Key Indicators of good ethos & conduct in Medical System

➢Maintenance of records for a minimum period of 3 years.

➢If any request is made by patient the medical records should be made
available within 72 hours.
➢A separate register of medical certificates issued should be maintained.
➢Physician should display registration number prominently.
➢Physician shall display suffix to names of only recognized medical
diploma’s, certificates and degrees.
➢Highest assurance should be given to patient care.
➢The co-professionals should expose any unethical conduct.
➢Payment terms should be clearly displayed for the professional services
rendered.
➢Physicians should comply to Drugs & Cosmetics act 1940, Pharmacy act
1948, Narcotic drugs & Psychotropic substances act 1985, Medical
Termination of Pregnancy act 1971, Transplantation of Human Organ
act 1994, Mental Health act 1987, Prenatal Sex Determination act 1994,
Drug & Magic Remedies act (objectionable advertisement) 1954,
Persons with disabilities (equal opportunities & full participation) act
1995, Biomedical waste (management & handling) rules 1998.
➢Strict adherence to policy of beneficence (action of benefit of others) &
nonmaleficence (obligation not to inflict harm intentionally).
➢Physicians should have the patience to receive carefully, delicately treat
& maintain secrecy of personal details of patient & should notify healthy
people about communicable diseases.
➢Physician shouldn’t exaggerate nor minimize the gravity of situation,
➢Physician shouldn’t charge for referral of patient & shall discuss about
treatment plans with other physicians.
➢Appointment of substitute is permitted only when he/she is able to
discharge the assigned responsibilities in particular department.
➢No remarks to be made by the higher authority regarding the diagnosis &
treatment plan of physician.
➢Physician is permitted to make formal announcement publicly about-
▪ Starting Practice.
▪ Change of type of Practice,
▪ Change of address.
▪ Temporary absence of duty.
▪ Resumption of another practice.
▪ Succeeding to another practice.
▪ Public declaration of charges.

➢If shop is opened for the purpose of only dispensing drugs, the conduct in
not deemed right.
➢Physician shall not receive any gift, gratuity or commission.
➢Physician shouldn’t prescribe any of the secret remedies.
➢For Euthanasia to be conducted there should be presence of Chief
Medical Officer/Medical Officer/In charge of Hospital from Hospital
Staff in accordance to the transplantation of Human Organ Act 1994 in
compliance to beneficence policy.
➢It is a gross misconduct if physician prescribes steroids/psychotropic
drugs without rationale judgement in treatment.
➢Selling scheduled H & L drugs is also a gross misconduct over the
counter drug.
➢Physicians can give lectures to the public, talks on Radio, Tv & internet
pertaining to health, diet & allied aspect.
➢Physicians shouldn’t make usage of unusually large signboards.
➢Physicians shouldn’t refuse treatment on religious grounds.
➢Before performing surgical operation; consent by spouse or guardian in
case of minor is deemed necessary.
➢Physician can’t publish photograph’s pertaining to any patient without
his/her permission.
➢Physician shall not claim to be a specialist without specializing in
concerned subject at the master’s level of qualification.
➢Qualified professionals under any organization can’t perform act of
artificial insemination/invitro fertilization without informed consent
from the individual.
➢The physician serving in rural area if found absent on two or more
occasions during inspection by District Health Authority/Chairman/
Zilla Parishad; shall be construed as a professional misconduct.
➢Physician posted in medical college/institution as a teaching
faculty/otherwise shall remain in college/hospital premised during
assigned duty hours. If found absent on two or more occasions shall be
construed as a professional misconduct.
➢Upon professional misconduct, enquiry is conducted & gives opportunity
to be heard in person. Punishment will be as deemed by authority of
institute if essential.
➢The deletion of the physician in the register roll shall be publicized
widely in local press.
➢The name of the physician should be restored in the register, if removal is
for a temporary period.
➢Decision about the physician who is suspended for a temporary period
must be taken within 6 month’s.
➢The medical council can restrain physician from performing
procedure/practice; who is under constant scrutiny.
 Types of Consent during Physician Patient Interaction

1) Informed Consent:
• It respects the autonomy of patient.
• Written consent is deemed necessary for procedures, surgery &
investigations.
2) Valid Consent:
• For consent to be valid, it should be free, voluntary & informed.
• Adult can give voluntary consent. But in case of children the
parents/guardian (legal) have the privilege to give consent for medical
treatment.
3) Implied consent:
• It is the inferred consent by physician based on patient’s necessity, action
& the situation he/she is going through.
4) Express Consent:
• It is a free willed consent expressed either verbally or written to a
physician.
5) Invalid Consent:
• The consent is deemed invalid if it is done under influence, fraud,
misinterpretation.
• The consent given by a minor/intoxicated person or a person of unsound
mind is declared invalid.
 Vulnerable group in medical treatment:
It includes the following-
a. Children.
b. Unconscious/comatose patient’s.
c. Mentally disabled persons.
d. Elderly patients.
e. Women (health decision is a subject to spouse/family approval in a
patriarchal society).
f. Imprisoned & institutionalized personnel.
g. Socially marginalized sex workers, drug addicts & homeless.
h. Persons with stigmatized diseases like HIV & leprosy.
i. Patient’s with temporarily impaired competency skills due to
acute/chronic diseases

Examples of certain medical conditions where there is severely

defective neonates
• Spina Bifida
• Down Syndrome
• Tay sach’s disease
➢Ethical dilemma experienced by physicians in these medical conditions
• Terminally ill patients such as pancreatic cancer, GIST, Prostate Ca,
Cervical Ca, Breast, Ca, Colon Ca, Kidney Ca, Cirrhosis of liver, Ca of
Lung.
• Senile Dementia/Alzheimer’s Disease.
• Unconscious patient’s kept live on ventilator & life support systems.
 Concept of Death & Euthanasia in Brief

