3. Professional Negligence
Every medical practitioner is required :
a) To possess ‘reasonable’ medical
b) To exercise ‘reasonable’ care and skill.
The quantum of ‘knowledge’ and ‘skill’
has not been prescribed. A doctor is
expected to have such knowledge and skill
as possessed by other doctors of his
standing in similar circumstances.
4. Types of Professional Negligence
The two main types of professional
Other types are:
5. Medical Malpractice/ Negligence
Can be compensated by money
Do not demand legal punishment
Manipulation of medical records
Performing criminal abortion etc
Breach of ethics
May lead to debar the physician.
6. Elements of Malpraxis suits :
Liability for negligence arises if following
conditions are satisfied :
1. Duty of care :-
There must be duty on the part of doctor to
take care of the patient.
2. Dereliction of duty :-
Failure of doctor to exercise that duty.
3. Direct causation :-
Failure to exercise duty of care must directly
result into the harm to the patient.
4. Damage :-
The harm must be caused and must be
7. Civil Negligence :
• Simple absence of care and skill
• Nature and extent of harm is such that it can be
compensated in terms of money (damages).
• Amount of harm/damage is a measure of extent of
• If proved, the doctor is liable to pay damages.
• Tried by Civil Courts
• No special violation of Law
• Consent of the patient amounts to good defence
• Contributory negligence may also constitute a
8. Criminal Negligence :
• More serious than civil negligence
• There is Carelessness
Disregard for life and safety of the patient.
• Extreme departure from ordinary standard of
• The nature and extent of Loss/harm is such that it
can not be compensated in terms of money.
• Practically limited to cases in which the patient has
• Examples – operating on wrong person or wrong
9. Important Doctrines :
Res Ipsa Loquitur :-
Ordinarily negligence of a doctor must be proved
in court by the patient or relatives through expert
Res Ipsa loquitur is the exception – it means “the
thing or fact speaks for itself.”
It enables the patients lawyer to prove his case
without medical evidence.
E.g. wrong prescription, swab in abdomen etc.
10. Vicarious Liability :
“A liability that exists, in absence of
blameworthy conduct on the part of
Based on the principle,
“Respondent superior” (let the master answer)
Here, the employer is responsible for the
negligent acts of his employee, provided :
i) There is employee-employer relationship.
ii) The employees conduct occurs during the course of
iii) While on job.
11. CONTRIBUTORY NEGLIGENCE
Any unreasonable conduct or absence of
ordinary care on the part of the patient, which,
along with doctor’s negligence, has contributed
to the harm complained of.
Some contribution by the patient.
Doctor partly held responsible.
“last clear chance”
12. CONTRIBUTORY NEGLIGENCE
- Failure to give correct history.
- Failure to carry out doctor’s instructions.
- Refusal to take suggested treatment.
- Leaving the hospital DAMA.
- Failure to seek timely assistance/advice.
Failure to attend for follow-up.
13. CONTRIBUTORY NEGLIGENCE
Legal aspects :
- Contributory negligence is a good
defence for the doctor, but
- Only a partial defence and, if proved,
doctors liability can be
- Burden of proof lies entirely on the
- Doctor can not plead it, if fails to give
14. THERAPEUTIC MISADVANTURE
Almost every therapeutic drug and
every therapeutic procedure carry
inherent risks or complications.
Ignorance of the doctor about
possibility of reaction or continuation
in prescribing the drug with adverse
reaction amounts to negligence.
15. THERAPEUTIC MISADVANTURE
The doctor is not considered as negligent if
he can prove that :
- Steps he took were quite justified.
- The hazard was quite unexpected & was not
known to occur.
- Reasonable precautions were taken.
- No better treatment or procedure was
17. PRECAUTIONS AGAINST NEGLIGENCE
• Establish good rapport with the patient.
• Maintain proper and complete record.
• Employ laboratory tests, whenever
• Obtain informed consent.
• Seek consultation whenever necessary.
• Never guarantee a cure.
• Do not employ experimental methods
without valid reason/informed consent.
19. DEFENCES AGAINST NEGLIGENCE
1. No duty of care owed to the plaintiff.
2. Duty discharged according to prevailing
3. It was a case of therapeutic misadventure.
4. Novus actus intervenins.
5. It was an error of judgment.
6. Contributory negligence (partial defence)
7. Res judicata (Sec 300Crpc)
8. Time limit (within 2 years)
20. Civil Negligence Criminal Negligence
1. Simple absence of care
2. Can be compensated in
terms of money.
