This document discusses ethical issues in medical research. It provides an overview of key topics like the historical perspectives on medical ethics including the Nuremberg Code and Tuskegee Syphilis Study. It describes the origin of guidelines like the Declaration of Helsinki and ICH-GCP. It discusses informed consent processes and the roles of ethics committees in reviewing research protocols and ensuring ethical standards are followed.

1. Dr. Kumbhare Manoj Ramesh
Professor
S.M.B.T. College of Pharmacy
Nashik-422403
Ethical issues in Medical Research
A Workshop on
RESEARCH METHODOLOGY FOR UNDERGRADUATE STUDENTS
28th June and 29th June 21

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Learning 'objectives
After completion of session, learner will be able to-
Historical Perspectives: Nuremberg Code, Tuskegee Syphilis Study, The
declaration of Helsinki
• Origin of International Conference on Harmonization – Good Clinical Practice
(ICH–GCP) guidelines.
• Independent Ethics Committee / Ethics Committee-composition, roles,
responsibilities, review and approval process and ongoing monitoring of safety data
Ethical principles governing informed consent process
• Patient Information Sheet and Informed Consent Form
• The informed consent process and documentation

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INTRODUCTION
• 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

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Informed consent to clinical research
•Well-established common law policy for ascertaining information disclosure in
informed consent claims within the treatment context that governs the doctor–
patient relationship.
•India became one of the preferred destinations for globalised clinical trials because
conducting a trial in India can potentially reduce the cost of trial by up to 60% due
to cheap labour, low infrastructure costs and easier access to participants.

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EVOLUTION 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
 Ayurveda follow Charaka
 Muslim physicians – ‘conduct of a physician’ by Ishaq bin Ali Rahawi

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TO QUOTE FROM HIPPOCRATES -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……….

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HISTORY
•Clinical Historical background In the early 1960s, most notably in the United States- unethical medical
research
•Brooklyn Jewish Chronic Disease Hospital in which elderly patients.
In 1966, Henry Beecher’s article, ‘Ethics and Research,’ in the New England Journal of Medicine reported
22 examples of medical research that involved suboptimal ethical treatment of human subjects (1932–
1972), the U.S. National Health Service conducted a research titled the ‘Tuskegee Study of Untreated
Syphilis in the Negro Male.’ The study was done on about 600 black men, of whom 399had syphilis

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Research ethic’s declarations and treaties
Treaties -A number of treaties and declarations have been reported in the literature, which
addressed fundamental principles of ethical conduct in biomedical research: the Nuremberg Code,
the Declaration of Helsinki, EU Convention on Human Rights and Biomedicine Convention on
Human Rights and Biomedicine (the Oviedo Convention) various guidelines promulgated by the
Council for International Organizations of Medical Sciences, and a number of treaties and
conventions

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Nuremberg Code (1947)
In the nineteenth century, the judgment of the trial of the Nazi doctors at
Nuremberg is the commonly recognized starting event for modern
research ethics. It contained ten paragraphs, referred to as the Nuremberg
Code
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Statements of Nuremberg Code
1 Voluntary consent to be based on sufficient knowledge of the nature, duration, purpose,
methods, inconveniences, hazards, and effects of the research
2 Research would yield fruitful results for the good of society not procurable by other
methods
3 Research to be based on animal research and prior knowledge
4 All unnecessary physical or mental suffering and injury to be avoided
5 No experiment be conducted in which death or disabling injury will occur (except where
physicians were also subjects)
6 Degree of risk would not exceed that determined by the humanitarian importance of the
problem to be solved

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Statements of Nuremberg Code
7 Preparation and facilities be provided to protect subjects against even the remote
possibility of injury, disability, or death
8 The research be conducted by scientifically qualified persons and require the highest
degree of skills and care
9 Subjects be free to bring an experiment to an end if they reached the physical or
mental state where continuance seemed impossible
10 Researchers be prepared to terminate the experiment if they had cause to believe,
in their good faith, skill, and judgment, that continuation was likely to result in
injury, disability, or death to a subject
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Declaration of Helsinki (1964)
Declaration of Helsinki In 1964, the Declaration of Helsinki, published by the World
Medical Association (WMA), introduced an authoritative attestation of the need for prior
review of any kind of human research This shortcoming of the Declaration indicated that
the rights and safety of the research participants still lied with the individual investigator.
Then came the revision of the Declaration of Helsinki in 1975 that required the
assessment of research protocols by an independent research ethics committee.