Death:
Cessation of vital functions of body including heartbeat, breathing & brain activity.
Euthanasia:
In Greek its termed as “Eu Thanatos” – euphemistically called as mercy killing.
Types of Euthanasia:
a) Voluntary Euthanasia:
In this type of euthanasia patient asks for life to be ended voluntarily.
b) Non voluntary Euthanasia:
• In this type the patient is not in a position to convey about termination of life. Eg-
Coma, Senile, Mentally challenged, severely damaged brain or neonate.
• Here the caretaker/parent/guardian has expressed concern to the physician but not the
patient.
• Implied consent is considered only when there is a grievous situation(jeopardy) on the
patient’s health.
c) Involuntary Euthanasia:
It is the termination of life against the wishes or will of the patient.
Eg- Aktion T4 Program of World War II
d) Active Euthanasia:
It is a intentional /deliberate intervention of health professional to cause death in
euthanasia.
Eg- Use of lethal drug
e) Passive Euthanasia:
It is a kind of euthanasia where doctor on the patient’s request allows event of death
in the natural course of illness.
Eg- switching of life support systems, discontinuing medication, removal of feeding
tube, withholding surgery.
Legal implications based on Medical Conduct & in Profession
• IPC 306- ‘Abetment of Suicide’
- The person convicted shall face an imprisonment upto 10 years.
• 299 A- ‘Culpable Homicide’
- It is an act performed with the intention of causing death.
• The competent patient has the right to refuse treatment. Doctor has to accept the
patient’s obligation without trying coercion & should be fully aware of
consequences.
• Doctor shouldn’t withdraw the treatment of patient of any medical condition until he
has obtained opinion of three medical practitioners from the panel.
 Examples of Active Euthanasia Performed:
• Dr Kervorkion (1922- 2011) assisted death of 130 terminally ill patients.
• Dr Nigel Cox was charged with attempted murder (1992) for injecting I.V (KCl) to
relieve her suffering in arthritic condition.

Countries where there is regulated Euthanasia:

• Nethelands
• Belgium
• Luxemborg

Countries where Physician assisted suicides are permitted:

• Switzerland
• Germany
• Albania
• Colombia
• Japan
❖ The case which drew the attention of whole world as the patient was in a
comatose/vegetative condition for prolonged term-
• Aruna Shanbaug (25-year-old) in 1973 was brutally assaulted by a ward boy. It left
her with limited consciousness, blind & in- vegetative state. She was alive till May
2015, where she passed awa following lung infection.
❖ Case which drew the attention of whole world was of Dr Savita Halappanavar who
was admitted in a hospital at Ireland, 2012 for threatened miscarriage at 17 weeks.
Doctors in hospital refused to terminate the pregnancy because the foetal heart was
still beating & the prevalent laws didn’t permit to terminate stating life of foetus is
supreme to existence but as time passed on mother developed septicaemia. But when
termination was attempted, the mother later on succumbed to complications of
septicaemia & organ failure.
• Later the laws were amended in a jewish country to aid in termination of pregnancy in
case od threatened complications to mother during the pregnancy tenure.
 Terminology Related to Embryology, Genetics & State of
Consciousness
Zygote: A single cell containing full complement of DNA formed from
fusion/fertilization of ovum & sperm.
Morula: Cluster of cells formed by first few divisions of zygote.
Embryo: It is the progression of development from the stage of morula to 8 weeks
Foetus: It is the term used for development from stage of embryo until birth.
Coma: It is a state of impaired consciousness where there is no sign of wakefulness
or awareness in person (No functioning of cortex & reticular activating system).
Minimal Consciousness: In this state there is minimal & fleeting evidence of
awareness in a person. (Some parts of cortex & reticular activating system are
functional)
Vegetative State: In this state there are no signs of awareness. Eyes may open or
close & have sleep cycles. There is no awareness of activities around/self. (Damage
to cortex, reticular activating system & brainstem are functional, allowing
spontaneous breathing & heart beat).
Persistent Vegetative State: It is the state of individual where vegetative period has
persisted beyond 1 month.
Permanent Vegetative State:
It is the state of individual where there is no improvement in signs of consciousness
beyond 1 year.
Locked in State:
It is a rare situation in stroke. It is a condition where cerebral cortex & reticular
activating system may be preserved but damage to motor pathways renders patient
completely paralyzed.

Abbreviation Related to Life Support Mechanism

• DNR: Do not Resuscitate
• ACLS: Advanced Cardiac Life Support
• AND: Allow Natural Death
 Phases of Clinical Trial While Determining Action of Drug for
Therapy
Phase 1:
• A team of 10-40 volunteers are chosen for experiment.
• In this phase the aim is to determine action of drug in human with property of
ascertaining safety, dosage & side effect.
• In case of cancer, drugs can be used on severely ill patients.
Phase 2:
• In this case the drug is administered to small number of patients (<100) suffering
from disease in order to evaluate its efficacy, dosing strategy & side effects.
Phase 3:
• In this phase drug is administered to large number of patients (300-1000); sometimes
at multiple locations to confirm effectiveness, safety & side effects, compared to
standard protocols in treatment methods.
Phase 4:
• This is the phase where drug is available in the market. In this phase, there are
reviews, effect on diverse population , immediate/short/long term side effects are
evaluated.

