The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.

1. DECLARATION OF HELSINKI
PRESENTED BY :
POOJA GUPTA
GOURAV SINGH LODHI
M. PHARM.-3RD SEM
DEPARTMENT OF PHARMACY B.U. ,BHOPAL

2. CONTENTS
 HISTORY
 INTRODUCTION
 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
 ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
MEDICAL CARE

3. HISTORY
 Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.
The first international set of guidelines for human experimentation, the
Declaration reflected the longstanding interest of the World Medical
Association (WMA) in issues of medical ethics and the enduring shadow of the
Nazi medical war crimes.
 It has undergone 6 revisions & 2 clarifications.
 Prior to Nuremberg code only specific countries had National policies (for
example – Germany ).

4. Brief History of the Declaration of Helsinki
 First adopted in 1964
 Significant additions in 1975
 Minor amendments in 1983, 1989 & 1996
 Major revision and reorganization in 2000
 Notes of clarification in 2002 and 2004
 Latest revision begun in 2007 and completed in October 2008

5. INTRODUCTION
In 1964, the World Medical Association wrote the Declaration of Helsinki. There
were a set of ethical recommendation for human experimentation, and become the
foundation of human research ethics. The main points set out in this Declaration
were that animal experiments should come before any animals are experimented
on, there should always be a review by an independent committee before the
experiment, informed consent is always necessary, only qualified people should
carry out experiments, and that the benefits of the research should outweigh the
risks. Since 1964, it has been revised six times but still remains largely the same.
to be continue

6. The rules set out in the Declaration were very influential in creating the five general ethical
principles, which are as follows:
1. Beneficence and Non-maleficence
2. Fidelity and Responsibility
3. Integrity
4. Justice
5. Respect for Peoples rights and dignity

7. BASIC PRINCIPLES FOR ALL MEDICAL
RESEARCH
 The World Medical Association (WMA) has developed the Declaration of Helsinki as a
statement of ethical principles for medical research involving human subjects, including
research on identifiable human material and data. The Declaration is intended to be read
as a whole and each of its constituent paragraphs should be applied with consideration
of all other relevant paragraphs.
 Consistent with the mandate of the WMA, the Declaration is addressed primarily to
physicians. The WMA encourages others who are involved in medical research
involving human subjects to adopt these principles.

8.  The Declaration of Helsinki Geneva of the WMA binds the physician with the words,
“The health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act in the patient's best interest when
providing medical care.”
 The Declaration of Helsinki is the duty of the physician to promote and safeguard the
health, well-being and rights of patients, including those who are involved in medical
research. The physician's knowledge and conscience are dedicated to the fulfilment of this
duty.
 In Declaration of Helsinki , Medical progress is based on research that ultimately must
include studies involving human subjects.
 The primary purpose of medical research involving human subjects is to understand the
causes, development and effects of diseases and improve preventive, diagnostic and
therapeutic interventions (methods, procedures and treatments). Even the best proven
interventions must be evaluated continually through research for their safety, effectiveness,
efficiency, accessibility and quality.

9.  Medical research is subject to ethical standards that promote and ensure respect for all human
subjects and protect their health and rights.
 While the primary purpose of medical research is to generate new knowledge, this goal can never
take precedence over the rights and interests of individual research subjects.
 It is the duty of physicians who are involved in medical research to protect the life, health, dignity,
integrity, right to self-determination, privacy, and confidentiality of personal information of
research subjects. The responsibility for the protection of research subjects must always rest with
the physician or other health care professionals and never with the research subjects, even though
they have given consent.
 Medical research should be conducted in a manner that minimises possible harm to the
environment.

10. 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 preventive, diagnostic or therapeutic value and if
the physician has good reason to believe that participation in the research study will not
adversely affect the health of the patients who serve as research subjects.
 The benefits, risks, burdens and effectiveness of a new intervention must be tested
against those of the best current proven intervention, except in the following
circumstances: • The use of placebo, or no treatment, is acceptable in studies where no
current proven intervention exists; or • Where for compelling and scientifically sound
methodological reasons the use of placebo is necessary to determine the efficacy or
safety of an intervention and the patients who receive placebo or no treatment will not
be subject to any risk of serious or irreversible harm. Extreme care must be taken to
avoid abuse of this option

11.  At the conclusion of the study, patients entered into the study are entitled to be informed
about the outcome of the study and to share any benefits that result from it, for example,
access to interventions identified as beneficial in the study or to other appropriate care or
benefits.
 The physician must fully inform the patient which aspects of the care are related to the
research. The refusal of a patient to participate in a study or the patient’s decision to withdraw
from the study must never interfere with the patient-physician relationship.
 In the treatment of a patient, where proven interventions do not exist or have been ineffective,
the physician, after seeking expert advice, with informed consent from the patient or a legally
authorized representative, may use an unproven intervention if in the physician's judgement it
offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this
intervention should be made the object of research, designed to evaluate its safety and
efficacy. In all cases, new information should be recorded and, where appropriate, made
publicly available

12. THANK YOU