Declaration of Helsinki P chirag

Seminar on Declaration of Helsinki :

Seminar on Declaration of Helsinki Guided by: Mrs. Hetal D. Solanki Assistant Professor M. Ph. Dept. of Pharmacology Prepared by: Chirag J. Solanki M.Ph . (QA Dept.) Roll N`o : 11 cs_apc_09@yahoo.in Dharmaj Degree Pharmacy College

What is Declaration of Helsinki?:

What is Declaration of Helsinki? Ethical Principles for Medical Research Involving Human Subjects D eveloped by the World Medical association (WMA), as a set of ethical principles for the medical community regarding human experimentation, and is widely regarded as the cornerstone document of human research ethics The declaration of Geneva of the World Medical Association binds the doctor with the words “ The health of my patient will be my first consideration ” International Code of Medical Ethics declares that “ Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest ”.

History:

History The Declaration was originally adopted in June 1964 in Helsinki, Finland and has since undergone six revisions . Prior to the 1947 Nuremberg code Declaration of Geneva (1948), a statement of physician's ethical duties.

Revisions Of Helsinki Declaration:

Revisions O f H elsinki D eclaration 18th WMA General Assembly, Helsinki, Finland, June 1964 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 2000 53rd 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

Basic principles :

Basic principles Confirm to the moral and scientific principles. B ased on laboratory and animal experiments. Conducted only by scientifically qualified persons. O bjective Vs. I nherent risk Special caution should be exercised by the doctor.

Declaration of Helsinki Oct. 08:

Declaration of Helsinki Oct. 08

INTRODUCTION   :

INTRODUCTION Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects and intended to be read as a whole. T he Declaration is addressed primarily to physicians . It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research The Declaration of 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 .”

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Continue… Populations that are under represented in medical research should be provided appropriate access to participation in research. T he well-being of the individual research subject must take precedence over all other interests. 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). In medical practice and in medical research, most interventions involve risks and burdens.

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Continue… Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Physicians should consider the ethical, legal and regulatory norms and standards.

PRINCIPLES FOR ALL MEDICAL RESEARCH :

PRINCIPLES FOR ALL MEDICAL RESEARCH It is the duty of physicians to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. Study must confirm to the generally accepted scientific principles and based on adequate laboratory and animal experimentation. Appropriate caution must be exercised in the conduct of medical research that may harm the environment. The design and performance of each research study involving human subjects must be clearly described in a research protocol.

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Continue… The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. It must be conducted only by individuals with the appropriate scientific training and qualifications. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs .

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Continue… Study must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Study may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects.

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Continue… Participation by competent individuals as subjects in medical research must be voluntary. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity. Each potential subject must be adequately informed . Researcher must seek consent for the collection, analysis, storage and/or reuse.

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Continue… If the potential subject is in a dependent relationship with the physician or may consent under duress. For a potential research subject who is incompetent, physician must seek informed consent. When incompetent subject is able to give assent to decisions about participation in research, the physician must seek that assent . Research involving subjects who are physically or mentally incapable of giving consent. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research.

ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE   :

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. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention. At the conclusion of the study, patients entered into the study are entitled to be informed.

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Continue… The physician must fully inform the patient which aspects of the care are related to the research. 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, may use an unproven intervention. if in the physician's judgments it offers hope of saving life.

References::

References: http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=* http ://en.wikipedia.org/wiki/Declaration_of_Helsinki http ://www.cirp.org/library/ethics/helsinki/ http ://www.wma.net/en/20activities/10ethics/10helsinki/index.html http ://www.wma.net/en/30publications/10policies/b3/index.html

THANK YOU:

THANK YOU