Important Documents in Research Ethics:

• The Nuremberg Code 1947.
• WMA World Medical Association); Declaration of Helsinki 1964.
• CIOMS (Council for International Organizations of Medical Sciences). It has set the
international guidelines for biomedical research involving human subjects, 1993.
• International Conference on Harmonization guidelines for Good Clinical Practice
1996.
• ICMR (Indian Council of Medical Research). It has set the ethical guidelines for
biomedical research on human participation 2006.
• Schedule Y Drugs & Cosmetics Act 1945, Amended in 2013.

Main Principles of Research in Compliance with ethics-

• Beneficence- Benefit the patient.
• Non maleficence- Do no harm.
• Respect- Respect the autonomy of patient.
• Justice- Seek justice for the patient in treatment.
• Integrity- Maintain integrity while interacting with the patient.
 Good Research Practice:
It consists of ethical standards followed in procedures, review & conduct for doctors
involved in research activity

Human Papilloma Virus (HPV) Vaccine Trial (2006)

• In 2006, 24000 teenage girls from tribal regions of Andhra Pradesh & rural districts of
Gujarat were selected for vaccine trial.
• Study was halted in 2010, when seven death’s were reported from growth.
• A writ petition filed in supreme court citing numerous irregularities including misuse
of regulatory loophole, violation of human right, exploitation of vulnerable
population.

Havasupai Tribe Case

• American University 1989 took up a research study to find out genetic cause for high
incidence of Diabetes Mellitus in Havasupai Tribe.
• Blood samples were taken, DNA had been used in studies related to inbreeding,
mental illness & human migration.
• Havasupai Tribe expressed emotional distress at use of their tissue samples & data in
violations of their dignity & civil rights.
• American University was directed to restore the civil rights & dignity of tribe in form
of compensation & welfare of the tribe.

Justice Jeopardized:
• In 1996, American based pharmaceutical company ‘Pfizer’ approached Nigerian
Government to conduct clinical trial of new antibiotic ‘Trovafloxacin’. It violated
the civil rights & ethical principles I conducting clinical trials.
• When there was outbreak of meningitis, 100 children were admitted in Infectious
Disease Hospital.
*100 children in control arm were treated with ‘Ceftriaxone’
• 11 children under study died while many others suffered neuropathic complications.
 Therapeutic Obligation
• When the intended drug is for therapeutic purpose the physician is obliged to act
responsibly in conducting trials.
• In 1994, Zidovudine was used for clinical trial along with placebo as control for a
group in Zimbabwe, Africa.

Importance of Understanding Genetics in Conducting Research

Ethically
Genetics: Study of genes, heredity & variations in living organism.
Genome: Complete study of genetic material of an organism/individual inclusive of
chromosomes.
Genomics: It means study of genetic material in its complete form.
Human Genetics: It relates to study of genes & heredity specific to humans &
includes cytogenetics, molecular genetics, biochemical genetics, population
genetics, developmental genetics, clinical genetics & genetic counselling.
Medical Genetics: It relates to the diagnostic techniques, management & research
of hereditary disorders.
Clinical Genetics: It is the practice of clinical medicine in area of genetic disorders.
Genetic Clinics: It is the clinical set up managed by physicians, counsellors &
nutritionists.
Genetic Tests: These tests are conducted with the purpose of Pre-implantation
genetic diagnosis, pre-natal genetic testing & adult genetic screening for medical
disorders.
Genetic Angst: It is the social anxiety in a person/community related to misuse of
genetic information.

Successful Gene Therapy

• In 1990, 4-year-old Ashanti De Silva was treated for severe combined immuno-
deficiency caused by a single gene defect that blocked formation of adenosine de
aminase (ADA) in body.
• Introduction of normal variant into blood appeared to correct the defect.
• She continues to live normally with repeated injection of corrected T cells ; every 2
months.
• “Glybera” is a drug marketed for gene therapy to restore lipoprotein lipase enzyme in
patient’s suffering from LPLD (Lipoprotein Lipase Deficiency) is currently the most
expensive drug in the world.
• 18 year old Jesse Gelsinger was the first patient known to have died in a clinical trial
for gene therapy in 1999. He suffered from non herited ornithon transcarbamylase
deficiency that resulted in inability to metabolize ammonia.

Types of Gene Therapy

a) Somatic Cell Gene Therapy:
• It targets nonreproductive/somatic cells of the body.
• The therapeutic effect lasts for life of treated cell.
• Patient’s offspring would inherit genetic defect as genetic alteration is only at the
level of somatic level.
b) Germ Line Gene Therapy:
• Genetic modification targets gamete cells, ovum & sperm.
• Faulty genes are either removed/replaced but technology is difficult compared to
somatic cell gene therapy.
• There is possibility of permanent correction of genetic hereditary disorders.

Eugenics:
It is the method where human genetic traits can be improved through selective
reproduction of those people with desired trait & restriction of reproductive rights to
people of undesirable traits with emphasis on improved physical features & superior
intellectual capabilities. Eg- ‘Herceptin- drug used in breast cancer’.

