DECLARATION OF HELSINKI - History and principles

This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.

1. DECLARATION OF HELSINKI ANAGHA K B KH.PH.P2MPG23002

2. The declaration of Helsinki was adopted in response to the cruel and inhuman research undertaken in concentration camps in other places during the Nazi regime in Germany. Subjects had been forced to take part in trials in which severe suffering and even deliberate killing were accepted. The research undertaken in concentration camps was investigated at the Nuremberg trials in 1945 and 1946 by the victorious Allied forces of World War II. Twenty of the 23 defendants were medical doctors and all were accused of having been involved in cruel Nazi human experimentation. Introduction

3. Pseudo‑medical experiments were conducted in many camps and on a wide scale. The Nazis also intentionally destroyed the records of these activities. To test a hypothesis on the infection - deliberately infecting healthy individuals with syphilis, typhus, and gonorrhea. Children were given earthworm embryos in their food and they were also infected with scarlet fever. Cancer research projects were done by removing cervices of women prisoners, an intravaginal camera was used during these experiments, which caused severe pain.

4. Women had cancer tissue implanted in the uterus for experimental purposes. Muscle surgery - multiple excision of larger pieces of thigh and lower leg muscle in a series of operations. Neural operations had done by extraction of some of the nerves in the lower leg. Operations were performed in aseptic conditions Operations were done forcibly. SS‑men gagged victims’ mouths and held their legs down, and the operations were carried out.

5. Mentally ill women prisoner’s legs, or an arm and shoulder blade amputated. These women were all killed on the operating table with an injection containing a lethal dose of evipan . Low‑temperature experiments - Prisoners were kept outside naked for 15 hours at temperatures of −25°C . Every hour they were doused down with cold water and their temperature was taken. These were the cruelest experiments conducted in Dachau, and most of the victims died.

6. Picture of all the types of experiments and criminal acts done by Nazi physicians

7. Nazi physician Carl Clauberg , who performed medical experiments on prisoners. Josef Mengele, German physician and SS captain. nicknamed The Angel of Death

8. August 1947 1933 - 1945 1964

9. World Medical Association WMA is an international organization representing physicians. It was founded on September 17, 1947, in Paris by physicians from 27 different countries. P urpose : to serve humanity by endeavoring to achieve the highest international standards in Medical Education, Medical Science, Medical Art and Medical Ethics, and Health Care for all people in the world. collaborates with the WHO and forms partnerships with various health professional associations, governmental and non-governmental agencies, and regional medical associations. key partnership is the World Heath Professions Alliance (WHPA).which unites international associations for physicians, nurses, and pharmacists to advocate for high standards of healthcare for all people.

10. DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the World Medical Association (WMA): 18th WMA General Assembly, Helsinki, Finland, June 1964 Purpose : To outline ethical principles for medical research involving human subjects, including identifiable human material and data. Primarily addressed to physicians, but the WMA encourages adoption by all participants in medical research involving human subjects. Physicians must promote and safeguard the health of patients involved in medical research, guided by their knowledge and conscience.

11. Amendments : 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 WMA General Assembly, Seoul, Korea, October 2008 General Assembly in October 2013, Fortaleza

12. 1975 1983 1989 1996 2000 2008 2013

13. General Principles of the Declaration of Helsinki Physicians must promote and safeguard the health, well-being, and rights of patients, including those in medical research, guided by their knowledge and conscience. Medical progress is based on research that ultimately must include studies involving human subjects. The primary goal of medical research is to understand diseases and improve preventive, diagnostic, and therapeutic interventions, continuously evaluating even the best proven interventions for their safety, effectiveness, efficiency, accessibility, and quality. Medical research must adhere to ethical standards that respect and protect all human subjects. 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.

14. Physicians conducting medical research are responsible for protecting the life, health, dignity, integrity, self-determination, privacy, and confidentiality of personal information of research subjects. Physicians must consider national and international ethical, legal, and regulatory standards for research involving human subjects. Research should minimize potential harm to the environment. Medical research involving human subjects must be conducted by individuals with appropriate ethical and scientific education, training, and qualifications, under the supervision of competent and qualified physicians or healthcare professionals The statement can be simplified as: Underrepresented groups should have appropriate access to participate in medical research. Physicians should involve patients in research only if it is justified by its potential preventive, diagnostic, or therapeutic value and does not adversely affect the patient’s health. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

15. Physicians can integrate medical research with medical care if it's justified by potential preventive, diagnostic, or therapeutic benefits and if they have good reason to believe it won't negatively impact patients. New interventions must be tested against the best current proven intervention, except in cases where no current intervention exists or where a placebo is necessary for efficacy or safety, but extreme care must be taken to avoid abuse. Patients are entitled to be informed about the study's outcome and any benefits it may provide, such as access to beneficial interventions or other appropriate care. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE

16. Physicians must clearly communicate research-related care aspects to patients, ensuring the patient-physician relationship remains intact despite refusals or withdrawals from studies. Physicians may use unproven interventions in patient treatment if they offer hope of saving life, re-establishing health, or alleviating suffering, with informed consent and research to evaluate safety and efficacy, and new information recorded and publicly available.

17. REFERENCE https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/ https://historycollection.com/25-images-nazi-medical-experiments-murderous-doctors-tortured-patients/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1323276/

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