Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Ethics in health research (history)

Concept of ethics
Importance of ethics in health research,
Brief overview on history of ethics in public health

  • Login to see the comments

Ethics in health research (history)

  1. 1. Ethics in health research (History) Course Instructor: Ashok Pandey (MPH/BPH, DGH) Research Officer - Nepal Health Research Council, Nepal Research Fellow (Fredskorpset, Norway) CSF Global, Banani, Dhaka, Bangladesh 11/2/2017University of South Asia, Dhaka, Bangladesh 1
  2. 2. 11/2/2017University of South Asia, Dhaka, Bangladesh 2 • Concept of ethics • Importance of ethics in health research, • Brief overview on history of ethics in public health
  3. 3. Ethics “Ethics” --- “Ethos” --- Character OR  Behavior related to customs and moral values of the people.  A way of characterizing actions with regard to human dignity  Medical Ethics - Protects the Patient  Research Ethics - Protects the Study Participants OR Community
  4. 4. Example Suppose you are the driver in the trolley car and your trolley car is hurdling down the track at 60 miles per hour at the end of the track you noticed five workers working on the track, You tried to stop but you can’t. Your break don’t work, You feel desperate because you know that if you crash into this five workers, they will all die Lets assume you know that for sure and you fell helpless. Until you notice that there is off to the right, a side track, at the end of that track, There is one worker working on the track. You are steering wheel works, So you can, turn the trolley car if you want to onto this side track killing the one but sparing the five. What’s is the right thing to do?, What would you do? Lets take a poll How many would turn the trolley car onto the side track How many wouldn’t. How many would go straight ahead 11/2/2017University of South Asia, Dhaka, Bangladesh 4
  5. 5. Another trolley car case This time you are not the driver of the trolley car. You’re an looker. You are standing on the bridge and looking the trolley car and down the track come a trolley car, at the end of the track are five workers, the breaks don’t works, the trolley car about to careen into the five and kill them and now, you are not the driver. You really fell helpless until you notice standing next to you leaning over the bridge is it very fat man and you could give him a shove he would fall over the bridge onto the track right in the way of the trolley car he would die, but he would spare the five. 1. How many would push the fat man over the bridge 2. How many wouldn’t? 11/2/2017University of South Asia, Dhaka, Bangladesh 5
  6. 6. Lets imagine you are the doctors in emergency room and six person come to you. They’ve been in the terrible trolley car wreck. Five of them sustained moderate injuries one is severely injured you can spend all day caring for the one severely injured victim, but in that time five would die, or you could look after the five, restore them to health, but during that time the one severely injured person would die How many would save the five How many would save the one 11/2/2017University of South Asia, Dhaka, Bangladesh 6
  7. 7. Another doctor case You are the transplant surgeon and you have 5 patient each in desperate need of an organ transplant in order to survive one need the heart, one a lung, one a kidney, one a liver and a fifth pancreas and you have no organ donors. You are about to see them die and then it occurs to you that in the next room, there is the healthy guy come for the check up and he is taking the nap. You could go in very quietly yank out the five organs, that person would die but you can save the five How many would do it? 11/2/2017University of South Asia, Dhaka, Bangladesh 7
  8. 8. Definitions  Ethics is the science of morality. It deals with the right or wrong of any activity.  Research ethics: analysis of moral worth of all the actions involved in human or animal research.  Ethics: “principles of right conduct” 9/15/2016Ashok Pandey 8
  9. 9. Activities in research  Collection of information: primary or secondary sources of information.  Using technology for investigation or treatment: draw blood, collect body fluids or tissues, expose to radiation, analyze samples, genetic pattern (access to sensitive information).  Following up on the participants.  Using participant data to draw inferences and disseminate information. 9/15/2016Ashok Pandey 9
  10. 10. Importance of ethics in research  Major expansion in health research, technological advances, newer vaccines and drugs.  Newer more intrusive interventions: organ transplantation, stem cells in therapy, cloning.  Heavy investment, financial interests.  Many instances of violation.  Internationalization of research. 9/15/2016Ashok Pandey 10
  11. 11. History of ethics in public health 11/2/2017University of South Asia, Dhaka, Bangladesh 11
