Medical Ethics

Seminar on Medical Ethics, presented on 11/02/2018

1. MEDICAL ETHICS Moderator : Prof. S. Ghoshal

2. We should not get confused – Ethics are not : F eelings Religion Law Science

3. Ethics ?????? Ethical norms are not universal, they depend on the sub culture of the society

4. Medical Ethics System of moral principles that apply values to the practice of clinical medicine and in scientific research Rules of etiquette adapted by the medical profession Considerations of the motives behind that conduct

5. Principle of respect for Autonomy Patient has capacity to act intentionally with understanding Controlling influences that would imitigate against a free and voluntary act – not allowed

6. Desiring to benefit the patient, physician strongly want to provide Blood Transfusion : believing it to be clear “medical benefit ” Patient must be so informed : The consequences of refusing BT : made clear to the patient at risk of dying from blood loss Properly and compassionately informed, patient is free To accept BT or To refuse BT

7. The Principle of Non- maleficience “Above all, do no harm,“ – Make sure that the procedure does not harm the patient or others in society Not to intentionally create a harm or injury to the patient, either through acts of commission or omission This Principle affirms the need for medical competence

8. Medical mistakes may occur, however, this principle articulate a fundamental commitment as the part of health care professionals to protect their patients from harm Eg . Most would be willing to experience some pain if the procedure in question would prolong life

9. PRINCIPLE OF DOUBLE EFFECT When interventions undertaken by physicians create a positive outcome while also potentially doing harm it is known as the "double effect." Single action – two effects : good effect and bad effect

10. Uterine Carcinoma How to Best Treat her ????? TAH + BSO : A Life Saving Procedure Mother Fetus What action is morally allowable or what is our duty ? Woman has the right to self defence and action of hysterectomy is aimed at defending and preserving her life

11. The Principle of Beneficence Ordinary meaning of this principle : Health care providers have a duty to be of benefit to the patient, as well as to take positive steps to prevent or to remove harm from the patient Non maleficience : constant duty (one ought never to harm another individual) whereas beneficence is a limited duty

12. This duty becomes complex if two patients appeal for treatment at same time ???? Criteria of urgency or ???? First come first served

13. Eg . 1 case where principle of beneficience is given priority over the principle of respect for patient autonomy ?? Emergency medicine One person suffered grave accident and aggressive treatment is required. Like stoping the bleeding and mending the broken bone or suturing the wounded Vs Patient who tried to hang himself and was brought to hospital by attendants, where patients are clear and they are danger to themselves

14. Placing the patient in a protective environment in the belief that patient is compromised and cannot exist in his own hest interest at the moment.

15. The Principle of Justice The distribution of scarce health resources, and the decision of who gets what treatment The burdens and benefits of new or experimental treatments must be distributed equally among all groups in society

16. The Principle of Justice Aristotle once said “ giving to each that which is his due ” : fair distribution of goods in society When some goods and services are in short supply, fair means of allocating scarce resources must be determined

17. Persons who are equals should qualify for equal treatment For eg . All people > 65 years, category of persons is equal with respect to one factor, their age but the criteria chosen says nothing about need or other noteworthy factors about the person in the authority.

18. In fact, our society uses a variety of factors as criteria for distributive justice, including the following : To each person as equal share To each person according to need To each person according to effort To each person according to contribution To each person according to merit

19. Most controversial issue in modern health care Question : who has the right to health care ? As a society we want to be beneficient and provide some decent minimum level of health care for all citizen regardeless of ability to pay.

20. The demand of the principle of justice must apply at the bed side of the individual patients but also systemically in the laws and policies of society that govern the access of a population to health care. Much Works remain to be done in this arena

21. History of Medical Ethics Hipporcrates to the modern day 400 BC to 2018

22. Hippocrates (400 BC) Greek physician Code of ethical principles for doctors and their students Hippocrtatic oath

23. Some clinicians see the oath as a rite of passage, others can’t remember taking it, and some think it is irrelevant.  Whether doctors view it as meaningful or not, the oath still has the power to encourage debate, prompting them to consider what kind of vow would uphold the standards of their profession, or even if they should take a vow at all. “ I swear by Apollo the Healer, by Asclepius, by Hygieia , by Panacea, and by all the gods and goddesses, making them my witnesses, that I will carry out, according to my ability and judgment, this oath and this indenture .”

24. Nuremberg code 20 th august 1947, 16 german nazi physicians conducted pseudoscientific medical experiments upon concentration camp prisoners Filled with description of torture, deliberate mutilation and murder

25. Defence argued : no international law governing what was and what couldnot be considered ethical human experiment Nuremberg code was drafted A set of principles centred upon the consent and autonomy of the patient, not the physician The Doctors Trial

26. 1951 : Hanrietta Lacks : HeLa Cells Hanrietta’s cervical tumor : HeLa cells Young black woman : piece of her cancerous tumor extracted without her knowledge 1 st human cell line to survive in vitro, since then immortalized for testing new medical treatments Serious concerns surrounding the lack of informed consent and taking samples from living patients.

