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Principles of Ethics in Human Research: Surgical Trials (& tribulations) Lisa Schwartz, PhD Arnold L Johnson Chair in Health Care Ethics McMaster University.

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Presentation on theme: "Principles of Ethics in Human Research: Surgical Trials (& tribulations) Lisa Schwartz, PhD Arnold L Johnson Chair in Health Care Ethics McMaster University."— Presentation transcript:

1 Principles of Ethics in Human Research: Surgical Trials (& tribulations) Lisa Schwartz, PhD Arnold L Johnson Chair in Health Care Ethics McMaster University CORE 2008

2 A Troubled History ► Nuremberg & Japan ► Tuskegee ► Milgram experiments ► HeLa cell line

3 History ► The Tuskegee Syphilis Study remains one of the most outrageous examples of disregard of basic ethical principles of conduct (not to mention violation of standards for ethical research). In 1976, historian James Jones (1981) interviewed John Heller, director of the Venereal Diseases unit of the PHS from 1943 to Among Heller's remarks were the following: "The men's status did not warrant ethical debate. They were subjects, not patients; clinical material, not sick people" (Bad Blood; p. 179). ► Tuskegee University

4 The response ► Nuremberg code ► Declaration of Helsinki ► CIOMS Statement ► Tri-Council Policy Statement (Canada) ► National Committee on Ethics in Human Research (Canada) ► Belmont Report (US) ► Office of Human Research Protection (US) ► MRC guidelines (http://www.mrc.ac.uk/ethics UK) ► British Sociological Society (UK) ► Nuffield Reports (UK) ► Research Ethics Boards

5 Problems ► They need to be interpreted ► Variability of application

6 2 underpinning themes in human research

7 2 Underpinning Themes -I- The good of the many (the general good) The good of the few (individual interests)

8 Research is beneficial ► Can bring benefits, goods, better lives, safer lives… ► No argument there. ► Research is a good thing.

9 Research entails risks ► No research is risk free ► Some risks can be anticipated ► Some risks can be mitigated ► Some risks can be avoided ► But because it is research we cannot anticipate all risks

10 Some Guiding Principles ► Respect for participants (living & not) ► Beneficent intentions ► Utility ► Justice

11 Consultation Draft of TCPS December 3, March 31, 2009 ► ► Updated & open for review at PRE website ► ► ► ► New core principles:   concern for welfare;   respect for autonomy;   respect for equal moral status of all humans

12 Respect for Participants ► Respect for autonomy and human dignity ► Informed Consent ► Honesty ► Confidentiality fairly applied ► Fair recruitment procedures ► Follow up ► Collaborative research

13 Ends, means, subjects and objects There is a danger of reducing research subjects to research objects

14 Edward Weston Nude 1936 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography Masters of PhotographyMasters of Photography

15 Edward Weston Shells 1927 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography Masters of PhotographyMasters of Photography

16 Ends, means, subjects and objects ► Be aware of the humanity in each person ► Treat persons as ends in themselves and never solely as means to ends

17 Recruitment and Consent ► ► Recruiting from among my own patients   Ask an RA or resident to do the recruiting   Be available for questions ► ► Do I need consent or REB approval for chart reviews?   Yes, but it may be expedited. ► ► Can substitute decision makers consent for research?   Sometimes

18 Vulnerable ► Special populations  Children, adolescents, Indigenous persons, marginalized, low income, homeless, ► All research participants  Because of the unknown

19 Beneficence ► Given that we will ask persons to take risks for the benefit of others we must do what we can do mitigate these risks and avoid them wherever possible ► Duty to do good ► Duty to do good research ► Duty to anticipate and avoid harm ► TCPS: Balance Benefits and Harms

20 Beneficence / Non-Maleficence ► Intentions ► Outcomes Balance the good of many with the good of few

21 Minimal Harm Research Why must minimal harm research be given REB review? ► To ensure adequate methodological rigor ► To ensure confidentiality  Eg surveys are a breach of privacy ► To reduce risk  of stigma, emotional or other harm ► To maintain trust ► May be expedited

22 Utility ► Make best use of scarce resources ► Research participants are a valuable resource ► Ensure value of the research question ► Ensure quality of method

