Dec Le Ration

INSTITUTE OF PHARMA SCIENCE
CHANDIGARH UNIVERSITY
PRESENTATION ON
DECLARATION OF HELSINKI
SUBMITTED BY SUBMITTED TO
DEEPANSHU RAJPUT Mr. KUNDAN BORA
23MPC10008 ASSISSTANT PROFESSOR
M.PHARM (Chemistry)
Introduction
Declaration of HELSINKI
• Set of ethical principles.
• Developed by WMA for medical community–human
experimentation.
• Followed nuremberg code (1947).
• Regarded as cornerstone document of Human
research ethics.
• Included within clinical trial protocols.
• In 1961, public opinion around the world was shocked
by the thalidomide scandal. 2,000 children died and
10,000 children were seriously disabled.
• Government authorities were then required to take
action and make regulatory arrangements to oversee
the testing of new medicines.
• In 1964, the world medical association (WMA) developed
and indeed continues to review and adapt the
declaration of helsinki as a guide for performing research
in human beings.
BASIC PRINCIPLES
• Conform to accepted scientific principles.
• Design formulated in experimental protocol, reviewed
by IEC.
• Conducted by qualified and trained persons.
• Importance in proportion to inherent risk.
• Assessment of risks vs. Benefits.
• Safeguard subject’s integrity (privacy)
• Abstain unless hazards are predictable.
• Preserve accuracy when publishing.
• Adequately inform or right to withdraw.
• Obtain true informed consent in writing.
• Reliance on legal guardian.
• State compliance with declaration.
Scope
• 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.
ETHICAL PRINCIPLES Of
RESEARCH
• Hippocrates was the first physician to define the ethical
principles of research in humans. These principles are
still valid today:
• Autonomy – To respect the autonomy of the participant
or of their representative;
• Beneficence – To act always in the best interest of the
participant;
• Non-maleficence – To do as little harm as possible to
the participant;
NEW RESEARCH 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.
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.
• The research protocol should always contain a statement of the ethical
considerations involved and should indicate that there is compliance with
the principles enunciated in this declaration.
• Medical research involving human subjects should only be conducted if
the importance of the objective outweighs the inherent risks and burdens
to the subject. This is especially important when the human subjects are
healthy volunteers.
• Medical research is only justified if there is a reasonable likelihood that
the populations in which the research is carried out stand to benefit from
the results of the research.
• When a subject deemed legally incompetent, such as a minor child, is
able to give assent to decisions about participation in research, the
investigator must obtain that assent in addition to the consent of the
legally authorized representative.
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.
Conclusion
• Every patient entered into the study should be assured
of access to the best proven prophylactic, diagnostic and
therapeutic methods identified by the study.
• The physician should fully inform the patient which
aspects of the care are related to the research. The
refusal of a patient to participate in a study must never
interfere with the patient– physician relationship
THANK
YOU

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INSTITUTE OF PHARMA SCIENCE

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