Transplantation of Human Organ Act

• The bill was passed in 1994.
• It was amended in 2009 & 2011.
• It was ratified in 2014.
• In 2009, the amendment made in the act was applicable even to the tissues. In this
amendment the donors could be persons who are not near relatives. Eg-
Grandchildren in addition to parent, children, spouse & sibling.
• In 2011, the amendment made in the act allowed retrieval of organs from deceased
person from a registered organ retrieval centre.
• The amendment allowed medical professional to certify brain death other than
neurologist to certify & recommend appointment of transplant coordinator at every
transplant centre.
 Social Justice:
It means equal access to the resources in medical system & non discrimination
in treatment principles.
Personalism:
It recognizes dignity & uniqueness of every human being, valuing individual
autonomy & confidentiality within a collective framework.
Subsidiarity:
It tells us about how common good can be ascertained in public ethics & who
should decide…
Epidemiology:
It is the study of distribution & determinants of health related states/events in
specific population & application of this study to control health problems.
Epidemiological Study:
It is beneficial & useful for the community only when there are honest
discussions with community leaders, sharing information, keeping promises, timely
action, transparency, competence & respectful behaviour are indispensable in this
study.
• There should be equitable distribution of burden & benefits of participants in
research.
• According to WHO report, out of pocket payment accounts 97% of total private
health expenditure & 80% of total health expenditure in India.
• Clinical trials of HPV vaccine developed by an international company for prevention
of cancer of cervix began in India 2009; in anticipation for inclusion in
immunization schedule.
• There were reports of adverse effects including death of some girls who participated
in study.
• Doctor should always treat with compassion, counselling & patience rather than
condemnation.
 Window Period:
It is a period where tests may not show positive result, hence universal
precautions are recommended for every surgery.
• National Rural Health Mission- 2005
• National Urban Health Mission- 2013
• QALY- Quality Adjusted Life Year
• Doctor has to be conscious about cultural sensitiveness, individual autonomy &
human right.
Resource Allocation in Public Health:
• Publicity- Decisions & their rationale.
• Reasonableness- Reasonable & relevance.
• Appeals- Redressal of problems faced.
• Enforcement- Public regulation of process.

Ebola Virus (2014):

• Symptoms- fever , sore throat, muscle pain, headache, vomiting, diarrhoea & rash.
Decreased functioning of kidneys & liver.
• Onset- 2 days to 3 weeks post exposure.
• Diagnosis- Viral RNA.

Swine Flu (2009):

• Respiratory disease caused by influenza virus.
• Affects respiratory tract of pigs.
• Result in barking cough, decreased appetite, nasal secretions & listless behaviour.
• Last for 3-7 days, serious infections last for 10 days.
• Tamiflu had limited benefits.
 Emigration of Health Care Professionals for Better Prospectus & Income:
• 20% of trained nurses move to U.K, U.S.A & Saudi.
• Indian doctors emigrate to USA (4.9%), U.K((10.9%), Australia (4%), Canada
(2.1%).
• 60000 Indian Physicians are presently working in U.S, U.K & Australia.
• In India, Doctor- Patient ratio is 0.6: 1000. Global average of Doctor Patient is 1.5:
1000.
Medical Error:
• It is the failure of planned action to be completed as intended or use of a wrong plan
to achieve an aim.
Common diagnostic errors:
• Error/delay in diagnosis.
• Failure to use indicated test.
• Use of outmoded test/therapy.
• Failure to act on results of monitoring /testing.
Common Treatment Errors:
• Errors in performance of an operation/procedure/test.
• Error in administering treatment.
• Error in dose/method of using drug.
• Delay in treatment/responding ot abnormal test.
• Inappropriate care.

Preventive Errors:
• Failure to provide prophylactic treatment.
 Types of Stem Cells
a) Human Embryonic Stem Cells (ESC’s)
These are pluripotent cells derived from blastocyte stage of human embryo in vitro.
b) Human Somatic Stem Cells:
• Here the stem cells are isolated from adult tissue like bone marrow, adipose tissue &
blood.
• Since 1988, umbilical cord blood has emerged as a possible source of stem cells.
c) Human Induced Pluripotent Stem Cells(iPSC’s)
• These cells are derived from adult human cells that have been genetically re-
programmed to develop pluripotent capacity.
• Japanese researcher Shinya Yamanaka has been awarded Nobel Prize in 2012 for
outstanding work in this area.
• Haematopoetic Stem cells are derived form bone marrow which are already in use for
blood dyscracia like leukemia; in form of marrow stem cell transplant.

Cloning:
It is the technique employed in duplication of biological material.

Guidelines & Declaration related to Genetics & Biomedical

Research
• UNESCO- The Universal Declaration of Human Genome & Human Rights-1997.
• UNESCO- International Declaration on Human Genetic Data-2003.
• UNESCO- Universal Declaration on Bioethics & Human Rights-2005.
• ICMR- Ethical Guidelines for Biomedical Research on Human Participants-2006.
 Possible Applications of Cloning
• Reviving endangered or extinct species.
• Cloning of Livestock.
• Drug production from livestock.
• Cloning in medical research.
• Therapeutic cloning.
• Reproductive cloning in humans.

Ethical Concerns with Research on Cloning

• Cloning humans for use of tissues & organs; it goes against the dignity & intrinsic
value of human being.
• Procreation using this technology goes against the concept of human being.
• Legal status of cloned individuals is a very big challenge & hard to accept as a
member of society.
• The social fabric revolving family structures & relationships is at greater risk.
• Anthropological studies in cloned individuals is never deemed right as it focused an
evolutionary history of how the people behave, communicate & socialize with one
another.

Robotics in Medicine
• Robotics is used for high precision instrumentation & monitoring of patients.
• Benefits of using robots in medicine are
- Shorter surgical time.
- Smaller incision.
- Less infection.
- Greater patient turn over.
- Shorter hospital stays.
 Ethical Concerns related to use of Robotics in Medicine
• There is a tradition of patient’s expectation to be cared & comforted by a human
doctor.
• High cost involvement in maintenance of robotic equipment & supporting computers
with dedicated network channel.
• The confidentiality of data is at risk. The data stored is vulnerable for hacking, change
of sequenced program codes & alter.
• Assignment of responsibility remains onerous task.

