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Ethics and Medical Research

Ethics and Medical Research. Richard L. Elliott, MD, PhD Professor and Director, M edical Ethics Mercer University School of Medicine. Ethics and Research. Who has done research? Published? When do you think are some ethical issues in research

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Ethics and Medical Research

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  1. Ethics and Medical Research Richard L. Elliott, MD, PhD Professor and Director, Medical Ethics Mercer University School of Medicine

  2. Ethics and Research • Who has done research? Published? • When do you think are some ethical issues in research • Have you encountered ethical issues in research?

  3. A few questions about ethics in research • Lack of informed consent – Do patients-subjects know what they are consenting to? • Mistreatment of subjects – Are subjects being treated fairly, not being abused? • Falsification of data – Is evidence-based medicine reliable? • Conflicts of interest – Is unfavorable data suppressed? • Authorship – Do we really know who is responsible for conducting a study?

  4. Prevalence of scientific misconduct: Fanelli 2% scientists admit to serious misconduct – fabrication, falsification, plagiarism 34% admit to questionable practices – dropping data points, changing research design to get favorable results

  5. Studying Scientific Misconduct • International Committee of Medical Journal Editors • Emanuel et al. What makes clinical research ethical? • Data falsification and fabrication • Fall 2012 - The Integrity of Evidence-Based Medicine • History of ethics in medical research • Tuskegee • Institutional Review Boards • Medical industry, medical research, and medical education

  6. ICMJE • International Committee of Medical Journal Editors • JAMA, NEJM, Lancet, BMJ, many others • http://www.icmje.org/ • Authorship, contributorship, and editorship • Peer review • Conflicts of interest • Privacy and confidentiality • Protection of human subjects and animals in research • Obligation to publish negative findings • Overlapping publications

  7. ICMJE - Authorship • Author means having made substantial intellectual contribution • Design, data acquisition, and/or analysis • Draft or revision of article, final approval • Each author should be able to take public responsibility for the work

  8. Ghost authors and “Guest” authors • Wislar et al. • 896 Corresponding authors published in JAMA, NEJM, Lancet, PLoS Medicine, Ann Int Med, Nature Medicine • Ghost authorship 11.0% in original research articles • Honorary authorship 25% in original research articles • 21% articles with inappropriate authorship • Gotzsche et al. PLoS Medicine • http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0040019 • 75% industry sponsored trial with ghost authors (stats mostly) • Major textbook of psychiatry ghost authored • Use of Prempro, HRT based on ghost authored paper • Vioxx studies by Merck used honorary and ghost authors

  9. ICMJE – Peer review • Peer review process not specified by ICMJE • Purpose: to provide fair, disinterested input on quality of article submitted • Blinded review (identity of author(s) removed) • Random selection of qualified reviewers • Reviewers disclose conflicts of interest • Having a peer read a paper is not peer review • Reviewers paper’s contents

  10. Concerns with peer review • Not truly blinded • Misuse of information learned during peer review • Peer review may be biased against revolutionary ideas

  11. ICMJE – Conflicts of interest • Freedom from financial or personal interests that create bias • Disclosure vs meaningful disclosure of financial interests • Other interests: personal relationships, academic competition, bias about value of work • Editorial Conflicts of interest • Revenue from advertisers

  12. ICMJE – Privacy and confidentiality • Protect identity of subjects, patients • Remove identifying information or disguise • Patient in her 40s vs 46 year old • Informed consent if potentially identifiable • Author and reviewer confidentiality should be protected

  13. ICMJE – Protection of human subjects • Paper should state whether study was carried out according to Helsinki Declaration • IRB approval • Protection of animal subjects

  14. ICMJE – Negative studies • Publication bias – failure to publish negative trials • Undermines meta-analytic studies of efficacy • Antidepressants • Many journals require studies to have been registered with clinicaltrials.gov

  15. ICMJE – Duplicate submissions • Submit to one journal only • If there are conflicting or competing publications from the same study, the journal editor should be informed

  16. Emanuel - JAMA • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for potential and enrolled subjects

  17. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Are the right questions being asked? • Avoid “trivial pursuits” - LPUs • Resource allocation • Non-maleficence (risks should be justified by possible benefits) • MCG psychotherapy study • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for potential and enrolled subjects

  18. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Is study carried out properly? Do researchers posses necessary expertise? • Invalid studies – clinical trials against improperly dosed comparison drug • VA study of psychosocial therapies with poorly defined interventions • What was meant by psychoeducation? Rehabilitation? • Fair subject selection • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for potential and enrolled subjects

  19. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Subject recruitment should meet scientific needs • Groups exposed to risks should share in benefits • Not biased by socioeconomic or other factors • Tuskegee • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for potential and enrolled subjects

  20. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Potential risks are minimized, potential benefits enhanced • Potential benefits are proportional to or exceed potential risks • Phase I trials? • Independent review • Informed consent • Respect for potential and enrolled subjects

  21. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Independent review • Review by a party with no stake in outcome of review • Reduce risks of potential conflicts of interest • MCG psychotherapy case – not independent review • Informed consent • Respect for potential and enrolled subjects

  22. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Independent review • Informed consent • Protection of vulnerable populations – children, incapacitated adults, prisoners, pregnant women, and others • Must consider possibility of coerced consent via inducements or vulnerability • Willowbrook • What needs to ne disclosed? Possible financial gain for researchers? • Respect for potential and enrolled subjects

  23. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711 • Social or scientific value • Scientific validity • Fair subject selection • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for potential and enrolled subjects • Privacy and confidentiality • Non-identification of subjects

  24. Scientific misconduct (fraud) • Falsification or fabrication of data • Newton, Mendel, Millikan • Scott S. Reuben faked data in 21 studies on pain medicines • Andrew Wakefield and relationship between vaccines and autism • Woo-Suk Hwang and cloning of human embryonic stem cells • Dipak Das U Conn resveratrol 26 articles retracted • Anil Potti, Duke, individualized treatments for ovarian cancer • 1/3 of 40 papers retracted, another 1/3 portions retracted • Marc D. Hauser Harvard evolutionary biologist fabricated and falsified data • Eric Poehlman obesity research imprisoned • Scientific recordkeeping • Importance of lab books in verifying collection of data

  25. Resources • Medapps.mercer.edu • http://www.wame.org/ethics-resources/web-resources-on-publication-and-research-ethics/ • http://www.fic.nih.gov/ResearchTopics/Pages/Bioethics.aspx

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