Informed Consent PDF

Opening Prayer Score Trend  Wall of 1st Fame 45(90 %) ADENIJI, OLAMI CANEDA, GINECA 2nd 4...

Opening Prayer Score Trend  Wall of 1st Fame 45(90 %) ADENIJI, OLAMI CANEDA, GINECA 2nd 44(88%) 3rd 43(86%) CHEMJONG,NUMASHA PLAYDA, CRESSA USMAN, SHERMAWATIE KING, KARYLLE POKHAREL, TIRZAH LAGAO, JOHANN PEGARIT, LERICHA PADILLOS, JELEA  The patient has the right to self-determination, to make free decisions regarding himself/herself. -WMA Declaration on the Rights of the Patients Informed Consent Catherine Grace Q. Aparece, MD  Objectives 1. Describe the different types of consent 2. Recognize the importance of obtaining valid consent from a patient for investigations and treatment 3. Explain how to proceed if a patient refuses treatment or is incompetent to give consent  SGD 3 ON SPOTLIGHT CAST(SGD 3) X Y TAHO VENDOR POLICE OFFICER DOCTOR NURSE TANOD Case 1 The Story of X and Y Narrator: X and Y , cousins, 28 and 15 years old respectively came in to the emergency room after a motorcycle accident in San Roque. 1 hour earlier… Taho vendor: Tahoo… Hootah… Tahoo… Y: Watch out!!! ( hit the taho vendor) X: Oh no, my finger! Y: Huhuhu, I’m bleeding… And … Is he dead? X: I don’t know, let’s go Brgy Tanod: Opps!! What happened? Did you just hit someone? X and Y: No, and we are fine! Bye.. Case 1 The Story of X and Y Narrator: At the emergency room… Doctor: ((To X): you have an avulsion- fracture on your 5th digit of your left hand; To Y: and you sustained an- eight –cm lacerated wound on your knee. Your wounds need suturing. X: Doc, can we just take medicines? Doctor: Yes, but the wound healing will be delayed if you don’t have them sutured. Nurse, please secure their consents and prepare the minor OR. Nurse: Yes, doc. Noted...(To Y:) Sir, how old are you? Y: 15 Nurse: Oh, you cannot sign yet. X: I will do it for him nurse. The Story of X and Y Narrator: As they were in pain, the older cousin X signed the consent for himself and his younger cousin Y. When the doctor was done suturing , the police officer arrived. Police officer: “Good evening. Are you from San Roque?” X and Y: “No sir. We are from San Vicente.” Police Officer. “Alright.. Anyway,I heard you crashed and hit the Taho vendor. May I see your License and vehicle registration.“ Y:“ No Sir. We are completely fine. “ X: “ And we did not hit anybody “ Police officer: “ Ok…I do not see the documents…And I cannot see any injury here… because they are already covered “ X: “ Sir, I am not aware that I was injured and I did not want to be sutured either. “ Police officer :”Really??Doctor, may I see the consent?” Nurse: “Here it is officer.”(and the officer handcuffed X on the hospital bed) X : “Sir, please spare us. We did not steal the motorcycle.” Y: “and we did not hit the Taho vendor.” Posted with permission for educational purposes  The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention  Implied consent Patient indicates the willingness to undergo certain procedure or treatment by his behavior Minor or less invasive treatment/procedure  Expressed consent Verbal or written communication by a patient wishing to receive treatment.  Proxy consent Consent given by authorized person  Informed Consent a voluntary uncoerced decision, which is made by a competent autonomous individual to accept or reject some proposed course of action Habiba 2001 Informed Consent Legal concept not medical Central to the bioethical values of individual autonomy and dignity documented by written , signed and dated informed consent form. Informed Consent: Physician’s context Consent in medical procedures , as the act or result of reaching an accord, a concurrence of the mind or the actual willingness to undergo a medical procedure without any guarantee or warranty of certainty of success or cure, that may occur. Informed Consent Being a legal concept, it is documented by written , signed and dated informed consent form Informed consent form Merely not a form that is signed, but is a process in which the subject has understanding of the medical treatment /procedure or research and its risks Elements of a Valid Informed Consent Material disclosure of information, benefits, complications and risks by the attending physicians themselves Competence or capacity of the patient or surrogate to make a decision Willful and voluntary nature of the informed consent decision Informed consent form Must be written in a language/ dialect understood or easily understood by the subjects Must remove the possibility of coercion or undue influence Subject must be given sufficient time to consider consent or participation or non -participation  Posted with permission from the COH When is informed consent required? When the medical treatment / procedure or research involves patients, children, incompetent, incapacitated persons, healthy volunteers, immigrants or others. When the medical treatment/ procedure or research uses , and collects human genetic material , biological samples or personal data.  