Experts Explain What We Need to Know About Informed Consent


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Consent is defined as: permission for something to happen or agreement to do something. In the issue of medicine, it involves a patient providing permission for a treatment or for a clinical procedure. Informed consent is the legal and ethical requirement of doctors before they can proceed to do something to a patient or a participant. This should be provided as: written, oral, and implied.

Why informed consent is very important in a clinical trial?

Informed consent is a signed document a clinical research institution must get from each individual that will be participating in a study. It is federal law to have written informed consent before any person can take part in any clinical trial. Signing an informed consent form is a written agreement that you or your representative fully understand the parameters of a given trial and are willing to participate in the study. However, the informed consent process does not simply involve signing a form. It also involves asking questions and speaking with the physicians to make sure you fully understand what you agreeing to. Before you can make an informed decision about enrolling in a clinical trial, the FDA requires that you are made aware of certain information:

You are voluntarily participating

The risks that will be involved with the study

What your role in the study is

How the study will be conducted

Meanwhile, a group called ICAN or Informed Consent Action Network stated:  

At the Informed Consent Action Network, you are the authority over your health choices and those of your children. In a medical world manipulated by advertising and financial interests, true information is hard to find and often harder to understand. Our goal is to put the power of scientifically researched health information in your hands and to be bold and transparent in doing so, thereby enabling your medical decisions to come from tangible understanding, not medical coercion.

From Joanna Morales ESQ – Cancer Rights Attorney

When you’re considering a particular treatment or procedure that is being offered to a clinical trial, you can’t receive that treatment or procedure until you’ve gone through the informed consent process. So nothing can begin until you have actually agreed to participate and sign these legal documents.

The informed consent document is part of a larger process where people are being given information about the process of the study about possible risks and benefits and about the patient’s rights involved in participating in a clinical trial.

The informed consent document is going to give you information about the risks as well as the benefits of participating in a clinical trial and the risks that you might see in an informed consent document are going to be specific to the treatment or procedure that’s being provided.

When a patient signs in an informed consent document, they are not signing away their rights. They are actually gaining some rights; their right to privacy, their right to ask question as the clinical trial moves forward and information about participating in a clinical trial. While it protects the patient and it protects the provider, it doesn’t require a patient to give up their right to protection if their healthcare providers do something negligent in their care.

A patient might want to drop out of a trial because of how they’re experiencing a procedure. So if they had a particular treatment that they are not responding well to or it’s particularly difficult for the patient, they might decide that they don’t wanna participate in a clinical trial and that’s perfectly fine. It’s up to the patient to decide how they want to move forward.

If at any point you decide it’s not something that you want to participate in, you don’t have to. You don’t have to sign that document and you don’t actually have to participate in a trial. So you can go back to your healthcare team and say “this isn’t for me” and “maybe there’s something else that is available to me” and to talk to them about what your other options are.  

From Arthur Caplan, PhD – Medical Ethicist, NYU

There could be extra steps, more measurements, more tests and that certainly something you should be told about and give your permission to do.

Another core part of informed consent is that you understand you can drop out; you understand you can leave without penalty.

What I try to tell researchers all the time is that a signature is not informed consent. Informed consent is a process; its communication; its understanding.

You choose to do it and we want you to have integrity because it’s a very generous thing when people agreed to be in research.  

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