Ethical issues in biomedical research

ETHICAL ISSUES INETHICAL ISSUES IN
BIOMEDICAL RESEARCHBIOMEDICAL RESEARCH
Dr. SUMAN BAISHNABDr. SUMAN BAISHNAB

INTRODUCTIONINTRODUCTION
 The Word Ethics derives from the Greek word –
Ethikos
 Meaning - Moral principles governing human
character & conduct
Medical Ethics include:
 Moral values and judgments applied to
medicine
 Ethical guidelines governing the health care
system – both medical practice and research

EVOLUTION OF THE CONCEPTEVOLUTION OF THE CONCEPT
 The concept of ethics in western clinical
practice was introduced as early in 400 BC-by
the father of modern medicine “Hippocrates”
 In Indian Medicine
 Siddha follow Theraiyars
 Ayurvedha follow Charaka
 Muslim physicians – ‘conduct of a physician’ by
Ishaq bin Ali Rahawi

TO QUOTE FROM HIPPOCRATESTO QUOTE FROM HIPPOCRATES
-Written 400 B.C.-Written 400 B.C.
I SWEAR by Apollo the physician, and
Aesculapius, and Health, and All-heal, and all the
gods and goddesses, that, according to my ability
and judgment,
I consider for the benefit of my patients, and
abstain from whatever is deleterious and
mischievous
I will give no deadly medicine to any one if
asked, nor suggest any such counsel……….

 This term was introduced by a British Doctor
Thomas Percival (1705 – 1804)
 In 1847, the American Medical Association
adopted its first code of ethics – based mainly
on Thomas Percival’s work
 In 1960 – 1970 – “Medical Ethics” (internal
concerns of the professions) has gone
through dramatic shift into “Bio
ethics”(matters of public, political debate).
EVOLUTION OF THE CONCEPT…EVOLUTION OF THE CONCEPT…

MEDICO ETHICAL DECLINE – A HISTORYMEDICO ETHICAL DECLINE – A HISTORY
 During World War II, the Nazi regime in
Germany-- human medical experimentation on
large numbers of people in its concentration
camps
 In particular, Josef Mengele’s experiments on
prisoners at Auschwitz earned him the
nicknames “the Angel of Death” and “Dr.
Death”
 Between 1937 and 1945, Japanese medical
personnel participated in the torture killings of
as many as 10,000 Chinese and Korean
prisoners during the II Sino – Japanese War

MEDICO ETHICAL DECLINE – AMEDICO ETHICAL DECLINE – A
HISTORY…HISTORY…
 During world War II, the Japanese tried out
various biological weapons on Chinese
subjects
 Japanese surgeons also performed vivisection
and other medical experiments to torture
American prisoners of war in several islands of
the Pacific

The following are some of the unethicalThe following are some of the unethical
and cruel experiments conducted byand cruel experiments conducted by
Nazis which led to theNazis which led to the
““ Nuremberg CodeNuremberg Code ””
1. Experiments on twins
2. Freezing experiments
3. Malarial experiments
4. Mustard gas experiments
5. Sulfonamide experiments
6. Sea water experiments
7. Sterilization experiments
8. Typhus experiments
9. Experiments with poison
10. Incendiary bomb experiments
11. High altitude experiments

Evidences for Some of the Experiments

Evidences for Some of the Experiments…

AFTERMATHAFTERMATH
 Many diedMany died
 Murdered to study the post mortem effectsMurdered to study the post mortem effects
 survivors left mutilated, suffering permanentsurvivors left mutilated, suffering permanent
disability, weakened bodies, and mentaldisability, weakened bodies, and mental
distressdistress
 On August 19,1947, the doctors captured byOn August 19,1947, the doctors captured by
allied forces were put on trial in USA,allied forces were put on trial in USA,
commonly known as the Doctors’ Trialcommonly known as the Doctors’ Trial

THE NUREMBERG CODETHE NUREMBERG CODE
 Verdict delivered AugustVerdict delivered August
19, 194919, 1949
 Subsequently, Dr. LeoSubsequently, Dr. Leo
Alexander and AndrewAlexander and Andrew
Canway Ivy drafted aCanway Ivy drafted a
ten point memorandum,ten point memorandum,
Permissible MedicalPermissible Medical
Experiments –Experiments –
““The NurembergThe Nuremberg
Code”Code”

