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Informed consent in Clinical Research

“Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of the given procedure or intervention. The informed consent form must be in patients native language or can be explained for easy understanding.

In general Informed consent requires the patient or responsible party to sign a declaration confirming that they understand the risks and benefits of the procedure or treatment.

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The informed consent process means that when you know what to do, the health care provider has sent you specifics about the illness, along with monitoring and recovery choices.

This information can include:
  • The name of your condition
  • The name of the procedure or treatment that the health care provider recommends
  • Risks and benefits of the treatment or procedure
  • Risks and benefits of other options, including not getting the treatment or procedure

    Signing informed consent means
  • You have received all the information from your health care provider regarding your treatment options.
  • You understand the information and you have had a chance to ask questions.
  • Use this information to decide whether you plan to pursue the prescribed care option(s) explained to you.
    You can choose to only provide a portion of the prescribed treatment occasionally. Speak to the clinician about the choices.
  • By signing a consent form, you give your permission (agreement) if you agree to accept any or any of the care services. The submitted and signed form is a formal document that helps the doctor to follow up with the treatment plan.
Clinical Significance

Informed consent is required for many aspects of the health care.

These include consent for:

  • Treatment, 
  • dissemination of patient information, 
  • discussion of HIPPA laws, 
  • specific procedures, 
  • surgery, 
  • blood transfusions, and 
  • anesthesia.  

Obtaining informed consent in medicine is process that should include:
(1) describing the planned intervention,
(2) emphasizing the patient’s role in the decision-making,
(3) discussing alternatives to proposed intervention,
(4) discussing the risks of proposed intervention and
(5) eliciting the patient’s preference (generally by signature). Discussion of all risks is paramount to informed consent in this context.

Most consent covers general risks, procedural-specific risks, no-treatment threats and medication alternatives. In fact, certain consent forms give no guarantees that the planned treatment would include a solution for the issue being discussed.

Protection of patients is a key healthcare priority and successful informed consent is considered a patient safety concern. Recently the Joint Commission discussed the difficulties of maintaining reliable, informed consent.

The emphasis of the patient signature as an indication of the understanding is being called into question. The process of informed consent is shifting to focus more on the communication and less on signatures.

Studies of  the informed consent have found that there are many barriers to obtaining efficient informed consent.

A big hurdle is that for certain people, many consent forms contain wording that is too high a reading standard. The use of multimedia and interactive media devices is promoted to address some of the inefficiencies of the consent process.

Patients should be energetically engaged as a way to enhance communication and ensure patient safety and understanding. 

In emergency cases, informed consent can be withheld where there is insufficient time to seek consent or when the patient is unable to speak and there is no surrogate decision-maker. Not every treatment always includes direct, informed consent.

For example taking a patient’s blood pressure is a part of many medical treatments. on the other hand, a discussion regarding the risks and benefits of using a sphygmomanometer usually is not required.

Clinical Significance in Human Clinical Studies

Informed consent is mandatory for all human-involving clinical trials. The consent procedure must respect the right of the patient to make decisions and adhere to clinical trial guidelines for the particular hospital.

Adherence to the ethical standards in study design and execution is generally monitored by an Institutional Review Board (IRB).

The IRB was founded in the United States in 1974 by the National Research Act, which provided for oversight of human experimentation triggered by controversial testing methods used in the studies on Tuskegee syphillis and others.

Ethical and safe research standards have been an area of the federal and presidential interest since then, with the development of several organizations and task forces since 1974 dedicated to this topic alone.

Valid informed consent for the research must include three major elements:
(1) disclosure of the information,
(2) competency of the patient (or surrogate) to make a decision, and

(3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks. 

If such conditions are met an IRB can waive informed consent. Paramount to this is that the subjects in the study are at ‘minimal risk.’ Another definition of reduced risk work is the assessment of action usually found in emergency scenarios.
Examples of this include studying medications used in the emergency room for intubations, or conducting a retrospective chart review.

Changes in informed consent change by FDA during COVID 19

Changes in a protocol are typically not implemented before review and approval by the IRB/IEC, and in some cases, by FDA.

Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.

Such changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be implemented without IRB approval or before filing an amendment to the investigational new drug (IND) or investigational device exemption (IDE), but are required to be reported afterwards.

FDA encourages sponsors and investigators to work with their IRBs to prospectively define procedures to prioritize reporting of deviations that may impact the safety of trial participants.”   financial-and-legal-matters/informed-consent/what-is-informed-consent.html


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