THE DECLARATION OF HELSINKI

Presented by :-
(Group 7)
SHARON PINTO
PRIYANKA KAR
SHIV KARAN SINGH
SHRIJIT PILLAI
(MSC-CRM PRIST UNIVERSITY)
Introduction:-
Is an international standard for the conduct of clinical
research adopted by International Conference on
Harmonization(ICH) Good Clinical Practice standards.

A global ethical standard for medical research and was

approved at the WMA General Assembly by a majority vote
of 75%.

It is the mission of the clinical research professionals

to safeguard the health of the people.
Historical Overview:-
Its origin has been found in the Nazi Disaster and has
undergone several modifications.

Prior to 1947 Nuremberg Code, there was no accepted

code of conduct governing the ethical aspects of human
research.

The Declaration more specifically addressed clinical

research, reflecting changes in medical practice from the
term 'Human Experimentation' used in the Nuremberg
Code
Codes and Guidelines
Nuremberg Code (1947).

W.M.As Declaration of Helsinki (1964).

Belmont Report (USA) (1979).

Council for International Organizations of Medical Sciences (CIOMS)

1993.

International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use
(ICH), in 1996, Guideline on Good Clinical Practice,E6 (GCP).
 Nuremberg Code (1947)
Voluntary and Informed consent.
Anticipate scientific benefits, Useful.
Animal experimentation first.
Avoid physical and mental suffering.
Benefits outweigh risks.
No intentional death or disability.
Protection from harm.
Subject free to withdraw.
Qualified investigators.
Investigator will stop if harm occurs.
1979 Belmont Report
Three ethical principles related to research on human subjects:

1.Respect for Persons

2. Beneficence

3. Justice
World Medical
Association
It is an international organization of physicians was first
established on September 17,1947.
First general Assembly of WMA was held in Paris, France.
Mission:- Serve humanity by endeavoring to achieve the
highest international standards in medical education, science,
ethics and health care for all peoples of the world.
Presidency:-
Dr. Patrisha Zobel de Ayala 2010-2011.
 Declaration of Helsinki 1964

Adapted from
Nuremberg Code by the
World Medical
Association(WMA).

First adopted in Helsinki,

Finland.
Declaration of Helsinki 1964
World Medical Association declaration of
Helsinki-2008
(Ethical principles for Medical Research Involving Human subjects)

Introduction (Para 01-10)

Principles For All Medical Research. (Para 11-30)
Additional Principles For Medical Research Combined With

Medical Care. (Para 31-35)

WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKI
Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA 53th WMA General Assembly,

General Assembly, Helsinki, Washington 2002 (Note of
Finland, June 1964, and Clarification on paragraph 29
amended by the: added)

29th WMA General Assembly, 55th WMA General Assembly,

Tokyo, Japan, October 1975 Tokyo 2004 (Note of
Clarification on Paragraph 30
added)
35th WMA General Assembly,
Venice, Italy, October 1983
59th WMA General Assembly,
Seoul, October 2008
41st WMA General Assembly,
Hong Kong, September 1989
Seven Ethical Pillars of Clinical
Research
TRUTHFULNESS
AUTONOMY

BENEFICENCE
CONFIDENTIALITY

NON MALFEASANCE JUSTICE

FIDELITY
Declaration of Helsinki
Autonomy
Consent
Para 20 The subjects must be volunteers and
informed participants in the research project.

