What Is Informed Consent For You As A Patient In Clinical Trials?

Informed consent is more than just a written agreement or approval from you. As a patient or participant in a clinical trial or investigation, you should be presented with sufficient information to make a well-informed decision. This is the basis of informed consent.

Information required to give your consent

To make a well-informed decision, you should not only get sufficient information but also enough time to think it over and discuss it with friends or family. This should, among other things, include the following:

  • What will be done to you during the clinical trial
  • What the research plan looks like
  • The purpose of the research
  • The length of the trial and participation
  • A description of the steps following your consent
  • Risks you may be subject to
  • Potential health and treatment benefits
  • If any compensation or treatment is available
  • Your rights as a participant in the trial

This information should also be presented to you in a way where you understand the meaning. Technical language or medical terms that you do not understand does not qualify as providing you with all the needed information. You should also have the possibility to ask any questions you feel you need answers to.

Your decision to partake in a clinical trial should always be voluntary, never forced or coerced. Throughout the entire process, you should also be provided with the information you inquire about relating to the clinical investigation.

What is the purpose of a clinical trial?

The purpose of a clinical trial is to find out if new medical devices are safe and if the benefits of using them outweigh the risks involved for the patient. Clinical trials also aim to establish how these devices should be used, on whom, and for what.

To summarise, clinical trials study the use of medical devices or medical products in real people. So, as a participant in a clinical trial, you need to understand that you are essentially used to studying and learning more about a certain product.

It is possible that you can receive helpful treatment in this process, but there are also unknown risks involved. Exactly what these risks are can only be answered by the research team or doctor conducting the trial.

What can be tested during a clinical investigation?

Medical devices are not the only products that can be tested during a clinical investigation. Other medical products such as medications and other treatment options can also be investigated during a clinical trial.

Are you thinking about participating in a clinical trial?

People decide to partake in clinical investigations for many different reasons. Some simply want to volunteer to help advance science; others are looking for alternative treatment options to what is currently available on the market.

Whatever your reason, all clinical trials have specific eligibility criteria, meaning there are certain requirements you will need to fulfill to be suitable for a particular trial. You can usually find these criteria in the details of the trial, and exceptions are rarely made if you do not meet them.

Where can I find clinical trials?

There are several ways of finding clinical trials. If you are looking for a trial as a treatment for a disease or illness, you may want to discuss options with your physician.

If you are interested in joining a clinical trial for other reasons, perhaps as a volunteer, you can also search for various options online in your country and region.

Before you decide to participate in a clinical investigation, ensure that you have received all the relevant information you need and have had the time to consider it before you give the research team or doctor your informed consent.

Helpful Resources:

  • https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601699/
  • https://www.webmd.com/a-to-z-guides/what-to-know-informed-consent-clinical-trials

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