history_of_bioethics,_international_and_national_ethical_guidelines new.pptx

1. DILLA UNIVERSITY
COLLEGE OF HEALTH SCIENCE AND MEDICINE
Seminar on history of bioethics, international and national
ethical guidelines
Prepared by: - Melkam Andargie

2. History of Bio-Ethics
1.Hippocratic Oath ("First do no harm")
• It is often said that the exact phrase "First do no harm" is a part
of the original Hippocratic Oath.
• Although the phrase does not appear in the AD 245 version of
the oath, similar intentions are vowed by, "I will abstain from
all intentional wrong-doing and harm".
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3. • The Nuremberg trials were held by the Allies against
representatives of the defeated Nazi Germany for plotting and
carrying out invasions of other countries and other crimes in
World War II.
• Between 1939 and 1945, Nazi Germany invaded many
countries across Europe, inflicting 27 million deaths in the
Soviet Union alone.
2. Nuremberg trials
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4. • Proposals for how to punish the defeated Nazi leaders ranged
from a show trial (the Soviet Union) to summary execution
(the United Kingdom).
• In mid-1945, France, the Soviet Union, the United Kingdom
and the United States agreed to convene a joint tribunal in
Nuremberg, with the Nuremberg Charter as its legal
instrument.
2. Nuremberg trials cont…
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5. • Aimed to protect human subjects from enduring the kind of cruelty and
exploitation the prisoners endured at concentration camps.
The 10 elements of the code are:
• Voluntary consent is essential,
• The results of any experiment must be for the greater good of society,
• Human experiments should be based on previous animal experimentation,
• Experiments should be conducted by avoiding physical/mental suffering
and injury,
• No experiments should be conducted if it is believed to cause
death/disability,
3. 1947 Nuremberg code
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6. • The risks should never exceed the benefits,
• Adequate facilities should be used to protect subjects,
• Experiments should be conducted only by qualified scientists,
• Subjects should be able to end their participation at any time,
• The scientist in charge must be prepared to terminate the
experiment when injury, disability, or death is likely to occur.
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3. 1947 Nuremberg code

7. • WMADG oath said that “I solemnly pledge myself to
consecrate my life to the service of humanity.
• I will give to my teachers the respect and gratitude which is
their due;
• I will practise my profession with conscience and dignity;
• The health of my patient will be my first consideration; I
will respect the secrets which are confided in me;
4. World Medical Association Declaration of Geneva
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8. • I will maintain by all means in my power the honour and noble
traditions of the medical profession; my colleagues will be my
brothers;
• I will not permit considerations of religion,
• Nationality, race, party politics, or social standing to intervene
between my duty and my patient;
4. World Medical Association Declaration of Geneva
cont…
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9. • I will maintain the utmost respect for human life, from the
time of conception;
• Even under threat, I will not use my medical knowledge
contrary to the laws of humanity.
• I make these promises solemnly, freely, and upon my honour.”
4. World Medical Association Declaration of Geneva
cont…
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10. • The Declaration of is a set of ethical principles regarding human experimentation
developed originally in 1964 for the medical community by the World Medical
Association.
• It was the first international set of ethical principles for research involving human
subjects. In the following years this guideline became the most influential one and
still is.
• The basic principles include respect for individuals, the right to make informed
decisions, recognition of vulnerable groups, and more.
5. The Declaration of Helsinki
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11. 5. The Declaration of Helsinki cont…
• The Declaration of Helsinki has been revised six times, in
1975, 1983, 1989, 1996, 2000, and 2008.
• The Declaration of Helsinki is especially important to protect
the well-being of human subjects involved in biomedical
research.
• It serves as a call of duty for physicians, that need to safeguard
the welfare of the human subjects.
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12. Effect of the Declaration of Helsinki
• The Declaration of Helsinki dealt with clinical research more
directly, but was portrayed as a weakening of the stringent
protections of Nuremberg.
• Nevertheless, for a quarter of a century only minor changes
were made and it became engrained in the international culture
of research ethics.
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5. The Declaration of Helsinki cont…