The principle of informed consent incorporates the patient’s right to choose from among the options presented by the physician The principle of informed consent incorporates the patient’s right to choose from among the options presented by the physician  If the physician has successfully communicated to the patient all the information the patient needs and wants to know about his or her diagnosis, prognosis and treatment options, the patient will then be in a position to make an informed decision about how to proceed.  However, to arrive at informed consent, it is necessary to provide the patient with adequate information about all aspects of his/her choices and this information should be sufficient and accurate (Hadda and Vernarec, 2001)  The presentation and explanation of the information should be adjusted to suit the patient’s language, level of maturity and competence. Nidhi, 1997  Although the term ‘consent’ implies acceptance of treatment, the concept of informed consent applies equally to refusal of treatment or to choice among alternative treatments  SGD 18 ON SPOTLIGHT CAST(SGD 3) MOTHER FATHER/ HUSBAND DOCTOR NURSE  Case 2 The Yellow Baby Narrator: A two-day old neonate was delivered in a difficult delivery and was thickly meconium stained. While being roomed in, he was noted to have a yellowish discoloration. Now he ‘s showing a blank stare, twitching of lips and jerking of extremities. Mother: “Doc, my baby is shaking!!” Doctor: “Nurse, hook to O2 and give Diazepam please. “ Mother: “What happen to him Doc?” Doctor: “Oh your baby has jaundice up to his knees. This yellow pigment already reached his brain. That’s why he is having seizure. “ Mother:” Is there anything you can do for my baby Doc?” Doctor: “We need to give him anticonvulsant, and place him in phototherapy when he’s stable. I will also insert OGT.”  Narrator: In the evening, the OGT was accidentally removed and the baby had another episodes of seizure. Nurse: “Maam, unfortunately, the hospital run out of stock for anticonvulsant as well as OGT, please buy these prescriptions somewhere quickly.” Mother: “I will wait until my husband arrives, he tried to sell our carabao.” Narrator: 3 hours later… Husband: “Our carabao was sold to our rich neighbor but he said the payment will be next day since he still has to withdraw the money.” Narrator: The couple sought the help of the barangay captain and so they were able to procure the prescription.  In the evening, the OGT was again accidentally removed and the baby had another episodes of seizure. Nurse: “Maam, you need to buy these prescriptions” Mother: “But we don’t have money. I wish to bring my baby home and take care of him.” Doctor: “Your baby’s condition is not good. He needs treatment. If you insist to go home, possible untoward outcome may happen. Your baby may die and if he survives, he may have neurologic deficits. “ Mother: (cried) “Huhuhu… Doc, I completely understand but I have decided to refuse … I will sign…If something happens to my baby, you and the nurses will not be accountable.” I am_____,mother of _______.I decided to take my child home and refused medications. I understand the condition as explained by the doctor and nurses. It is my own will and I understand the possible consequence  “Competent patients have the right to refuse treatment, even when the refusal will result in disability or death.” But if patient refuses, are doctors up to there also?  As far as patients have the right to obtain information about their health care, they have also the right to accept or reject any suggested options Levinsky, 1996  In seeking a patient’s informed consent, physicians should: – (a) Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.  In seeking a patient’s informed consent, physicians should: – (b) Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information – (c) Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner.  