Para 22 After ensuring that the subject has

understood the information, the physician should
then obtain the subject's freely-given informed
consent, preferably in writing .
Declaration of Helsinki
Beneficence
Para 5 In medical research on human subjects,
considerations related to the well-being of the
human subject should take precedence over
the interests of science and society.
Para 18 Medical research involving human
subjects should only be conducted if the
importance of the objective outweighs the
inherent risks and burdens to the subject.
Declaration of Helsinki
Non Malfeasance
Para 16
Every medical research project involving
human subjects should be preceded by
careful assessment of predictable risks
and burdens in comparison with
foreseeable benefits to the subject or to
others.
Declaration of Helsinki
Fidelity duty of care
Para 11
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.
Para 15
Medical research involving human subjects should be conducted only
by scientifically qualified persons and under the supervision of a
clinically competent medical person.
The responsibility for the human subject must always rest with a
medically qualified person and never rest on the subject of the
research, even though the subject has given consent.
Declaration of Helsinki
Truthfulness - Honesty
Para 27
Both authors and publishers have ethical
obligations. In publication of the results of
research, the investigators are obliged to
preserve the accuracy of the results.
Negative as well as positive results should
be published or otherwise publicly available.
Declaration of Helsinki
Confidentiality
Para 21
Every precaution should be taken to
respect the privacy of the subject, the
confidentiality of the patient's information
and to minimize the impact of the study on
the subject's physical and mental integrity
and on the personality of the subject.
Declaration of Helsinki
Justice
Para 30
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 study.

Para 8
Medical research is subject to ethical standards that promote respect for all
human beings and protect their health and rights.

Some research populations are vulnerable and need special protection. The
particular needs of the economically and medically disadvantaged must be
recognized.
Declaration of Helsinki
Justice
Para 9
Research Investigators should be aware of the
ethical, legal and regulatory requirements for
research on human subjects in their own
countries as well as applicable international
requirements. No national ethical, legal or
regulatory requirement should be allowed to
reduce or eliminate any of the protections for
human subjects set forth in this Declaration.
Declaration of Helsinki

Para 29
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.
Duties of the Physician Researcher
Para 2
It is the duty of the physician to promote and safeguard
the health of the people. The physicians knowledge and
conscience are dedicated to the fulfillment of this duty.

Para 10
It is the duty of the physician in medical research to
protect the life, health, privacy and dignity of the
human subject.
The Ethical Responsibility of the
Physician Researcher
Para 15
The responsibility for the human subject must always rest with
a medically qualified person and never rest on the subject
of the research, even though the subject has given consent.

Medical Research involving human subjects should be

conducted only by scientifically qualified person and under
the supervision of a clinically competent medical person.
Declaration of Helsinki
Para 17
Physicians should abstain from engaging in research
projects involving human subjects unless they are
confident that the risks involved have been adequately
assessed and can be satisfactorily managed.

Physicians should cease any investigation if the risks are

found to outweigh the potential benefits or if there is
conclusive proof of positive and beneficial results.
 Declaration of Helsinki
Para 22
after ensuring that the subjects has
understood the information, the physician
should then obtain the subjects freely-
given informed consent, preferably in
writing.
Declaration of Helsinki 2008
Revision
Integration of notes of clarification in the text:
Many editorial and terminology changes.
Some reorganization of paragraphs.
Addition of requirement to include clinical trials in a publicly
accessible database (Para19).

Changes made
Para's 22-29: Additional requirements for informed consent.
Para 25: Different requirements for research on human material and
data.
Para 16: Acknowledgement of other healthcare professionals in
supervising medical research.
DECLARATION OF HELSINKI :-
Basic Principles
1. Conform to accepted scientific principles.
2. Design formulated in experimental protocol, reviewed by IEC.
3. Conducted by qualified and trained persons.
4. Importance in proportion to inherent risk.
5. Assessment of risks vs. benefits.
6. Safeguard subjects integrity (privacy).
7. Abstain unless hazards are predictable.
8. Preserve accuracy when publishing.
9. Adequately inform or right to withdraw.
10. Obtain true informed consent in writing.
11. Reliance on legal guardian.
12. State compliance with Declaration.
References
Principles of Clinical Research
By Gareth Hayes and Ignazio Di Giovanna

Federal Register / Vol. 73, No. 82 / Monday, April 28,

2008 / Rules and Regulations, 22800-16.

http://www.wma.net/e/policy/b3.htm

www.hhs.gov/ohrp/references/nurcode.html