Declaration of helsinki powerpoint presentation

Declaration of helsinki powerpoint presentation

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  DECLARATION OF HELSINKI PRESENTEDBY : POOJA GUPTA GOURAV SINGH LODHI M. PHARM.-3RD SEM DEPARTMENT OF PHARMACY B.U. ,BHOPAL
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  CONTENTS  HISTORY  INTRODUCTION BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH  ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE
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  HISTORY  Adopted bythe 18th WMA General Assembly, Helsinki, Finland, June 1964. The first international set of guidelines for human experimentation, the Declaration reflected the longstanding interest of the World Medical Association (WMA) in issues of medical ethics and the enduring shadow of the Nazi medical war crimes.  It has undergone 6 revisions & 2 clarifications.  Prior to Nuremberg code only specific countries had National policies (for example – Germany ).
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  Brief History ofthe Declaration of Helsinki  First adopted in 1964  Significant additions in 1975  Minor amendments in 1983, 1989 & 1996  Major revision and reorganization in 2000  Notes of clarification in 2002 and 2004  Latest revision begun in 2007 and completed in October 2008
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  INTRODUCTION In 1964, theWorld Medical Association wrote the Declaration of Helsinki. There were a set of ethical recommendation for human experimentation, and become the foundation of human research ethics. The main points set out in this Declaration were that animal experiments should come before any animals are experimented on, there should always be a review by an independent committee before the experiment, informed consent is always necessary, only qualified people should carry out experiments, and that the benefits of the research should outweigh the risks. Since 1964, it has been revised six times but still remains largely the same. to be continue
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  The rules setout in the Declaration were very influential in creating the five general ethical principles, which are as follows: 1. Beneficence and Non-maleficence 2. Fidelity and Responsibility 3. Integrity 4. Justice 5. Respect for Peoples rights and dignity
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  BASIC PRINCIPLES FORALL MEDICAL RESEARCH  The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.  Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.
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   The Declarationof Helsinki 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.”  The Declaration of Helsinki is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.  In Declaration of Helsinki , Medical progress is based on research that ultimately must include studies involving human subjects.  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). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
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   Medical researchis subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.  While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.  It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.  Medical research should be conducted in a manner that minimises possible harm to the environment.
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  ADDITIONAL PRINCIPLES FORMEDICAL 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 and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.  The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: • The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or • Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option
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   At theconclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.  The physician must fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never interfere with the patient-physician relationship.  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 from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available
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  THANK YOU