3. Tried in Civil court.
4. No specific and clear
violation of Law.
5. A dispute between the
two parties in their
6. Strong evidence is
sufficient to prove.
7. Repairable damage
1. gross carelessness and
regard to life & safety of
2. Not so. Doctor is
punishable with fine and/or
3. Tried in Criminal courts.
4. Specific violation of a
5. A case between the state
and the accused doctor.
6. Guilt should be established
beyond reasonable doubt.
7. Irreparable damage
21. Professional Negligence Infamous Conduct
1. Absence of care and
skill or willful
2. Damage to the patient
should be present.
3. Duty of care should be
4. Tried by courts – Civil
5. Punishable with fine or
imprisonment or both.
6. Appeal – to higher
1. Violation of code of
2. Need not be present
3. Need not be present.
4. Tried by State Medical
5. Punishable with penal
erasure – temporary or
6. Appeal – to State or
22. Voluntary agreement, compliance
S. 13 of Indian Contract Act :
When two or more persons agree
upon the same thing in the same
sense, they are said to consent.
Two types : a) Implied
CONSENT IN MEDICAL PRACTICE
23. Valid Consent
Free, fair and voluntary
No Force, Fraud or Coercion (Sec90IPC)
Adult patient of sound mind
Obtained before the procedure
Specific for the procedure
Proper age ( <12 89 IPC, <18 87 IPC)
CONSENT IN MEDICAL PRACTICE
24. Informed consent
Obtained after giving full understanding of
Nature of proposed procedure.
Alternative procedure available.
Risks and benefits involved in both.
Potential risks of not performing the procedure.
Relative chances of success / failure.
CONSENT IN MEDICAL PRACTICE
25. No consent required
From an accused of offence brought by
police. (Sec 54 CrPC)
Life saving emergency treatment done in
Procedures made compulsory by Law.
CONSENT IN MEDICAL PRACTICE
26. Special circumstances
Consent of spouse for the treatment of other is
generally not required.
Consent of spouse required if
Procedure involves danger to life.
May limit sexual or reproductive functions.
May result in death of unborn child.
CONSENT IN MEDICAL PRACTICE
27. At the end of the class, the student shall be able to –
Define & understand, Enumerate the types
of Consent. Importance of ‘Informed
consent’. Objectives of ‘Consumer
protection act’ and about Ethical & Legal
aspects of Bio medical Research.
28. Consumer Protection Act, 1986
“Consumer Protection Act is not the
weapon of offence, it is the remedy
made available to the aggrieved
consumer to deal with defect or
deficiency in Service”
In April 1992 – Kerala State ,
Commission. Amendment (50) 1993
Amended in 2002
29. The objectives of C.P. Act :
1. To protect the interests of the consumers of
different commodities, for which they pay,
but do not get standard quality of service.
2. To provide mechanism for inexpensive and
speedy redressal of consumer grievances.
3. To promote and protect the rights of the
consumers by establishing Central and State
Consumer Protection Councils.
4. To provide for organization of activities
aimed at consumer education and
30. The Grievance Redressal Mechanism:
1. District Level
District Consumer Disputes Redressal Forum
Three member forum chaired by a person who
is/was/ qualified to be a District Judge.
Two other members having ability, integrity,
knowledge and experience.
One of the members is a woman.
Can entertain claims for compensation upto
Rs. 20 lacs.
31. 2. State Level
State Consumer Disputes Redressal
Also a three member commission chaired
by a person who is/has been a High Court
Two other members as in District Forum.
Can entertain claims between Rs. 20 lacs to
Rs. one crore & appeal from district forum.
32. 3. National Level
National Consumer Disputes Redressal
Five member commission Chaired by a
person who is/has been a Supreme Court
Four other members including a lady.
Can entertain claims more than Rs. one
crore and appeals from State Commission.
33. Consumer Courts :
The consumer forum/commission has got the
same powers as those of Civil Courts under
Every proceeding is deemed to be a ‘judicial
1. For the noncompliance of the order made by
the forum/commission, the person can be
punished with imprisonment ranging from
the one month to 3 years and fine from Rs.
