Ayesha S. Abdullah

1. Ethics of Biomedical Research Ayesha S. Abdullah

2. Learning outcomes • Recognize the importance of ethics in biomedical research and identify ethical issues that can arise at various stages of a research project. • Identify the frameworks of ethics for biomedical research and apply the basic principles drawn from these frameworks in a given research context • List the characteristics of ethically sound quality research and the role of IRB for ensuring quality and safety in research. • Recognize the perilous outcomes of research where ethics are compromised

3. Cliché “Honesty is the best policy” “It is the only policy”

4. Review • What is research in essence? • Why research? • How research?

5. Research • Research is the systematic collection, analysis and interpretation of information to answer certain questions or solve a problem. The Truth is discovered Purpose Solve a problem

6. Ethics

7. Why Ethics has become an important theme in contemporary biomedical research

8. 1. Medical Progress • What do we understand by this term? • How can this be accomplished?

9. Better understanding of how a particular disease happens Pathogenesis How can patient care be made safer? Patient safety science How can we make better health care workers? Health Professions education research How can known or new diseases be treated better? Clinical Trials How can diseases be prevented? How can we keep the existing health care professional updated on the recent advances in health care? CME / CPD How can we improve patient care? Health System Research

10. 2. Complex Doctor-Patient Relationship in Research • Routine patients & research • Research on Special groups of patients- children, pregnant women • Vulnerable group of research participants- legally, physically or mentally vulnerable • People with physical or mental disability, prisoners, refugees

11. 3. Doctor-Pharmaceutical Relationship in Research • Interdependent relationship that can create significant ethical issues • The average cost of developing a new drug in US is estimated to be 300-600 million US dollars and 70% of this comes from pharmaceutical industry (PHRM) not the NIH • The PHRM depends on the academic / health care institutions and professionals for • The design and conduct of clinical trails • The pool of patients • The publication of their results • The use of their products/medications • or equipment

12. 3. Doctor-Pharmaceutical Relationship • USA National survey results, 2007 • 3167 physicians • 94% had some kind of personal interaction with the PHRM • 83% received food in the workplace • 35% received reimbursement for meetings and conferences • 28% received payments for lectures and enrolling patients • Pharmaceutical Research & Manufacturers of America implemented a code of conduct in 2002 • So they make the developing countries their experiment field Campbell, Eric G., Russell L. Gruen, James Mountford, Lawrence G. Miller, Paul D. Cleary, and David Blumenthal. National Survey of Physician-Industry Relationships. N Engl J Med 356, no. 17 (April 26, 2007), 1742-1750.

13. Pharmaceuticals & Research • Marketing Strategies that apparently look harmless • trivial gifts- pens, diaries etc • Educational trips with recreational events • Getting your articles published • Samples for patients • Getting your writing pad printed • All marketing tools and who pays for this marketing • The end-user of their products i.e. the patient • Who is the guardian of the patient’s rights and saftey?

14. Steven Nissen http://www.telegraph.co.uk/science/2016/06/12/high-cholesterol-does-not-cause-heart-disease-new-research-finds/

15. 4. Ethically Challenging Complex Modern Health Care Practice Human Ken Doll Rodrigo Alves shows off his new look following ANOTHER cosmetic procedure Reality star has spent over £373,000 on cosmetic procedures He has now had 51 cosmetic procedures http://www.dailymail.co.uk/tvshowbiz/article-4270704/Human-Ken-Doll-Rodrigo-Alves-shows-new-look.html#ixzz4f0R3kLAO

16. 4. Ethically Challenging Complex Modern Health Care Practice

17. 4. Ethically Challenging Complex Modern Health Care Practice

19. What can go wrong and how wrong can things get

20. 1. Tuskegee study(1932-1972) Some examples • Beginning in the 1930s, 400 cases and 200 controls African American men signed up with the U.S. Public Health Service for free medical care at Macon County, Alabama • The service was conducting a study on the effects of syphilis on the human body. • The men were never told they had syphilis. They were told they had "bad blood" and were denied access to treatment, even for years after penicillin came into use in 1947. • Promised free burial in exchange for the right to autopsy needed for the study • By the time the study was exposed in 1972, 28 men had died of syphilis, 100 others were dead of related complications, at least 40 wives had been infected and 19 children were born with congenital syphilis.

23. 2. Porton Down (1940-1960) • UK Govt and Military research centre • RAF Volunteer - Flu trial • Sarin and Mustrad gas • Died in 1953 aged 20 years • Admitted to negligent death in 2003 https://www.gov.uk/government/news/the-truth-about-porton-down https://www.theguardian.com/uk/2003/sep/28/military.antonybarnett https://en.wikipedia.org/wiki/Ronald_Maddison Ronald Maddison

26. 3. Vijay Soman & Philip Felig (1978) • NEJM- Review manuscript • Am J Med got similar manuscript by Soman and Felig http://www.nytimes.com/1981/11/01/magazine/a-fraud-that-shook-the-world-of-science.html?pagewanted=all

27. 4. Eric Poehlman- 2006 • First scientist jailed for his research • Professor at the University of Vermont • Published over 200 articles. • March 2005, Jailed for scientific misconduct, admitting that seventeen of his grant applications submitted to the National Institutes of Health were based on false data. • Furthermore, ten of Poehlman’s published papers were proven to be fictitious. https://ori.hhs.gov/poehlman_notice http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html

