The Helsinki Declaration is a foundational document outlining ethical principles for human experimentation in biomedical research, established by the World Medical Association in June 1964. It emphasizes informed consent, the well-being of participants, and the importance of ethical oversight in both clinical and non-clinical research. The declaration has undergone several revisions to address ongoing ethical concerns and ensure the protection of human subjects.

1. HELSINKI DECLARATION
By:
Radhika Chintamani

2. CONTENTS
I. INTRODUCTION
II. HISTORY
III. GENERAL STATEMENT
IV. PRINCIPLES
V. CLINICAL RESEARCH
VI. NON CLINICAL RESEARCH
VII. REFERENCES

3. INTRODUCTION
 Helsinki declaration is 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.
 The Declaration was originally adopted on June 1964 in
Helsinki, Finland.

4.  The purpose of biomedical research involving human subjects
must improve - diagnostic
- therapeutic
- prophylactic procedures.
helps to understand the etiology and pathogenesis of the disease.

5.  Declaration Of Geneva Of The World Medical Assembly
binds the physician with the words: “The health of my patient
will be my first consideration”.
 International Code Of Medical Ethics Declares “ A
physician shall act only in the patient’s interest when providing
medical care which might have the effect of weakening the
physical and mental condition of the patient”.

6. HISTORY
 Originally adopted on June 1964 in Helsinki, Finland.
 Undergone 7 revisions and 2 clarifications.
 1947 deceleration of the Nuremberg Code.
 1948 deceleration of Geneva

7.  First Revision (1975): -Twice length of original
-Concerns interest of subject.
-Independent committee concept.
-Institutional Review Board (1981)
-Informed consent
 Second to Fourth Revision(1975-2000)
second revision 1983
third revision 1989
 Fifth revision 2000
 Sixth revision 2008
 Seventh revision 2013

8. Nuremberg Code
 Voluntary, well-informed, understanding consent of the human
subject in a full legal capacity.
 Aims - positive results for society.
 Based on previous knowledge
 Set up in a way that avoids unnecessary physical and mental
suffering and injuries.
 Not to be conducted if it implies a risk of death or disabling
injury.

9.  The risks of the experiment should be in proportion
 Preparations and facilities must be provided adequately -
protect the subjects against the experiment’s risks.
 The staff who conducts the experiment must be fully trained
and scientifically qualified.
 The human subjects must be free to immediately quit the
experiment at any point
 Medical staff must stop the experiment at any point when they
observe that continuation would be dangerous.

10. GENERAL STATEMENT
 Purpose – directed towards the increase of knowledge about the
human condition in relation to its social and natural environment.
Research is for the betterment of all.
Conducted - dignity and well being.
professional fair treatment and transparency
no greater risk.

11.  Evaluation – all stages of proposal
(research design , experimentation, deceleration
of results, use of results)
- benefits and dangers.

12. PRINCIPLES
I. Principles of Essentiality
II. Principles of voluntariness , informed consent and
community agreement.
III. Principles of non-exploitation
IV. Principles of privacy and confidentiality
V. Principles of precautions and risk minimization

13. VI. Principles of professional competence
VII. Principles of accountability and transparency
VIII. Principles of the maximization of the public interest and
of distributive justice.
IX. Principles of institutional arrangement.
X. Principles of public domain
XI. Principles of totality of responsibility
XII. Principles of compliance.

14. CLINICAL RESEARCH
 New diagnostic and therapeutic tool should be used by
the physician to treat the sick people so that it offers
hope for saving.
 Benefits , hazards and discomfort of the method used
should be weighted.
 Any medical treatment, the patient should be assured of
the best proven diagnostic and therapeutic treatment.

15.  Refusal of the participant in the study must never interfere with
physician-patient relationship.
 If the physician considers its not essential to obtain informed
consent, the specific reasons for this proposal should be stated
in the experimental protocol for transmission to independent
committee.
 Physician can combine medical research with professional care
the objective being the acquisition of new medical knowledge.

16. NON CLINICAL RESEARCH
 Purely scientific application. Protect the health of the
person on whom biomedical research is being carried
out.
 Subject should be volunteers.
 The investigator should discontinue the research if it is
harmful.

17. REFERENCES
1. Kavitha Raja, Fiddy Davis, Sivakumar. Ethical issues.
Perspective for the Physiotherapist.
2. Indian council of medical research.
3. Delon Human and Sev S. Fluss. “The World Medical
Association’s Declaration Of Helsinki: Historical And
Contemporary Perspectives”

18. SUMMARY
 Helsinki declaration is a set of ethical principles
regarding human experimentation developed for the
medical community by the WMA .
 Originally adopted on June 1964 in Helsinki, Finland.
 Nuremberg Code - Aims - positive results for society.
 Principles.