NAME: DEVIKA HEMANT NIGDE DESHMUKH

5TH YEAR BLS LLB SEMESTER 10

SUBJECT: LAW AND MEDICINE
HUMAN EXPERIMENTATION ON DRUGS

SR NO . CONTENTS PG NO.

1. Introduction 2

2. Reasons for Experimentation 3

3. Rules of Experimentation 4

4. International Regulation for 5-

Experimentation on Humans

A. THE NUREMBERING CODE. 5-7

B. THE HELSINKI DECRALATION, 1984. 8-9
C. RESEARCH WITH CHILDREN 10-11
D. EXPERIMENTS ON PRISONERS 12-13

1|Page
INTRODUCTION
In this exclusive field of human experimentation of drugs, the name of the
Chinese God of medicine, Emperor Shen Nung, who is said to have lived about
twenty centuries He stands out first.
He could see, according to Chinese tradition, his own stomach and see the
reactions and observe the effect on his own system of the various medicines he
swallowed.
Purkinje (1787-1869) a distinguished pharmacologist tested upon himself the
action of camphor, belladonna, stramonium and turpentine.
Anton Stoerck (1731-1803) made special efforts to increase our knowledge of
the use of the drugs.
He first experimented upon himself and then administered various medicines in
the hospitals.
He studied the effect of hemlock, meadow saffron, aconite, stramonium and
henbane writing brief and clear monograph about his observations.
In olden times, drugs were ad ministered to sick and their effects were taken as
the guiding factor to cure sick.
PROS AND CONS OF EXPERIMENTS ON HUMAN BEINGS:
Pros:
(1) Subjective symptoms can be studied,
Cons:
(1) Pathological changes cannot be studied in full.
(2) Pharmacological action of drugs cannot be studied analytically.
(3) The result of long-continued administration of drugs in doses sufficient to
induce fatal pathological tissue changes cannot be studied. Of course these
results are available to some extent in cases of poisoning with drugs either
accidentally or willfully to cause death.

2|Page
REASONS FOR EXPERIMENTATION
1. Therapeutic use
• To improve the condition of the patient who did not respond to regular
treatment and
2. Research:
• To conduct the experiment to study the effects of different chemical
agents on human bodies so that it can be concluded useful or useless in
the treatment of the diseases.
3. Safety:
• To know whether these chemical agents are safe for human consumption.
4. Mode of administration:
• To study the safe dosage of how much? How often? How long? The safe
mode of administration oral or injectable- Intra muscular or intravenous
etc.
We need volunteers to try the drugs on them. They have to be informed about
the aim of the research, expected effects of the drug and / or side effects of the
drug. There should not be any force, fraud. Misrepresentation of the facts or any
pressure over the subjects to give consent for the research.
However the experimentation of the drugs on human being was misused for
earning money and reckless human experiments were conducted on fetus,
minors, Illiterate, insane or people In the custody of the State (as they were
under Custody of somebody else). Resulting in to disastrous effects on them.
The consent given or taken for the same may not be free from ethical questions.
The reckless human experimentation conducted on the prisoners of 2nd world
war in concentration camps and on helpless civilians have thrown permanent
black shade on human experimentations.

Therefore it was Important to issue guide lines for the same.

3|Page
 RULES FOR EXPERIMENTATION
1. The drug must not be harmful chemical agent
2. The drug must have been tried by other experiments in
laboratory or on animals before using them for human
experimentation.
3. There should be scientific justification for trying them on Human
beings.
4. Once the side effect or harmful effect is notice the experiment
should be Immediately stopped
5. Experiment should be done only after taking the informed
consent of the patient and / or parents and / or guardian and
should be stopped as soon as the consent is withdrawn
6. There should be no monetary gains to the patient because of the
research.
7. The patient should not be suffering from any other disease so as
to vitiate the results of the research e.g. he should not have a
kidney disease if the drug is excreted by the kidneys.