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Continue…
Declaration of Helsinki (1964)
With the revised version, it seemed that biomedical research involving human subjects
finally had been furnished with a firm system of internationally accepted norms and
principles . Today, the Declaration of Helsinki is considered as a document of ethical
principles for medical research involving human subjects, including research on
identifiable human material and data.

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

15. Research ethics committees The system of prior ethical review of medical research
employs to protect the rights and welfare of human participants, ensuring the legal
and ethical application of codes of practice of medical research conduct. US federal
regulations for the protection of human research subjects define “human subject” as
“a living individual about who man investigator obtains data through intervention or
interaction with the individual, or identifiable private information”
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Research ethics committees
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16. An institution’s Research Ethics Committee (REC) aims to safeguard the
welfare, dignity, and safety of the participants, ensures that ethically approved
research is conducted in line with the approved protocol, and promotes public
confidence in the conduct of human research. RECs play key roles in
promoting ethical practices in biomedical research and in identifying solutions
to ensure that the interests of researchers and society do not take precedence
over the rights of the participants
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Research Ethics Committee
Functions :
a. Prior review of human research proposals, scrutinizing the ethical standards for research conduct in legal
framework
b. Observations to the investigators, to modify the research proposal to meet the required ethical standards
c. Decision to approve or reject the research proposal
d. Monitoring the conduct of approved research proposals ,ensuring that their conduct continues to conform to the
approved protocol
e. Resolution, or referral for resolution, of complaints in relation to the conduct of approved research projects or the
conduct of the ethical review of those projects
f. Premature termination and/or suspension of the con-duct of a research proposal whenever it becomes evident that
continuing conduct will expose participants to greater levels of risk than those approved
g. Accountability and quality assurance by reporting to the relevant institution about its performance
Applications to the RECs follow the official review of the proposal, and one of the following decisions may be
sought:
1. Accept without changes
2. Accept with suggested changes
3. Recommend submission to committee of another region
4. Revise and resubmit (with changes)
5. Reject (with reasons)
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18. Currently, majority of the research misconduct and irregularities are related to
studies funded by the pharmaceutical industry and strongly linked with the
financial interests of this industry. Technical faults in the research design,
wrong recruitment process, insufficient sample size, and weak statistical
analysis of the data often lead to non-publishable research. Another form of
research misconduct is the procedural irregularities by misinterpreting the trial
data, attempting to draw favorable conclusions than those warranted by the
available data . Reporting of fabricated favorable results due to the comparison
of the drug under study only against placebo or a non-gold standard drug also
leads to research misconduct.
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Research misconduct
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19. Patient information sheet
Once informed consent is obtained, the research subject is given a patient information
sheet detailing the following aspects of the study:
1. Title of the research project
2. Invitation to participate in the research
3. Purpose and significance of research
4. Time commitments
5. Termination of participation, indication voluntary contribution
6. Risks involved
7. Costs and compensation
8. Anonymity and confidentiality
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Confidentiality
Confidentiality means the nondisclosure of certain information except to
another authorized person. The concept of confidentiality applies that the
information a person reveals to a professional is private and has limits on
how and when it can be disclosed to a third party There is no breach of
confidentiality if the following recordings for any purpose were used, as
long as they were effectively anonymised
a. Conventional X-rays
b. Images taken from pathology slides
c. Laparoscopic images of the inside of abdominal cavity
d. Images of internal organs
e. Ultrasound images
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21. Privacy is the quality of being secluded from the presence or view of others.
Privacy in research refers to the right of an individual to make decisions
concerning how much information about their physical status, health, social