27. 2017 : Charlie Gard Born in UK, with exceedingly rare condition – Infantile onset encephalopathy mithochondrial DNA depletion syndrome (MDDS) Legal battle between : parents and his doctors over withdrawing life support Social media : playing a dominant role to facilitate discussions autonomy, end of life care and parental rights The case became controversial because the medical team and parents disagreed about whether experimental treatment was in the best interests of the child after Charlie had seizures that caused brain damage, GOSH formed the view that further treatment was  futile   and might prolong suffering Legal Battle between Child’s parents and medical team over ending life support and continuing experimental medicines and life support

28. Informed consent Definition A patient willing acceptance of a medical intervention after adequate disclosure from understanding of the nature of the intervention, risks, benefits and alternative treatment options.

29. What constitutes Informed Consent Disclosure : information to allow reasonable person to make a decision Understanding : Comprehension of the information given Voluntary : no coercion or incentive to accept or deny a treatment Aggrement : verbal or written (Preferred)

30. MEDICAL ETHICS AND LAW Medical ethics is closely related to law. Quite often, ethics prescribes higher standards of behavior than does the law and occasionally ethics requires that physicians disobeys laws that demand unethical behavior.

31. Good Clinical Practice Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance , monitoring, auditing, recording, analyses and reporting of clinical trials . serves to protect the rights, integrity and confidentiality of trial subjects Today, the GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

32. Historical Background of GCP

33. 1964, the Declaration of Helsinki “The World Medical Association has developed ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty”

34. Reasons for GCP

35. The is a harmonised standard that protects the rights, safety and welfare of human subjects , minimises human exposure to investigational products , improves quality of data , speeds up marketing of new drugs and decreases the cost to sponsors and to the public . Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and consistent with the principles of theDeclaration of Helsinki, and that the clinical trial data is credible

36. There are 13 core principles of GCP and they are as follows When summarised , simply mean: All clinical trials should be conducted in accordance with ethical principles , sound scientific evidence and clear detailed protocols. The benefits of conducting trials should outweigh the risks. The rights, safety and wellbeing of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality . The care must be given by appropriately qualified personnel with adequate experience. Records should be easily accessible and retrievable for accurate reporting, verification and interpretation. Investigational products should be manufactured according to Good Manufacturing Practice

37. Ethics Commitee A heterogenous group of members who are qualified, experienced in their professional field and proficient enough to review and evaluate both scientific and ethical aspects

38. Basic role of Ethic Committee can be summed as: • To protect the rights, safety and well being of patients; by – Prevent studies that pose an unacceptable risk of harm to participants – Ensure that all participants in research are aware about the pros and cons for their participation and have given appropriate Informed Consent . • To promote fair ethical policies and procedures which will maximize the likelihood of achieving good and patient-oriented outcomes

39. • To enhance the ethical tenor between health care professionals and organisations conducting clinical trials . • Overview and monitor thoroughly, compliance of sites with Standard Operating Procedures (SOPs), regulations, guidelines and ETHICS . • Offering due consideration to community views

40. Ethics committee Composition There should be a heterogeneous group of at least 7 members (5 as per ICH-GCP). The EC members should be – Qualified, experienced in their professional field and proficient enough to review and evaluate both scientific & ethical aspects ( familiar with GCP). • Adequate representation of age, gender etc is maintained. • Maximum of 15 members are recommended – Chairperson : Outsider (Not from the institution if its Institution Review Board) – Member – Secretary – Member list must include at least each one of the following– a basic medical scientist, clinician, legal expert, social worker, philosopher/priest, & a lay person. – Experts from different arenas may be also invited for scientific review. – A representative of Patient groups like for HIV, may also be included.

41. Postgraduate Institute of Medical Education and Research (PGIMER) Ethics Committee 13 members 1 . Chair Person : Kare Narain Pathak Professor Emeritus & Former Vice-Chancellor Panjab University Chandigarh 160014 India List can be seen @ http://pgimer.edu.in/PGIMER_PORTAL/AbstractFilePath?FileType=E&FileName=Institute%20Ethics%20Committee.pdf&PathKey=EDITORREPOSITORY_PATH

42. Medical Ethics and Oncology In everyday oncology practice, we make a wide range of ethical decisions. Many of these decisions seem straightforward, with those involved agreeing on the right course of action Other decisions are difficult , with conflicting perspectives regarding the wishes , needs and best interests of patients.

43. An article suggests an ethical framework to facilitate the decision-making of practitioners in relation to challenging practice situations.

44. Medical Ethics and Oncology

45. Problems and their solutions ???

46. The situation is not that simple Every Time Patient dying of painful intestinal carcinoma, patient might chose to forego CPR in event of cardiac arrest, ,or the patient might chose to forego life-sustaining technology such as dialysis or ventilator. The reason for such a choice is based on the belief of the patient that prolonged living with a painful and debilitating condition is worse than death, a greater harm Good Palliative Care VS Euthanasia

47. Problem 2 80 years old female, Mrs Amarjeet from chandigarh , lives alone Recently diagnosed with carcinoma breast Prior to diagnosis she was independent woman, enjoyed the company of friends and neighbor She has no family in india and her son lives in canada

48. Now her mood seems low and she states she doesnot wish to live any longer She has refused all medical interventions and has given living will She doesnot want any hospitalization One morning her neighbor finds her on sofa, still fully dressed as previous enening , incoherent Brought to hospital, What would be Best treatment for her Active treatment No treatment Hospice admission Just ignore her ??????