23 US Hearings on Human Experimentation, 1973 ► “Those who have borne the brunt of research – whether it is drugs or even experimental surgery – have been the more disadvantaged people within our society; have been the institutionalised, the poor, and minority members.” ► Sen. T Kennedy, prt 3, , p. 841

24 Justice & Inclusiveness ► Given that risks cannot be avoided altogether ► But are justified because of the benefits research confers ► Justice asks us to share the burdens and benefits of research fairly ► Fair distribution of risks  Do not over burden participants ► Fair distribution of benefits  Give everyone access to the benefits of being studied and of study outcomes

25 2 Underpinning Themes -I- Tension between the good of the many (the general good) vs The good of the few (individual interests)

26 2 Underpinning Themes -II-Trust&Trustworthiness

27 Trust ► Ticket ► Key

28 Without trust… ► The suspicion and fear generated by the Tuskegee Syphilis Study are evident today. Community workers report mistrust of public health institutions within the African American community. Alpha Thomas of the Dallas Urban League testified before the National Commission on AIDS: "So many African American people I work with do not trust hospitals or any of the other community health care service providers because of that Tuskegee Experiment" (National Commission on AIDS, 1990). ►

29 Academic Freedom & Responsibilities ► Depends on trustworthiness and integrity ► honest and thoughtful inquiry, ► rigorous analysis, ► accountability for the use of professional standards ► the whole process should always be open to critical assessment and debate (TCPS)

30 Research Ethics Boards ► The REB is your friend ► Element of peer review ► Protects participants ► Protects researchers

31 Special Issues for Research in Surgery? ► ► What is the difference between research and innovation?   “Most surgeons innovate on a daily basis, tailoring therapies and operations to the intrinsic uniqueness of every patient and their disease.” (quoted in Biffl et al) ► ► Is placebo (sham) surgery ethical? ► ► Are trials designed to evaluate efficacy of existing standards ethical?

32 Surgical Innovations Requiring Formal Review (Biffl et al) If the innovation is planned*, AND: ► The surgeon seeks to confirm a hunch or theory about the innovation;OR: ► The innovation differs significantly from currently accepted local practice;OR: ► Outcomes of the innovation have not been previously described;OR: ► The innovation entails potential risks for complications; OR: OR: ► Specific or additional patient consent appears appropriate, ► Then: a) The described review by a local surgical innovations committee is required, plus b) submission to the national innovations registry is required, and c) additional informed consent is required of the patient specific to the nature of the proposed innovation. ► *If an innovation occurred unplanned, it should be regarded as performed on ► an individual as-needed basis for the benefit of that particular patient, unless ► it meets any of the other five criteria. In such instances, postoperatively, the ► patient or patient’s surrogate should be informed of the innovative nature of ► the procedure. If it does not meet any of the criteria, the innovation falls under ► acceptable modifications of surgical technique.

33 When innovation becomes research (Biffl et al) ► “A systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge” ► REB review is mandatory before the research begins.

34 Are placebos ethical? “The NPWC agreed that as a general rule, research subjects in the control group of a trial …should receive an established effective therapy.” ► “The use of placebos should remain firmly grounded in the fiduciary obligations of physicians towards patients as formulated in Article 3 of the Declaration of Helsinki.” ► "The Declaration of Geneva of the World Medical Association binds the physician with the words, "the health of my patient will be my first consideration.”’ CIHR Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004)

35 A placebo comparator is acceptable in the following situations: ► There are no established effective therapies for the population and for the indication under study. ► Existing evidence raises substantial doubt regarding the net therapeutic benefit of available therapies, ► Patients are refractory to the available therapies by virtue of their past treatment history or known medical history, ► The study involves adding a new investigational therapy to established effective therapies, (established effective therapy + new therapy vs. established effective therapy + placebo), ► Patients have determined that the response to the established effective therapies for their condition is unsatisfactory to them. ► Patients have previously refused established effective therapies for their condition." ► * For articles (e) and (f) the determinations of response satisfaction and refusal of treatment must take place outside of the context of recruitment for the clinical trial and prior to the offering of trial participation to the potential subject, and be documented in a standardized manner. Under these conditions, study subjects would not necessarily be considered "refractory" to the available therapies since the choice to discontinue available therapies is based on their own opinion and values, not those of the clinicians responsible for their care. As such, regulatory approval of the therapy under investigation would not necessarily be restricted. CIHR Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004)

