1. What is Research Ethics? Historical Background Need for Training 12/20/2015 Research Ethics. Ghaiath 1

2.  Ethics and bioethics  Research Ethics  Historical background on the development of international guidelines and codes  Conclusion

3.  The expressive level (unanalyzed expressions or feeling that, by themselves, don’t provide reasons or justification)  The pre-reflective level (justification via law, religious tenets, social values, codes of ethics, etc.; accepted uncritically)  The reflective level (reasoned ethical argument/defence based on ethical principles, rules, virtues, values to which we consciously subscribe; justification provided) Thomas J and Waluchow W, 1998

4.  explicit critical reflection on moral beliefs, practices and problems  philosophical study of morality This is at the reflective level… (contrast with “descriptive ethics”)

5. Ghaiath Ethics of Pt. Safety, July 08. 5  Bioethics is about the study of ethical issues arising along health care or research, and the associated decision- making process to resolve them.

6. Ghaiath Ethics of Pt. Safety, July 08. 6  When there is conflict of moral values, beliefs, and objectives e.g. between the health care providers and the patients.  When there is conflict of commitments and responsibilities: e.g. saving patients' lives vs. using the available resources "rationally"  When there is the concern that our patients rights/values are not respected.  When the issue in focus is related to justice in allocating the available resources  Finally, when we, as care providers feel that we are not sure what we should do.

7. Ghaiath Ethics of Pt. Safety, July 08. 7 The three questions are:  How to take an ethically acceptable decision to the issue in focus?  Why did we take this decision? (i.e. why we chose this ethical option and not another?)  How to implement the decision we have taken?

8. Clinical Ethics The study of ethical questions & dilemmas raised by HCP-Patient interaction Research Ethics The study of ethical questions & dilemmas raised by studying human as research subjects Organization al Ethics Interested in resource allocation ethics, and staff relations in organizations 12/20/2015 Research Ethics. Ghaiath 8 Public Health Ethics The study of ethical issues raised by public health interventions

9.  It is the field of ethics that systematically analyze the ethical and legal questions raised by rresearch involving human subjects.  Its main focus is to ensure that the study participants are protected and, ultimately,  that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.  It works when and only when it is applied before the research is conducted 12/20/2015 Research Ethics. Ghaiath 9

10. Born in Scandal… The Evolution of Research Ethics 12/20/2015 Research Ethics. Ghaiath 10

11. ­ James Lind “scurvy study in sailors - Salisbury ­ Edward Jenner cowpox vaccine test ­ 1897 Guiseppe Sanarelli yellow fever test

12.  1900 Walter Reed established several [first ever] “safeguards” 1. Self-experimentation 2. Only adults would be enrolled in research 3. Written informed consent 4. Reimbursement (inducement)

13.  Pre-World War II  Research standards left up to the discretion of the individual researcher  World War II  Experiments conducted on inmates of Nazi concentration camps  1945-1949 - Trials in Nuremberg, Germany– physicians convicted of crimes against humanity

14. Nuremberg Code (1947) ­ As a result of WWII Nazi experiments ­ First international code in research ethics  Voluntary consent absolutely essential (restricting research with infants, children, developmentally challenged, etc.)  Risk/Benefit Analysis essential to ethics review  Scientific Soundness is important to ethics review

15.  The first provision of the code requires that “the voluntary informed consent of the human subject is absolutely essential.” The code provides other details implied by such a requirement:  capacity to consent  freedom from coercion  comprehension of the risks and benefits involved The code on the web: http://ohsr.od.nih.gov/nuremberg.php3 http://ohsr.od.nih.gov/nuremberg.php3 12/20/2015 Research Ethics. Ghaiath 15

16. Experiment should be designed and based on: ­ The results of animal experimentation ­ Knowledge of natural history of disease ­ The anticipated results will justify the performance of the experiment ­ Avoidance of all unnecessary physical or mental suffering and injury

17. × No experiment should be conduct where: ­ There is a prior reason to believe that death or disabling injury will occur ­ Exception: experimenting physicians also serve as subject ­ Degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem

18.  Proper arrangements made to protect the subjects against the possibilities of: ­ Injury ­ Disability ­ Death Experiment to be conducted by highest qualified persons ­ Highest degree of skill and care required through all stages of the experiment

19. o During the course of the experiment the human subjects should be at liberty: ­ To bring the experiment to an end ­ Scientist in charge should be prepared to: ­ Terminate the experiment at any stage if he/she has probable cause to believe that continuation of the experiment is likely to result in injury, disability or death

20.  The World Medical Association created the Declaration of Helsinki in 1964 & amended in: Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996), Edinburgh (2000), Washington (2002), and Tokyo (2004)  “The well-being of the subject should take precedence over the interests of science and society”  Consent should be in writing  Use caution if participant is in dependent relationship with researcher  Limited use of placebo  Greater access to benefit 12/20/2015 Research Ethics. Ghaiath 20

21.  Respect for Persons – people are not a means to an end; researchers have duty to protect life, health, privacy and dignity of research participants  Standard of care must be best available, even for control group  Proxy consent and assent for vulnerable populations

24.  In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972.  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. 12/20/2015 Research Ethics. Ghaiath 24

25. US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research wrote The Belmont Report in response to the Tuskegee and Willowbrook Controversies. This Led the US Department of Health and Human Services (and others) to adopt Federal Regulations regarding Research Ethics: The Common Rule or US 45 CFR 46, last revised in 2001

26.  Informed consent  Research in developing countries  Protection of vulnerable populations  Distribution of the burdens and benefits  Role of ethics committees 12/20/2015 Research Ethics. Ghaiath 26

27. ­ First code to consider less developed communities ­ Individual informed consent ­ Appropriate inducements ­ Special populations ­ Privacy and confidentiality ­ Independent ethics committee review In collaborative research: ­ Responsive to health needs of host country ­ Agree in advance that products will be made reasonably available afterward

28.  Formed bu US,Japan and Europe  Its goal is to standardize the process by which new drugs are developed, tested and brought to market.  The ICH guidelines require review by an ethics committee and informed consent of participants. 12/20/2015 Research Ethics. Ghaiath 28

29.  Kano trovan clinical trials in 1996, on pediatric age group, during the worst ever meningococcal meningitis.  Lack of proper Governmental authorization and informed consent during the studies publicized in 2000, by Washington Post.  Court trial and release of investigation panel reports stalled in Nigeria.  Suit for 5.8 billion USD moved to the USA and report leaked there too.  Settlement out of court being discussed.

30.  “Research Scandals” led to the development of guidelines  Guidelines alone can not stop the violations of ethical conduct of research  It happened everywhere, and nobody is immune… including Sudan  Please bear that in mind when studying Research Ethics

32.  www.nursingtimes.net www.nursingtimes.net  http://ohsr.od.nih.gov/nuremberg.php3 http://ohsr.od.nih.gov/nuremberg.php3 .