4|Page
INTERNATIONAL REGULATION FOR EXPERIMENTATION ON
HUMANS
A. THE NUREMBERG CODE
HISTORY
• The Nuremberg Code is a set of research ethics principles for human
experimentation created by the U.S. v Brandt court as one result of
the Nuremberg trials at the end of the Second World War.
• In a review written on the 50th anniversary of the Brandt verdict, Jay
Katz writes that "a careful reading of the judgment suggests that [the
authors] wrote the Code for the practice of human experimentation
whenever it is being conducted.
• After World War II, a series of trials were held to hold members of the
Nazi party responsible for a multitude of war crimes.
• The trials were approved by President Harry Truman on 2 May 1945, and
were led by the United States, Great Britain, and the Soviet Union.
• They began on 20 November 1945, in Nuremberg, Germany, in what
became known as the Nuremberg trials.
• In the trial of USA v Brandt, which became known as the "Doctors' Trial",
German physicians responsible for conducting unethical medical
procedures on humans during the war were tried. They focused on
physicians who conducted inhumane and unethical human experiments
in concentration camps, in addition to those who were involved in over
3,500,000 sterilizations of German citizens.
• The code was initially ignored, but gained much greater significance about
20 years after it was written.
• As a result, there were substantial rival claims for the creation of the Code.
Some claimed that Harold Sebring, one of the three U.S. judges who
presided over the Doctors' trial, was the author.
• Leo Alexander, MD and Andrew Ivy, MD, the prosecution's chief medical
expert witnesses, were also each identified as authors.
• In his letter to Maurice Henry Pappworth, an English physician and the
author of the 1967 book ‘Human Guinea Pigs’, Andrew Ivy claimed sole
authorship of the code.
• Leo Alexander, approximately 30 years after the trial, also claimed sole
authorship. However, after careful reading of the transcript of the
Doctors' trial, background documents, and the final judgements, it is more

5|Page
 accepted that the authorship was shared and the code grew out of the
trial itself.

The ten points of the Nuremberg Code

The ten points of the code were given in the section of the
judges' verdict entitled "Permissible Medical Experiments"

1. The voluntary consent of the human subject is absolutely essential. This

means that the person involved should have legal capacity to give
consent; should be so situated as to be able to exercise free power of
choice, without the intervention of any element of force, fraud, deceit,
duress, overreaching, or other ulterior form of constraint or coercion; and
should have sufficient knowledge and comprehension of the elements of
the subject matter involved as to enable him to make an understanding
and enlightened decision. This latter element requires that before the
acceptance of an affirmative decision by the experimental subject there
should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all
inconveniences and hazards reasonably to be expected; and the effects
upon his health or person which may possibly come from his participation
in the experiment. The duty and responsibility for ascertaining the quality
of the consent rests upon each individual who initiates, directs, or
engages in the experiment. It is a personal duty and responsibility which
may not be delegated to another with impunity.
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 an 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.

6|Page
 7. Proper preparations should be made and adequate facilities provided to
protect the experimental subject against even remote possibilities of
injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified
persons. The highest degree of skill and care should be required through
all stages of the experiment of those who conduct or engage in the
experiment.
9. During the course of the experiment the human subject should be at
liberty to bring the experiment to an end if he has reached the physical
or mental state where continuation of the experiment seems to him to
be impossible.
10.During the course of the experiment the scientist in charge must be
prepared to terminate the experiment at any stage, if he has probable
cause to believe, in the exercise of the good faith, superior skill and
careful judgment required of him that a continuation of the experiment
is likely to result in injury, disability, or death to the experimental subject.

IMPORTANCE

The Code is considered by some to be the most important document in the

history of clinical research ethics, because of its massive influence on global
human rights. In the United States, the Code and the related Declaration of
Helsinki influenced the drafting of regulations promulgated by the United States
Department of Health and Human Services to ensure ethical treatment of
human research subjects, known as the Common Rule, which is now codified in
Part 46 of Title 45 of the Code of Federal Regulations. These regulations are
enforced by Institutional Review Boards (IRBs)

7|Page
 B. THE HELSINKI DECRALATION, 1984.

