G. J.

ADVANI LAW COLLEGE

NAME OF THE STUDENT : ISHA CHAVAN

CLASS AND DIVISION : T.Y. LL. B - A

ROLL NUMBER : 28

SUBJECT : LAW AND MEDICINE

ASSIGNMENT TOPIC : EXPERIMENTATION IN

CUSTODY, INCLUDING
PSYCHIATRIC CUSTODY

SUBMISSION DATE : 28 FEBRUARY, 2022

NAME OF FACULTY : DR. SABEENA GONSALVES

 TABLE OF CONTENTS

SR. NO. TITLE PAGE NO.

1 Introduction 1–5

2 Objectives of the Study 5

3 Consent 5–6

4 Regulatory Frameworks 6–8

5 International Conventions 8 – 10

5.1 The Nuremberg Code, 1947 8

5.2 The Helsinki Declaration, 1964 9

5.3 International Covenant on Civil and Political Rights 9

(ICCPR), 1966

5.4 Good Clinical Practices (ICH – GCP), 1997 9 – 10

6 Case Laws 10 – 11

7 Conclusion 11 – 12

8 Bibliography 13 – 15
 1) INTRODUCTION:

Medicines are vital for promoting physical health and welfare. So, a medicine either helps to
prevent certain illnesses or diseases, or it helps to reduce pain and sufferings of individuals
faced with certain illnesses. Creating or making drugs or medicine is a long and rigorous
process, and it includes several steps. One of the primary steps would be making of the
medicine or drug and then last and the most important step would be to check the efficacy of
the medicine or the drug.

In order to check the efficacy of the medicine or drug, carefully planned experiments needs to
be carried out. Since the beginning these kinds of experiments have involved animals. Such
studies have been helpful, but are not always sufficient. Animals may react to a chemical
differently as compared to humans. Also, a chemical that is safe for animals may cause serious
side effects in human beings.

Similarly, in vitro studies, that is, studies carried outside the human body, may not display the
same effects as human beings when they are administered with the chemicals or drugs. Thus,
experimentation on human beings becomes necessary to establish the desired effects and safety
of a particular chemical or drug.

Clinical trial or experimentation is a research-based study or experiment performed in people

for evaluating a medical or behavioural intervention. It is the primary way for researchers to
find out if a new drug or medicine is safe and effective in people and also to examine if a new
drug is more effective or has any side effects. Basically, they are planned experiments designed
to answer questions with respect to the most appropriate treatment or drug for peoples or
patients with a specific medical condition.

The World Health Organization1 has defined clinical trials as:

“A clinical trial is any experimentation research that prospectively assigns human participants
or groups of humans to one or more physical health related interventions to evaluate the effects
on physical health outcomes.”

1
Hereinafter WHO

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In India, the Drug and Cosmetic Act 1940 and Drug and Cosmetic Rules 1945, has defined a
clinical trial as follows:

“Clinical trial means systematic research of recent medicine(s) in human subject(s) to generate
data for discovering and/or verifying the clinical, pharmacological (including
pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of
determining safety and/or efficacy of the recent medicine.”

According to International Council for Harmonization of Technical Requirements for

Pharmaceuticals for Human Use (ICH) clinical trials are, ‘any investigation in human subjects
intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic
effects of an investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution, metabolism, and excretion
of an investigational product(s) with the object of ascertaining its safety and/or efficacy.’

The National Institutes of Health (US) has defined clinical trials as follows:

“A research study in which one or more human subjects are prospectively assigned to or more
interventions (which may include placebo or other control) to evaluate the effects of those
interventions on health – related biomedical or behavioural outcomes.”

The two of the above-mentioned definitions include the term ‘intervention’. An intervention
can be defined as a manipulation of the subject or subject’s environment for the purpose of
modifying one or more health – related biomedical or behavioural processes and/or endpoints.
Interventions may include, but are not restricted to experimental medicines, medical devices,
preventive care, surgical and radiological procedures, behavioural patterns, etc.

