Research Ethics for JPCFM (Jan2011)
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A lecture I gave for the PG residents of the Joint Program of Community and Family Medicine in Jeddah, Saudi Arabia (Jan. 2011)
![INTRODUCTION TO RESEARCH ETHICS Ghaiath M.A. Hussein Assistant Professor, Faculty of Medicine King Fahad Medical City King Saud Bin Abdulaziz University for Health Sciences Contacts: [email_address] ; 00966566511653](https://image.slidesharecdn.com/6786658/85/research-ethics-for-jpcfm-jan2011-1-320.jpg)
![OUTLINE OF PRESENTATION ,[object Object],[object Object],[object Object],[object Object],Research Ethics, Jan. 2011](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Research Ethics for JPCFM (Jan2011)
- 1. INTRODUCTION TO RESEARCH ETHICS Ghaiath M.A. Hussein Assistant Professor, Faculty of Medicine King Fahad Medical City King Saud Bin Abdulaziz University for Health Sciences Contacts: [email_address] ; 00966566511653
- 6. خريطة توضح حجم دول العالم من حيث الإنفاق على البحوث والتنمية وأكثر واقل عشر دول إنفاقا على البحوث في العالم ( بالدولار لكل مواطن لكل عام ). المصدر : www.worldmapper.org Research Ethics, Jan. 2011
- 7. خريطة توضح حجم دول العالم من حيث عدد المقالات العلمية المنشورة، وجدول يوضح عدد المقالات العلمية المنشورة لكل مليون من السكان لعام 2001 م . المصدر : www.worldmapper.org Research Ethics, Jan. 2011
- 8. Research Ethics, Jan. 2011
- 9. THE KNOWLEDGE MANAGEMENT CYCLE Research Policy makers Statistics Clinicians Research Ethics, Jan. 2011
- 10. HOW DOES RESEARCH IMPROVE HEALTH? 3/15/2010 Research Ethics. Ghaiath Research Ethics, Jan. 2011
- 11. WHAT MAKES A GOOD RESEARCH? Research Ethics, Jan. 2011
- 14. HISTORICAL BACKGROUND Born in Scandal… The Evolution of Research Ethics Research Ethics, Jan. 2011
- 17. NAZI DOCTORS’ EXPERIMENTATION Research Ethics, Jan. 2011
- 22. Research Ethics, Jan. 2011
- 28. ETHICAL PRINCIPLES OF RESEARCH What makes research ethical? Research Ethics, Jan. 2011
- 32. WHAT ARE THE ETHICAL ISSUES THAT ARISE IN RESEARCH? Benefit/harm analysis Vulnerability (Risk-Vulnerability Matrix) Informed Consent Fairness and equity in research participation Privacy and confidentiality Conflict of Interests (COI) Research Ethics, Jan. 2011
- 39. NAZI EXPERIMENTS Research Ethics, Jan. 2011
- 40. HIGH ALTITUDE EXPERIMENTS Research Ethics, Jan. 2011
- 48. Research Ethics, Jan. 2011
- 56. WHO IS VULNERABLE? Making use of this definition… let’s brainstorm! Research Ethics, Jan. 2011 www.amanet-trust.org
- 67. ASSESSMENT OF RISK-VULNERABILITY Research Risk depends on both Level of Invasiveness (physical, psychological or emotional) and Vulnerability of participants. Vulnerability is generally a pre-existing condition, in that it exists regardless of whether the research is conducted or not. It can be inherent or situational .
- 68. TRI-COUNCIL POLICY STATEMENT ETHICS REVIEW (CONT.) Invasiveness : consider the physical, psychological, emotional and legal harms that could be caused by or exacerbated by the research. Group Invasiveness Vulnerability Low Medium High Low Exp. Exp. Full Medium Exp. Full Full High Full Full Full
- 69. EXAMPLES: Low Vulnerability/Medium Invasiveness: Anonymized survey of health care practitioners to determine whether their work environment poses challenges to their practice. High Vulnerability/Medium Invasiveness: Determining whether obese children aged 9 to 12 adhered to a diet recommended by their family physician.
- 70. RISK/VULNERABILITY MATRIX Research Ethics, Jan. 2011
- 72. INFORMED CONSENT
- 75. Disclosure VOLUNTARINESS Capacity Research Ethics, Jan. 2011
- 102. CONFLICTS OF INTEREST (COI)
- 121. ETHICAL REVIEW OF RESEARCH Research Ethics, Jan. 2011
- 125. PROGRAM EVALUATION/ QUALITY ASSURANCE AND RESEARCH Characteristic Research Evaluation Goal or Purpose Generate new knowledge for prediction Program or Policy Decision-Making Questions/ Nature of Problem To fill a gap in the literature – derived by scientist Derived to assess impact and outcome of program Guiding Theory/ Techniques Hypothesis testing Theory underlying program interventions Dissemination Scientific Journals Internal and External Reports Allegiance Scientific Community Funding source, policy makers
- 126. DISCUSSION… Q & A Research Ethics, Jan. 2011
Editor's Notes
- At the end of World War II, the International Military Tribunal prosecuted Nazi war criminals, including Nazi doctors who performed experiments on concentration-camp prisoners. The tribunal’s decision includes what is now called the Nuremberg Code , a 10-point statement outlining permissible medical experimentation on human participants. Other provisions require the minimization of risk and harm, a favorable risk/benefit ratio, qualified researchers using appropriate research designs, and freedom for the participant to withdraw at any time.
- In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972. More than 400 men with latent syphilis were followed for the natural course of the disease rather than receiving treatment. As a result, in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . Those principles—respect for persons, beneficence and justice—are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.
- In 1993, CIOMS issued the International Ethical Guidelines for Biomedical Research Involving Human Subjects , with the purpose to indicate how the ethical principles of the Declaration of Helsinki can be applied effectively, particularly in developing countries. • informed consent • research in developing countries • protection of vulnerable populations • distribution of the burdens and benefits • role of ethics committees
- These Nazi experiments included hypothermia experiments depicted in this slide whereby prisoners were submerged in a tank filled with cold water. The goal of this type of these experiments was to determine how long German pilots, who had to parachute into the cold north sea, would survive.
- High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. Many of those who did not die immediately were put under water until they died. Autopsies followed. .
- Prospective IC: This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.
- Recorded data: audio, video, photo Quotes: direct quotes or specific anecdotes (e.g. “this tall guy who works at O’Grady’s”) could be identifying
- The conflict lies in the situation, not in any behavior or lack of behavior of the individual. That means that a conflict of interest is not intrinsically a bad thing.
- Last point: but TCPS acknowledges that there may be points where this overlaps with research
- Undergraduate course-based research is reviewed by a departmental TCPS-compliant REB. The instructor must submit a template to the REB. Graduate course-based research is reviewed by the University’s Ethics Boards.