2,000 to Rs. 10,000/-
2. For false and frivolous complaints, the
complainant can be fined up to Rs. 10,000/-
34. • Step 1
• Send a notice to the construction company/ developer,
before filing a formal complaint. It is important for the
consumer to give notice to the opposite party regarding the
deficiency in service or unfair practice. This is to see if the
other party is willing to offer the compensation to make the
good the loss suffered by the consumer. If the developer
refuses or neglects the notice, the you can approach the
35. • Step 2
• Submit a formal complaint under the Consumer Protection Act,
1986. You need not hire a lawyer for filing the suit. Fill
this complaint form and submit it to the commission.
• On a plain paper, mention the details of the complainant and the
opposite party. Otherwise, you can consult consumer grievance
redressal forums which also help consumers in filing and forming
petition at nominal charges. One such non-governmental
organisation is International Consumer Rights Protection Council.
• The consumer should file the complaint in the district forum which
has under its jurisdiction the other party's residence or office of
profit or the area where the project is located.
36. • Step 3
• You have to submit the fee through a demand draft. The consumer
forum follows difference jurisdiction to entertain complaint:
• If the claim is for less than Rs 20 lakh, the District Consumer
Disputes Redressal Forum will hear the plea.
• If the claim is for more than Rs 20 lakh but less than Rs 1 crore, the
State Consumer Dispute Redressal Commission will entertain the
• If the claim is more than Rs 1 crore, the National Consumer
Disputes Redressal Commission will attend to the plea.
37. Fee details
For district forums
• Up to Rs 1 lakh: Rs 100
• Between Rs 1-5 lakh: Rs 200
• Between Rs 5-10 lakh: Rs 400
• Above Rs 10 lakh and up to Rs 20 lakh: Rs 500
For state forums
• Above Rs 20 lakh but less than Rs 50 lakh: Rs 2,000
• Above Rs 50 lakh and up to Rs 1 crore: Rs 4,000
For the National Commission
• A standard amount of Rs 5,000
38. (Consent & C. P. A. etc.)
At the end of the class, the student shall be able to –
1) Define and understand what is ‘Consent’.
2) Enumerate and understand types of consent.
3) Describe ‘Informed Consent’ and elements of valid
4) Describe the objectives of ‘Consumer Protection
Act’ and mechanism available for redressal of
39. • Abortion/Miscarriage –
It is premature expulsion of foetus from
mother’s womb at any time of pregnancy
before full term.
• 7-10 days – after Implantation of
developing ovum k/a Embryo.
• >2 Months -K/a fetus
• After birth K/a Neonate up to 1 month
• Infant – up to 1 year.
1. Natural (Spontaneous) Abortion
In 10-15% of pregnancies- in 1st trimester.
Causes – Defect in ova/ fetus.
- Local diseases/ defects
- General diseases
- Accidental trauma
- Hormonal deficiency
2. Artificial (Induced) Abortion
a) Legal /Justifiable- with provisions under MTP act.
( Declaration of Oslo 1970 )
b) Criminal Abortion- Unlawfully induced expulsion.
42. The Medical Termination Of
Pregnancy Act, 1971
An Act to provide for the termination of certain pregnancies by registered
medical practitioners and for matters connected therewith or incidental
Medical Termination of Pregnancy (MTP) is a maternal health care measure, which
helps to avoid the maternal mortality and morbidity resulting from illegal
43. Legal/Justifiable Abortion
Legal provisions/grounds for M.T.P.
1. Therapeutic – When continuation of pregnancy endangers
life of mother.
2. Eugenic- Risk of child being born with physical/ mental
(Disease, Drugs, X-rays & Insane)
3. Humanitarian – When Pregnancy caused due to Rape.
4. Socio-economic- When Pregnancy caused due to failure of
44. Under this act, there are certain indications
for the legal termination of pregnancy.
The continuance of the pregnancy would
involve a risk to the life of the pregnant
woman or of grave injury to her physical or
45. 2. Eugenic
There is a substantial risk that if the child were born, it would suffer from such
physical or mental abnormalities as to be seriously handicapped.
• If the pregnant woman in the first three
months suffers from German measles,
smallpox, chicken pox, toxoplasmosis, viral
hepatitis or any severe viral infection
Drugs •Thalidomide, cortisone, antimitotic drugs,
hallucinogens or antidepressants.
• If the pregnant woman is treated with X-rays
Others • Insanity of the parents
46. 3. Humanitarian
Pregnancy caused by rape may effect the mental health of the mother. It is
assumed that the victim mother does not want the child and does not want
to bear the continuing result of a crime for which she was not culpable.
