In this section about informed consent, I will cover two types of forms you may end up signing. The first is one is the consent form which you may be asked to sign by a hospital during your stay and the second is the form signed before undergoing clinical research. It is important not to confuse the two, in addition to knowing what it means for you when you do sign the form.
First and foremost, a consent form is just a piece of paper, and while pieces of paper tend to carry an almost mystical authority for many people, it should be known that these forms in particular are not necessarily binding in many important respects. In most cases, forms are a way for the hospital or physician to show that information exchange took place, and the patient subsequently consented to the procedure. This gives all the more reason to make sure you have the information detailed in the first part of this series prior to signing anything when at all possible.
For consent forms themselves to have any power, they must still follow the guidelines mentioned before. The more general the information and authorization a form is, the less relevant it is. For example, signing a blanket consent form that authorizes the hospital to perform any and all procedures on your body is next to useless. Your signature does not mean that the standard of informed consent outlined by the courts no longer applies. Another thing to keep in mind is that a consent form is not a binding contract, meaning you can back out of a procedure even after you’ve signed the form. This is generally discouraged, and patients should very carefully consider their choices prior to consenting to a medical procedure, but it is still your legal right to refuse treatment at any point that it is possible to do so (it’s probably too late if you are already on the operating table and under sedation). People have a right to deny treatment, even when doing so will result in their death.
Informed Consent Forms for Research
The reason that consent forms are different for clinical research is that they are required by Federal regulations, and therefore must include certain information. The same principles apply in research as they did with any other medical procedures, and once again they are based on patient autonomy. Autonomy rests on the basic notion that persons should be treated with respect, which includes considering them capable of making decisions that impact them. If you don’t believe this, then I’ll go ahead and make the decision for you and say you should.
Medical research is obviously very important, but a large share of responsibility is left to the individual participants to safeguard their own interests against those of the researchers. One of the requirements for research to be conducted is something called clinical equipoise. This concept means that there is both sufficient reason to believe that the intervention will not induce harm, balanced by sufficient lack of evidence that there is a great benefit. After all, if you know for a fact that something will attain a certain goal, research would be unnecessary. For this reason, be sure to understand, at minimum, the intent, likely outcome, and risks of any trial or experimental procedure you undergo. This involves reading the informed consent form carefully, and discussing anything that is unclear to you with the researcher. Taken directly from “The Rights of Patients”, here is a list of things you should find and understand on a consent form when participating in research.
- A statement that the study involves research, an explanation of its purposes and the expected duration of the subject's participation, and a description of the procedures to be followed, identifying which are experimental;
- A description of reasonably forseeable risks or discomforts to the subject;
- A description of any reasonably expected benefits to the subject or to others;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation about any compensation or medical treatments available if injury occurs;
- An explanation of whom to contact for answers to questions about the research and research subject's rights, and whom to contact in the event of a research-related injury;
- A statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits; and that the subject may discontinue at any time without penalty or loss of benefits to which the subject is otherwise entitled.1
And again, here are some external sources for your consideration.
Example of a hospital consent form (note how broad it is)
Example of a research consent form
Guide to Informed Consent from the National Cancer Institute.
1. Annas,George, "The Rights of Patients" p209-210
