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What is Informed Consent in Clinical Trials?

October 5, 2022
What is Informed Consent in Clinical Trials?
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Informed consent is a fundamental ethical practice that most states require for medical professionals before performing serious medical procedures or treatments on a patient. More often than not, a patient—or guardian in certain circumstances—will receive a form from their medical provider before the visit outlining the treatment or procedure, the risks and benefits, and if there are any alternative courses of treatment that can be performed.
Informed consent is required as a standard of practice, and variations exist in both the legal and medical realms.

Informed consent is crucial in enrolling in a clinical research trial because it gives the potential participant all the information needed to understand what they are participating in. Without informed consent, the participants may not fully understand what they are volunteering for.

It is very important for people considering participating in a clinical research trial to understand their role in the study. These studies test the safety and effectiveness of new treatments on people. Because of this, participants need to know that they act as human subjects in a clinical research study, not as patients.

Although volunteers may receive personal treatment and care from doctors throughout the trial, they must also be informed that:

  • There are several risks involved in clinical trial participation
  • Benefits are not guaranteed by the research team
  • They have the right to quit the clinical trial at any time
  • The study may not follow the standard medical procedures

This information provided in the informed consent process allows you to know what you are signing up for.

No matter what type of clinical trial you are participating in, you are entitled to informed consent through the Patient Bill of Rights, including but not limited to:

  • The right to safe, considerate and respectful care and attention
  • Volunteer confidentiality
  • Complete information (including protocols, risks, and benefits), explained in a way that is understood by all volunteers
  • Appropriate diagnosis and treatment of pain and discomfort
  • A medical summary will be sent to your physician once the trial has concluded

As a clinical study volunteer, you also maintain the right to quit a trial at any point. However, you may need to check with your research team for any adverse effects that may take place if you are not present for the entire duration of the trial.

Aside from the Patient Bill of Rights and informed consent procedures, other safeguards protect the rights and safety of any clinical study participants. The Protocol Review Process makes sure that all protocols must be reviewed and approved by an institutional review board (IRB) before a trial can begin. There is also a Patient Representative. They facilitate communication between the patient and the hospital. They are also readily available to discuss any issues with the volunteer.

Do your research before joining a clinical trial to ensure that you are making an informed decision. As a clinical trial participant, you will always have the right to know the answers to important questions—you have the right to ask the clinical study team any questions you have at any point in the informed consent process.

The term informed consent is often mistakenly viewed as the same as getting a research participant's signature on the consent form. The FDA believes obtaining a research participant's verbal or written informed consent is just a part of the informed consent process. Informed consent involves providing the potential participant with:

  • Adequate information to allow the potential participant an informed decision about participation in the clinical investigation.
  • Assisting the potential subject's understanding of the information.
  • Enough time to ask questions and discuss with your loved ones the research protocol and whether or not you should participate.
  • Obtaining informed consent from the potential participant's voluntary decision to participate.
  • Continuing to provide further information as the clinical investigation progresses or as the subject or situation requires.

In order to be effective, the informed consent process must provide sufficient opportunity for the participant to consider whether to participate. The FDA considers this to include allowing enough time for participants to evaluate the information and giving time and opportunity for the potential participant to ask important questions and have them answered. The investigator (or other research team members conducting the informed consent interview) and the participant should discuss the contents of the informed consent form. This process must occur under situations that minimize the possibility of pressure or undue influence.

When applicable, one or more of the following elements of information must also be provided within the informed consent form:

  • A statement that the research treatment or procedure may involve unexpected risks (to the participant, unborn baby, if the participant is or may become pregnant).
  • Any reasons why the research subject's participation may be terminated by the clinical trial investigator (e.g., failure to follow the requirements of the clinical trial or changes in lab values that fall outside the clinical trial limits).
  • Added costs to the research participant that may result from participating in the trial.
  • The consequence of quitting a trial before it is completed (e.g., if the research and procedures need a slow and organized end of research participation).
  • A statement that findings discovered during the clinical trial will be provided to the clinical research subject.
  • The approximate number of research participants that will be enrolled in the study.

The potential research subject must have an opportunity to:

  • Read the informed consent form.
  • Ask questions about anything they do not understand.

Usually, if someone is considering participating in a clinical trial, they may take the consent form home to discuss with family, friends, or advocates.

A study investigator should only obtain consent from a potential research subject if:

  • Enough time was given to the potential research subject to consider whether or not to participate.
  • The investigator hasn't persuaded or influenced the potential research subject.

The information must be in a language that is understandable to the research participant.

Informed consent may not include language that:

  • The research participant is made to ignore or appear to ignore any of the participant's legal rights.
  • Releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Participating in clinical research trials is voluntary. You have the right to refuse treatment or to quit the clinical trial at any time. Read the informed consent form carefully. Ask important questions about any information you don't understand or find confusing.

Call Santos Research if you are Interested in Enrolling in a Clinical Trial

Participating in clinical trials helps in discovering the medicines of the future.

If you are interested in Paid Medical Trials at Santos Research Center, Corp., please contact us at (813) 249-9100 or visit us at 5927 Webb Rd Tampa FL 33615.

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Santos Research Center, Corp. is a research facility conducting paid clinical trials, in partnership with major pharmaceutical companies & CROs. We work with patients from across the Tampa Bay area.

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