Clinical trials find new ways to prevent, detect, or treat diseases. They are experimentation
carried out in human beings who are healthy volunteers or patients to investigate the efficacy,
side effects and safety of medicines, medical devices, diagnostic tools, and treatment
techniques used to prevent, diagnose, treat or reduce symptoms in humans.

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 Clinical trials also called medical research and research studies are used to determine whether
new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the
fastest and safest way to find treatments that work.2

The concept of clinical trial in drug development is not of recent times. Its origin can be traced
to time immemorial. The first ever clinical trial was mentioned in the Book of Daniel in The
Bible. This experiment was carried out by King Nebuchadnezzar II and not by any medical
practitioner. In 10th century a Persian scientist Ibn Sina wrote a book named Al – Quanun fi al
– Tibb, in which he suggested the testing of new medicines on animals and humans before they
could be used.

The modern-day experiment was conducted by Dr. James Lind in 1747, in which he
demonstrated that citrus fruits cure scurvy. He compared the effects of various acidic
substances, on groups of afflicted sailors, and came to the conclusion that the groups were
given oranges and lemons recovered from scurvy within few days. Also, Dr. James Lind is
considered as the father of the controlled clinical trials in the modern era. After this it took
almost a century before the advancement of clinical trials.

In the 1900’s, during the two world wars various trials were conducted on war prisoners. The
Nazi’s conducted various human experimentation on a large number of people during the
Second World War. They conducted experiments on twin children to study the similarities and
differences in the genetics of twins and also to see whether the human body can be unnaturally
manipulated. In 1942, in of the studies or experiments they placed prisoners naked in the open
for several hours with temperatures below freezing. They assessed the different ways of
rewarming survivors.

The Japanese also conducted lethal human experiments during Second Sino – Japanese War
and World War II. The experiments like vivisection of living people, prisoners’ limbs were
amputated and reattached to some other body part, others had parts of their bodies frozen and
thawed to study the resulting untreated gangrene. Also, some prisoners were injected with
strains of diseases, disguised as vaccines, to study the effects.

2
Dr. Lily Srivastava, Law & Medicine (2010), 116

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 Since the Second World War there were several experiments were carried out which involved
prisoners and patients from hospitals. In the Unites States3, prisoners were used for
experimentation from at least 1914. The federal government had on numerous occasions
funded numerous biomedical and behavioural experiments involving prisoners in the 1970’s.
The greatest use of prisoners was in initial tests of drugs, performed mainly by private drug
companies. They became a principal subject for testing new drugs in the US and were also
being used to test drugs for researchers in other countries.

They even experimented on disabled people. Such experiments included giving hepatitis to
mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in
Maryland, and injecting cancer cells into chronically ill people at a New York hospital.

One of such experiments was the Stanford Prison Experiment. It was a psychological study of
human responses to captivity and its behavioural effects on the authorities and inmates of the
prison. The experiments were conducted in 1971 by a team of researchers led by psychologist
Philip Zimbardo at Stanford University. Many of the subjects were emotionally traumatized
and showed alarming anti – social behaviour. Due to this, the experiment was terminated
entirely.

One was involving prisoners and patients in a mental hospital in Guatemala. In 1946 – 48,
American infected the prisoners and patients with syphilis, to test whether penicillin could
prevent certain sexually transmitted disease. The study was not able to produce any useful
information.

Another one was conducted in 1963. Where the researchers injected cancer cells into 19 old
and debilitated patients at a Jewish Chronic Disease Hospital in Brooklyn, to see if their bodies
would reject them. It must be noted that the consent of the patients was not obtained.

Dr. Leo L. Stanley conducted various experiments on the inmates at the California’s San
Quentin State Prison from 1918 to 1922. The inmates were subjected to various medical
procedures, including receiving transplanted testicles from recently executed prisoners and
many even received transplanted sex organs from goats and boars. Tuberculosis treatments
were also tested on prisoners. In the Stateville Correctional Center in Illinois, as many as 400

3
Hereinafter US/ U.S.

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inmates were exposed to malaria in hope to find a cure. There were several other such
experiments carried out and where the consent of the subjects involved was not obtained.