47. 4. Social and Economic
When the pregnancy has resulted from a failure of contraceptive methods in
case of a married woman, which is likely to cause to cause serious injury to her
When social or economic environment, actual or reasonably expected, can
injure the pregnant woman’s health.
48. MTP & Duration
Only qualified M.O
Up to 12 wk – one M.O
12 wk-20 wk – opinion of 2 M.O
In emergency termination by 1 doctor in good faith by
Place:- In Govt. hospitals Or place approved by Govt.
Consent :- By pregnant woman, if >18yrs. In minor
Guardian. Spouses consent not required.
49. Methods for inducing criminal abortion
1) Abortifacient drugs :
a) Ecbolics- act on uterus. E.g. Quinine, Lead
b) Emenogogues- Increase menstrual flow.
e.g. Savin, Borax , Estrogens etc.
c) GIT irritants- Castor/ croton oil.
d) Uterine Stimulants- Oil of tansy, oil of
e) Drugs irritants to other systems-
e.g. Lead, Arsenic,
calatropis, Plumbago etc.
50. 2) Mechanical Violence :-
a) General Violence
b) Local violence
a) General Violence- e.g. cycling, Riding, Jumping,
use of alternate hot & cold baths, uterine massage,
b) Local Violence- local irritation or Dilatation of
cervix with/ without rupture of membranes.
Rupture of Membranes
54. ABORTION & MTP
Sr.No. Natural Criminal
1) Cause Predisposing Pregnancy in
diseases Widow / unmarried
2) Infection Rare Frequent
3) Marks of violence Not seen present on Abdomen.
4) Genital No injuries Present.
5) Toxic effect Absent Erosions &
inflammation due to
drugs present in
vagina , Cx.
6) Foreign Not present May be seen.
bodies in Genital tract
7) Fetus Wounds absent Rarely may
55. Complications leading to death -
• Immediate - Vagal inhibition.
- Hemorrhage & Shock.
- Air embolism/ Fat embolism.
• Delayed - Septicemia / Pyaemia.
- Peritonitis / Toxemia.
• Remote - Jaundice & Renal failure.
- Bacterial endocarditis
- Pulmonary embolism
- Poisonous effects of drugs.
57. Hemorrhage, softening of external os, vaginal walls,
Injuries to vaginal canal, cervix.
Signs of injuries to abdomen.
Material & liquid from vagina, uterine cavity and blood
sent for chemical & bacteriological examination.
Urine & Vomitus- for C.A.
Evidence of abortion in living -
58. Post Mortem Evidence of criminal abortion -
Abortion by the drugs- GIT- E/O irritant poisoning, Vagina &
Cervix for erosions. Sent to RFSL.
Instrumental abortion- Injury to vagina, cervix, uterus.
Peritoneum, pelvic organ & floor for injury,
hemorrhage or inflammation, E/O air embolism, E/O
Abortion by syringing- May be fluid in vagina & soiling the
clothes, Segmentation of the coronary vessels.
Right side of heart, superior & inferior vena cava may contain foamy
• What is MTP? What are the rules?
• Define abortion or infanticide.
• Give the classification of abortion.
• Describe the Methods used in criminal abortion
• What are the complications of criminal abortion
• Define live birth, stillbirth & dead birth.
• Enlists the Signs & tests for live birth.
• Enumerate the Acts of commission & acts of
60. References/Bibliography :
Parikh’s textbook of Medical Jurisprudence and
Toxicology, 5th edition, 1990.
Modi’s Medical Jurisprudence and Toxicology, 21st
The essentials of Forensic Medicine and Toxicology by
Dr. K.S.N.Reddy, 25th edition, 2006.
Reference books –
Principles of Forensic Medicine by Apurba Nandy, 2nd
61. At the end of the class, the students shall be
1) Define & classify abortion & infanticide.
2) Describe the rules of the MTP Act.
3) Describe the methods used in criminal abortion and their
4) Conduct examination of a woman who has allegedly
5) Describe the concept of live birth & stillbirth.
6) Describe the signs & tests for live birth.
7) Enumerate the acts of commission & acts of omission.
8) Describe the development of fetus & medico legal
• Definitions & classification of abortion &
• Rules of the MTP Act.
• Methods used in criminal abortion and their
• Examination of a woman who has allegedly
• Concept of live birth, stillbirth & dead birth.
