The Declaration of Helsinki outlines ethical principles for medical research involving human subjects, emphasizing the importance of informed consent, risk-benefit analysis, and the protection of vulnerable groups. It has undergone multiple amendments since its initial adoption in 1964, reflecting evolving ethical standards in clinical research. Researchers are required to adhere to these principles and local regulations when conducting studies involving human participants.

1. Welcome
DECLARATION OF HELSINKI
Dr. NOOR US SABAH
PHARM- D
CSRPL_INT_OFL_WKD_175/1022
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2. INDEX
• Introduction
• History
• Amendment
• Principles
• Conclusion
• Resourses
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3. INTRODUCTION
HISTORY
• Evolved due to the Thalidomide Tragedy.
• First Approved By 18th Assembly Of WMA (World Medical
Association) in Finland 1994 .
• Adopted By GCP/ICH.
• Mission of Clinical Research Professionals to safeguard the
health of people.
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DECLARATION OF HELSINKI
Ethical principle
Medical
Research
Human Subject

4. AMENDMENTS
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Adopted by the 18th WMA General Assembly, Helsinki, Finland, June
1964
Amended by the:
✔ 29th WMA General Assembly, Tokyo, Japan, October 1975
✔ 35th WMA General Assembly, Venice, Italy, October 1983
✔ 41st WMA General Assembly, Hong Kong, September 1989
✔ 48th WMA General Assembly, Somerset West, Republic of South Africa,
October 1996
✔ 52nd WMA General Assembly, Edinburgh, Scotland, October 200053rd WMA
General Assembly, Washington DC, USA, October 2002
(Note of Clarification added)
✔ 55th WMA General Assembly, Tokyo, Japan, October 2004
(Note of Clarification added)
✔ 59th WMA General Assembly, Seoul, Republic of Korea, October 2008
✔ 64th WMA General Assembly, Fortaleza, Brazil, October 2013
This Version Is
The Only Official
One

5. GENERAL PRINCIPLES
1 RISK AND BURDENS AND BENEFITS.
A trial should be initiated and continue only if the anticipated Benefit justify the
Risks.
2. VALNERABLE GROUPS AND INDIVIDUALS.
3. SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOL.
Based on scientific evidence the Research Protocol is developed and should
approved by designated ethics committee.
4. PRIVACY AND CONFIDENTIALITY.
During the course of trial, every precaution must be taken to protect the privacy
of Research Subject and the confidentiality of their personal information.
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The Right and Safety and Well-
being of trial subjects are the most
important considerations
Which should
prevail over interest
of science and society

6. Cont…
5. INFORMED CONSENT.
Obtaining informed consent is very important.
6. RESEARCH ETHICS COMMITTEE (REC).
REC should be unbiased.
It has the right
✔ To review the protocol
✔ To monitor the progress of research
✔ To modify the protocol if necessary
✔ To investigate any serious adverse events
On completion of study the final report must be submitted to
the REC.
7. POST TRIAL PROVISION
Subjects participating the trials must have provisions made
by the trial sponsor for post trial access for treatment that
have shown benefits during the study.
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Valid informed
consent for
research must
include
Voluntary
participation
. description
of clinical
investigati
on
Risk and
discomfort
Benefits
Alternativ
e
procedure
or
treatment
Confidenti
ality
Post trial
provisions
Contacts

7. 8. USE OF PLACEBO.
9. RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS.
All research projects must be registered in the publicly accessible database. On completion of the study, the results
must be published for dissemination of the new knowledge. Negative, positive or inconclusive results must be
published. Any report not in concordance with the Declaration of Helsinki should not be accepted for publication.
10. UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE
Application of unproven interventions in clinical practice, when a proven intervention exists in the
treatment of an individual patient, the physician, after seeking expert advice, with informed consent of the
patient or legally authorised representative, may use the unproven intervention for the benefit of the patient.
However, this intervention should be made aware to the participant and the recorded new information should be
made publicly available.
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In this use of Placebo is permitted
While testing the risk/ benefits/ burden and
effectiveness of new intervention
Only when if no proven intervention is exists to
compare with new intervention
Cont…

8. CONCLUSION
It is mandatory that the researchers, who undertake studies involving human subjects, tissues, or
medical records, should be intimately familiar with the contents of the Declaration of Helsinki, as
well as their local and national research standards and regulations.
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9. Thank You!
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