the research staff. You will receive a copy of the signed form which you should keep for future reference.
During the course of the study, the sponsors or a governing review board may make changes or additions to the consent form which will require your understanding and a new signature, so once again, you may have a chance to "eat an elephant." However, it should be easier the second time around!