  12. 12. Ethics in Health Research  Ethics in Medicine has been practiced since the ancient times. Charaka Samhita, Hippocratic oath. (202 codes of conduct)  But it also has been recognized as essential in Health Research in the present day. 9/15/2016Ashok Pandey 12
  13. 13. The Basics of Ethics in Research  Dishonest, fraudulent, or unethical researchers can circumvent the scientific method 1. Nazi Germany Experimentation - Charges brought against 23 German physicians in the Nuremberg War Crime Trials for their medical experiments – included: 1. Freezing Experiments (hypothermia experiment) 1. Malaria Experiments 2. High-Altitude Experiments (test chamber) - Led to the development of Nuremberg Code 9/15/2016Ashok Pandey 13
  14. 14. 11/2/2017University of South Asia, Dhaka, Bangladesh 14
  15. 15. Need more: Go through it 11/2/2017University of South Asia, Dhaka, Bangladesh 15
  16. 16. 2. The Tuskegee Syphilis Study  Was investigation of long-term effects of untreated syphilis on males  Decision was made to do long-term prospective study and follow long-term effects until death  Participants were never told real nature of study – were not afforded informed consent  Treatment for syphilis was withheld (even after discovery of penicillin to treat syphilis) – study continued for 40 yrs. 9/15/2016Ashok Pandey 16https://www.cdc.gov/tuskegee/timeline.htm
  17. 17. 11/2/2017University of South Asia, Dhaka, Bangladesh 17 Need more: Go through it
  18. 18. Thalidomide Tragedy  In the late 1950s, thalidomide was approved as a sedative in Europe  The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.  Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent.  Some 12,000 babies were born with severe deformities due to thalidomide.  U.S. Senate hearings followed and in 1962 the so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety.  For the first time, drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them 11/2/2017University of South Asia, Dhaka, Bangladesh 18 http://www.ors.umkc.edu/research-compliance-%28iacuc-ibc-irb-rsc%29/institutional- review-board-%28irb%29/history-of-research-ethics
  19. 19. 11/2/2017University of South Asia, Dhaka, Bangladesh 19 https://images.search.yahoo.com/search/images;_ylt=AwrSbgYjrfpZY2UA2hdXNyoA;_ylu=X3oDMT EyOWwwdHFiBGNvbG8DZ3ExBHBvcwMxBHZ0aWQDQjQ4MzVfMQRzZWMDc2M- ?p=thalidomide+tragedy&fr=mcafee
  20. 20. Declaration of Helsinki. In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non- therapeutic research." The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today. 11/2/2017University of South Asia, Dhaka, Bangladesh 20
  21. 21. Issues addressed in the Declaration of Helsinki include: 11/2/2017University of South Asia, Dhaka, Bangladesh 21 • Research with humans should be based on the results from laboratory and animal experimentation • Research protocols should be reviewed by an independent committee prior to initiation • Informed consent from research participants is necessary • Research should be conducted by medically/scientifically qualified individuals • Risks should not exceed benefits
  22. 22. National Research Act (1974 )  Due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed.  The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,  The Commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States. 11/2/2017University of South Asia, Dhaka, Bangladesh 22
  23. 23. The Belmont Report The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research prepared the Belmont Report in 1979. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. The Report is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. The three basic ethical principles and their corresponding applications are: 11/2/2017University of South Asia, Dhaka, Bangladesh 23 Principle Application Respect for persons Informed consent Beneficence Assessment of risks and benefits Justice Selection of subjects
  24. 24.  Nazi atrocities in World War II drew attention to the lack of international standards on research with human subjects and led to the formulation of the Nuremberg Code.  The thalidomide disaster led to the adoption of the "Kefauver Amendments" to the Food, Drug and Cosmetic Act, requiring drug manufacturers to prove to the FDA the effectiveness of their products before marketing them.  The Declaration of Helsinki is the basis for Good Clinical Practices used today.  The Tuskegee Syphilis Study is probably the worst case of unethical human subjects research in the history of the United States.  The National Research Act codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report. 11/2/2017University of South Asia, Dhaka, Bangladesh 24 Summary of the history
  25. 25. 11/2/2017University of South Asia, Dhaka, Bangladesh 25
  26. 26. 11/2/2017University of South Asia, Dhaka, Bangladesh 26
  27. 27. Thank you 11/2/2017University of South Asia, Dhaka, Bangladesh 27 Photo credit: https://marisaskitchentalk.files.wordpress.com/2011/10/funny-monkey.jpg

×