The Ten Points of the Nuremberg Code
1.The voluntary consent of the human subject is
absolutely essential
This means that the person involved should
have legal capacity to give consent; exercise free
power of choice, without the intervention of any
element of force, fraud, dishonesty, pressure,
over-reaching, or other hidden form of constraint
or force; …….
The duty and responsibility for ascertaining the
quality of the consent rests upon each individual
who initiates, directs or engage in the experiment

The Ten Points of the Nuremberg Code…
2.The experiment should be such as to yield
fruitful results for the good of society,
unprocurable by other methods or means of
study, and not random and unnecessary in
nature
3.The experiment should be so designed and
based on the results of animal experimentation
and a knowledge of the natural history of the
disease or other problem under study that the
anticipated results will justify the performance of
the experiment

4.The experiment should be so conducted as to
avoid all unnecessary physical and mental
suffering and injury
5.No experiment should be conducted where
there is a priori reason to believe that death or
disabling injury will occur; except, perhaps, in
those experiments where the experimental
physicians also serve as subjects
6.The degree of risk to be taken should never
exceed that determined by the humanitarian
importance of the problem to be solved by the
experiment

7.7.Proper preparations should be made andProper preparations should be made and
adequate facilities provided to protect theadequate facilities provided to protect the
experimental subject against even remoteexperimental subject against even remote
possibilities of injury, disability, or deathpossibilities of injury, disability, or death
8.8.The experiment should be conducted only byThe experiment should be conducted only by
scientifically qualified persons. The highestscientifically qualified persons. The highest
degree of skill and care should be requireddegree of skill and care should be required
through all stages of the experiment of those whothrough all stages of the experiment of those who
conduct or engage in the experimentconduct or engage in the experiment

9.9.During the course of the experiment the humanDuring the course of the experiment the human
subject should be at liberty to bring thesubject should be at liberty to bring the
experiment to an end if he has reached theexperiment to an end if he has reached the
physical or mental state where continuation ofphysical or mental state where continuation of
the experiment seems to him to be impossiblethe experiment seems to him to be impossible
10.10.During the course of the experiment theDuring the course of the experiment the
scientist in charge must be prepared toscientist in charge must be prepared to
terminate the experiment at any stage, if he hasterminate the experiment at any stage, if he has
probable cause to believe, in the exercise ofprobable cause to believe, in the exercise of
the good faith, superior skill and carefulthe good faith, superior skill and careful
judgment required of him that a continuation ofjudgment required of him that a continuation of
the experiment is likely to result in injury,the experiment is likely to result in injury,
disability, or death to the experimental subjectdisability, or death to the experimental subject

DECLARATION OF GENEVA
 TheThe Declaration of GenevaDeclaration of Geneva was adopted bywas adopted by
the General Assembly of thethe General Assembly of the World MedicalWorld Medical
Association at GenevaAssociation at Geneva in 1948 and amended inin 1948 and amended in
1968, 1984, 1994, 2005 and 20061968, 1984, 1994, 2005 and 2006
 It is a declaration of physicians' dedication toIt is a declaration of physicians' dedication to
the humanitarian goals of medicine, athe humanitarian goals of medicine, a
declaration that was especially important indeclaration that was especially important in
view of the medical crimes which had just beenview of the medical crimes which had just been
committed in Nazi Germanycommitted in Nazi Germany
 The Declaration of Geneva was intended as aThe Declaration of Geneva was intended as a
revision of the Oath of Hippocrates to arevision of the Oath of Hippocrates to a
formulation of that oath's moral truthsformulation of that oath's moral truths

THE DECLARATION OF GENEVA
AMENDED – 2006, READS…
At the time of being admitted as a member of theAt the time of being admitted as a member of the
medical profession:medical profession:
 I solemnly pledge to dedicate my life to theI solemnly pledge to dedicate my life to the
service of humanityservice of humanity
 I will give to my teachers the respect andI will give to my teachers the respect and
gratitude that is their duegratitude that is their due
 I will practise my profession with morality andI will practise my profession with morality and
dignitydignity

