The document discusses ethical considerations in clinical research, highlighting the protection of participants and the integrity of data. It reviews historical unethical studies, outlines key ethical principles such as the Nuremberg Code and the Belmont Report, and addresses current issues in research ethics, including the treatment of vulnerable populations. Emphasizing the importance of informed consent and risk-benefit assessments, the document serves as a comprehensive guide to ethical standards in clinical trials.

1. Welcome
Ethical consideration in Clinical Research- Protecting
Participants and Ensuring Data Integrity.
Dr. Ankita Srivastava
MDS Endodontics
CSRPL_STD_IND_HYD_ONL/CLS_
085/05202
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2. Index
• Clinical Research ands its goal
• What is Ethics ?
• Ethics in Clinical trials-a historical perspective
• Importance of ethics in Clinical Research
• Chronology of Regulation of Research Involving Human Subjects
• Fundamental Principal of Ethical Research
• Current Ethical issues in Clinical Research
• Reference
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3. Clinical Research and its goal?
• National Institutes of Health (NIH) define clinical research as medical research that test new
treatments and therapies on people.
• The ultimate goal was to develop medical knowledge that improves patient care or increase the
understanding of human biology.
• The U.S Food and Drug administration (FDA) describes the following types of clinical Research
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Treatment
research
Genetic
Research
Diagnostic
Research
Epidemiological
research
Genetic
research
Prevention
Research

4. What is Ethics?
The word ethics is derived from the Greek word, Ethos, which means custom or character. Ethics is the
systematic study of values, so as to decide what is right and what is wrong.
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Historical
perspective

5. SYPHILLIS – TUSKEGEE STUDY (1932-1972)
• Conducted in Tuskegee, Alabama
• To determine the natural history of untreated latent
syphilis.
• Over 400 African/American men with syphilis, 200
men without syphilis, who served as the control
Ethical issues:
• Inadequate disclosure of information
• Subjects believed that they are getting free
treatment
• Told that spinal taps was therapy
• US govt actively prevented men from recieveing
penicillin
• 1972, press reports caused the U.S government to
stop the study
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6. NAZI EXPERIMENTS & NUREMBERG TRIAL
• In 1946, American Military tribunal opened
criminal proceedings against 23 leading
German Physicians for their willing
participation in war crime and crime against
humanity.
• German physicians conducted medical
experiments on thousands of Concentration
camps prisoners without their consent.
• This led to the NUREMBERG CODE
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7. Thalidomide tragedy (1957)
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• It was developed in West Germany with the
trade name Contergan.
• Chemie Grunenthal company developed and
sold the drug.
• It was approved as Sedative in Europe.
• Dr William McBride discovered this drug also
alleviated morning sickness in pregnant women.
• More than 10,000 children in 46 countries were
born with Phocomelia (absence of limbs)

8. Importance of Ethics in Clinical Research
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It ensures integrity and safety of the patients who volunteer to participate in the trials.
It prevents participants from being exploited by the research team
Code of Ethics
• Nuremberg code
• The Declaration of Helsinki
• The Belmont report
• The U.S common rule.