Types of Transplant
1) Auto-transplant: It is the transplantation of tissues from one part of body to another
in same person.
Eg- Bone chips & skin grafts.
Advantages- Tissue & blood compatibility
- Risk of infections & hypersensitivity reactions are less.
2) Allotransplant: It is the transplantation of organ/tissue form one member to another
of the same species.
Challenges are-
• Tissue compatibility
• Immune reaction
• Transmission of disease.
3) Xenotransplant: It is the transplantation of tissues/organs between different species.
• Animal transplants are acceptable only in situations when human organs are not
available.
• Artificial tissues & organs are also considered to be xenotransplant.
 Bioengineering & Nanotechnology Applications
• The creation of artificial human tissue using bioengineering & nanotechnology by
using biomaterials like- 3D scaffolds & hydrogels as a base for construction of
desired tissue.
Live Donor:
“A living human being from whom cells, tissues, organs have been removed
for purpose of transplantation”
Characteristics-
• Genetically related with parent, sibling or child.
• Emotionally related as in case of spouse, in-laws, joint family.
• Unrelated either genetically or emotionally.
Deceased Donor:
When the human being is declared dead & his/her tissues/organs are used then it is
termed as deceased donor.
1) Donor after brain death/deceased heart beating donor:
The person’s organs/tissues are used only after brain death has been declared.
2) Donor after cardiac death/Deceased non heart beating donor:
It is the term used when the donor has been declared dead using cardiopulmonary
criteria of assessment of life.
❖ Transplant success rate is better when organs are recovered from patient’s with brain
death in whom circulatory system is maintained.
3) Beating Heart cadaver;
It is the term used when brain death of an individual is confirmed but ventilator &
perfusion are maintained until organs are removed.
❖ India’s first domino kidney transplant was successfully conducted across 3 hospitals
in Mumbai, 2013. It involved 5 donors, 5 recipients & 10 surgeons & simultaneous
surgeries lasted for about 6 hours.
Brain Death:
It is a condition where there is irreversible loss of all functions of brain including brain
stem. It is characterised by-
• Coma
• Absence of brain stem reflexes
• Apnea
❖ The protocol to be followed has been clearly stated in “Ethical Guidelines for
Biomedical Research on Human Participants, 2006”
 MOHAN (Multi Organ Harvesting Aid Network)
It is an organization which stipulates how the organs should be matched using blood
group, HLA testing, gender, age & geographical proximity while considering organ
transplantation.
❖ ‘Indian Transplant Registry’ was established by Indian Society of Organ
Transplantation in 2005,
❖ SEEK- Screening & Early Evaluation of Kidney Disease.
❖ In India, National Transplant Registry is yet to be formed.
❖ THOA- Transplant of Human Organs Act
❖ NOTTO- National Organ & Tissue Transplant Organisation.
• It has 2 divisions-
a) National Human Organ & Tissue Removal & Storage Network.
• National Biomaterial Centre.

Transplantation of Human Organ Act:

• The bill was passed in 1994.
• It was amended in 2009 & 2011.
• It was ratified in 2014.
• In 2009, the amendment made in the act was applicable even to the tissues. In this
amendment the donors could be persons who are not near relatives, Eg-
Grandchildren in addition to parent, children, spouse & sibling.
• In 2011, the amendment made in the act allowed retrieval of organs form deceased
person from a registered organ retrieval centre.
• The amendment allowed medical professional to certify brain death other than the
neurologist to certify & recommends appointment of transplant coordinator at every
transplant centre.
Social Justice:
It means equal access to the resources in medical system & non discrimination in
treatment principles.
Personalism:
It means dignity & uniqueness of every human being valuing individual autonomy &
confidentiality within a collective frame work.
 Subsidiarity:
It tells us about how common good can be ascertained in public ethics & who should
decide…
Epidemiology:
It is the study of distribution & determinants of health related states/events in
specific population & application of this study to control health problems.
Epidemiological Study:
• It is beneficial & useful for the community only when there are honest discussions
with community leaders, sharing information, keeping promises, timely action,
transparency, competence & respectful behaviour are indispensable in their study.
• There should be equitable distribution of burden & benefits of participants in
research.
• According to WHO report, out of pocket payment accounts 97% of total private
health expenditure & 80% of total health expenditure in India.
• Clinical trials of HPV vaccine developed by an international company for prevention
of cancer of cervix began in India in 2009; in anticipation for inclusion in
immunization schedule.
• There were reports of adverse effects, including death of some girls who participated
in study.
• Doctor should always treat with compassion, counselling & patience rather than
condemnation.

Window Period:
It is a period where tests may not show positive result, hence universal precautions are
recommended for every surgery.
• National Rural Health Mission- 2005.
• National Urban Health Mission- 2013.
• QALY- Quality Adjusted Life Year.
• Doctor has to be conscious about cultural sensitiveness, individual autonomy &
human rights.

Human Allocation in Public Health:

• Publicity- Decision & their rationale.
• Reasonableness- Reasonable & relevant.
• Appeals- Redressal of problems faced.
• Enforcement- Public regulation of process.

Ebola Virus (2014):

• Symptoms- Fever, sore throat, muscle pain, headache, vomiting, diarrhoea & rash.
Deceased functioning of kidney & liver.
• Onset- 2 days to 3 weeks past exposure.
• Diagnosis- Viral RNA.
 Swine Flu (2009):
• Respiratory disease caused by influenza virus.
• Affects respiratory tract of pigs.
• Result in barking cough, decreased appetite, nasal secretions & listless behaviour.
• Lasts for 3-7 days. Serious infections last for 10 days.
• Tamiflu had limited benefits.