THE DECLARATION OF GENEVA…
 The health of my patient will be my firstThe health of my patient will be my first
considerationconsideration
I will respect the secrets that are confided in me,I will respect the secrets that are confided in me,
even after the patient has diedeven after the patient has died
I will maintain by all the means in my power, theI will maintain by all the means in my power, the
honour and the noble traditions of the medicalhonour and the noble traditions of the medical
professionprofession
 My colleagues will be my sisters and brothersMy colleagues will be my sisters and brothers

THE DECLARATION OF GENEVA…
I will not permit considerations of age, diseaseI will not permit considerations of age, disease
or disability, creed, ethnic origin, gender,or disability, creed, ethnic origin, gender,
nationality, political affiliation, race, sexualnationality, political affiliation, race, sexual
orientation, social standing or any other factor toorientation, social standing or any other factor to
intervene between my duty and my patientintervene between my duty and my patient
 I will maintain the utmost respect for human lifeI will maintain the utmost respect for human life
 I will not use my medical knowledge to violateI will not use my medical knowledge to violate
human rights and civil liberties, even underhuman rights and civil liberties, even under
threatthreat
 I make these promises solemnly, freely andI make these promises solemnly, freely and
upon my honorupon my honor

THE DECLARATION OF HELSINKI- 1964
 The “Declaration of Helsinki”, first
published by World Medical
Association in 1964
 Addresses international standards
primarily for physicians involved inphysicians involved in
biomedical research
 But, WMA encouragesBut, WMA encourages otherother
participants in medical researchparticipants in medical research
involving human subjects to adoptinvolving human subjects to adopt
these principlesthese principles
 Cited as a reference in most
national or international guidelines

THE DECLARATION OF HELSINKI-
1964… The heart of the declaration is the statement
that
“The well-being of the human subject should
take precedence over the interests of science
and society"
It also gives special attention to the
importance of written informed consent
 The Helsinki declaration has beenThe Helsinki declaration has been amendedamended sixsix
times since,times since, most recently in October 2008most recently in October 2008
 The current (2008) version is the only official
one; all previous versions have been replaced
and should not be used or cited except for
historical purposes (http://www.wma.net/e/policy/pdf/17c.pdf)

 The Belmont Report (1979)The Belmont Report (1979)
 CIOMS International Ethical Guidelines forCIOMS International Ethical Guidelines for
Biomedical Research Involving HumanBiomedical Research Involving Human
Subjects (2002)Subjects (2002)
 International Conference on HarmonizationInternational Conference on Harmonization
Guidelines for Good Clinical Practice (1996)Guidelines for Good Clinical Practice (1996)
 Title 45 US CFR, Part 46–The Common RuleTitle 45 US CFR, Part 46–The Common Rule
 Title 21 US CFR, Parts 50 and 56Title 21 US CFR, Parts 50 and 56
 ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical
Research on Human Participants (2006)Research on Human Participants (2006)
SELECTED CODES AND REGULATIONS
GUIDING RESEARCH WITH HUMAN
SUBJECTS

The Belmont Report (1979)The Belmont Report (1979)
Published by the U.S. National Commission for
the Protection of Human Subjects of Biomedical
and Behavioral Research
Describes three broad ethical principles that
guide the conduct of bio medical research, viz.
Respect for Persons – Informed Consent
Beneficence – Risk-Benefit Evaluation
Justice – Selection of Research Subjects

CIOMS International Ethical Guidelines forCIOMS International Ethical Guidelines for
Biomedical Research Involving Human SubjectsBiomedical Research Involving Human Subjects
The Council of International Organizations of
Medical Sciences (CIOMS) in conjunction with
the World Health Organization (WHO) issued this
guideline (lastly amended in 2002)
Adopts the three ethical principles of Belmont
Report and maintains most of the tenets of
Nuremberg and Helsinki
But provides additional and valuable guidance
and commentary on externally sponsored
research and research with vulnerable
populations

Title 45 of the U.S. Code of Federal Regulations,Title 45 of the U.S. Code of Federal Regulations,
Part 46 (45 CFR 46)Part 46 (45 CFR 46)
The Common Rule stipulates both the membership and
the function of IRBs and specifies the criteria an IRB
should employ when reviewing a research protocol and
determining whether to approve it.
The Common Rule also delineates the types of
information that should be included in an informed
consent document and how consent should be
documented.
Subparts B, C, and D of 45CFR46 describe additional
protections for DHHS (United States Department of
Health & Human Services) funded research with fetuses
and pregnant women, prisoners, and children,
respectively.