13. • Tuskegee syphilis study, official name Tuskegee Study of
Untreated Syphilis in the Negro Male, American medical
research project that earned notoriety for its unethical
experimentation on African American patients in the rural
South.
• The project, which was conducted by the U.S. Public Health
Service (PHS) from 1932 to 1972, examined the natural course
of untreated syphilis in African American men.
6. 1972 Scandal of the Tuskegee Syphilis Study
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14.  Principles of 1981 Declaration of Lisbon are
 Right to medical care of good quality,
 Right to freedom of choice,
 Right to self-determination,
 The unconscious patient,
7. 1981 Declaration of Lisbon
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15.  The legally incompetent patient,
 Procedures against the patient’s will,
 Right to information,
 Right to confidentiality,
 Right to Health Education,
 Right to dignity,
 Right to religious.
7. 1981 Declaration of Lisbon cont…
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16. Ethical Theories
1. Teleological Theories
• All teleological ethical theories locate moral goodness in the consequences
of our actions.
• According to teleological (or consequentialist) moral theory, all rational
human actions are teleological in the sense that we reason about the means
of achieving certain ends.
• Moral behavior, therefore, is goal goal-directed.
• from the teleological point of view, human actions are neither right nor
wrong in and of themselves.
• What matters is what happens as a consequence of those actions.
• Thus, it is the consequences that make actions, good or bad, right or wrong.
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17. 2. Deontological Theories
• There are many philosophers who reject the entire teleological
agenda by arguing that moral goodness has nothing to do with
the pleasure, happiness, and or consequences.
• Deontological theories are by definition duty-based.
• That is to say, that morality, according to deontology, consists
in the fulfillment of moral obligations, or duties.
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Ethical Theories cont…

18. • Duties, in the deontological tradition, are most often associated
with obeying absolute moral rules.
• Hence, human beings are morally required to do (or not to do)
certain acts in order to uphold a rule or law.
• The rightness or wrongness of a moral rule is determined
independent of its consequences or how happiness or pleasure
is distributed.
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Deontological Theories cont…

19. International Ethical Guidelines
Guideline 1: Scientific and Social Value and Respect for
Rights: -
 The ethical justification for undertaking health-related research
involving humans is its scientific and social value:
 the prospect of generating the knowledge and the means
necessary to protect and promote people’s health.
Guideline 2: Research Conducted in Low-Resource Settings
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20. Guideline 3: Equitable Distribution of Benefits and Burdens in the
Selection of Individuals and Groups of Participants in Research: -
 Sponsors, researchers, governmental authorities, research ethics
committees and other stakeholders must ensure that the benefits and
burdens of research are equitably distributed.
Guideline 4: Potential Individual Benefits and Risks of Research: -
 To justify imposing any research risks on participants in health research,
the research must have social and scientific value.
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International Ethical Guidelines

21. Guideline 5: Choice of Control in Clinical Trials: -
 the research ethics committee must ensure that research participants in the
control group of a trial of a diagnostic, therapeutic, or preventive
intervention receive an established effective intervention.
Guideline 6: Caring for Participants’ Health Needs: -
 in context of clinical trials, researchers and sponsors must make adequate
provisions for addressing participants’ health needs during research and, if
necessary, for the transition of participants to care when the research is
concluded.
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International Ethical Guidelines

22. Guideline 7: Community Engagement: -
 Researchers, sponsors, health authorities and relevant
institutions should engage potential participants and
communities in a meaningful participatory process that
involves them in an early and sustained manner in the design,
development, implementation, design of the informed consent
process and monitoring of research, and in the dissemination
of its results.
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International Ethical Guidelines

23. Guideline 8: Collaborative Partnership and Capacity-
Building for Research and Research Review
 It is the responsibility of governmental authorities to ensure
that such research is reviewed ethically and scientifically by
competent and independent research ethics committees and is
conducted by competent research teams.
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International Ethical Guidelines

24. Guideline 9: Individuals Capable of giving Informed Consent
Guideline 10: Modifications and Waivers of Informed
Consent: -
• Before a waiver of informed consent is granted, researchers
and research ethics committees should first seek to establish
whether informed consent could be modified in a way that
would preserve the participant’s ability to understand the
general nature of the investigation and to decide whether to
participate.
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International Ethical Guidelines

25. Guideline 11: Collection, Storage and use of Biological
Materials and Related Data
 health or employment records, are collected and stored;
institutions must have a governance system to obtain
authorization for future use of these materials in research.
Guideline 12: Collection, Storage and use of Data in Health-
Related Research: -
 Researchers must not adversely affect the rights and welfare of
individuals from whom the data were collected.
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International Ethical Guidelines

26. Guideline 13: Reimbursement and Compensation for Research Participants: -
 Participants should be reasonably reimbursed for costs directly incurred during the
research, such as travel costs, and compensated reasonably for their inconvenience
and time spent.
Guideline 14: Treatment and Compensation for Research-Related Harms
 Sponsors and researchers must ensure that participants who suffer physical,
psychological or social harm as a result of participating in health-related research
receive free treatment and rehabilitation for such harms, as well as compensation
for lost wages, as appropriate.
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International Ethical Guidelines

