Ethics and Practice of

modern science
Feb 1st 2022, Lecture 5
Rama Akondy
Ethics in conducting research.

Ethics in reporting research.

Why should you think about ethics in
science?
Ethical issues brought up by you all
Tuskgee syphilis study AP report
Tuskegee study sciencedirect

Genetic memory in assassin’s creed; Rick and Morty (endangering a minor); Arnim Zola and Bucky;
Human centipede; Jurassic Park

DNA discovery (Rosalyn Franklin not credited)

Guidelines for conducting human research
The Nuremberg Code of 1947 - The first international treatise on the ethics of research
involving human beings. Some of the guidelines it includes

 Informed consent is essential.

 Research should be based on prior animal work.
 The risks should be justified by the anticipated benefits.
 Research must be conducted by qualified scientists.
 Physical and mental suffering must be avoided.
 Research in which death or disabling injury is expected should not be conducted.
50 Years later: The significance of the Nuremberg code
“The Stateville Penitentiary Malaria study was an experiment in the 1940s
where prisoners were infected with malaria to test the effects of anti
malarial drugs.” (Siddharth Dasgupta’s response)
Do you think if informed consent was sought it would have made the study
ethical? or if it was not Malaria infection but the phase 3/4 trial of a vaccine,
this trial would have been ethical?
“I think using prisoners as sample for the testing was unethical by itself
because it creates a certain idea of which lives are dispensable and which
are not. I think the only ethical way to test the drug or a vaccine would be on
a sample that already has the disease, I don’t see how artificially inducing a
disease can be ethical even after consent since harm is being done.”
Human challenge studies
Malaria https://www.nature.com/articles/nri2902
Influenza https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6489464/
Norovirus (Emory University, Juan Leon)
Guidelines for conducting human research
• In 1964, the World Medical Association formulated guidelines on
conducting research on humans, known as the Declaration of Helsinki.
• The Nuremberg Code focuses on the human rights of research
subjects, the Declaration of Helsinki focuses on the obligations of
physician-investigators to research subjects.
• In 1979, the Belmont Report for the first time enunciated the three
basic ethical principles for research involving human subjects:
respect for persons, beneficence and justice.
Guidelines for conducting human research
• In 1979, the Belmont Report for the first time enunciated the three
basic ethical principles for research involving human subjects:
respect for persons, beneficence and justice.

“It is important to distinguish between biomedical and behavioral

research, on the one hand, and the practice of accepted therapy on the
other, in order to know what activities ought to undergo review for the
protection of human subjects of research.”
Guidelines for human research in India
• ICMR National ethical guidelines for biomedical and health research
involving human subjects. Link HERE
• 137 page document that covers ethical issues, responsible conduct of
research, review process, conduct of clinical trials.
• National ethics committee registry (naitik.gov.in)

(My opinion – we need good self-paced, elearning modules)

Conducting research with animals
• Mice, rats, hamsters , guinea pigs, ferrets, non-human primates
• ICMR, Section 3.2.2 lists some 6 acts and guidelines including CPCSEA
and INSA.

Forcing my opinion on you again – better training material is essential.

Should you make a pathogen in the lab?
Kawaoka and Fouchier research in 2012 to enable avian influenza H5N1 viruses to transmit
among ferrets by aerosol.
What is H5N1? A type of avian flu virus that occurs naturally in various types of birds but
has surfaced in humans in the last ten years. It doesn't transmit easily between people.
Almost all reported cases are due to direct or close contact with infected birds.

Why make a virus? How influenza viruses mutate to become transmissible in humans is not
known. Ron Fouchier of Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka
of University of Wisconsin independently set out to discover how H5N1 mutates. They
reasoned that it'd be better to gain knowledge for its prevention in a controlled
environment.
Responsible conduct of research
• Conflict of interest. Identify, mitigate and manage
• Data acquisition sharing and management
• Registering clinical trials with the Clinical Trials registry of India.
Responsible reporting of research
• Plagiarism
• Deliberate data manipulation
• Inadvertent errors
• Transparency

Checks and balances?

Interested in looking up examples of problematic, peer reviewed

studies? – Elizabeth Bik’s tweets; Pubpeer; Retraction watch blog.