DECLEARATION OF HELSINKI
MISS. JOSHI U.L.
M.PHARM, SEM- III
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vilad Ghat, Ahmednagar
BASIC PRINCIPLES OF ALL MEDICAL RESEARCH
ADDITIONAL PRINCIPLES FOR ALL MEDICAL
RESEARCH COMBINED WITH MEDICAL CARE
Adopted in June 1964.
Has undergone 6 revisions2 clarifications.
First significant effort by medical community to regulate
Prior to Nuremberg Code only specific countries had National
policies (for example - Germany).
Forms basis of most subsequent documents.
WHAT IS DECLARATION OF HELSINKI?
Set of ethical principles.
Developed by WMA for medical community–human
Followed nuremberg code (1947).
Regarded as cornerstone document of Human research ethics.
Included within clinical trial protocols.
DECLARATION OF HELSINKI
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
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
Conform to accepted scientific principles.
Design formulated in experimental protocol, reviewed by
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.
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
ETHICAL PRINCIPLES OF RESEARCH
Hippocrates was the first physician to define the ethical
principles of research in humans. These principles are still
Autonomy – To respect the autonomy of the participant or of
Beneficence – To act always in the best interest of the
Non-maleficence – To do as little harm as possible to the
Justice – To act fairly to all.
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,
BASIC PRINCIPLES FOR ALL
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,
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
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.
At the conclusion of the study, every patient entered into the
study should be assured of access to the best proven
prophylactic, diagnostic and therapeutic methods identified by
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–
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.
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
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
3. The social medicine portal (1st June 2008) “FDA abandons
declaration of Helsinki for international clinical trials”.