In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s surrogate is not available, physicians may initiate treatment without prior informed consent  The physician should include information about: – The diagnosis (when known) – The nature and purpose of recommended interventions – The burdens, risks, and expected benefits of all options, including forgoing treatment DECISION-MAKING FOR INCOMPETENT PATIENTS  Respect for patient autonomy is central to professional ethics and physicians should involve patients in health care decisions commensurate with the patient’s decision-making capacity  However, many patients are not competent to make decisions for themselves. these patients require substitute decision-makers, either the physician or another person  Even when a medical condition or disorder impairs a patient’s decision-making capacity, the patient may still be able to participate in some aspects of decision making.  SGD 17 ON SPOTLIGHT CAST A B DOCTOR CHILDREN Case 3 The Widow and the Orphan Narrator: An 85 year old widow and a retired public school teacher, A was diagnosed with Gastric Carcinoma. She has 5 children , all of them were married , 3 abroad and 2 somewhere in the country. She lives with her orphaned former student B who takes care of her like her true mother  A : “B, If my condition gets worse, please remember that I don’t want an operation nor resuscitation.” For 2 days, A has been coughing and could not sleep. B: “You are so sick.I should take you to the hospital.” Doctor: “Are you the patient’s daughter? Her result turns out to be COVID positive. I’m sorry, she is critical.”  B: “Doctor, I am not. We are not even related by blood. But I treated her as if she is my mother. “ Doctor: “So who will decide on this?” B: “I will inform her children.” Narrator: Due to her deteriorating condition, B informed the doctor of the old woman’s wish and called her children. When her condition was even deteriorating, her children arrived at the hospital Children: “We are her children doctor. Please do everything to save her. “ B: “But she wished not to be operated nor resuscitated!” When a patient lacks decision-making capacity, the physician has an ethical responsibility to: Identify an appropriate surrogate to make decisions on the patient’s behalf: Recognize that the patient’s surrogate is entitled to the same respect as the patient. Provide advice, guidance, and support to the surrogate. Assist the surrogate to make decisions in keeping with the standard of substituted judgment When a patient lacks decision-making capacity, the physician has an ethical responsibility to: Assist the surrogate to make decisions in keeping with the best interest standard when the patient’s preferences and values are not known and cannot reasonably be inferred Consult an ethics committee or other institutional resource when: – No surrogate is available or there is ongoing disagreement about who is the appropriate surrogate. – Ongoing disagreement about a treatment decision cannot be resolved.  SGD 4 ON SPOTLIGHT CAST HABAL2X DRIVER DOCTOR Q DOCTOR R NURSE 1 NURSE 2 POLICE OFFICER Case 4 The story of Mr.X Narrator: An unidentified man was found wounded and lying unconscious at the highway. A habal-habal driver found him and brought him to the nearest hospital. Habal-habal driver: “Maam, I found him on the road. Nobody could identify him and no ID was found on his pocket” Doctor Q: “The patient is very cold and bleeding profusely. Nurse please take the vitals!”  Nurse 1: “Doc, palpatory BP. “ Doctor R : “Start double line and prepare intubation set. “ Nurse 2: “Noted doc.” Nurse 1: “Should we admit this patient?” Doctor Q: “Yes” Nurse 2: “Ok noted Doc. I ‘ll prepare the consent forms.” Doctor R: “Hey! He has no watcher, we cant admit him.” Doctor Q: “Laryngoscope please…” Doctor R: “Woow! You cannot do that. Nobody signed the consent yet.”  Nurse 2: I’ll let the Habal-habal driver sign since he’s the one who brought him here.” The police officer arrived. Police officer: “Has anyone identified him?” Nurse 1: “None Sir.” Police Officer: “We will take a photo and announce this in social media so that he can be identified.” Doctor R: “Thank you officer. We will wait for them because we cannot do anything to him without the consent of his family.”  Except in emergency situations in which a patient is incapable of making an informed decision, withholding information without the patient’s knowledge or consent is ethically unacceptable  The obligation to communicate truthfully about the patient’s medical condition does not mean that the physician must communicate information to the patient immediately or all at once. References Medical Bioethics, Legal and Clinical Cases by Leo Olarte, 2021 Ethics Manual, 3rd Ed ,World Medical Association GMPH Patient Record with Consent