Emigration of Health Care Professionals for Better Prospectus & Income:

• 20% of trained nurses move to U.K, U.S.A & Saudi.
• Indian doctors emigrate to USA (4.9%), U.K (10.9%), Australia (4%), Canada
(2.1%).
• 60000 Indian Physicians are presently working in U.S, U.K & Australia.
• In India, Doctor-Patient ratio in 0.6-1000. Global average of Doctor- Patient is 1.5-
1000.
Medical Error:
It is the failure of planned action to be completed as intended or use of a wrong plan
to achieve an aim.

Common Diagnostic Errors:

• Error/delay in diagnosis.
• Failure to use indicated test.
• Use of outmoded test/therapy.
• Failure to act on results of monitoring/testing.

Common Treatment Errors:

• Errors in performance of an operation, procedure/test.
• Error in administering treatment.
• Error in dose/method of using drug.
• Delay in treatment/responding to abnormal test.
• Inappropriate case.

Other Possible Failures:

• Failure of Communication.
• Equipment Failure.
• Other System Failure.
❖ Medical errors can be classified according to outcome (fatal, non-fatal), setting
(inpatient, outpatient), intervention (medication, surgery), & probability (low, high)
complex clinical condition, extremes of patient age, surgeries & multiple drug
prescriptions.
Eg- Improper transfusion, electrocautery, tissue damage due to pressure, post-
surgical wound infection, administration of incorrect drug/dosage, prescription to
wrong patient & faulty intubation.
Most Common Medical Errors:
• Insufficient knowledge & uncertainty about procedures.
• Ignorance of sources of errors.
• Poorly defined responsibility.
• Low community spirit.
• Insufficient communication.
• Clinical autonomy & low acceptance of change.
• Strong Professional Identity.
• Low priority task & logistic problems.

❖ NABH- National Accreditation Board for Hospitals & Health Care.

❖ NABL- National Accreditation Board for Testing & Calibration Laboratories.
• There is an NGO called ‘People for better treatment’ which facilitates better medical
services for the lower socio-economic group people.

• ‘Nimesulide’ – a drug used as analgesic & antipyretic for paediatric patients

developed liver complications & died.

Proper Settings for providing Rational Health Care-

• Out patient registration & patient flow.
• Quality of floorings, rooms, safety & ventilation.
• Documentation & storage of case history, treatment, charts, investigation & discharge
record.
• Quality of diagnostic laboratory & equipment.
• Sterilization procedure for drape’s instruments, operation theatre & rooms.
• Patient handover procedures by health care personnel in a hospital set up.
• Standard Protocol should be at place for care of patients.
• Sexual harassment of women at work place (Prevention, Prohibition & Redressal)
Act, 2013.
• Declaration of Geneva- ‘My colleagues will be my brothers and sisters’.
• National AYUSH Mission (NAM) in September 2014.
• The Central level institute fostering Ayurveda is “All India Institute of Ayurveda in
New Delhi” under ministry of AYUSH, Gov’t of India.
• The Central level institute which regulates the functioning of homoeopathic colleges
along with designing proper curriculum for the professional courses at various
homoeopathic colleges in India.
• The Central Government has cleared the deck for ‘ The Recognition of New Systems
of Medicine Bill- 2014’
• The Drugs & Magic Remedies Act, 1954, (Objectionable Advertisement). It is very
essential Act for the Indian Scenario to control advertisement of drugs in certain
cases to prohibit advertisement for certain purposes of remedies alleged to possess
magic qualities.
• Unaccredited Drug Therapy
- Acupuncture
- Acupressure
- Magnetotherapy
- Reiki Medicine
- Massage
- Reflexology (Physiotherapy)
• Naturopathy uses elements of nature to boost immunity & in vigour health by using
material resources- water, air, sunrays & mud.
• Yoga uses the principles of body postures, breathing techniques, reflexes, channelizes
the energy flow through the nadi’s & activating the highest spiritual chakra to in
vigour immunity & soothe the mind & body.
• Ayurveda uses herbal formulations in treatment which may contain heavy metals &
steroids. It is based on tri-dosha theory like Vata, Pitta, Kapha & emphasis is more
on diet.
• Homoeopathy is a system of medicine based on principle of ‘Similia Similibus
Curantur’ with holistic approach in treatment according to traits, tendencies &
outlook of mind with consideration to physical function of the body,
• U.S Cardiologist , Genetist & Researcher ‘ Eric Topol’ wrote a book called ‘ The
Creative Destruction of Medicine’. It describes the genomes & future of medicine
which thought provoking & envisions a future dominated by patient driven approach
to health care.
• Indian Medical Council regulates to prescribe drugs with generic names.
❖ “Physician Payment Sunshine Act”
- It mandates that all payments or benefits of any kind to physicians/health care
providers should be reported to pharmaceutical companies.
- The Indian Medical Council regulated the colleges & health care institutions should
never accept Industry sponsored Seminars, Conferences or Continued Medical
Education series.
• In Latin “Primum Non Nocere means - Above all do no harm”
• World Medical Association adopted ‘Declaration of Helsinki, 1964’ which ratified the
ethical principles for medical research involving human subjects.
Criteria for Authorship:
• Substantial contribution to concept & design of research, analysis & interpretation of
data.
• Drafting & Reviewing intellectual content of paper.
• Final approval of version to be published.
• Agreement to be accountable for all aspects of research.

Plagiarism:
It is the wrongful appropriation & use of another author’s language, thoughts, ideas &
representation of them as one’s own original work.
Eg- German Defence Minister had t resign over allegations of plagiarism in PhD thesis,
2011.

Copyright:
• It is a exclusive legal right given the originator for a fixed number of years to publish,
print, perform or record-literary, artistic or musical material.
• It exists until 70 years after death of content creator & is not linked to last edition of
publication.

