This document discusses the ethics of conducting research on human subjects. It begins with an introduction noting the troubled history of human experimentation and the need to carefully address ethical concerns to protect participants. It then outlines some of the key codes and guidelines for ethical research, like the Nuremberg Code and Declaration of Helsinki. The main body discusses the ethical framework, including principles like informed consent, minimizing harm, and fair participant selection. It also examines the roles of institutional review boards and transparency. Examples of past unethical trials like the Thalidomide tragedy and Tuskegee syphilis study are provided. The document concludes by discussing how to balance risks and benefits in research.

1. Welcome
Ethical Concerns Regarding Research on
Human Subjects
Vidhya Jakky
M.Sc. Genetics
Student ID: 110/062023

2. Index
1. INTRODUCTION 3
2. ETHICS OF CLINICAL RESEARCH 4
3. CODES AND GUIDELINES 5
4. FRAMEWORK OF ETHICAL PRINCIPLES 6
5. EXAMPLES OF UNETHICAL CLINICAL TRIALS 11
6. BENEFITS AND RISK IN RESEARCH 13
7. REFERENCES 14

3. 1. INTRODUCTION
• Research involving human subjects has anything but a glorious legacy. The term
‘human experimentation’ still evokes, in many, the ghastly impression of the
infamous experiments conducted on war prisoners during World War II.
• Furthermore, this negative impression was propagated in the postwar period by
some notable cases of unethical handling of human subjects in medical research
episodes involving prisoners, the mentally disabled, the poor, or ethnic minorities,
such as, for instance, the ill-famed Tuskegee syphilis study.
• Research on human subjects raises several ethical concerns that need to be
carefully addressed to ensure the well-being and rights of the individuals
involved.

4. 2. ETHICS OF CLINICAL RESEARCH
• Ethical requirements in clinical research:
• Promote the responsible conduct of useful clinical research and progress in
understanding and intervening in human health and illness.
• Goal- generating knowledge useful for understanding human health and
preventing, diagnosing, and treating human disease
• Study human beings and ask a small number of people to bear risk and burden in
service to the many.
• Minimize the possibility of exploitation and harm
• Ensure that the rights and welfare of subjects are respected while they contribute
to the generation of knowledge
• Help to maintain public trust

5. 3. CODES AND GUIDELINES
• Nuremberg Code (1949)
• Declaration of Helsinki (1964- multiple revisions-2013)
• The Belmont Report (1979)
• CIOMS/WHO International Guidelines (1993, 2002, 2015)
• ICH/GCP-International Conference on Harmonization- Good Clinical Practice
(1996, 2016)

6. 4. FRAMEWORK OF ETHICAL PRINCIPLES
4.2
Privacy and
confidentiality
4.7
Transparency
and
accountability
4.6
Institutional
Review Board
4.5 Fair
selection
4.1
Informed
consent form
4.3
Minimizing
Harm
4.4
Beneficence

7. 4.1 INFORMED CONSENT FORM:
Participants should be fully informed about the nature, purpose, risks, and
benefits of the research. They must voluntarily provide their informed consent
without any deception.
4.2 PRIVACY AND CONFIDENTIALITY:
Participants’ privacy should be protected, and their personal information should
be kept confidential. Researchers should take appropriate measures to
anonymize and secure data.
4. FRAMEWORK OF ETHICAL PRINCIPLES (Cont.)

8. 4.3 MINIMIZING HARM:
Researchers have a responsibility to minimise any potential physical,
psychological, or social harm to participants’ well-being and provide
appropriate support.
4.4 BENEFICENCE:
The term "beneficence" is often understood to cover acts of kindness or
charity that go beyond strict obligation. Two general rules have been
formulated as complementary expressions of beneficent actions in this
sense:
i. Do not harm and
ii. Maximise possible benefits and minimise possible harms.
4. FRAMEWORK OF ETHICAL PRINCIPLES(Cont.)

9. 4.5 FAIR SELECTION:
• Is it preferable to test an early potential risky
therapy in healthy infants? Affected adults who
can consent but have mild disease or severely ill
infants who are otherwise likely to die?
• The selection process should be transparent,
without any bias or discrimination and based on
scientific criteria, protecting vulnerable
participants.
4. FRAMEWORK OF ETHICAL PRINCIPLES (Cont.)

10. 4.6 INSTITUTIONAL REVIEW BOARD(IRB) APPROVAL:
Research involving human subjects should undergo ethical review by an
independent committee, such as IRB, to ensure compliance with ethical
guidelines and regulations.
4.7 TRANSPARENCY AND ACCOUNTABILITY:
Researchers should maintain transparency in reporting their findings and be
accountable for their actions and decisions throughout the research process.
4. FRAMEWORK OF ETHICAL PRINCIPLES (Cont.)

11. 5. EXAMPLES OF UNETHICAL CLINICAL TRIALS
5.1 THALIDOMIDE TRAGEDY
Thalidomide was a widely used drug in the late
1950s and early 1960s for the treatment of
nausea in pregnant women. It became apparent
in the 1960s that thalidomide treatment resulted
in severe birth defects in thousands of children.

12. 5. EXAMPLES OF UNETHICAL CLINICAL TRIALS
(Cont.)
5.2 SYPHILIS TRAGEDY:
The Tuskegee syphilis study, conducted by the US
Public Health Service, took place between 1932 and
1972 with the aim of following the natural history of
the disease when left untreated. The subjects belonged
to a rural black population, and the study was not
halted when effective treatment for syphilis became
available in 1945.

13. 6 BENEFITS AND RISKS IN RESEARCH
Risks and benefits of research may affect the individual subjects, the families of the
individual subjects, and society at large. Assessment of the justifiability of research should
reflect at least the following considerations:
(i) Brutal or inhumane treatment of human subjects is never morally justified.
(ii) Risks should be reduced to those necessary to achieve the research objective. It should be
determined whether it is, in fact, necessary to use human subjects at all. Risk can perhaps
never be entirely eliminated, but it can often be reduced by careful attention to alternative
procedures.
(iii) When research involves a significant risk of serious impairment, review committees
should be extraordinarily insistent on the justification of the risk.
(iv) When vulnerable populations are involved in research, the appropriateness of involving
them should itself be demonstrated.
(v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures
used in the informed consent process.

14. 7. REFERENCES:
• Nardini C. The ethics of clinical trials. Ecancermedicalscience. 2014 Jan 16;8:387. doi:
10.3332/ecancer.2014.387. PMID: 24482672; PMCID: PMC3894239.
• Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment
of disease. Toxicol Sci. 2011 Jul;122(1):1-6. doi: 10.1093/toxsci/kfr088. Epub 2011 Apr
19. Erratum in: Toxicol Sci. 2012 Feb;125(2):613. PMID: 21507989.
• E. Cuerda-Galindo, X. Sierra-Valenti, E. González-López, F. López-Muñoz, Syphilis and
Human Experimentation From World War II to the Present: A Historical Perspective and
Reflections on Ethics, Actas Dermo-Sifiliográficas (English Edition), Volume 105, Issue
9, 2014, Pages 847-853, ISSN 1578-2190,
• Emanuel E, Wendler D, Grady C. What makes clinical research ethical? J Am Med Assoc.
2000; 283(20):2701-11; Chpt 11 Oxford Textbook 2008
• Emanuel E, Wendler D, Killen J, Grady C. J Infect. Diseases 2004; 189:930-7
• https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-
report/index.html

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