What Is Informed Consent in Clinical Trials?

Western medicine is guided by a set of strict ethical guidelines that dictate, when, where, and how medical practitioners can interact with patients. These guidelines are designed to protect patients from abuse and to ensure maximal patient safety in clinical settings.

Maintaining these ethics is most important, perhaps, in the context of clinical trials, which, by their nature, involve experimental treatments.

One of the pillars of medical ethics is informed consent – the requirement that patients understand all the potential risks and benefits of any treatment and accordingly give their consent based on that knowledge.

Let’s explore how informed consent works in clinical trials.

What is informed consent?

We’ll start with the basics: what is the fundamental definition of informed consent?

The American Cancer Society describes informed consent in this way:

“A process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services.”

What are the legal justifications for requiring informed consent?

After the horrors of Nazi medical experimentation on prisoners, and America’s own dark history of similar experimentation on vulnerable populations, the concept of informed consent has become a cornerstone of international law:

“Informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to…  research involving human being[s] as subjects for study.”

Basically, every American patient, under law as well as under the medical licensing rules that healthcare providers must adhere to, has the right to ask questions regarding their healthcare and to have those questions answered to the best ability of the healthcare provider – before receiving care.

The medical treatment cannot begin until the patient, on the condition that he or she is legally able to make such decisions, understands all aspects of the procedure and actively consents.

Of course, not all questions regarding risks and efficacy are entirely answerable – especially in clinical trial settings, where the entire purpose of administering treatments is to discover how effectively they work, and what unwanted side effects they might produce.

What are the ethical justifications for requiring informed consent?

The most basic ethical precepts dictate the necessity of informed consent, most notably the concept of human autonomy:

“The concept of consent arises from the ethical principle of patient autonomy and basic human rights. [The] patient has all the freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way. Even a doctor can only act as a facilitator in patient’s decision making.”

How does informed consent factor into clinical trials?

Clinical trials are intended to answer questions that, at that point in the research process, do not have documented answers. Here are the questions that researchers in clinical trials seek to answer through their work:

  •  Is an innovative new treatment worth the potential downsides? Do the potential benefits outweigh the potential negative side effects?
  • What is the ideal dose, frequency of dose, method of administration, etc. to achieve optimal results?
  • Is the proposed treatment effective at treating the condition it is intended to treat?

What should patients know before giving informed consent?

Medical ethics requires that clinical trial participants know, to the greatest extent possible, the risks and potential benefits of the clinical trial they enroll in.

Here is the basic information patients should have in order to make an informed decision:

  •  How the research plan works
  • What investigative work the research team will perform on them
  • What discomforts/risks they might expect
  • Participation in the trial is entirely voluntary and patients can remove themselves at any point

Here are a few key considerations that patients should be aware of before giving their informed consent to participate in a clinical trial:

  • You are assuming some degree of inherent risk in accepting a yet-unproven treatment
  • The treatment may not benefit you
  • You are participating in a medical experiment, which is likely a very different experience than you would expect in a conventional medical setting

What information should clinicians provide to patients before beginning a clinical trial?

By necessity, informed consent can only be given when the patient fully understands key information. Here is the information that clinicians are required to provide to patients before they begin the trial:

  • Explanatory statement regarding the experimental nature of the trial
  • What the research seeks to achieve (purpose)
  • Duration of the research
  • A detailed explanation of all the procedures to be performed in the trial
  • List of all reasonably predictable risks
  • Types of discomfort the patient might experience
  •  Information regarding alternative therapeutic approaches that might benefit the patient

Those are just a few examples of the information patients should expect to receive before a clinical trial. It’s your right to know and understand all aspects of the nature of the medical research you participate in before undergoing treatment.

Serious researchers take their legal and ethical responsibility to provide this information seriously.

Informed consent does not release doctors or researchers from all liability

When patients enlist in even the most well-designed clinical trials, they understand that they might encounter negative health effects from the treatment. Discovering potential unwanted health impacts of a proposed treatment under investigation, after all, is one of the main reasons for such trials in the first place.

However, participants’ provision of informed consent does not release institutions and individuals from legal liability if they commit medical malpractice or other forms of negligent behavior.

Exceptions to informed consent

There is one major legal exception to informed consent: researchers must alert prospective participants to all reasonably predictable risks associated with a trial, but not risks associated with the incorrect administration of care.

Via American Medical Association Journal of Ethics:

“While a physician is required to disclose all reasonable information, he or she is not required to disclose a risk that is not inherent in proper performance of the procedure—a risk, in other words, that would result only from the procedure’s being performed incorrectly.”

That’s just one of the many reasons why selecting a reputable, professional research group and vetting the organization carefully before enrolling in a trial is so important.

Contact Northwest Florida Clinical Research Group to learn more about informed consent

We’re always ready and willing to discuss all aspects of the clinical trial work we do. To learn more about informed consent and how it works, please don’t hesitate to contact Northwest Florida Clinical Research Group.Also, if you’re interested in giving your informed consent to become a part of the exciting work we perform to develop and refine innovative treatments for difficult neurological conditions, head over to our Clinical Trials page.

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