Children’s also have used as subjects in various human experimentation and it is not a recent
phenomenon. The best known and the most controversial medical research including children
was by Dr. Krugman in 1950s.He conducted studies and research on hepatitis at the
Willowbrook State School, an institution for mentally retarded children. After obtaining the
consent from the parents, the newly admitted children were systematically infected with strains
of hepatitis virus to study the effects and progression of the disease. It is believed that the
parents were not informed about the degree of risk involved and they were manipulated in
giving their consent.

2) OBJECTIVES OF THE STUDY:

 To understand the concept of experimentation/ clinical trials.
 To learn about the experimentation on prisoners and patients.
 To understand the concept of informed consent
 To learn about different international covenants on clinical trials.
 To know about the regulations and laws related to experimentation.

3) CONSENT:

Consent is crucial with respect to experimentation, especially informed consent. It is a vital

requirement in ethical clinical research, in which subjects voluntarily give their willingness to
participate in a particular clinical trial, after providing them with all the aspects of the trial that
are relevant to the subject’s decision to participate. It is documented through a written, signed
and dated consent form. The U.S. Army Yellow Fever Commission is considered the first
research group in history to use consent forms.

Informed consent, a technical term often used from a legal perspective, implies that the process
of securing consent from a person meets the required standards. It implies that the person from
whom consent is sought should have adequate reasoning ability, a clear understanding of the

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 facts, a good idea of the choices available, an appreciation of the implications and
comprehension of the consequences, and he/she should be able to voluntarily choose a
particular option.4

There have been several instances in the past where experiments were carried unethically
denying the subjects the right to informed consent. Therefore, the Nuremberg Code and the
Helsinki Declaration (both will be discussed in detail later) were promulgated to emphasize on
the concepts of informed consent and voluntary participation as the basic requirements of
human experimentation. It also contains provisions with respect to volunteers belonging to
vulnerable groups like children.

Informed consent requirements are provided under Food and Drug Administration’s5
regulations in 21 CFR part 50 called Protection of Human Subjects. It states that informed
consent must be obtained from the subject or the legally authorized representatives of the
subject. The basic elements of informed consent are as follows:

 Description of clinical investigation;

 Risks and discomforts;
 Benefits;
 Alternative procedures or treatments;
 Confidentiality;
 Compensation and medical treatment in event of injury;
 Contacts;
 Voluntary participation.

4) REGULATORY FRAMEWORKS:

The FDA and the Office for Human Research Protections 6 are two government authorities in
the US under the department of Health and Human Services 7 which are responsible for

4
American Medical Association. Informed consent. Available at http://www.amaassn.org/ama/pub/physician-
resources/legal-topics/patient-physician-relationshiptopics/informed-consent.page
5
Hereinafter FDA
6
Hereinafter OHRP
7
Hereinafter HHS

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controlling the supervision of clinical trials. Both of these authorities need a review of proposed
experimentation by an Institutional Review Board (IRB), which is responsible for the ethical
review of the experimentation.

HHS has issued regulations to govern research which is conducted or funded by government
agencies, codified at 45 C.F.R. Part 46. Subpart C of 45 C.F.R. Part 46 provide additional
protections pertaining to biomedical and behavioral research involving prisoners as
subjects. The regulations are applicable to all biomedical and behavioral research conducted
or supported by HHS. It is important to note that the regulations provide that "biomedical or
behavioral research conducted or supported by HHS shall not involve prisoners as subjects"
unless the research is specifically authorized within the subpart.

Along with these rules and regulations, IRB has mentioned some more conditions to be
followed by the HHS while conducting research with prisoners. There are also regulations
mentioned for private institution carrying out research and experiments.