network, and thoughts and feelings will be shared with investigators . To
protect the privacy rights of family members, researchers must be careful in
determining whether family members should be considered as research
participants.
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22. Respect in research refers to respect for people and respect for truth. People
have the right to dignity and privacy (informed consent and confidentiality).
Respect for truth implies probity and respect for the intellectual rights of
others. All possible efforts should be directed to avoid plagiarism and clinching
false conclusions by over and under emphasizing the results.
Responsibility of the human subject involves voluntary informed consent,
avoiding deception, rewards and incentives, privacy, and disclosure.
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Respect and responsibility
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India became one of the preferred destinations for globalised clinical trials because
conducting a trial in India can potentially reduce the cost of trial by up to 60% due to
cheap labour, low infrastructure costs and easier access to participants.In the early 2000s,
with increasing policy support from the Indian government, the global pharmaceutical
industry became interested in moving its trial operations to India.3 In 2005, the
government amended Schedule Y of the Drugs and Cosmetics Rules 1945, appended to
the Drugs and Cosmetics Act 1940. This statute regulates the import, manufacture,
distribution and sale of drugs and cosmetics in India. The amendment of Schedule Y
in 2005 established the guidelines for the conduct of clinical trials in the country
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To complement Schedule Y, the Indian Council of Medical Research
(ICMR), the apex body for the formulation, coordination and promotion
of biomedical research in India, updated the ethical guidelines for
human subject research in 2006, which were first released in 2000 and
updated again in 2017.
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India adopted the Good Clinical Practice (GCP)
India adopted the Good Clinical Practice (GCP) guidelines (originally
released by the International Conference on Harmonization) in 2001; these
guidelines prescribe the ethical and scientific quality standards for designing,
conducting and recording trials that involve the participation of human
subjects.
The GCP guidelines lay down an elaborate consent process that is expected
to be followed by researchers.
Despite being the primary sources for governing the ethics of clinical
research in India, the ICMR and GCP guidelines lack enforceability.
Failures to adhere to guidelines, at the most, lead to either suspension of trial
or disciplinary hearings.
Schedule Y is the lone legal source that makes informed consent mandatory
for clinical research in India.
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ICMR - Ethical Guidelines for Biomedical Research on Human Participants
(2006)…
Out of these 12 principles the following are given the priority
Autonomy of the individual (right of competent adults to make informed
decisions about their own medical care. The principle underlies the
requirement to seek the consent or informed agreement of the patient before
any investigation or treatment takes place)
Beneficence ( the quality or state of doing or producing good : the quality or
state of being)
Nonmaleficence (a principle of bioethics that asserts an obligation not to
inflict harm intentionally. It is useful in dealing with difficult issues
surrounding the terminally or seriously ...)
Justice
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Law of informed consent in treatment
Here I will analyze how informed consent is understood in tort law in India. Other than
the Consumer Protection Act 1986 (CPA), where doctors are treated as service providers
and patients as consumers of such services and the lack of informed consent as a
deficiency in service.
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With a booming clinical research industry and large swathes of vulnerable population groups,
India needs to move abreast with the legal developments in informed consent in other common
law jurisdictions. But it would be naive to deny the significant effect that law has on the whole
process of informed consent. People give and take consent in the shadow of law. For that, the
development of clear and concise legal standards is required to tackle grievances arising out of a
lack of informed consent in research
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References
[1] Thomson CJH. Research ethics committees; 2012.
[2] Wisely J. Research ethics committees. Brit J Gen Pract 2008;58(553):580.
[3] Beecher HK. Ethics and clinical research. Bull World Health Org 2001;79(4):367–72.
[4] Thomas SB, Quinn SC. The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV
education and AIDS risk education programs in the black community. Am J Public health
1991;81(11):1498–505.
[5] Saif M. World Medical Association Declaration of Helsinki: ethicalprinciples for medical
research involving human subjects. J Am MedAssoc 2000;284:3043–5.
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