• Signs & tests for live birth.
• Acts of commission & acts of omission.
63. ARTIFICIAL INSEMINATION
Artificial introduction of semen into the vagina,
cervix or uterus to produce pregnancy.
Types:- 1) AIH-husband
3) AIHD-donor semen to
which semen from husband added.
When husband is Impotent, Sterile.
Rh incompatibility between husband & wife.
Mental disease or hereditary disease in husband.
64. 1. A.I.H : If the semen of the
woman’s husband is used, it is
known as artificial insemination
homologous or artificial
2. A.I.D. : If semen of some other
person other than the husband is
used it is known as aritificial
3. A.I.H.D. : Pooled donor semen
is composed of donor semen to
which semen from the husband
has been added
66. Biological Aspects
Semen is obtained by masturbation and one ml. is deposited by means
of a syringe in or near the cervix
usual time taken for sperm to travel from vagina to tubes is 6-24 hrs
Fertilisation can occur in 48 hrs
Success rate is 70-75%
Frozen semen: done by
adding glycerol. And
storage below -79 C
67. Biological Aspects
Timing of insemination is important as the life span of
spermatozoa in the female genital tract is short
The time of maximum fertility coincides with the time of
Ovum survives in the fertilizing form 8-12 hrs after it leaves
69. Techniques used
1. Intrauterine insemination: 'Washed sperm', that is, spermatozoa
which have been removed from most other components of the
seminal fluids, can be injected directly into a woman's uterus in a
process called intrauterine insemination (IUI)
2. Intracervical insemination: Intracervical insemination, or 'ICI' is the
easiest way to inseminate. This involves the deposit of raw fresh or
frozen semen which has been provided by the woman's partner or by a
sperm donor into the cervix usually by injecting it with a needle-less
70. Techniques used
3. Intrauterine tuboperitoneal insemination: Intrauterine
tuboperitoneal insemination (IUTPI) is insemination where both the
uterus and fallopian tubes are filled with insemination fluid
71. Techniques used
4. Intratubal insemination : IUI can furthermore be combined with intratubal
insemination (ITI), into the Fallopian tube although this procedure is no
longer generally regarded as having any beneficial effect compared with IUI
72. Surrogate Motherhood
A women who by contract agrees to
bear a child for someone else
It is intended to help a couple, of
whom the woman is infertile but the
male has no reproductive deficiency.
The legal problems of surrogate
motherhood are those of artificial
73. Surrogate Motherhood
1. Gestational Surrogacy (GS): When the intended mother is not be able to
carry a baby to term , her egg and the intended father's sperm are used to
create an embryo that is implanted into and carried by the surrogate
2. Traditional Surrogacy (TS): This involves artificially inseminating a
surrogate mother with the intended father's sperm via IUI, IVF or home
3. Traditional Surrogacy & Donor Sperm (TS/DS): This involves
artificially inseminating a surrogate mother with donor sperm via IUI, IVF
or home insemination
74. Surrogate Motherhood
4. Gestational Surrogacy & Egg Donation (GS/ED): If there is no intended
mother or the intended mother is unable to produce eggs, the surrogate
mother carries the embryo developed from a donor egg that has been
fertilized by sperm from the intended father
5. Gestational Surrogacy & Donor Sperm (GS/DS): If there is no intended
father or the intended father is unable to produce sperm, the surrogate mother
carries an embryo developed from the intended mother's egg (who is unable
to carry a pregnancy herself) and donor sperm
6. Gestational Surrogacy & Donor Embryo (GS/DE): When the intended
parents are unable to produce either sperm, egg, or embryo, the surrogate
mother can carry a donated embryo
75. Surrogate Motherhood
1. Womb Leasing: Artificial insemination with the semen of
barren woman’s husband is carried out in a hired woman.
after surrogate birth, the baby is returned to his biological father
and his wife.
2.Another method: A healthy mature ovum is removed from the
wife and fertilized in vitro with the husbands semen. The
embryo is implanted in the womb of the hired woman.
76. Legal Aspects
• In cases where the difficultyarises from the impotence of a husband
who is neverthelessfertile,it would seem that artificialinsemination
with the semen of the husband(AIH)can be regarded as a justifiable
and unobjectionable procedure. However, the birth of a child in wedlock
as a consequence of such inseminationdoes not constituteevidence of
proper consummation of marriage.
