Informed Consent In Clinical Research

Many people might perceive informed consent as a simple signature, although it goes beyond that. While it involves getting verbal or written consent from a research participant, there are other factors involved. Perhaps you have a clinical trial coming up and wish to understand the informed consent process. In that case, you may read on to find answers to your questions.


What is the informed consent process?

Informed consent refers to a signed document that a person receives from a clinical research institution before participating in clinical trials. While it can be verbal, implied, or unanimous, the Federal Law emphasizes the written form for easy reference. Informed consent also means that you have fully understood the parameters of a given trial and are willing to participate.

Before you decide to participate in a study, the Food and Drug Administration (FDA) requires you to obtain the following information:

  • The risks involved in the study
  • Your role in the study
  • The manner of the research conducted
  • Your voluntary participation in the study

Fortunately, you’ll have ample time to ask all questions relating to the study and discuss with your family and friends for their support. If you decide to continue, you’ll be required to sign a written informed consent document along with your legal representative, after which you’ll receive a copy.   You can withdraw your consent without any repercussion.


Why is informed consent necessary in clinical research?

Due to the clinical research’s nature, it’s crucial to understand what you’re volunteering for and its risks. You also need to know their roles in the whole process and what you should and shouldn’t do. Because these trials are intended to ascertain the efficiency and safety of new therapies and treatments, you must understand that you aren’t a patient but a test subject.

While patients may receive treatment from physicians during the trial, you should also be aware of the following:

  • The study may not follow typical medical procedures
  • You’re not guaranteed any benefits
  • You can withdraw from the trials at any time
  • There are risks involved in clinical trials

The informed consent process gives you detailed information on what to expect and how to embrace them for an informed decision.


What does an informed consent form entail?

While informed consent forms differ among clinical research institutions, they should have basic information like the purpose, duration and risks involved in a trial. It should also contain the trial costs, procedures description, substitute care options, and participants’ rights. Additionally, it should state if the participant will be informed of emerging research finds, and the number of participants enrolled for the trial. Confidentiality should also be documented in the form to protect participants’ identities.


What else should you know about informed consent?

You should be aware that an informed consent form must not contain language that could cause you to ignore your rights or release the institution from liability due to negligence. You have the right to ask questions to clear your doubts or opt out of the trials should you feel threatened.

If you wish to volunteer for a clinical trial, you may partner with HRMD Research, as they adhere to industry standards while ensuring the participants’ safety. You may visit for more information on clinical trials processes.



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Written by HealthStatus Crew
Medical Writer & Editor

HealthStatus teams with authors from organizations to share interesting ideas, products and new health information to our readers.

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