27. Guideline 15: Research involving Vulnerable Persons and
Groups: -
Guideline 16: Research involving Adults incapable of giving
Informed Consent: -
Guideline 17: Research involving Children and Adolescents: -
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International Ethical Guidelines

28. • Guideline 18: Women as Research Participants
• Guideline 19: Pregnant and Breastfeeding Women as Research Participants
• Guideline 20: Research in Disasters and Disease Outbreaks
• Guideline 21: Cluster Randomized Trials: - all stakeholders should:
determine who the research participants are and what other individuals or
groups are affected, whether it is required or feasible to obtain informed
consent.
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International Ethical Guidelines

29. Guideline 22: Use of Data Obtained from the Online Environment and Digital Tools in Health-
Related Research
 When researchers use the online environment and digital tools to obtain data for health related
research they should use privacy-protective measures.
Guideline 23: Requirements for Establishing Research Ethics Committees and for their Review
of Protocols: -
 All proposals to conduct health-related research must be submitted to a research ethics committee.
Guideline 24: Public Accountability for Health-Related Research:
 Stakeholders have an obligation to comply with recognized publication ethics for research and its
results.
Guideline 25: Conflicts of Interest
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International Ethical Guidelines

30. National Ethical Guidelines
1. Ethical justification and scientific validity: For research to
be ethical, the methods must be
 valid and practically feasible, clear objective, be designed using
sound scientific principles, have sufficient statistical power, and be
based on adequate knowledge
2. Science and social value: The proposed protocol should
demonstrate valid scientific basis/ground, enhance health or
generalizable knowledge, and benefit individuals and the
community where the research is conducted.
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31. 3. Favourable risk-benefit ratio of research participants and their
communities:
4. Fair selection and enrollment of human subjects: The
justification for selection and the equitable nature of
selection of research subjects should be described.
5. Privacy: Privacy should be respected, confidentiality
maintained,
6. Independent/IRB review: “Individuals that are not
affiliated with the research must review the research and
approve, amend, or terminate the research.”
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National Ethical Guidelines

32. 7. Informed consent process: The information provided to
participants should be complete and appropriate to the
participants’ level of understanding.
8. Community engagement: Research is quite often
generalized to the community from which individual
participants are drawn from.
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National Ethical Guidelines

33. References
1. Lloyd, Geoffrey, ed. (1983). Hippocratic Writings (2nd ed.). London: Penguin Books. pp. 94. ISBN 978-0140444513.
2. Sokol, Daniel K. (2013). "'First do no harm' revisited". BMJ. 347: f6426. doi:10.1136/bmj.f6426. PMID 24163087. S2CID 33952216.
Retrieved 20 September 2014.
3. Lonie, Iain M. (1981). The Hippocratic treatises, "On generation," "On the nature of the child," "Diseases IV" a commentary. Berlin: De
Gruyter. p. 7. ISBN 9783110863963.
4. King, Helen (1998). Hippocrates' woman : reading the female body in ancient Greece. London: Routledge. pp. 132–156. ISBN 978-
0415138956.
5. Markel, Howard (13 May 2004). ""I Swear by Apollo" — On Taking the Hippocratic Oath". New England Journal of Medicine. 350
(20): 2026–2029. doi:10.1056/NEJMp048092. PMID 15141039.
6. https://www.massdevice.com/the-nuremberg-code-and-its-impact-on-clinical-research/
7. WMA - The World Medical Association-WMA Declaration of Lisbon on the Rights of the Patient
8. Wildes, K. (1993). The Priesthood of Bioethics and the Return of Casuistry, Journal of Medicine and Philosophy, 18(1), 33-49.
9. Swanton, C. (2003). Virtue Ethics: A Pluralistic View. Oxford: Oxford University Press.
10. Pellegrino, E. & Thomasma, D. (2003). The Virtues in Medical Practice. Oxford: Oxford University Press.
11. Nussbaum, M. (1990). Aristotelian Social Democracy. In: R.B. Douglas, G. Mara & H. Richardson (Eds.), Liberalism and the Good.
New York: Routledge, 203-252.
12. Noonan, J.T. (1970). An Almost Absolute Value in History. In: J.T. Noonan (Ed.), The Morality of Abortion: Legal and Historical
Perspectives. Cambridge: Harvard University Press, 51-59.
13. Nussbaum, M. (1988). Non-relative Virtues: An Aristotelian Approach, Midwest Studies in Philosophy, 13(1), 32-53.
14. International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International
Organizations of Medical Sciences (CIOMS); 2016.
15. Ethiopian National Ethics Guidelines - National Research Ethics Review Guideline Fifth Edition
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