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declaration of helsinki ppt

history,introduction,nuremberg code,basic principal of all medical reserch

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declaration of helsinki ppt

  1. 1. DECLEARATION OF HELSINKI PRESENTED BY MISS. JOSHI U.L. M.PHARM, SEM- III (PHARMACOLOGY) ROLL NO.08 1 GUIDED BY Prof. J.B.wadekar M pharm (Pharmacognocy) Dr. Vithalrao Vikhe Patil Foundation’s College of Pharmacy Vilad Ghat, Ahmednagar 2019-2020
  2. 2. CONTENTS HISTORY INTRODUCTION NUREMBERG CODE BASIC PRINCIPLES OF ALL MEDICAL RESEARCH ADDITIONAL PRINCIPLES FOR ALL MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 2
  3. 3.  Adopted in June 1964.  Has undergone 6 revisions2 clarifications.  First significant effort by medical community to regulate research.  Prior to Nuremberg Code only specific countries had National policies (for example - Germany).  Forms basis of most subsequent documents. HISTORY 3
  4. 4. INTRODUCTION WHAT IS DECLARATION OF HELSINKI?  Set of ethical principles.  Developed by WMA for medical community–human experimentation.  Followed nuremberg code (1947).  Regarded as cornerstone document of Human research ethics.  Included within clinical trial protocols. 4
  5. 5. DECLARATION OF HELSINKI  In 1961, public opinion around the world was shocked by the thalidomide scandal. 2,000 children died and 10,000 children were seriously disabled.  Government authorities were then required to take action and make regulatory arrangements to oversee the testing of new medicines.  In 1964, the world medical association (WMA) developed and indeed continues to review and adapt the declaration of helsinki as a guide for performing research in human beings. 5
  6. 6. BASIC PRINCIPLES  Conform to accepted scientific principles.  Design formulated in experimental protocol, reviewed by IEC.  Conducted by qualified and trained persons.  Importance in proportion to inherent risk.  Assessment of risks vs. Benefits.  Safeguard subject’s integrity (privacy). 6
  7. 7.  Abstain unless hazards are predictable.  Preserve accuracy when publishing.  Adequately inform or right to withdraw.  Obtain true informed consent in writing.  Reliance on legal guardian.  State compliance with declaration. 7
  8. 8. SCOPE  Developed 10 principles first stated in Nuremberg code.  Linked to declaration of geneva (1948).  Statement of physicians ethical duties.  DoH specifically addressed clinical research.  Relaxed need for IC which nuremberg code deemed absolutely essential. 8
  9. 9. ETHICAL PRINCIPLES OF RESEARCH  Hippocrates was the first physician to define the ethical principles of research in humans. These principles are still valid today:  Autonomy – To respect the autonomy of the participant or of their representative;  Beneficence – To act always in the best interest of the participant;  Non-maleficence – To do as little harm as possible to the participant;  Justice – To act fairly to all. 9
  10. 10. NEW RESEARCH TOPICS  The progress of science and technology has led to continued development of ethical principles and guidelines as a variety of different new research topics continues to expand, for example, Assisted reproduction, Stem-cell research, Prenatal diagnostics. 10
  11. 11. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH  It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.  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. 11
  12. 12.  The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this declaration.  Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.  Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.  When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 12
  13. 13. 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 prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects.  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. 13
  14. 14. 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.  The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient– physician relationship 14
  15. 15. THE NUREMBERG CODE  Informed consent is absolutely essential.  Qualified researchers must use appropriate research designs.  There must be a favorable risk/ benefit ratio.  Participants must be free to stop at any time. 15
  16. 16. SIGNIFICANCE The nuremberg code has not been officially accepted as law by any nation or as official ethics guidelines by any association. In fact, the code's reference to hippocratic duty to the individual patient and the need to provide information was not initially favored by the american medical association. The western world initially dismissed the nuremberg code as a "code for barbarians" and not for civilized physicians and investigators.  However, the code is considered to be the most important document in the history of clinical research ethics, which had a massive influence on global human rights. The Nuremberg code and the related declaration of Helsinki are the basis for the code of federal regulations. 16
  17. 17. REFERENCE 1. WMA - Declaration of Helsinki – 2000 version (including notes of clarification 2002 & 2004). 2. Human D, Fluss S (July 2001) “The world medical association’s declaration of Helsinki: Historical and contemporary perspectives. 3. The social medicine portal (1st June 2008) “FDA abandons declaration of Helsinki for international clinical trials”. 17
  18. 18. THANK YOU. 18

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