The FDA also has promulgated similar rules and regulations. They have provided the required
informed consent in research and clinical trials involving FDA – regulated products. These
rules are provided under 21 C.F.R. Part 50 (Protection of Human Subject) and Part 56
(Institutional Review Boards), present the minimum requirements of information to clinical
subjects, especially the risks and benefits. It also has put special emphasize that no potential
volunteers should be coerced to participate in the study.

The restrictions with respect to research involving prisoners is mentioned under Subpart C of
the Common Rule. These restrictions were introduced in 1978 and they apply not only to
research conducted by a federal agency, but also to private institutions who receive federal
fundings.

Apart from that the above-mentioned regulations the rights of the prisoners and patients are
protected by the U.S. Constitution through the Eight Amendment Claims and Fourteenth
Amendment Claims. The Eight Amendment Claims allows the prisoners as a population to
participate in medical research studies and prohibiting them will in contravention of their
constitutional rights under the Eight Amendment and the Due Process and Equal Protection
clauses. Also, the inmates suffering from various diseases may be deprived from of life –

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saving therapies if they are not allowed to participate. The aforementioned Amendment
prohibits the infliction of cruel and unusual punishment. The Fourteenth Amendment also
mandates the inclusion of prisoners in clinical trials.

5) INTERNATIONAL CONVENTIONS:
Prior to 1947, there were no generally accepted guidelines or code of conduct to govern
the human experimentation. There were some countries, like Germany and Russia, had
national policies. The worst exposure of misuse of human experimentation came to light at
the end of the Second World War. There were thousands of experiments carried out
randomly, mostly by unqualified persons, under revolting physical conditions. Thus
several international conventions were introduced to regulate the experiments. They are as
follows:
5.1 Nuremberg Code 1947:
The Nuremberg Code was the first modern effort by the international community to create
instructions governing experimentation on humans. The goal of the Code is to protect the
rights of subjects and to prevent the horrendous non-therapeutic, non-consensual medical
experiments carried out by Nazi researchers during World War II from recurring. The code
consists of ten principles some of which were from an existing document called the
Guidelines for Human Experimentation, formulated in 1931. The first and most important
is that anyone participating in an experiment must give informed assent. This means
nobody can be forced to participate in human experiments. All participants must
understand the potential risks.
The Code states that in medical experiments involving human subjects, voluntary assent of
the human subject is essential. The individual must be able to exercise the free power of
choice and must have sufficient knowledge of the nature of the experiment to make an
enlightened decision. The subject should be informed of the nature, duration, and
purpose…the methods and means, all inconveniences and hazards reasonably to be
expected…and the effects upon his physical health or person which may possibly come
from this participation in the experiment.

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 5.2 The Helsinki Declaration 1964:
Although, the Nuremberg Code is accepted and praised as the most important and well –
known with respect to human experimentation, today, it is the Helsinki Declaration 8 which
is hailed by all the doctors doing research involving humans. It is a set of ethical principles
relating to human experimentation developed for the medical community by the World
Medical Association in 1964, at Helsinki in Finland.
The underlying fundamental principle of the Declaration is to respect the individuals, their
right to self – determination and their right to make an informed decision with respect to
participation in the research, both initially and during the course of the research.
The duties of the persons conducting the experimentation are also provided under the
Declaration and it is specifically highlighted that the welfare of the subject must always
take precedence over the interests of science and society. The Declaration consists of 37
Articles. It must be noted that the Declaration is not a legally binding instrument under the
international law.

5.3 International Covenant on Civil and Political Rights (ICCPR) 1966

International covenant on civil and political rights (ICCPR) seriously focused on human
rights in clinical trials. According to this covenant No one shall be subjected to torture or
to cruel, inhuman or degrading treatment or punishments. In particular, no one shall be
subjected without his free assent to medical or scientific experimentation.
All the signatories are legally binding to this obligation. This covenant guarantees
individuals the right to be free from non-consensual medical experimentation.