9. Nuremberg code,1947
• The Nuremberg trial started in August,1947
• Nazi doctors and scientists were put on trial for the murder of
concentration camp inmates who were used as research subjects.
• During the trial fundamental ethical principal for human subject research were codified into the
Nuremberg Code that sets forth 10 articles.
 Article 1:” The voluntary consent of the human subjects is absolutely essential.”
 Article 9 : subjects has the right to withdraw any time
 Article (2-8,10): Scientific Value; Favourable risk/benefit ratio, Suffering by subjects to be avoided.
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The Nuremberg code became the first codification of research guidelines to protect human subjects; But without the force of law.
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10. 10 guidelines from Nuremberg code
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NUREMBERG CODE
It should be
based on
previous
knowledge that
justifies the
experiment.
Avoid uncessary
physical and
mental suffering
and injury.
Not be
conducted if
there is risk of
death or
disabling injury.
The risk should
be in proportion
and not exceed
the expected
humanitarian
benefits
Voluntary, Well
informed
,understanding
consent of the
human subject.
Aim at positive
resultfor society
that cannot be
procured in some
other way.
Medical staff
must stop the
at any point if
its dangerous
The humans
subjects can
withdraw at any
point if they are
not willing.
Protection of
subjects
against risk.
The staff
should be fully
trained
scientifically
qualified
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11. Declaration of Helsinki
“the most widely accepted guidance worldwide on medical research involving human subjects.”.
Christie. BMJ 2000.
• The World Medical Association adopted a formal code of ethics for physician engaged in clinical research in
1964 in Helsinki, Finland at its 18th General assembly.
• Latest complete revision in 2013, October(Helsinki Declaration).
• It extend Nuremberg code to include
Research Combined with medical care
Incompetent subjects and vulnerable subjects
Review by independent review committee
International Research
However, like all other guidelines, they lack the force of law.
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12. Belmont Report
• This document was created by the National
Commission for the Protection for the
Human Subjects of Biomedical and
Behavioral Research in 1979.
• The report established 3 tenants of ethical
research.
Respect for person
Beneficence( to do no harm)
Justice (Fairness of the selection of
subject)
Created in outcry over Tuskegee Syphilis study.
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13. Chronology of Regulations in Research
involving Human subjects
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Nuremberg,1947
(Code)
Declaration of
Helsinki,1964(Guidelines)
U.S National research
Act,1979(Report)
ICH-GCP,1996(SOP) MGCP 2.1
MGCP 2.1-Clinical trials should be conducted in accordance with the ethical principles that have their origin in
the Declaration of Helsinki, and that are consistent with GCP- and the applicatory regulatory requirements.eg
Malaysian Control of Drugs and Cosmetic Regulations 1984.
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14. Other International guidelines
• International Covenant of civil and political rights(1976) adopted by the United Nations General
Assembly.
• The World Health Organization(WHO)-consider the WHO’s guidelines for ethics in medical
experimentation.
• The council for international organization of medical science (CIOMS) issued the International
ethical guidelines for biomedical research involving human subjects
.
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15. The Fundamental Principles of Ethical
Research
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S. No Requirements Principles
1 Social and clinical value Beneficence
2 Scientific Validity Beneficence, Respect for person
3 Fair Subject Selection Justice
4 Favourable Risk-benefit ratio Beneficence and Non-maleficence
5 Respect for potential and enrolled
subject
Respect for person
6 Informed consent Respect for subject autonomy
7 Independent review
8 Privacy and Confidentiality

16. Vulnerable population
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People who are relatively or absolutely incapable of protecting their own interest are
termed as vulnerable research population.
• Examples include very poor, illiterate patients, children, individual with questionable capacity to
give consent, prisoners, foetuses, pregnant women, terminally ill patients, students, employees,
comatose patients, tribals, and the elderly.
Declaration of Helsinki states that medical research involving an underprivileged or
vulnerable population is only justified if the research is responsive to the health needs
and populations stands to benefit from the result of the research.
• Inclusion of the vulnerable population should be justified.
• Care should be taken to ensure no harm to the child in pregnant females.
• Even though child is legally considered incompetent, Consent should be taken from child’s parents.
• Clinical research that involves patients who have an incurable disease must make sure the patients
isn’t consenting because of any false assumption of benefiting personally from the research.
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17. 17
Current ethical issues in clinical research
COVID 19 Vaccine Trials
Infecting volunteers with Coronavirus as
a way to test potential vaccine
Stem Cell Research
Maintaining the anonymity of human tissue
donors, ownership of the tissue itself , long
term storage sample and manipulation of
genetic material to create novel organism
Human Gene Editing
The development of the CRISPR tool (clustered regularly
interspaced short palindromic repeats) for editing the
human genome opens up the possibility to edit human
embryos, as explained in the Mayo Clinic Proceedings.
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18. 18
References
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Title Link
Patient Recruitment https://clinicalcenter.nih.gov/recruit/ethics.html
Principles of Clinical Ethics and Their
Application to Practice
https://karger.com/mpp/article/30/1/17/204816/Principles-
of-Clinical-Ethics-and-Their
Ethics in Clinical Research: Foundations and
Current Issues
https://school.wakehealth.edu/education-and-
training/graduate-programs/clinical-research-management-
ms/features/ethics-in-clinical-
research#:~:text=Core%20Principles&text=Verifying%20t
he%20scientific%20validity%20of,before%20they%20offer
%20their%20consent
Clinical ethics revisited https://bmcmedethics.biomedcentral.com/articles/10.1186/
1472-6939-2-1

19. Thank You!
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