History

1. The Declaration of Helsinki (DoH) is a set of ethical principles

regarding human experimentation developed originally in 1964 for the
medical community by the World Medical Association (WMA). It is widely
regarded as the cornerstone document on human research ethics.
2. The Declaration was originally adopted in June 1964 in Helsinki, Finland,
and has since undergone seven revisions (the most recent at the General
Assembly in October 2013) and two clarifications, growing considerably in
length from 11 paragraphs in 1964 to 37 in the 2013 version.
3. The Declaration is an important document in the history of research ethics
as it is the first significant effort of the medical community to regulate
research itself, and forms the basis of most subsequent documents.
4. Prior to the 1947 Nuremberg Code there was no generally accepted code
of conduct governing the ethical aspects of human research, although
some countries, notably Germany and Russia, had national policies [3a].
5. The Declaration developed the ten principles first stated in the
Nuremberg Code, and tied them to the Declaration of Geneva (1948), a
statement of physicians' ethical duties. The Declaration more specifically
addressed clinical research, reflecting changes in medical practice from
the term 'Human Experimentation used in the Nuremberg Code.
6. A notable change from the Nuremberg Code was a relaxation of the
conditions of consent, which was 'absolutely essential' under Nuremberg.
7. Now doctors were asked to obtain consent 'if at all possible' and research
was allowed without consent where a proxy consent, such as a legal
guardian, was available (Article II.1).
8. The current (2013) version is the only official one; all previous versions
have been replaced and should not be used or cited except for historical
purposes. The WMA would like to thank all those who submitted
comments and suggestions for the most recent revision of the DoH.
9. In 2014, the WMA produced a celebratory publication to mark the
50th anniversary of the adoption of the Declaration of Helsinki. “The
World Medical Association Declaration of Helsinki: 1964-2014 50 Years of
Evolution of Medical Research Ethics” Since 2016, the Declaration of
Taipei on Ethical Considerations regarding Health Databases and
Biobanks has complemented the Declaration of Helsinki.

8|Page
Important Provision of the Helsinki Declaration

1. Bio medical research involving human subjects must confined to generally

accept scientific principle and should be based on adequately performed
laboratory and animal experimentations.
2. Design and performance of each experimental procedure involving human
subjects should be clearly formulated in an experimental protocol
3. Bio-medical research Involving human subjects should be conducted by
scientifically qualified person and under supervision of clinically competent
Medical person.
4. Bio medical research involving human subjects cannot legitimately carried
out unless the importance of objective achieved is more or in proportion to
the inherent risk to the subject
5. Every Bio-medical research involving human subjects should be pre-Ceded by
the careful assessment of the pre detectable risk in comparison with forcible
benefit of the subject.
6. Right of safeguard of the integrity of the human research subject should
always be respected.
7. Every precautions must be taken to respect the privacy of the research
human subject
8. Physician should abstain from engaging himself in research project involving
human subject unless they are satisfied that the hazards involved are pre
detectable and Curable
9. Physician is obliged to preserve accuracy In Publication of the results of the
research
10.While obtaining informed consent from the research human being should be
particularly cautious that it should be free consent not under any duress &
the human subject is not under any undue influence and / or has dependent
relationship with him
11.In case of legal incompetence of the human subject informed consent is to
be taken from parents and / or legal guardian n according to the statutory
provisions of law if there is any suspicion than through due process of law.
12.Research Protocol should always contain a statement of involved ethical
consideration and should indicate that the principles enunciated in the
research are complied with.
13.Special precaution must be taken by the doctor in performing clinical
research in which personality of the patient is likely to be altered by the drugs
14.The research team should discontinue the research if they think that
Continuation of the research is harmful to the patient.

9|Page
C. RESEARCH WITH CHILDREN

1. Research with children and mentally disabled individuals raises difficult

legal and ethical issues.
2. It is the obligation of researchers and those who review research to
protect both the rights and welfare of research subjects.
3. Ethicists, legal scholars, and national commissions have examined the
circumstances under which it is acceptable to use incompetent people as
research subjects, since they are unable to provide consent for
participation.
4. Furthermore, there is an extensive set of federal rules that govern the use
of children as research subjects.
5. Children may be used as research subjects after a careful weighing of risks
and benefits, and as long as they participate in the decision to the extent
they are able to do so.
6. However, research projects that will not provide children with direct
benefit, such as some placebo-controlled trials, raise particularly difficult
issues concerning the protection of these subjects.
7. While biomedical research is an important and socially desirable
undertaking, it must proceed only when the rights and welfare of the
subjects are scrupulously protected.
8. The current federal regulations on research adopt the sliding-scale
approach to participation of children in research which was proposed by
the National Commission. Essentially, the rules create four categories of
research with children

• CATEGORY 1: Research not involving greater than minimal risk. Such

research is permissible as long as adequate provisions are made for
obtaining the permission of the parent and the child's assent.
• CATEGORY 2: Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subject. To approve this
type of research the IRB must find that the risk is justified by the
anticipated benefit to the subject and that the risk-benefit ratio is at least
as favorable to the subject as alternative approaches. Again, a parent's
permission and the child's assent are required. This is likely to be the
category into which the majority of psychopharmacological research with
children falls today.
• CATEGORY 3: Research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject's condition. This category of

