Ethical Issues in Medicine and Research

Dr. Jishnu Sathees LaluCommunity Medicine

AIMS-Kochi

Table of Contents

Introduction

History

Principles of Ethics

Physician patient relation

Physician society relation

Physician colleague relation

Medical research

Medical education

Medical ethics in India

Conclusion

Contents 1 Contents 2

Introduction • Scientific knowledge arises from experiments

• In medical science, experiments provide the basis for induction.

• Claude Bernard- experiments should be conducted in a way that shows respect for the ethical principles that have always prescribed over the practice of medicine.

• Doctors make constant ethical decisions everyday in clinical work. Unlike medical paternalism- patients are better informed

Ethics • Study of morality and moral principles that governs

a person’s behaviour or the conducting of an activity.

• Medical ethics- moral values and judgment as they applied to medicine.

• Bioethics- ethical issues arising from new situation and possibilities brought about by advances in biology and medicine.

• Ethics helps medical professionals to recognize difficult situations and to deal with them in a rational and principled manner.

What is an Ethical issue?• When you have to judge what is right

or wrong.• A dilemma- making a different

choice.• Prolonging life,ending life..etc• Day to day issues can involve: • Respecting people,treating people

with dignity, supporting patient choice etc.

Historical background • Ethics in clinical

practice evolved from priest -supplicant relationship in 4000BC .

• Greeks separated medicine from religion

• Physician paternalism prevailed till the early 20th century.

• Unethical behaviour was common among scientists.

• Insufficiently informed of what was done or who could not refuse to participate.

• In 1714, Charles Maitland inoculated smallpox in 6 prisoners, promising them release.

• Antidotes of Hemlock were tested on prisoners.

• William Wallace demonstrated the infectivity of Syphilis by inoculating healthy subjects.

• Medical ethics gained importance – to respect individual decision and protect morality.

Thomas Percival- 1803

1900 Berlin code of ethics

Nuremberg code

International Code of reference for biomedical research – Declaration of Helsinki

• In 1978,the Belmont report of US commissioners stated ethical principles and guidelines: Respect, beneficence and Justice.

• 1982, CIOMS proposed International guidelines based on the Nuremberg code, DoH and the Belmont report, to apply in developing countries.

1985, Beachamp and Childress-

Principles of ethics

ethics

Autonomy

Beneficence

Non maleficence

Justice

Who decides what is Ethical?

• It can differ from society to society • Some fundamental ethical principles are

agreed by most human beings – Universal declaration of human rights.

• At the global level- WMA has set forth ethical statements for physicians no matter where they live and practice.

WMA• Only international Org represent all

physicians• They have undertaken the role of

establishing general standards in medical ethics that are applicable world wide.

• They updated the Hippocratic Oath for 20th century use. Declaration of Geneva.

• 3rd general assembly – developed an International code of Ethics

Hippocratic Oath

• Declaration of Helsinki- Ethical guidelines for research on human subjects.

• Adopted policy statements on socio medical topics including medical education and health systems.

Non rational Rational• Obedience• Imitation • Feeling or desire• Intuition • Habit

• Deontology• Consequentalism• Principlism • Virtue ethics

History

How do individual decide what is ethical?

Description of the contents

1.Respect & equal treatment

2.Communication and consent

3.Decision making

4.Confidentiality5.Beginning of

life issues6.End of life

issues

1.Dual loyalty2.Resource

allocation3.Global health

1.Challenges to medical authority

2.Relationship with colleague , teachers and students

3.Relationship with other health professionals

1.Research in medical practice

2.Declaration of Helsinki

3.Honest reporting of ressults

4.Whistle blowing

Physicians and patients

Physicians and

society

Physician and colleague

Medical research

Ethical application

Physicians and Patients

PP relationship is the cornerstone of medical practice and therefore of medical ethics.

Declaration of Geneva- “the health of my patient will be my first consideration”

Physician autonomy Patient Autonomy

Respect and equal treatment• “All humans are born free and equal

in dignity and rights.”- universal declaration of human rights

• No factors to intervene between his/her duty and his/her patient.

• Physician compassion enables patients trust- contributes to the healing process

Challenges in care of infectious cases like HIV/AIDS.

WMA states that such pts need competent and compassionate treatment.