36 Equipoise ► Ethical acceptability of placebo requires clinical equipoise ► "Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial.” ► According to the collective wisdom of expert practitioners. CIHR Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004)

37 History & the Fiduciary Duty ► “the members of the ethics subcommittee believe that the duty of the clinician in clinical research is the same as that of the clinician outside of clinical research. The committee supports this principle as fundamental, rooted not only in traditional medical ethics but also equally in the reflection of tragic recurrent experiences which occur when physicians forget or deny their inalienable obligations to their patients”. CIHR Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004)

38 M.H. Pappworth in 1967 ► “No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second. No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good.” ► Pappworth M.H. Human Guinea Pigs; Boston: Beacon Press, 1967; pg. 27

39 References ► Albin R L 2005 “Sham surgery controls are mitigated trolleys.” Jrl of Medical Ethics 31: ► Biffl W. et al 2008 “Responsible Development and Application of Surgical Innovations: A position statement of the society of university surgeons”. Journal of the American College of Surgeons; 206: ► Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th edn. Oxford University Press ► CIHR Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004) ► Centre for Disease Control and Prevention ► Health Care Consent Act Ontario, 1996 ► Hornblum, Allen M 1998 Acres of Skin. Routledge, NY ► Morgenstern L 2008 “Can surgical research be ethical?” Surgical Innovation 15: ► MRC guidelines for good clinical practice in clinical trials ► Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical Journal 301: ► Pappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston ► Ross, S et al 2008 “Ethical issues associate with the introduction of new surgical devices, or just because we ca, doesn’t mean we should” Jrl of Obstetrics and Gynaecology of Canada 30(6): ► Tri-Council Policy Statement ► Uris L, 1992 QB VII Harper Collins London

40 References cont’d ► Stirrat GM, Farrow SC, Farndon J, et al. The challenge of evaluating surgical procedures. Ann Royal Coll Surg 1992; 74: ► Deveraux PJ, Bhandari M, Clarke V, et al. Need for expertise based randomised controlled trials. Brit Med J 2005; 330: ► Bednarska E, Bryamt D, Deveraux PJ. Orthopaedic surgeons prefer to participate in expertise-based randomized trials. Clin Orthop Relat Res2008; 466: ► McCullough P, Taylor I, Sasako M, et al. Randomised trials in surgery: problems and possible solutions. Brit Med J 2002; 324: ► Lilford R, Braunholtz D, Harris J, et al. Trials in surgery. Brit J Surg 2004; 91:6-16. ► Miller FG. Ethical issues in surgical research. Thoracic Surg Clin 2005; 15: ► Polgar S, Ng J. Ethics, methodology and the use of placebo in surgical trials. Brain Res Bull 2005; 67: ► Boyle K, Batzer FR. Is a placebo-controlled surgical trial an oxymoron? J Min Invasive Gyn Surg 2007; 14: ► Fung EK, Lore JM. Randomized controlled trials for evaluating surgical questions. Arch Otolaryngol Head Neck Surg 2002; 128: ► Hall JC, Hall JL. Randomization in surgical trials. Surgery 2002; 132: ► Kao SK, Tyson JE, Blakely ML, et al. Clinical research methodology: introduction to randomized trials. J Am Coll Surg 2008; 206: ► Bourton L, Ravaud P, Nizard R. The design and assessment of prospective randomised, controlled trials in orthopaedic surgery. J Bone Joint Surg 2007; 89B: ► Ruhbari NN, Diener MK, Wente MN, et al. Development and perspectives of randomized controlled trials in surgery. Am J Surg 2007; 194:S148-S152. ► Stirrat GM. Ethics and evidence base surgery. J Med Ethics 2004; 30:

41 Respect for persons ► TCPS  Respect for Human Dignity  Free and Informed Consent  Privacy and Confidentiality Subjects are not objects


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