5.4 Good Clinical Practices (ICH – GCP) 1997

Good Clinical Practice (GCP) is an internationally recognised ethical and scientific quality
standard set for formulating, conducting, recording and reporting clinical trials which
involve the human subjects. GCP guidelines assure that the statistics and outcomes are
credible and accurate. It respects and protects the rights, integrity and confidentiality of the
subjects. Sponsors, investigators, the ethics committees and any clinical experimentation

8
Hereinafter the Declaration

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 organizations which are involved in the clinical trial are obliged to follow the relative GCP
standard irrespective of the size of trial or the conditions of subjects.

6) CASE LAWS:
 Experimentation/ Clinical Trials:
Wright vs Fred Hutchinson Cancer Research Center 9
In this case, the Cancer Research Center and its investigators were sued by family
members of cancer patients who had participated in a series of clinical trials which led
to several deaths. The US District Court for the Western District of Washington granted
the Center’s motion for judgment in its favour, the jury finding that the trial participants
had given their consent.85 The court held that the breach of informed consent in clinical
trials is not deemed a violation of a federal right as defined by law. It also held that
there was no statutory basis for a private right of action that the petitioners sought to
assert given that alternate tort or procedural remedies were available to the petitioners.

 Informed Consent:
Cantebury vs. Spence10
In this landmark decision, the US Court of Appeal laid down the propositions required
for informed consent. They are as follows:
 Every adult of sound mind enjoys the right to self – determination, that is, he
or she has the right to decide what shall be done to his or her body.
 It is the duty of the doctor to obtain, not just consent, but informed consent,
from his patient, which the patient gives after being informed of alternate lines
of action and the risks involved in each of them.
 It is the duty of the doctor to disclose to his patient all material risks which a
reasonable man would consider to be significant, before the patient opts for the
line of investigation or treatment.

9
269 F2d 1286 (W. D. Wash. 2002)
10
1972 464 2d 772

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  Therapeutic privilege, however, allows a doctor to withhold certain
disclosures, if such disclosures could pose a serious threat of a psychological
or physiological nature.
 When informed consent of the patient is not obtained before a surgery, the same
would amount to offences of assault and battery.

7) CONCLUSION:
With the advancements in the fields of medicine and science and technology, new and more
effective drugs and medicines are being invented all over the world. Thus, experimentation
on human beings has becomes necessary to monitor the efficacy of the new drugs and
chemical agents.
Since, long-time animals were involved in such experiments. Although, it is helpful, not
always reliable or sufficient. Animals may react differently as compared to humans. So, it
becomes vital to observe the effectiveness and side effects of the drugs by experimenting
on humans.
Experimentation may not be harmful if conducted in a careful and controlled manner. It
can play a vital role in developments of medicine and drugs which can combat diseases,
treat chronic diseases and improve the health of people. It is a key research tool for
advancing medical knowledge. They can be helpful to discover new treatments for
diseases, as well as new ways to detect, diagnose and reduces the chances of developing
certain diseases.
Volunteers or subjects are the most important part of such experiments. Firstly, such
volunteers should give their consent voluntarily. Then they should be informed about the
object of the experiments, expected side effects and possible risks. Lastly, they should be
informed about the duration of the experiment and it should be made clear to them that
they can opt out of the experiment at any stage.
Prisoners and psychiatric patients have been subjects of such experimentations since
decades and not only in the US, but also around the world. They have been a part of several
unethical and inhuman experiments. Many have even lost their lives during such
experimentations. As there were no proposed guidelines for conducting experiments

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involving humans, the doctors or the people involved in conducting the experiments
injected the subjects with deadly viruses, diseases, etc. without their consent.
The volunteers were not informed about the reason of conducting such experiments, the
side effects, risks, etc. They were made part of the experiments against their will. It is
possible that many of such experiments have never come to light.
Seeing the atrocities which were committed against the war prisoners by allied powers few
international conventions were introduced to regulate experimentations involving humans.
In US, also, laws and regulations were introduced which regulate the clinical trials. These
rules and regulations have become stricter with time.
The companies which carry out the trials have to strictly follows the guidelines, like,
obtaining consent from the volunteers, conducting controlled and ethical trials, informing
about risks and side effects of the trials, etc. Failure to follow such rule may lead to
cancellation of the drug or medicine and the companies may be fined.