Intimate nature of the PP relationship can give rise to sexual attraction- should be resisted

Emotional attachment with a patient can adversely affect the clinical judgment

Communication and Consent• Informed consent is one of the central

concept of the present day medical ethics.

• No more medical paternalism - now communication requires much more information provided by the physician to make their decision.

2 exceptions for informed consent by competent

patients1)Gives over the decision making

authority to the physician or to a third party

2)Instances where the disclosure of information would cause harm to the patient.

Decision making for incompetent patients

• Many patients are not competent to make decisions for themselves. eg; young children, comatose, mental or neurological condition

• Ethical issue arises in the determination of the appropriate substitute decision maker and in the choice of criteria for discussion on behalf of incompetent patients.

• Physicians make decision for patient only if the designated substitute cannot be found.

• Physician should challenge the decision of the substitute through relevant legal authorities if required.

Confidentiality • The physician duty to keep patient information

confidential has been a corner stone of medical ethics.

• The International code of Medical Ethics states “It is ethical to disclose confidential information when the patient consents to it or when there is a real and immenent threat of harm can be only removed by a breach of confidentiality”

• The high value placed on Confidentiality has 3 sources:1. Autonomy 2.respect for others and 3. Trust

Breach of confidentiality • Healthcare institutions• Medical students• When communication is impossible• Legal requirement • Psychiatric patient intends to harm• HIV/AIDS patient continues

unprotected sex

Beginning of life issues • Laws , regulation and policies related to this

are:• Contraception• Assisted reproduction• Prenatal genetic screening• Abortion • Severely compromised neonates• Research issues : incl production of new

embryos or the use of spare embryos to obtain stem cells

End of life issue • Ranges from attempts to prolong

lives of dying patients through highly experimental technologies to effort to terminate life prematurely through Euthanasia and medically assisted suicide.

• Euthanasia• Assistance in suicide

Euthanasia • Means knowingly and intentionally

performing an act that is clearly intended to end another person’s life.

• Commits the act with the primary intention of ending the life of that person , undertaken with compassion and without personal gain.

Types of Euthanasia• Euthanasia can be classified in different ways, including:1. Active euthanasia – where a person deliberately

intervenes to end someone’s life – for example, by injecting them with a large dose of sedatives

2. Passive euthanasia – where a person causes death by withholding or withdrawing treatment that is necessary to maintain life.

3. Voluntary euthanasia – where a person makes a conscious decision to die and asks for help to do this

4. Non-voluntary euthanasia – 5. Involuntary euthanasia – where a person is killed against

their expressed wishes

Euthanasia status

• Legalized1)Netherlands2)Belgium3)Colombia 4)Luxemburg

• Criminalized1)Mexico2)Thailand3)Northern territory of

Australia

Recent cases of Euthanasia• Passive euthanasia is legal in India.

• In 2011 for a bedridden rape victim late Aruna Shanbaug.

• The Marlize munoz case of 2013- brain dead- remove life support- unethical and illegal to do so in a pregnant mother

Assistance in suicide• Knowingly and intentionally providing a person

with the knowledge to commit suicide.

• Arise as a result of pain or suffering that is considered by the patient intolerable.

• Physicians are regarded as the appropriate instrument of death.

• Hampering the natural course of death is unethical in any code of ethics

AIS in the world

• Legalized 1)Switzerland2)Germany3)Japan4)Some of the US states

CASE STUDY Dr. Sam, an experienced and skilled surgeon, is

about to finish night duty at a community hospital. A young woman is brought to the hospital by her mother, who leaves immediately after telling the intake nurse that she has to look after her other children. The patient is bleeding vaginally and is in a great deal of pain.

Dr. Sam examines her and decides that she has had either a miscarriage or a self-induced abortion. He does a quick dilatation and curettage and tells the nurse to ask the patient whether she can afford to stay in the hospital until it is safe for her to be discharged. Dr.Amritesh comes in to replace Dr. Sam, who goes home without having spoken to the patient.

Case analysisDr. Sam’s conduct was deficient in several respects: (1) communication – he made no attempt to

communicate with the patient regarding the cause of her condition , treatment options or her ability to afford to stay in the hospital while she recovered;

(2) consent – he did not obtain her informed consent to treatment:

(3) compassion – his dealings with her displayed little compassion for her plight. His surgical treatment may have been highly competent and he may have been tired at the end of a long shift, but that does not excuse the breaches of ethics.

