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Journal of the Anatomical Society of India

Vol. 50, No. 2 (2001-07 - 2001-12)

Editorial

As regular contributors to this esteemed Journal must have observed, after I took over as Editor, the first qualitative change I brought in was to include an undertaking to bind the researchers to conform to Declaration of Helsinki. There is need to reason out why and so I am dealing with it in this editorial.

Research and development form essential ingredients in scientific pursuits and constitute pillars for better edifice to build upon. Researchers need a code of conduct or directive which guides and helps in making research in medical sciences meaningful ethical and at the same reasonably harmless.

WORLD MEDICAL ASSOCIATION brought out DECLARATION OF HELSINKI which provides ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended subsequently in the Years 1975, 1983, 1989, 1996 and latest in October 2000, it throws light on and asks to keep a watch on these aspects.

This in fact is a statement of ethical principles to provide guidance. It is founded upon the Declaration of Geneva of the World Medical Association which binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics which declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 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. It is sought that 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. 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.

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 design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.

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. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

So it is expected that all the members and contributors to the journal meticulously follow the guidelines. This is precisely the reason why a special advisory board was constituted and maintained to keep an eagles eyes on medical ethics, animal experimentations and biostatistics in line with Index Medicus recommendations also. Let us respect these guidelines verbatim i.e. in word and spirit.

Dr. Patnaik V.V. Gopichand- Editor J.A.S.I

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