Salami Publication:
• It means the combination of outcomes in the current paper with the previous papers
already published by an original author. In this publication data from a single study
are broken up & used to produce multiple papers from research paper.
• In 2011, Dean of social studies at Tilburg University had to resign when it was
discovered that the data presented in his research study has been fabricated.
• In 2010, A senior medical researcher at Dake University was forced to resign in 2010
after it was found that data published on cancer research were false.
• In 2009, Korean Researcher- ‘Woo Suk’ was sentenced for fraud when it was proved
that he published false report of successful stem cell cloning.
• Researchers & Authors are expected to keep raw data of their study for at least 10
years after it is published.

Abbreviations-
• CONSORT- Consolidated Standards of Reporting Trials.
• COPE- Committee on Publication Ethics.
• ICMJE- International Committee of Medical Journal Editors.
 ICMJE (International Committee of Medical Journal Editors)
It recommends & stipulates the conduct, reporting, editing & publication of
scholarly work in Medical Journals, 2013.

Peer Reviewed Journals:

The journals published in medical system are reviewed by the members approved for
reviewing research journals published by authors for the public domain. The
methods adopted in reviewing the journal are
a) Blinded
b) Unblinded
c) Multiple or single review with relative merits
 Declaration by a Physician registered under Indian Medical Council
a) I solemnly pledge myself to consecrate my life to service of humanity.
b) Even under threat, I will not use my medical knowledge contrary to laws of humanity.
c) I will maintain the utmost respect of human life from time of conception.
d) I will not permit consideration of religion, race, party politics/social standing to
intervene between my duty & my patient.
e) I will practice my profession with conscience & dignity.
f) The health of my patient will be my first consideration.
g) I will respect the secrets which are confined to me.
h) I will give to my teachers – the respect & gratitude which is their due.
i) I will maintain by all means in my power- the honour & noble tradition of medical
profession.
j) I will treat my colleagues with all respect & dignity. I make the promises solemnly,
freely & upon my honour.
 WMA Declaration of Lisbon on the right of the patient (1981)
1) Right to Medical Care of Good Quality:
• Every person is entitled without discrimination to appropriate medical care.
• Every patient has the right to be cared by a physician whom he/she knows free to
make clinical & ethical judgements without any outside interference.
• The patient shall always be treated in accordance with his /her best interests. The
treatment applied shall be in accordance with generally approved medical principles.
• In circumstances when a choice must be made between potential patient for a
particular patient that is in limited supply, all such patients are entitled to a fair
selection procedure for that treatment. That choice must be made on medical criteria
& made without discrimination.
• Patient has the right to continuity of health care. The physician has an obligation to
cooperate in the coordination of medically indicated care with other health care
providers treating the patient. The Physician may not discontinue treatment of a
patient as long as further medically indicated without giving the patient reasonable
assistance & sufficient opportunity to make alternative arrangements for care.
2) Right to freedom of choice
• Patient has right to choose freely & change his/her physician & hospital/health service
institution, regardless of whether they are based in private/public sector.
• Patient has right to ask for opinion of another physician at any stage.
3) Right to self determination
• Patient has right to self determination to make free decision regarding himself/herself.
Physician will inform the patient of the consequences of his/her decision.
• Mentally competent adult patient has the right to give/withhold consent to any
diagnostic procedure or therapy.
• Patient has the right to information necessary to make his/her decisions. Patient
should understand clearly what is the purpose of any test/treatment what the results
would imply & what would be the implication of withholding consent.
• Patient has the right to refuse to participate in research or teaching of medicine.
4) Unconscious Patient
• If the patient is unconscious /otherwise unable to express his/her will, informed
consent must be obtained whenever possible from a legally entitled representative.
• If a legally entitled representative is not available, but a medical intervention is
urgently needed, consent of the patient may be presumed, unless it is obvious &
 beyond any doubt on basis of patient’s previous firm expression or conviction that
he/she would refuse to intervention in that situation.
• However physicians should always try to save the life of a patient, unconscious due to
a suicide attempt.
5) Legally Incompetent Patient
• If a patient is a minor/ otherwise legally incompetent, consent of a legally entitled
representative is required in some jurisdictions. Nevertheless the patient must be
involved in the decision making to the fullest extent allowed by his/her capacity.
• If the legally incompetent patient can make rational decision his/her decision must be
respected & he/she has right to forbid the disclosure of information t his/her legally
entitled representative.
• If patient’s legally entitled representative or a person authorized by the patient forbids
treatment; which is opinion of physician should challenge the decision in relevant
legal/other institution. In case of emergency the physician will act in patient’s best
interest.
6) Procedures against the patient’s will
• Diagnostic procedures or treatment against patient’s will can be carried out only in
exceptional cases is specifically permitted by law & conforming to principles of
medical ethics.
7) Right to Information
• Patient has the right to receive information about himself/herself recorded in any of
his/her medical records & to be fully informed about his/her health status including
medical facts about his/her condition.
• However confidential information in the patient’s records about a third party should
not be given to the patient without consent of that party.
• Exceptional information may be withheld from patient when there is good reason to
believe that this information would create a serious hazard to his/her life or health.
• Information should be given in a way appropriate to the patient’s culture & in such a
way that patient can understand.
• The patient has the right not to be informed on his/her explicit request, unless required
for the protection of another person’s life.
• The patient has the right to choose; who if anyone should be informed on his/her
behalf.
8) Right to Confidentiality
• All identifiable information about a patient’s health status, medical condition,
diagnosis, prognosis & treatment & all other information of a personal kind must be
 kept confidential, even after death. Exceptionally descendants may have a right to
access information that would inform them of their health risk.
• Confidential information can only be disclosed if the patient gives explicit consent or
if expressly provided for the law. Information can be disclosed to other health care
providers only on a strictly ‘need to know’ basis unless the patient has given explicit
consent.
• All identifiable patient data must be protected. The protection of the data must be
appropriate to the manner of the storage. Human substances from which identifiable
data can be derived must be likewise protected.
9) Right to Health Education
• Every person has the right to health education that will assist him/her in making
informed choices about personal health & about available health services. The
education should include information about health, lifestyles & about methods of
prevention & early detection of illnesses.
• The personal responsibility of everybody of his/her own health should be stressed.
• Physician have obligation to participate actively in educational efforts.
10) Right to dignity
• Patient’s dignity & right to privacy shall be respected at all times in medical care &
teaching with due regard to his/her culture & values.
• Patient is entitled to relief of his/her suffering according to current state of knowledge.
• Patient is entitled to humane terminal care & to be provided with all available
assistance in making dying as dignified & comfortable as possible.
11) Right to Religious Assistance
• Patient has the right to receive or to decline spiritual & moral comfort including help
of a minister of his/her own religion.
 Extract of Medical Termination of Pregnancy Act 1971
1) Notwithstanding anything contained in Indian Penal Code (As of 1860) a registered
medical practitioner shall not be guilty of any offence under that code or under any
other law for time being in force. If any pregnancy is terminated by him in
accordance with provisions of this Act.

