THE DECLARATION OF HELSINKI

Presented byPresented by :- :-

(Group 7)(Group 7)

SHARON PINTOSHARON PINTO

PRIYANKA KARPRIYANKA KAR

SHIV KARAN SINGHSHIV KARAN SINGH

SHRIJIT PILLAISHRIJIT PILLAI

(MSC-CRM PRIST UNIVERSITY)(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.A’s 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 HELSINKIEthical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and 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

53th WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly, Seoul, October 2008

Seven Ethical Pillars of Clinical Research AUTONOMY

BENEFICENCE

NON – MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of HelsinkiAutonomy

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 HelsinkiBeneficence

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 HelsinkiNon 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 HelsinkiFidelity – 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 HelsinkiTruthfulness - 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 HelsinkiConfidentiality 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 HelsinkiJustice 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 HelsinkiJusticePara 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 physician’s 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 subject’s 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