28. 5. Malcolm Pearce (1994-95) • Chair , Ob-GY at St George’s Hospital Resigned as president of the Royal College of Obstetricians and Gynaecologists. Fabrication Gift Authorship Geoffrey Chamberlain http://www.independent.co.uk/arts-entertainment/science-doctoring-the-evidence-1170688.html

29. Who safeguards against research misconduct • The researcher • The participants • The organization- IRBs & IECs • The state • The profession • The community

30. Domains of Practice K Philosophy Faith Values A S

31. Definitions & concepts Ethics Ethics – the discipline concerned with what is morally good and bad, right and wrong with justification Morality The practice of ethics The quality or state of being accountable; especially :  an obligation or willingness to accept responsibility or to account for one's actions Accountability Breach of ethics is a moral failure

32. Ethical Principles • Ethics Ethical Principles Ethical Practices

33. Scientific misconduct • Research misconduct means • Fabrication, • Falsification, or • Plagiarism • in • Proposing • Performing • Reporting research results • Reviewing research https://ori.hhs.gov/definition-misconduct

34. Scientific Misconduct • Fabrication is making up data or results and recording or reporting them. • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. • Plagiarism is the appropriation of another person's ideas, processes, results, or words and reporting it is your own without giving appropriate credit. • Research misconduct does not include • error done unknowingly without dishonest intentions or • differences of opinion • in • Proposing • Performing • Reporting • Reviewing research

35. Research Ethics-what to do Topic Discussion Next Week on the Assigned Tasks to Groups on the Given points Methodology Data collection Analysis Interpretation Write-up dissemination Publication

36. 1. Selecting the Topic for Research • Has it been explored earlier? • If so, by whom and how? • If not, why not? • Who are the stakeholder? • Can someone be harmed and who? • Can someone get some undue benefit and how? • How would I fund it?

37. Selecting the Topic for Research • Are there any political issues attached? • Is there any conflict of interest of anyone ? • What are the potential consequences or outcome of this work? • Are there any risks involved for the participants, researcher or other stake holders? • How can these risks be avoided, minimised or justified?

38. 2. Planning methodology • Approval from relevant IRB/ IEC • Conducting a good informative and focussed literature review • Selecting the most valid and appropriate study design • Designing valid tools for data collection • Minimising risks for all stakeholders • How can I make my results reliable • Safeguard against biases and confounders • Maximising data collection • Triangulation especially in qualitative research

39. 3. Data Collection • Prior communication for field work • Where , through whom and how? • Again, are there risks involved, and if so, who does the research place at risk, and how? • Are there any limitations to data collection? • If yes how would I deal with it to maintain validity and reliability of my research? • Are there serious ethical concerns being raised- Do I need to stop the study before completion? • Steps to maximize data collection and reduce errors

40. 3. Data Collection • How would I take the informed consent and from whom? • Is there someone else’s permission required and how would I obtain that? • Maintaining informed consent over time • Is the information that I am providing clear and adequate? • Do I need written protocols for data collection to maintain quality in my study?

41. 3. Data Collection • Who would be my respondent?.... Sampling • Patients, friends, colleagues, key informants, participants, respondents or subjects? • Is my sampling strategy valid and justified? • Any forthcoming revelations and confessions and how would I deal with them? • Deals and promises (sharing results, insights etc)?

42. 4. Recording & Storing data • How can I accurately record information, especially about social events? • How would I maintain confidentiality of my data? • Do my respondents know and approve of what I have recorded? • Is my data sensitive? • Can it put people at risk if it falls into the hands of others? And who are these others? • How would I protect my data? • Have I kept notes of my personal perceptions and views separately? • For how long do I need to store my data

43. 5. Analysing, interpreting and communicating findings (write-up) • Valid data analysis and interpretation • Honest data presentation • Sharing the results or conclusions with individuals and organisations, what form and how much? • Would I present my findings at an international conference, who would fund it? • Would there be a conflict of interest? • Could there be feedback and reactions, and how would I deal with it? • Am I engaged in some kind of Plagiarism? • How can I avoid plagiarism?

44. Analysing, interpreting and communicating findings (write-up)- Plagiarism • Word-to-word • Structure- paraphrasing • Failure to put Quotation marks • Failure to cite properly • Mosaic plagiarism- patch working • Plagiarism of ideas • Authorship fraud- Gift and Ghost • Self –plagiarism

45. Is it Plagiarism • Changing words but copying the sentence structure of a source without giving credit • Citing a cross reference • Copying a diagram from another source with prior permission and full reference • Copying ideas from someone else without giving citation • Copying words/ sentences from your own article published earlier without citing the reference

46. Is it Plagiarism • Failing to put a quotation in quotation marks • Giving incorrect information about the source of a quotation • Mixing your own idea with earlier reported ideas and presenting as your own • Referring to an idea or phrase with citation or giving full reference • Turning in someone else's work as your own

47. Misleading data presentation

48. Misleading data presentation

49. In Summary Research is high risk zone for ethical issues Guidelines to resolve these issues are based on Ethics Values

50. Principles for ethical decision making in biomedical research • Autonomy • Nonmaleficence • Beneficence • Justice • Human Dignity • Veracity Nuremberg Code - 1947 Declaration of Helsinki- 1964 Belmont Report – 1970 International Ethical Guidelines for biomedical research involving human subjects- 1982 – 21 Guidelines GCP guidelines for clinical trials- 1995