2) Subject to provision of subsection (4); a pregnancy may be terminated by a

registered medical practitioner-
• Where the length of pregnancy does not exceed 12 weeks.
• Where the length of pregnancy exceeds 12 weeks but doesn’t exceed 20 weeks then
the opinion of two registered medical practitioners in good faith are formed that-
a) Continuance of pregnancy would involve in a risk to life of pregnant woman or a
grave injury to the physical & mental health.
b) There is substantial risk that if the child were born, it would suffer from such
physical/mental abnormalities as to be seriously handicapped
3) In determining whether the continuance of pregnancy would involve such risk of
injury to health as is mentioned in subsection (2) account may be taken of pregnant
woman’s actual/ reasonably foreseeable environment.
4) a) No Pregnancy of a woman, who hasn’t attained age of 18 years/ who have attained
18 years of age is a lunatic, shall be terminated except with the consent in writing of
her guardian.
b) Same as otherwise provided clause 1 (a), no pregnancy shall be terminated except
with the consent of pregnant women.
5) Place where pregnancy may be terminated. No termination of pregnancy shall be
made in accordance with the Act at any other place other than-
• A hospital established or maintained by Gov’t or
• A place for time being approved for purpose of this act by-
i. The provisions of sec (4) & provisions of subsections (2) of sec (3) as relating to
length of pregnancy & the opinion of not less than two registered practitioners; shall
not apply to the termination of pregnancy by registered medical practitioner in case
where he is of opinion- formed in good faith; that the termination of such pregnancy
is immediately necessary to save life of pregnant women.
ii. Notwithstanding anything contained in Indian Penal Code (45 of 1860), the
termination of pregnancy by a person who is not a registered medical practitioner
shall be an offense punishable under that code & that code shall to this extent, stand
modified.
 Teaching Medical Ethics at College Set up
It is a combination of classroom lectures; bedside teaching & good example would
leave a lasting impression on young doctor about ethical behaviour
It can be blended with
• Case studies.
• Occasionally guest lectures.
It would be ideal for discussion on principles related to treatment policies.
Pre- clinical years apt questions and curriculum
• Why did I chose this profession?
• Brief history of Medicine
• History of Medicine in India
• Who is a
• good Doctor?
• Who is a professional?
• Principles of ethics
• Code of ethics
• Indian tradition in medical ethics
• Effective communication.

Clinical Years:
• Informed Consent
• Confidentiality
• Communication- ‘breaking bad news’
• Allocation of resources
• Respect for patient autonomy
• Role of the family
• Patient as a participant in research
• Conflict of interests in tests & drug prescriptions
Pathology:
• Ethics of research on stored samples
• Biobanking
• Ethics of cord blood banks
Microbiology:
• Ethics of HIV testing
• Ethics in case of disease outbreaks
• Ethics of samples & nondisclosure
• Vaccines & clinical trials
Pharmacology:
• Research ethics
• Clinical trials
• Medical Representatives
• Unethical Prescription Practices
Forensic Medicine
• Medical Errors
• Patient Safety
• Medical Litigation
• Rights & duties of doctor
• Patient Rights
Psychiatry:
• Capacity for consent
• Surrogate consent
• Mental Health act
• Ethical treatment of Psychiatric patient
Paediatrics
• Surrogate decisions
• Assent & Consent
• Preimplantation & Genetic Diagnosis
• Prenatal Testing
• Child Abuse & Laws
• Ethics in research involving children
Obstetrics & Gynaecology:
• Ethical issues related to abortion
• Medical Termination of Pregnancy Act
• Sterilization Camp
• Assisted Reproductive Techniques
• Ethical Issues with surrogacy
• Prenatal Diagnostic Tests
• PCPNDT Act
Community Health Medicine
• Public Health Ethics
• Social role of the doctor
• Ethics related to epidemiological studies
• Allocation of resources
• National Health Priorities
• Global Health, Migrating doctors, medical tourism.
Medicine/I.C.U
• Euthanasia
• Unconscious patients
• Diagnosis of death-organ donation
• Advance directive/do not resuscitate
• Breaking Bad News
• Over diagnosis & Unethical Prescription Practices
Surgery:
• Communication & Informed Consent
• Patient Autonomy
• Ethics of Surgical Training
• Patients as Teachers
• Conflict of interests in implants & devices.