PCM Level 1 - Semester 1 Informed Consent Lecture (PDF)

Level 1 - Semester 1 PCM LECTURE (7) INFORMED CONSENT DR ZIAD MAHANA  PCM LECTURE - 3 0 Informed consent...

Level 1 - Semester 1 PCM LECTURE (7) INFORMED CONSENT DR ZIAD MAHANA  PCM LECTURE - 3 0 Informed consent Definition D EFINITION OF CONSENT  A voluntary agreement, compliance or permission. key elements Dr. Ziad Mahana 1  PCM LECTURE - 7 D EFINITION OF M ENTAL CAPACITY  The ability to… ▪ Use, understand & weigh information to make a decision. ▪ Communicate any decision made. ❖ To make any appropriate decision, the person should have mental capacity. Capacious vs Incapacious person  A person… Capacious ▪ With normal healthy mind & brain function. or Competent ▪ Who can generally understands what decision he/she needs to make & its ‫قادر او كفء‬ consequences  Conditions in which the person lacks mental capacity ① Mind is impaired & unable to give a decision.  As in the following mental health conditions: schizophrenia or bipolar disorder & dementia. ② Severe learning disabilities. ③ Brain damage: From a stroke or other brain injury. ④ Physical or mental conditions that cause confusion, drowsiness or a loss Incapacious person of consciousness. ⑤ Intoxication caused by drugs or alcohol misuse. IN CASE OF LACK OF CAPACITY !! ⎚ Another one can give or refuse consent → for example - An adult partner - Legal custodian - And/or an adult family member who is responsible for the patient Dr. Ziad Mahana 2  PCM LECTURE - 7 Assessment of mental capacity When?  Where there are doubts about capacity for giving a decision is doubtful.  An expert advice from a psychiatrist or psychologist with particular experience in By whom assessing capacity. ⎚ Does the person have an impairment of the mind or brain? ① ⏰ At the time of decision… It doesn’t matter whether this impairment is temporary or permanent ⎚ Does the person have a general understanding of: ② ▪ What decision they need to make. ▪ & Why they need to make it? ⎚ Does the person have a general understanding of the likely consequences of ③ Items to making, or not making, this decision? be ⎚ Is the person able to assessed ▪ Understand ④ ▪ Retain The information relevant to this decision? ▪ Use ▪ Weigh up ⎚ Can the person communicate their decision by ▪ Talking. ⑤ ▪ Using sign language. ▪ or any other means. Dr. Ziad Mahana 3  PCM LECTURE - 7 Self-determination (Autonomy) & consent  Autonomy = ‫االستقاللية‬:  Is the patient’s right to decide whether to agree (consent) or to refuses (refusal) of certain clinical examination or treatment. IN MEDICINE  Having mental capacity enable the patient to say “YES” to examination or treatment “i.e. consent” or to say “NO” “i.e. refusal”. To examine, treat or operate upon a patient without consent is assault in law Forms of consent ❶ When the patient presents himself at the doctor's clinic or outpatient  This implies that he agrees to be examined (Inspection – Palpation – Percussion – Auscultation). ** Expressed permission should be obtained for more complex procedures as ① Further examinations () like Rectal or Vaginal ② Withdrawal of blood for diagnostic purposes Dr. Ziad Mahana 4  PCM LECTURE - 7 ❷ It is specifically stated by the patient in distinct & explicit language. It can be: ORAL/VERBAL CONSENT WRITTEN CONSENT (Preferably in presence of disinterested party, like a nurse) OBTAINED FOR  Relatively minor examinations or therapeutic  All major diagnostic procedures. procedures as… ① Endoscopy. ① Blood collection for lab tests. ② Bone marrow aspiration, etc. ② ECG.  General anesthesia.  