Which criteria is needed for someone to give consent to a procedure?

Surgeons must establish and maintain effective relationships with patients and, where appropriate, with their supporters. Before surgery, surgeons should strive to have an honest and sensitive discussion with patients about their options for treatment that leads to informed and deliberate consent. They should reflect on their patients’ feedback about the care they received, and act appropriately and promptly when harm has occurred. In addition to the standards of Good Medical Practice, you should:

  • Recognise that seeking consent for surgical intervention is not merely the signing of a form. It is the process of providing the information that enables the patient to make a decision to undergo a specific treatment. Consent should be considered informed decision making, or informed request. It requires time, patience and clarity of explanation.
  • Establish whether a patient has a supporter as early as possible in the relationship and record this in your notes. If the patient agrees, you should involve the patient’s supporter in the consent discussion.
  • Establish that your patient has capacity to give consent as per the requirements of the Mental Capacity Act 2005. If your patient does not have capacity (including, for example, when they are unconscious or ventilated) you must act in your patient’s best interests and, where relevant, seek consent from a person authorised with a lasting power of attorney to give consent on behalf of your patient. The Mental Capacity Act 2005 sets out how you should assess your patient’s capacity and best interests.
  • In case you have to act in your patient’s best interests without the patient’s consent, where possible seek affirmation from a consultant colleague and discuss your intended actions with the patient’s supporter.
  • Involve young people and children in discussions and decisions around their care as outlined in the GMC guidance 0-18 years: guidance for all doctors. According to the GMC, young people are presumed to have capacity to give consent at 16 years of age. You should assess the capacity of children under 16 years to give consent on a case by case basis, depending on their maturity and capacity to understand the different courses of action involved in their treatment.
  • Ensure that consent is obtained either by the person who is providing the treatment or by someone who is actively involved in the provision of treatment.The person obtaining consent should have clear knowledge of the procedure and the potential risks and complications.
  • Obtain the patient’s consent prior to surgery and ensure that the patient has sufficient time and information to make an informed decision. The specific timing and duration of the discussion should take into account the complexity and risks of the proposed procedure. A patient’s consent should not be taken in the anaesthetic room.
  • At the consent discussion, provide information on the procedure and its implications. In particular, you should discuss information about:
    • The patient’s diagnosis and prognosis
    • Options for treatment, including non-operative care and no treatment
    • The purpose and expected benefit of the treatment
    • The likelihood of success
    • The clinicians involved in their treatment
    • The risks inherent in the procedure, however small the possibility of their occurrence,side effects and complications. The consequences of non-operative alternatives should also be explained.
    • Potential follow up treatment
  • Where possible, you should provide written information to patients to enable them to reflect and confirm their decision. You should also provide advice on how they can obtain further information to understand the procedure and their condition. This can include information such as patient leaflets, decision aids, websites and educational videos.
  • Make patients aware of national guidelines on treatment choices (such as NICE and SIGN guidelines). If your recommended treatment is not in keeping with current guidelines, you must explain your reason for not following current standard guidelines.
  • Sign the consent form at the end of the consent discussion, allowing the patient to take a copy for reference and reflection. On the day of the procedure, check with the patient if anything has changed since the consent discussion. If there has been a significant delay since the original signing, sign the relevant section on the form to confirm consent. The patient does not need to sign again.
  • In addition to completing the consent form, record in writing the details of the consent discussion with your patient. Any discussions around consent with the patient’s supporter and your colleagues should also be recorded in the patient’s notes.
  • In the case of cosmetic surgery, follow the requirements for consent set out by the Cosmetic Surgical Practice Working Party in Professional Standards for Cosmetic Practice. For invasive cosmetic procedures, the consent requirements include a two-stage process of consent with a period of at least two weeks between the stages to allow the patient to reflect on the decision.You should demonstrate capacity to identify the psychologically vulnerable patient and ensure that there is rapid and easy access to mental health services for help with the assessment and management of problem cases.
  • Make sure that the patient understands, and is agreeable to the participation of students and other professionals in his or her operation.
  • Gain agreement from the patient if video, photographic or audio records are to be made for purposes other than the patient’s records (for example, teaching, research, or public transmission).
  • Follow appropriate guidance for the retention of tissue, as set out in the Human Tissue Act 2004.

The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body.
Description of Clinical Investigation. ... .
Risks and Discomforts. ... .
Benefits. ... .
Alternative Procedures or Treatments. ... .
Confidentiality. ... .
Compensation and Medical Treatment in Event of Injury. ... .
Contacts. ... .
Voluntary Participation..
For consent to be considered valid: it must be voluntary. the patient must have the mental capacity to consent. the patient must be properly informed.