Physician and society

• Medicine is more social rather than a strictly individual activity. It relies on government, medical researches, health institutions etc and treat disease and illness that are much social as biological in origin.

• Medical profession have significant roles in public health, health education, environment protection, laws affecting the health and well being of the community. Etc

Dual Loyalty• When physicians are accountable

both to their patients and to a third party(governments,employers, insurances , police , family members etc)

• Physicians should resolve any conflicts between their own interests and those of their patients, in their patients favour.

Resource allocation• In circumstances where a choice

must be made between potential patients for a particular treatment that in limited supply, the selection should be based on medical criteria and made without discrimination.

• Avoid wasteful and inefficient practices ,even when patient requests

Global health• Globalization encompasses information

exchange, commerce , politics, tourism and many other human activities.

• The failure to recognize and treat highly contagious disease by a physicians in one country can have devastating effect on patients in other countries.

Case study 2• Dr. Reshma is becoming increasingly frustrated

with patients who come to her either before or after consulting another health practitioner for the same ailment. She considers this to be a waste of health resources as well as counterproductive for the health of the patients.

• She decides to tell these patients that she will no longer treat them if they continue to see other practitioners for the same ailment. She intends to approach her national medical association to lobby the government to prevent this form of misallocation of healthcare resources.

Case analysis• the patient is taking up Dr. Reshma’s time that could

be devoted to other patients in need of her services.

• However, physicians such as Dr. Reshma must be cautious in dealing with situations such as this. Patients are often unable to make fully rational decisions for a variety of reasons

• Dr. Reshma is also right to approach her medical association to seek a societal solution to this problem , since it affects not just herself and this one patient but other physicians and patients as well.

Physician and colleagues

Challenges to medical authority

• Physician belongs to a hierarchical system, internally and externally

• Internally :I. Among specialties II. Within specialtiesIII. Primary caregiver of the specific patient

• Externally: physicians are traditionally at the top of the hierarchy of caregivers, above the nurses and other health professionals.

Relationship with colleagues, teachers and students

• Physicians are expected to treat all members of the medical profession as family members.

• Treat colleagues respectfully and work cooperatively to maximize patient care.

• Physicians are restricted from paying or receiving any fees etc for referral of a patient and stealing patients from colleagues.

• Respect entails an appreciation of skills and experience of healthcare providers physicians ,nurses etc contribute to the care of patient.

Report unsafe or unethical medical practices.

• Report unsafe or unethical medical practices to appropriate authorities.

• Other alternatives can be considered before informing the authorities

Case study 3• Dr. Arjun, a newly appointed Anesthetist in a city

hospital, is alarmed by the behaviour of the senior surgeon in the operating room. The surgeon uses out-of-date techniques that prolong operations and result in greater post-operative pain and longer recovery times. Moreover, he makes frequent crude jokes about the patients that obviously bother the assisting nurses.

• As a more junior staff member, Dr. Arjun is reluctant to criticize the surgeon personally or to report him to higher authorities. However, he feels that he must do something to improve the situation.

Case analysis• Not only is he endangering the health of the patient but

he is being disrespectful to both the patient and his colleagues.

• Dr. Arjun has an ethical duty not to ignore this behaviour but to do something about it. As a first step, he should not indicate any support for the offensive behaviour, for example, by laughing at the jokes.

• If he thinks that discussing the matter with the surgeon might be effective, he should go ahead and do this. Otherwise, he may have to go directly to higher authorities in the hospital

Medical Research

Medical research

• Ethics in clinical research focuses on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large.

Research in medical practice

• Has to maintain competence through CME,Journals etc

• The ethical values of the physician – compassion, competence, autonomy – apply to the medical researcher as well.

• Rewards offered by medical research companies can conflict with the right of the patient to receive all the necessary information for making a decision on taking part in the trial.

Declaration of Helsinki• Ethical review committee approval-The

ethics committee may approve the project as presented, require changes before it can start, or refuse approval altogether.

• Scientific merit-• Social value-• Risks and benefits- • Informed consent-• Confidentiality• Conflicts of interest

Publication ethics• Defined as a self regulatory mechanism insisting on

integrity on the part of authors, peer reviewers and publishers to establish higher standards of editorial processing for the scholarly journals.