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8) BIBLIOGRAPHY:
Books:
Dr. Lily Srivastava, Law & Medicine (Universal Law Publishing Co., Delhi, 2010)

Textbook:
Prof. H. D. Pithawalla, Law and Medicine (Educational & Law Publishers, Mumbai, 2021)

International Conventions:
 The Nuremberg Code, 1947
 The Helsinki Declaration, 1964
 International Covenant on Civil and Political Rights (ICCPR), 1966
 Good Clinical Practices (ICH – GCP), 1997

Statutes:
 The Drug and Cosmetic Act 1940 and Drug and Cosmetic Rules 1945, India,
available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
 Federal Food, Drug and Cosmetic Act, USA, available at:
https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf

Research Papers:
 Bhakuni, H. (2020). Informed consent to clinical research in India: A private law
remedy. Medical Law International, 20(3), 256–283.
https://doi.org/10.1177/0968533220958185
 Amicus, Criminal Justice (2018). Shackled By Science: The Exploitative Use of
Prisoners in Scientific Experiments. Harvard Civil Rights – Civil Liberties Law
Review. https://harvardcrcl.org/the-shackles-of-science-the-exploitative-use-of-
prisoners-in-scientific-studies/
 Christopher, P. P., Stein, M. D., Johnson, J. E., Rich, J. D., Friedmann, P. D.,
Clarke, J., & Lidz, C. W. (2016). Exploitation of Prisoners in Clinical Research:

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 Perception of Study Participants. IRB, 38(1), 7–12.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4793400/
 Sandeep S. (2020). Clinical trials on humans: A study under international and
national laws. Maharshi Dayanand University. http://hdl.handle.net/10603/207244
 Baader, G., Lederer, S. E., Low, M., Schmaltz, F., & Schwerin, A. V. (2005).
Pathways to Human Experimentation, 1933-1945: Germany, Japan, and the United
States. Osiris, 20, 205–231. http://www.jstor.org/stable/3655257
 Comfort N. (2009). The prisoner as model organism: malaria research at Stateville
Penitentiary. Studies in history and philosophy of biological and biomedical
sciences, 40(3), 190–203. https://doi.org/10.1016/j.shpsc.2009.06.007
 Gregory D. (2008). Cheaper than Chimpanzees: Expanding the Use of Prisoners in
Medical Experiments. Prison Legal News. Page 1.
https://www.prisonlegalnews.org/news/2008/mar/15/cheaper-than-chimpanzees-
expanding-the-use-of-prisoners-in-medical-experiments/
 Caitlin F. (2012). The Prisoner’s Dilemma: The History, Ethical Dimensions, and
Evolving Regulatory Landscape of Clinical Trials on Inmates. Harvard DASH.
https://dash.harvard.edu/handle/1/10985164

Newspaper Articles:

 Sarah C. (2011, February 28). Report: Medical Experiments Conducted on U.S.

Prisoners, Patients. PBS. https://www.pbs.org/newshour/health/medical-
slideshow-code
 Daily Mail Reporter. (2011, February 28). America’s shocking secret: Pictures
that show how U.S. experimented on its own disabled citizens and prison
inmates. Mail Online. https://www.dailymail.co.uk/news/article-
1361275/Americas-shocking-secret-US-experimented-disabled-citizens-
prison-inmates.html
 Mike S. (2011, February 28). Ugly past of U.S. human experiments uncovered.
NBC News. https://www.nbcnews.com/health/health-news/ugly-past-u-s-
human-experiments-uncovered-flna1c9465329

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 Phil K. and Ruth E. (2016, July 19) What went on at the hospitals that
‘experimented’ on child patients? BBC News.
https://www.bbc.com/news/magazine-36803067

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