The Declaration of Helsinki is a beacon that illuminates the path to ethical and responsible medical research. It reminds us that while scientific progress is vital, it should never come at the expense of human dignity and ethical principles. This enduring declaration continues to guide the ethical conduct of research, reflecting the shared commitment to responsible research and the highest ethical standards. #DeclarationOfHelsinki #ResearchEthics #MedicalEthics #HumanResearch

1. Welcome
DECLARATION OF HELSINKI
AFSANA
B. PHARMACY
183/092023
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2. Index
CONTENTS
1. Introduction: History & Scope.
2. Development of Declaration of Helsinki.
3. Basic Principles of for all Medical Research.
4. Additional Principles for Medical Research combined
with Medical Care.
5. Conclusion.
6. References.
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3. Declaration of Helsinki
History of DoH
• Adopted in June 1964.
• Has undergone 6 revisions.
• 2 clarifications.
• First significant effort by medical community to regulate
research.
• Prior to Nuremberg Code only specific countries had
National policies (Germany for Example).
• Forms basis of most subsequent documents.
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4. Declaration of Helsinki
Scope of DoH
• Developed 10 principles first stated in Nuremberg Code.
• Linked to Declaration of Geneva (1948)
• Statement of physicians ethical duties.
• DoH specifically addressed clinical research.
• Relaxed need for IC which Nuremberg code deemed ‘
absolutely essential’.
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5. Declaration of Helsinki
• NEWRESEARCH TOPICS
• The progress of science and technology has led to
continued development of ethical principles and
guidelines as a variety of different new research topics
continues to expand, for example, Assisted reproduction,
Stem-cell research, Prenatal diagnostics.
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6. Declaration of Helsinki
Development of Declaration of Helsinki.
• First Revision 1975.
• Second Revision 1983.
• Third Revision 1989.
• Fourth Revision 1996.
• Fifth Revision 2000.
• Clarifications of Articles 29 & 30 2002 & 2004.
• Sixth Revision 2008
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7. Declaration of Helsinki
What is Declaration of Helsinki (DoH)?
• A set of ethical principles regarding human
experimentation
developed for the medical community by the World Medical
Association (WMA).
• It is widely regarded as the cornerstone document on
human research ethics.
• Followed Nuremberg Code (1947).
• Brazilian forum in 2000 describes- "Even though the
Declaration of Helsinki is the responsibility of the World
Medical Association, the document should be considered
the property of all humanity".
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8. Declaration of Helsinki
• BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
• It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the
human subject.
• Medical research involving human subjects must conform to generally accepted scientific principles, be
based on a thorough knowledge of the scientific literature, other relevant sources of information, and on
adequate laboratory and, where appropriate, animal experimentation.
• Appropriate caution must be exercised in the conduct of research which may affect the environment,
and the welfare of animals used for research must be respected.
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9. Declaration of Helsinki
• ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH
COMBINED WITH MEDICAL CARE
•
• The physician may combine medical research with medical
care, only to the extent that the research is justified by its
potential prophylactic, diagnostic or therapeutic value. When
medical research is combined with medical care, additional
standards apply to protect the patients who are research
subjects.
• The benefits, risks, burdens and effectiveness of a new
method should be tested against those of the best current
prophylactic, diagnostic, and therapeutic methods. This does
not exclude the use of placebo, or no treatment, in studies
where no proven prophylactic, diagnostic or therapeutic
method exists.
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10. Declaration of Helsinki
• THE NUREMBERG CODE
• Informed consent is absolutely essential.
• Qualified researchers must use appropriate research
designs.
• There must be a favorable risk/ benefit ratio.
Participants must be free to stop at any time.
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11. Declaration of Helsinki
• SIGNIFICANCE
• The nuremberg code has not been officially accepted as law by
any nation or as official ethics guidelines by any association. In fact,
the code's reference to hippocratic duty to the individual patient and
the need to provide information was not initially favored by the
american medical association.
The western world initially dismissed the nuremberg code as a
"code for barbarians" and not for civilized physicians and
investigators.
• However, the code is considered to be the most important
document in the history of clinical research ethics, which had a
massive influence on global human rights. The Nuremberg code
and the related declaration of Helsinki are the basis for the code of
federal regulations.
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12. Declaration of Helsinki
• Conclusion Is the DoH still relevant for the ethical conduct
of clinical Trials?
• YES.
• Remains morally binding for physicians over and above
national/local laws and/or regulations.
• Less influenced by interested parties than ICH GCP guidelines.
• Provides basis for conduct of CTs and has a focus on protection of
subjects/participants.
• “In medical research involving human subjects, the well
being of the individual research subject must take precedence over
all other interests”. • Upholds Kantian respect for persons and view
that individuals should not be treated simply as a means to an end
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13. Declaration of Helsinki
• REFERENCE
• 1. WMA - Declaration of Helsinki – 2000 version
(including notes of clarification 2002 & 2004).
• 2. Human D, Fluss S (July 2001) “The world medical
association’s declaration of Helsinki: Historical and
contemporary perspectives.
• 3. The social medicine portal (1st June 2008) “FDA
abandons declaration of Helsinki for international clinical
trial.
• 4. World Medical Association (2013). "Declaration of
Helsinki: Ethical Principles for Medical Research
Involving Human Subjects".
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14. Thank You!
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