• Violation : duplicate submission, multiple submissions, plagiarism, gift authorship, ghost authorship, salami publications etc

• Treatment based on such results can harm the patients

• Harms other researchers who waste time following up such studies

Whistle blowing • To prevent unethical research

• Those who are aware of such practices can inform the appropriate authorities.

• Whistle blowers are usually punished or prevented from disclosing the wrong doing.

• Juniors who are helpless can at least stay away from participating in such studies.

Unresolved issues• All aspect of medical research doesn’t enjoy

general agreement.

• Ethical acceptability of techniques in genetics, neurosciences and organ and tissue transplant is still questionable.

• Questions on what continuing care should be provided for the participants of research.

Unethical research cases• The monster study on orphans in

Davenport,1939

• Doctor's trial-1946-criminal trial for Nazi human exp

• Tuskegee syphilis experiments in 1972

• In jan 2012 GSK was fined $240000 for falsifying parental consent for a vaccine trial on 15000 children

Nazi human experiments• Exp on prisoners(Jews from across Europe)

• Exp conducted on twins, bone , muscle and nerve transplant, freezing exp , high altitude exp..etc

• To help German military in combat situations, develop new weapons..etc

• Most died and others were executed for post mortem studies

Case study 4• Dr. Diya, a general practitioner in a small rural town,

is approached by a contract research organization (C.R.O.) to participate in a clinical trial of a new non-steroidal anti inflammatory drug (NSAID) for osteoarthritis. She is offered a sum of money for each patient that she enrolls in the trial.

• The C.R.O. representative assures her that the trial has received all the necessary approvals, including one from an ethics review committee. Dr. Diya has never participated in a trial before and is pleased to have this opportunity, especially with the extra money. She accepts without inquiring further about the scientific or ethical aspects of the trial.

Case analysis• Dr. Diya should not have accepted so quickly. She

should first find out more about the project and ensure that it meets all the requirements for ethical research.

• She should only participate in projects in her area of practice, and she should satisfy herself about the scientific merit and social value of the project. If she is not confident in her ability to evaluate the project, she should seek the advice of colleagues in larger centers.

• She should ensure that she acts in the best interests of her patients and only enrolls those who will not be harmed by changing their current treatment to the experimental one or to a placebo. She should not agree to enroll a fixed number of patients as subjects since this could lead her to pressure patients to agree, perhaps against their best interests. they become available.

Medical students and doctors in training need to hone their clinical skills on patients to make themselves better doctors, but patients may not benefit directly from such attention.

Patients may be misinformed about the qualifications and experience of their care givers.

Ethical principles are applicable

Ethics in Medical Education

Medical Ethics in India

Ethics and ethical principles was followed during the Ayurvedic period of Charaka (600BC- 800AD).

Flash back• Policy statement on Ethical

Considerations involved in research on human subjects. – 1980 by ICMR.

• Ethical guidelines for biomedical research on Human Subjects- 2000

• Put in to force through Schedule Y.• 12 principles by inducting the 3 basic

ethical principles

MCI guidelines • Duties and

responsibilities of the physician in general

• Duties of physicians to their patients

• Duties of physician in consultation

• Responsibilities of physician to each other

• Duties of physician to the public and to the paramedical profession

• Unethical acts• Misconduct• Punishment and

disciplinary action

The way ahead• Though we formulated these

guidelines, are we adequately following them?

• The PG/PhD thesis- trains investigators the element of ethical research.

Conclusion

• Despite all these potential problems, medical research is a valuable and rewarding activity for physicians and medical students as well as for the research subjects themselves. Indeed, physicians and medical students should consider serving as research subjects so that they can appreciate the other side of the researcher-research subject relationship.

“Doing well and doing good might not always go hand in hand.”

References • Ethical issues in the development and use of guidelines for clinical

practice.Redman BK• Ethics and clinical practice guidelines- Margaret A Somerville• Ethical issues in implementation research: a discussion of the problems in

achieving informed consentJane L Hutton1*, Martin P Eccles2 and Jeremy M Grimshaw3

• Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach Marcel Mertz12 and Daniel Strech1

• Ethics in Medical Research in Humans: A Historical PerspectiveX. Sierra• Medical Ethics Mannual-2nd edition by WMA• Violation of publication ethics in manuscripts: analysis and perspectives:

subramani parasuraman et al• Ethics in clinical research : The Indian Perspective : J Sanmukhani• Ethical issues in the practice of Medicine: Dr. M S Valiathan