Question11: We will talk more about inform consent in sessions to come. Why do you think patient consent forms are so important? Please, share your opinion.

Apr 7 • Clinical Research Associate, Clinical trail, CRA certification, cracertification_Q&A, cracertification.co.uk • 1703 Views • Comments

Question11: We will talk more about inform consent in sessions to come. Why do you think patient consent forms are so important?  Please, share your opinion.

 

Answer:

CONSENT FORMS:

It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care before a person decides whether to participate, or whether to allow a child or incapable adult to participate.

This principle reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice.

The informed consent process relies on three principles:

·         Adequate information is provided (generally, what a “reasonable person” would want to know to make a decision)

·         Participants comprehend the information and

·         Consent is given voluntarily.

The consent form includes all the following information:

  • Why the research is being done?
  • What are the goals of researchers what is going to happen during the trial and for how long.?
  • What risks and discomforts are involved in the trial?
  • What benefits can reasonably be expected from the trial?
  • What alternative treatments are available?
  • The extent to which participant records will be kept confidential.
  • The fact that participation is voluntary, and that a participant has the right to leave the trial at any time.
  • Whom to contact if questions or problems arise during the course of a study?

Patient consent forms  helps a patient to make a informed decision and ensures him that he is participating in a decision, not merely signing a form or contract, with this understanding,  the informed consent process is seen as an invitation to patient to participate in his health care decisions rather than a signed agreement. It is also very important because it proves that patient is taking part in the clinical trial voluntarily and is well informed about the trial and can leave the trial on any stage.

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