1.-Introduction-to-Ethics-in-Research.pptx

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1. An Introduction to ETHICS IN RESEARCH ADG 121317 RMM 041816 ATA 120416

2. OBJECTIVE Share introductory concepts regarding ETHICS IN RESEARCH Definitions Importance Considerations Philippine Health Research Landscape Research Ethics System

3. DEFINITIONS RESEARCH Activity that inquires into a particular subject with the aim to develop or contribute to generalizable knowledge (including theories, principles and relationships) or any accumulation of information using scientific methods , observation, inference, and analysis. Not medical treatment, surveillance, audit, mere program evaluation Not unsystematic, disorganized, and without focus

4. DEFINITIONS RESEARCH WITH HUMAN BEINGS Any social science, biomedical, or epidemiologic activity that entails systematic collection or analysis of data with the intent to generate new knowledge in which human beings are exposed to manipulation, intervention, observation or other interaction with investigators either directly, or through alteration of their environment, or become individually identifiable through investigator’s collection, preparation, or use of biological material or medical or other records. (WHO)

5. DEFINITIONS CLINICAL TRIAL Any investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects, identify any adverse reactions, study absorption, distribution, metabolism and excretion of investigational product/s with the object of ascertaining its safety and/or efficacy (and registering it for public use)

6. ETHICS : Moral behavior ETHICS IN RESEARCH : framework applying broad ethical principles to the responsible conduct of research and to the use of any outcomes resulting from research (University of Reading) Focus on research participant Consider community and environment in ethics DEFINITIONS

7. DEFINITIONS RESEARCHER A qualified scientist who undertakes responsibility for the scientific and ethical integrity of a research at a specific site INVESTIGATOR Responsible for the conduct of the clinical trial at a trial site TECHNICIAN Collector of data

8. DEFINITIONS PROTOCOL A document that provides the background, rationale, and objectives of a research and describes its design, methodology, organization including ethical and statistical considerations (a research proposal is the submitted protocol for approval)

9. DEFINITIONS SPONSOR An individual, company, institution or organization responsible for the initiation of a clinical investigation, management and/or financing of a clinical trial

10. IMPORTANCE OF ETHICS IN RESEARCH Right thing to do Protection of research participants Provides advocates for research participants “Rights, safety, and well-being of [research participants] are the most important considerations and should prevail over the interests of science and society.” (ICH-GCP, 2016) Preserves credibility, trust, and accountability Reduces liabilities, wasted time and resources Turns useless, harmful, worthless to useful, helpful, worthy Obeys laws

11. Surge in number of researches Promoted as research hub Knowledge access Convenience subjects Free and Informed Consent Privacy and confidentiality PHILIPPINES HEALTH RESEARCH LANDSCAPE

12. Attraction : Large ethnic gene pool Low research costs Available pool who has not received any drug Available and educable researchers PHILIPPINES HEALTH RESEARCH LANDSCAPE

13. PHILIPPINES HEALTH RESEARCH LANDSCAPE Problems : Politics and commercialization Increased researches without a proportionate increase in trained researchers or research ethics committees More than 15,000 Filipino research participants but no participant advocacy group Unclear responsibilities, overlapping mandates Ethical misconduct

14. CONSIDERATIONS 1. Learn from the past Every scientific breakthrough was paid with people’s lives Good people have acted in bad ways Some researchers have acted inappropriately

15. HISTORY 1796 : Edward Jenner : Cowpox 1845 : J. Marion Sims : surgery without anesthesia 1865 : Joseph Lister : Antisepsis 1879 : Gerhard Hansen : Lepra bacillus inoculation into eye 1885 : Louis Pasteur : Rabies vaccine on human subject without animal studies 1895 : Arthur Wentworth : Lumbar puncture of two-year old girl 1895 : Sonerelli : Yellow Fever 1900 : Walter Reed : Yellow Fever in the Philippines 1906 : Richard Strong : Inoculation of cholera to Filipino prisoners 1932 : Tuskegee Clinical Syphilis Study 1940s : Nazi experiments on human endurance in war 1960 : Willowbrook Hepatitis Experiments Doctors Walter Reed and Richard Strong

16. RIGHT : Nazi Freezing Experiment. SS Sturmbannfuehrer Dr. Sigmund Rascher (right) and Dr. Ernst Holzloehner (left) observe the reactions of a Dachau prisoner who has been immersed in a tank of ice water in an attempt to simulate the extreme hypothermia suffered by pilots downed over frigid seas. (Dachau, Germany, 1942) LEFT: A prisoner in a compression chamber loses consciousness (and later dies) during an experiment to determine altitudes at which aircraft crews could survive without oxygen. (Dachau, Germany, 1942)

17. Dr. Walter Edmondson drawing blood from unidentified man for the Tuskegee Syphilis Study in early 1950s

18. HISTORY 1. Learn from the past (continued) Good people have acted in bad ways Efforts towards ethical research have been unsatisfactory

19. Nazi physician Karl Brandt and his fellow defendants in the dock at the Doctors Trial conducted at Nuremberg, Germany in 1946.

20. HISTORY 1803 : Percival’s Code “sound reason and consultation” 1833 : Beaumont Code “voluntary consent” 1947 : Nuremberg Code : human rights, consent 1964 : WMA Helsinki Declaration (2013) 1966 : UN Declaration of Human Rights 1974 : The Belmont Report 1985 : Bernard Williams : individual more than science 1982 : CIOMS International Ethics Guidelines (2015) 1996 : ICH Harmonized Tripartite Guidelines for GCP (2016) 2011 : WHO Standards and Operational Guidance 2017 : PNHRS National Ethical Guidelines for Health and Health-Related Research FDA Professional Societies Research Committees Institutional Research Ethics Committees

21. CONSIDERATIONS 2. Believe that there are correct ways of doing research

22. CONSIDERATIONS 3. Value the research participant Indispensable for the research (partner) Chooses to join Cannot be worse off by joining research “While the primary purpose of [research] is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research [participants]” (Helsinki, 2013) Protection of research participants is a universal concern Foremost responsibility of researcher is the protection of rights, safety, and welfare of research participants.

23. CONSIDERATIONS 3. Value the research participant As a person with inherent dignity who should be: An end and not a means (BENEFICENCE) Protected against harm and wrong (NON-MALEFICENCE) Respected as a person (AUTONOMY) Equal to other persons (JUSTICE)

24. 4. Value Self As honorable and trustworthy 5. Value Community and Environment Impact on community which participants represent both during and after research CONSIDERATIONS

25. RESEARCH ETHICS SYSTEM (Shared Responsibility for Ethics in Research) International Bodies Philippine Government Professional Societies Sponsors and Funding Agencies Institution: Research Ethics Committees Investigators and Researchers Research Participants The vigilant conscientious researcher has ultimate responsibility and accountability . He must be sensitive and attend to ethical soundness.

26. Research Ethics Committees Sponsors/ Funding Agencies Regulatory Agencies PHREB Research Institutions Researchers/ Investigators Research Participants National Structural Framework for Human Protection (Ethics) in Health Research (2006, 2014, 2016)

27. SUMMARY Ethics in research refers to the moral behavior in the conduct of research and use of its outcomes There are ethical ways of doing research Ethical conduct makes research helpful and worthy Research participants must be valued as persons: protected from harm, benefited, respected, and treated fairly Controls and guidelines exist at every level, but the researcher has ultimate responsibility for ethics in research Community and environment must not be forgotten

28. THANK YOU! 