Unit-1.

Introduction to One Health

Topic-2.Basics of Research Ethics
Outline of Session
The Fundamental Principles of Ethics
Some General Ethical Principles
IRBs or IECs and their Role
ABC ofApplying the Principles of Ethics
How Unethical Research C an C ause Harm
Learning Objectives
To define the fundamental ethical principles of research

To understand some general principles associated with ethical

and responsible conduct of research
To describe the ethical complexities of doing O ne Health
research

To describe the harms that can be caused by conducting

research in an unethical manner
ICMR Guidelines
Ethical guidelines:
https://main.icmr.nic.in/sites/def
ault/files/guidelines/ICMR_Ethic
al_Guidelines_2017.pdf

ICMR Bioethics Unit

publications:
https://ethics.ncdirindia.org/ICM
R_Ethical_Guidelines.aspx

Ethics Training:
https://www.youtube.com/watc
h?v=JMF4cdCzEdo
The Fundamental Principles of Ethics
Beneficence

Non-maleficence
Primum non nocere

Autonomy

Justice
Some General Ethical Principles
1. Essentiality 7.Professional competence
2. Voluntariness 8.Maximization of benefits
3. Non-exploitation 9.Institutional arrangements
4. Social responsibility 10.Transparency and
5. Privacy and confidentiality accountability
6. Risk minimization 11. Totality of responsibility
12.Environmental protection
Special Ethical C oncerns for O ne Health
Research
Interconnected systems make for complex inter-relationships

Multiple stakeholders are involved

Different stakeholders will be affected differently by the same

One Health intervention/solution
Can conventional “human centric” ethics
principles be applied to One Health?

And,do we need a“different” set of ethical

principles for One Health research?
IECs or IRBs and their Role
Research institutes should have IECs or IRBs
Independent
Review and approve research protocols prior to starting
research
Continue monitoring throughout research process
ABC ofApplying the Principles of Ethics
A = Apophenia

B = Bias

C = C onflicts of Interest
 Apophenia:CloudAnimals

Images: https://www.arabiaweather.com/en/content/why-do-we-sometimes-see-in-the-shapes-of-clouds-images-of-animals-and-human-faces
Can you solve this one?
Apophenia in Science
The reproducibility problem in science
“If you torture data long enough, it will confess to anything” –
Ronald C oase,N obel Laureate,Economics
“The first principle is that you must not fool yourself,and you
are the easiest person to fool.” – Richard Feynman,N obel
Laureate, Physics

Jones PM,Martin J.Increasing the reproducibility of research will reduce the problem of apophenia
(and more). Can JAnaesth. 2021Aug;68(8):1120-1134. English.doi: 10.1007/s12630-021-02006-1.
Epub 2021 May 7. PMID: 33963518.
Bias
Inevitable,but minimize!
Further readings:
Delgado-Rodriguez M,Llorca J.
Bias.Journal of Epidemiology &
C ommunity Health.2004 Aug
1;58(8):635-41.
BMJ.Epidemiology for the
uninitiated.C hapter 4:
Measurement error and bias.
https://www.bmj.com/about-
bmj/resources-
readers/publications/epidemiolo
gy-uninitiated/4-measurement-
error-and-bias
Website:
https://www,yourbias.is
HarveyAH,
Kirk U, Conflicts of Interest
Denfield GH,
Montague PR.
Monetary Compromising research integrity and quality
favors and their
influence on Landmark study on the ethical implications of how our minds
neural
responses and work:Harvey et al.
revealed
preference.
Journal of
N euroscience.
2010 Jul
14;30(28):9597-
602.
 Conflicts of Interest
HarveyAH,
Kirk U, “The results raise the
Denfield GH,
Montague PR.
important possibility
Monetary that monetary favors
favors and their
influence on bias judgments in
neural domains seemingly
responses and
revealed unrelated to the favor
preference. but nevertheless act in
Journal of
N euroscience. an implicit way through
2010 Jul
14;30(28):9597-
neural networks that
602. underlie normal,
ongoing preference
judgments.”
Harms of Unethical Research
Andrew Wakefield publishes in Lancet
C laims MMR vaccine linked to autism
Later found that data was falsified
Paper retracted,author discredited
Has spurred anti-vax movements in
developed countries
Has led to re-emergence of measles in US,
and other developed countries
COVID-19 and the Surgisphere Scandal
High-profile publications in high-impact journals based on data
collected by Surgisphere
Co-authors or reviewers denied access to data
External reviewers find glaring inconsistencies in data
Surgisphere refuses to share data citing intellectual property
concerns
Papers retracted – but damage done!
Many other examples…
N azi experimentation in concentration camps (WorldWar 2)
Tuskegee syphilis study (1932-1972)
Guatemala syphilis study (1946-1948)
Willowbrook hepatitis studies (1956-1970)
Stanford prison experiment (1971)
In Summary…
Four pillars:beneficence,non-maleficence,justice and autonomy
The importance of informed consent
The importance and role of Institutional Ethics Committees or
Institutional Review Boards in ensuring ethical research
Researchers should stay aware of their personal preferences and
cognitive biases
Responsible research and moral and ethical integrity form the
foundation stone of science
 ThankYou!
Reach out for more discussions:

Twitter: @Scepticemia
Email: pchatterjee@jhu.edu
pranab.chatterjee@stopamr.org