Title 21 of the U.S. Code of Federal Regulations,Title 21 of the U.S. Code of Federal Regulations,
Part 50 & 56 (21 CFR 50 & 21 CFR 56 )Part 50 & 56 (21 CFR 50 & 21 CFR 56 )
Part 50 – “Protection of Human Subjects”
Part 56 – “Institutional Review Boards”
Contain regulations that are similar, but not
identical, to those found in the “Common Rule”
Compliance with FDA regulations is required for
research that is testing a drug, biologic, or medical
device for which FDA approval will ultimately be
sought

ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical
Research on Human Participants (2006)Research on Human Participants (2006)
Any research using the human beings as
participants shall follow the principles given
below
1. Principle of Essentiality
Necessary for the advancement of
knowledge and for the benefit of all members of
the human species and for the ecological and
environmental well-being

Research on Human Participants (2006)…Research on Human Participants (2006)…
2.Principles of voluntariness, informed
consent
 Research subjects are fully explained of the
research, the impact and risk of such research
on the research subject and others.
 Research subjects retain the right to abstain
from further participation in the research
irrespective of any legal or other obligation.

3.Principles of non-exploitation
Research subjects should be remuneratedResearch subjects should be remunerated
4.Principles of Privacy and Confidentiality
The identity and records of the human subjectsThe identity and records of the human subjects
of the research or experiment are as far asof the research or experiment are as far as
possible kept confidentialpossible kept confidential

5.Principles of precaution and risk
minimization
 Due care and caution taken at all stages ofDue care and caution taken at all stages of
research (research (from its inception as a research idea,from its inception as a research idea,
its subsequent research design, the conduct ofits subsequent research design, the conduct of
research or experiment and its applicative useresearch or experiment and its applicative use))
to ensure that research subjects are put toto ensure that research subjects are put to
minimum risk, suffer from no irreversibleminimum risk, suffer from no irreversible
adverse effects and, benefit from researchadverse effects and, benefit from research

6.Principle of professional competence
The research is conducted at all times byThe research is conducted at all times by
competent and qualified persons who act withcompetent and qualified persons who act with
total integrity and impartiality and who have beentotal integrity and impartiality and who have been
made aware of, and are mindful of, the ethicalmade aware of, and are mindful of, the ethical
considerations to be borne in mind in respect ofconsiderations to be borne in mind in respect of
such research or experimentsuch research or experiment

7.Principles accountability and
transparency
Research/ experiment will be conducted in aResearch/ experiment will be conducted in a
fair, honest, impartial and transparent mannerfair, honest, impartial and transparent manner
8.Principles of maximization of public
interest and of distributive justice
Research should benefit all humans, inResearch should benefit all humans, in
particular, the research subjectsparticular, the research subjects

9.Principles of institutional arrangements
Take all appropriate steps to ensure thatTake all appropriate steps to ensure that
research reports, materials and data connectedresearch reports, materials and data connected
with the research are duly preserved andwith the research are duly preserved and
archivedarchived
10.Principles of public domain
Results are generally made known throughResults are generally made known through
scientific and other publications subject to suchscientific and other publications subject to such
rights as are available to the researcher andrights as are available to the researcher and
those associatedthose associated

11.Principles of totality of responsibility
The researchers
Funding agency
The institution(s) where research is conducted
Persons, groups or undertakings who sponsor,
use or derive benefit from research, market the
product (if any) or prescribe its use

12.Principles of compliance
Guidelines specifically laid down or prescribed
for that research or experimentation, are
meticulously observed and duly complied with

Out of these 12 principles the following areOut of these 12 principles the following are
given the prioritygiven the priority
 Autonomy of the individualAutonomy of the individual
 BeneficenceBeneficence
 Non-malficenceNon-malficence
 JusticeJustice

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