• When for any reason, AIH is not possible and AI is done withthe
semen of an unknown donor(AID),theposition is radicallydifferent
from the above. The legal issues arisingthere from are as follows:
78. 2. Legitimacy: The child will be illegitimate and cannot
3. Nullity of marriage and divorce: Mere A.I. is not a
ground for divorce, but A.I. due to impotence is ground for
4. Natural Birth: If a child is born naturally sometime after
A.I., the status of the natural born child remain legitimate
and the status of the child born by A.I. remains illegitimate
79. Legal Issues
5. Unmarried women or widow: If uses A.I. the child
6. Incest: between the child born by A.I. and the child of
the donor. It is not an offence in India
For the father: He may feel humiliated or may develop
psychiatric symptoms. He may develop bitter
feelings if the child is deformed or mentally retarded
For the mother: May develop neurosis feeling the
child is her alone. Or may develop an obsession to
know the donor or to have another child from the
1. Consent of donor and wife
2. Identity of donor must remain a secret
3. Donor must be mentally and physically healthy
4. Donor must not be relative or spouse
5. Blood group matching
6. Rh incompatibility must be ruled out
7. Couple and should be psychologically fit and mentally stable
8. Witness must be present
9. Pooled semen should be used
10. Physician carrying out the insemination should avoid
delivering the child
83. Test Tube Baby
The ovum is removed from the ovary and fertilised by the sperm of
Own ova fertilised by donor sperm.
Another woman’s ovum.
Donor ovum fertilised by donor
It is the technique of producing a genetically
duplicate of an organism artificially.
DNA is taken from oocyte and put in a petridish
together with a
donor cell and electric current is passed through it
to fuse as a
zygote. This is implanted in surrogate mother
85. Cloning and Test tube babies
Cloning: It is the technique of producing
a genetically identical duplicate of an
Test tube babies: The ovum is removed
from the ovary and fertilized by the
sperm of her husband invitro
86. • EUTHANASIA (mercy killing): It means producing
painless death of a person suffering from hopelessly
incurable and painful disease.
• Types: (1) Active or positive. (2) Passive or negative.
Active euthanasia is a positive merciful act, to end useless
suffering or a meaningless existence. It is an act of
commission, e.g. by giving large doses of drugs to hasten
death. Passive euthanasia means discontinuing or not
using extraordinary life-sustaining measures to prolong
life. This includes acts of omission, such as failure to
resuscitate a terminally ill or hopelessly
87. • incapacitated patient or a severely defective newborn infant. It is not
using measures that would probably delay death and permits natural
death to occur. Voluntary euthanasia means at the will of the person,
and involuntary means against the will of the person, i.e., compulsory.
Non-voluntary refers to cases of persons incapable of making their
wishes known, e.g., in persons with irreversible coma or severely
defective infants. Euthanasia advocates the administration of lethal
doses of opium or other narcotic drugs. It has no legal sanction.
• Netherlands is the first country to legalise euthanasia from April, 2002
in persons above 12 years. Strict rules govern assisted suicide. Patients
must face a future of unbearable, interminable suffering and must
make a voluntary, well-considered request to die. Another physician
must be consulted first and life must be ended in a medically
88. • Bioethics is the study of the ethical issue emerging from
advances in biology and Medicine.
• It is also moral discernment as it relates to medical policy
• Bioethicists are concerned with the ethical questions that
arise in the relationships among lifescinces ,biotechnology
medicine, politics and laws and philosophy . It includes the
study of values relating to primary care and other branches
89. • Medical ethics is the study of moral
values and judgments as they apply
90. • Principles
• One of the first areas addressed by modern bioethicists was that of human
experimentation. The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research was initially established in
1974 to identify the basic ethical principles that should underlie the conduct of
biomedical and behavioral research involving human subjects. However, the
fundamental principles announced in the Belmont Report (1979)—
namely, respect for persons, beneficence and justice—have influenced the
thinking of bioethicists across a wide range of issues. Others have added non-
maleficence, human dignity and the sanctity of life to this list of cardinal
values. Overall, the Belmont Report(1979) has guided research in a direction
focused on protecting vulnerable subjects as well as pushing for transparency
between the researcher and the subject. Research has flourished within the past
40 years and due to the advance in technology, it is thought that human
subjects have outgrown the Belmont Report (1979) and the need for revision is
• Another important principle of bioethics is its placement of value on