Operations. consenting Ages for treAtment (in egypt) The age of consent for medical examination, treatment, any diagnostic or invasive procedures is legally accepted as ≥ 18 years. For a child, or a patient of unsound mind…  His/her guardian or a local authority designated to care for the child can give consent. Validity of the consent ❶  It implies the understanding of the patient of: ① Condition or nature of illness. ② Purpose & nature of procedure or treatment proposed. ③ Risks & benefits of treatment or procedure. ④ Prospect of success or failure. ⑤ Risks & benefits of alternative treatment(s) or procedure(s). ⑥ Prognosis in the absence of intervention. ⑦ Acceptance or refusal (informed refusal) of the given procedure or intervention. Dr. Ziad Mahana 5  PCM LECTURE - 7 Informed Refusal  The concept of informed refusal states that the doctor must inform the patient: ① That he has right to refuse to submit to examination. If he refuses, he cannot be examined ② & That the result may go against him “So inform him about the risks of refusing a particular operation, test, medication, or other medical intervention”  To be legally valid: Such informed refusal must be reduced to writing with signatures of ① The Patient + ② The Doctor + ③ A Witness. General guidelines ❶ Consent should be: Free – Voluntary – Clear – Intelligent – Informed – Direct –Personal. ❷ There should be no: Fraud – Misrepresentation of facts – Compulsion – Coercion. ❸ The knowledge regarding the intervention: Should be imparted in an understandable language & format → So that a decision can be made by the patient. ❹ It should be in a proper form & suitably drafted for the circumstances. ❺ The written consent should be witnessed by another person, present at the signing.  To prevent any allegation that the consent was obtained under pressure. Special situations  Where there is no nearest relative or where the physician or institution has been unable to find the nearest relative, a physician may provide necessary No nearest treatment if: ❶ relative ① He believes that the proposed treatment is essential. ② Another treatment provider agrees in writing that the proposed treatment is essential. Dr. Ziad Mahana 6  PCM LECTURE - 7 ▪ Cannot be examined without consent. THE VICTIM ▪ The court cannot force a person to be medically examined. ▪ Can be examined by a doctor using reasonable force In criminal  If requested by a police officer ❷ AN ACCUSED cases  & If the examination may provide evidence to the commission of the offence. AN ARRESTED ▪ At his request → May be examined by a doctor PERSON  To detect evidence in his favor.  Served by whom? A FEMALE MEDICAL PRACTITIONER A MALE DOCTOR Better made by or under the Such an examination must be carried supervision of her out in the presence of a female nurse Female ❸ examination  Situations IN RAPE IN MEDICO-LEGAL CASES (OF PREGNANCY, DELIVERY, AND ABORTION) The victim should not be examined The woman should not be examined without her written consent Without her consent ❹ For sterilization & artificial insemination ▪ Consent of husband & wife. For mass immunization ❺ ▪ Law provides the consent. Or any procedure made compulsory by state ❻ For donation of organ after death ▪ The will of the deceased is enough. ❼ For prenatal diagnostic procedures ▪ Informed written consent of pregnant. ❽ Pathological ▪ Consent of next of kin (Close relatives). For autopsy ❾ Medico-legal ▪ No consent from the relatives. Dr. Ziad Mahana 7  PCM LECTURE - 7 ❷  Consent is invalid if: ① It is not an informed consent. ② Given for committing a crime or an illegal act: Such as criminal abortion. ③ Obtained by misrepresentation or fraud. ④ Given by one who had no legal capacity to give it: A minor or an insane person or under the influence of drugs or intoxication. exceptions to informeD consent (i.e. the consent is not required) ❶ Emergencies (e.g. danger to life or limb). ❷ Medico-legal postmortem examination. ❸ Examination of an arrested accused. ❹ Treatment of patient with ‘notifiable diseases’ for greater community interest. ❺ Psychiatric examination or treatment by court order. ❻ Prisoners (New entrants). therapeutic priVilege DEFINITION ▪ The doctor to withhold from patient the information (as to risk). ▪ If the disclosure would pose serious psychological threat to the patient (e.g. INDICATION malignancy). SO? ▪ Doctor should disclose full information to a competent relative of the patient. BlAnket (open) consent  The consent practiced in MOST HOSPITALS  That cover almost everything a doctor might do to a patient without mentioning anything specific. Dr. Ziad Mahana 8