10 | P a g e
research is approvable only if the IRB finds the risk represents a "minor
increase" over minimal risk; the research procedures are "reasonably
commensurate with the subject's actual or expected medical, dental,
psychological social or educational situation"; the intervention is likely to
yield generalizable knowledge of "vital importance" in RESEARCH WITH
CHILDREN: LAW AND ETHICS understanding or ameliorating the subject's
disease or condition; and the subject's assent is obtained. Both parents
must ordinarily give permission. This is a utilitarian approach to research
that cannot directly benefit the child. It allows for the use of children in
such research if the knowledge derived from the research is very
important and the risks are small. Still, there is a strong argument that this
type of research is ethically questionable since it permits nonconsenting
subjects who cannot benefit from their participation in the research to be
placed at risk for the sole purpose of acquiring new knowledge.
CATEGORY 4: Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children. This would include research
that would present more than a minimal risk of harm to children with no
Benefit to the individual child. For this research to be approved, the
Secretary of Health and Human Services must consult with a panel of
experts and give the public an opportunity to review and comment on the
Proposal. There is no indication that this has ever been done.
These rules depend to a large extent on determining that there is only
minimal risk to children or a minor increase over minimal risk.

The term "minimal risk" is defined as a risk that is not greater than those
"already encountered in daily life or during the performance of routine
physical or psychological examinations or tests".

11 | P a g e
 D. EXPERIMENTS ON PRISONERS
Throughout history, prisoners have been frequent participants in scientific,
medical and social human subject research. Some of the research involving
prisoners has been exploitative and cruel. Many of the modern protections
for human subjects evolved in response to the abuses in prisoner research.
Research involving prisoners is still conducted today, but prisoners are now
one of the most highly protected groups of human subject.

Prisoner consent
Prisoners can consent, although their consent cannot be said to be completely
voluntary due to their compromised and dependent status. Their status as
imprisoned human subjects becomes even more ethically problematic when
investigators offer incentives such as parole, phone calls, or objects that are
normally unavailable to prisoners.
When a person is in prison does not relieve him of an opportunity to serve his
country and human progress, by participating in medical research. "Every man
must do his part."
If there currently is no draft and no military conflict to endanger normal people,
we can still use this argument. Because disease always threatens society.
Nonconsensual medical experiments are wrong. The fact that young men are
killed in wars to which they did not consent is a separate injustice, which is
technically irrelevant to discussing medical experiments.
It is permissible to conduct medical experiments on prisoners if they volunteer
and provide informed consent. Prisoners who are sane still have some rights of
self-determination and autonomy.
It is wrong to say or to declare that no prisoner can consent to research.
Prisoners have harmed society and participating in medical experiments is one
of the ways that they can volunteer to help society.
The prisoners should not receive a reduction in their sentence as the result of
participation in medical experiments, since their participation is not part of their
punishment But an independent act.
Further, the possibility of reduction of sentences would inject an element of
coercion into the prisoner's decision. However, it is acceptable to pay the
prisoners, money for their participation. There are ethical concerns about
allowing medical experiments on prisoners, who volunteer
Technically, coercion requires that threat/harm must come from coercer. It is
not coercion either to refuse to help someone or to put conditions on the help.

12 | P a g e
Provided that the person refusing or making conditions did not cause the
victim's predicament. For example:
1. Poor student applies for educational loan from bank. Bank's conditions,
or refusal to provide loan, is not coercion, because the bank caused
neither student's poverty nor student's need for money.
2. Man drives woman out into desert and then gives woman a "choice":
consent to sex or be abandoned in middle of desert. Man coerced
woman because man caused woman's plight. Coercion invalidates any
consent da ad that might be given.

CONCLUSION

One could clearly recommend that: -

1. an informed consent, of the patient or of the nearest relatives, would be asked,
2. the patient could at each time withdraw him/herself of the research,
3. prejudices would be kept minimal,
4. a disciplinary ethical committee must have given a positive opinion,
5. the research will be published in a scientific journal with a referee system,
6. the person responsible for the research would have the objective and juridical responsibility
of the research,
7. Persons judicially non responsible or also prisoners would not be used for medical research if
it would not have a direct influence on their health.

13 | P a g e