Please select a module or learning objective:

Module 1

Learning Objective 1.1, 1.2, 1.3, 1.4 

Module 2

Learning Objective 2.1, 2.2, 2.3

Module 3

Learning Objective 3.1, 3.2, 3.3, 3.4, 3.5

Module 4

Learning Objective 4.1, 4.2, 4.3, 4.4

Module 5

Learning Objective 5.1, 5.2, 5.3

Module 6

Learning Objective 6.1, 6.2, 6.3, 6.4

Module 7

Learning Objective 7.1, 7.2, 7.3

 

Module 1

   Learning Objective 1.1:

  1. Centers for Disease Control and Prevention (2010) Distinguishing public health research and public health nonresearch. Atlanta, Georgia (http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf)

  2. Fairchild AL, Bayer R, Colgrove C (2007) Searching eyes: privacy, the state, and disease surveillance in America. Berkeley, California: University of California Press.

  3. Rubel A. Justifying public health surveillance: basic interests, unreasonable exercise, and privacy. Kennedy Inst Ethics J 2012;22(1):1–33.

  4. Selgelid MJ (2014) Public health: VII. Health surveillance. In: Jennings B, editor. Bioethics, 4th Edition. Farmington Hills, Michigan: Macmillan Reference.

  5. Verity C, Nicoll A (2002) Consent, confidentiality, and the threat to public health surveillance. BMJ 2002;324:1210–3.

  6. World Health Organization (2010) Research ethics in international epidemic response. Meeting report: WHO technical consultation 10–11 June 2009. Geneva (http://www.who.int/ethics/gip_research_ethics_.pdf).

 

   Learning Objective 1.2:

  1. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (2010) Tri-Council policy statement: ethical conduct for research involving humans. Ottawa (http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_ Web.pdf, accessed 29 August 2014).

  2. Cash R, Wikler D, Saxena A, Capron A (2009) Casebook on ethical issues in international health research. Geneva: World Health Organization (http://whqlibdoc.who.int/publications/2009/9789241547727_eng. pdf, accessed 29 August 2014).

  3. Chan KY, Ching JC, Xu MS, Cheung AN, Yip SP, Lam LY, et al. (2007) Association of ICAM3 genetic variant with severe acute respiratory syndrome. J Infect Dis 196(2):271–80.

  4. Chu D, Chen RC, Ku CY, Chou P (2008) The impact of SARS on hospital performance. BMC Health Serv Res 8:228.

  5. Ferry RF, van der Rijt T (2010) Overview of research activities associated with the World Health Organization: results of a survey covering 2006/07. Health Res Policy Syst 8:25.

  6. Hunt MR, Anderson JA, Boulanger RF (2012) Ethical implications of diversity in disaster research. Am J Disaster Med 7(3):211–21.

  7. Merchant RM, Elmer S, Lurie N (2011) Integrating social media into emergency-preparedness efforts. N Engl J Med 365(4):289–91.

  8. National Institutes of Health (2013) Clinical trial of interpersonal therapy for survivors of the Sichuan earthquake. Bethesda, Maryland (ClinicalTrials.gov identifier NCT01624935) (http://clinicaltrials.gov/ct2/ show/NCT01624935).

  9. Office for Human Research Protections (2012) International compilation of human research standards. 2012 edition. Washington DC: Department of Health and Human Services (http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html).

  10. Sumathipala A (2008) Research ethics must still apply in disaster zones. Sci Dev Net (http://www.scidev.net/global/disasters/opinion/research-ethics-must-still-apply-in-disaster-zones.html).

  11. World Health Organization (1997) Consultation on applied health research priorities in complex emergencies, 28–29 October 1997. Report. Geneva: Division of Emergency and Humanitarian Action (www.who.int/disasters/repo/5949.doc).

  12. World Health Organization (2011) Standards and operational guidance for ethics review of health-related research with human participants. Geneva (http://apps.who.int/iris/bitstream/10665/44783/1/9789241502948_eng.pdf).

  13. Zheng Y, Fan F, Liu X, Mo L (2012) Life events, coping, and posttraumatic stress symptoms among Chinese adolescents exposed to 2008 Wenchuan earthquake, China. PLoS One  7(1):e29404.

 

   Learning Objective 1.3:

  1. Anonymous (1949) Trials of war criminals before the Nuremberg military tribunals under Control Council Law No. 10, Vol. 2. 181–182. Washington DC, Government Printing Office.

  2. Bazin H (2001) The ethics of vaccine usage in society: lessons from the past. Endeavour 25(3):104–8.

  3. Brandt AM (1978) Racism and research: the case of the Tuskegee syphilis study. Hastings Center Rep 8(6):21–9.

  4. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council (1998) Tri-council policy statement: ethical conduct for research involving humans. Ottawa, Interagency Secretariat on Research Ethics.

  5. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council (2005) Tri-council policy statement: ethical conduct for research involving humans. Ottawa: Interagency Secretariat on Research Ethics.

  6. Council for International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Geneva.

  7. Council of Europe (1997) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo (http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm)

  8. Davies H (2007) Ethical reflections on Edward Jenners experimental treatment. J Med Eth 33(3):174–6.

  9. Department of Health and Human Services (1991) Public welfare. Part 46 (Protection of human subjects). Subparts A–E. US Code of Federal Regulations (Title 45).

  10. Department of Health and Human Services, Office of Science and Technology Policy (2011) Advance notice of proposed rulemaking: human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators (FR Doc. No.: 2011-18792). Rockville, Maryland.

  11. Department of Health and Human Services (2012) International compilation of human research standards. 2012 edition. Washington DC: Office for Human Research Protections (http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html).

  12. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20):2701–11.

  13. Emanuel EJ, Wendler D, Killen J, Grady C (2004) What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 189(5):930–7.

  14. Guenter D, Esparza J, Macklin R (2000) Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). J Med Eth 26(1):37–43.

  15. Henry LM (2013) Introduction: revising the common rule: prospects and challenges. J Law Med Eth 41(2):386–9.

  16. Kent G (1997) The views of members of local research ethics committees, researchers and members of the public towards the roles and functions of LRECs. J Med Eth 23(3):186–90.

  17. Levine MM (1996) The legacy of Edward Jenner. BMJ 312(7040):1177.

  18. Millum J, Wendler D, Emanuel EJ (2013) The 50th anniversary of the Declaration of Helsinki: progress but many remaining challenges. JAMA 310(20):2143–4.

  19. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC: Department of Health, Education, and Welfare.

  20. Nyika A (undated) The Trovan trial case study: After profits or to save lives? Dar es Salaam: African Malaria Network Trust, Tanzania Commission for Science and Technology (http://www.slideserve.com/bluma/the-trovan-trial-case-study-after-profits-or-to-save-lives-available-at-amanet-trust).

  21. Okonta PI (2014) Ethics of clinical trials in Nigeria. Niger Med J 55(3):188.

  22. Resnik DB (2012) Research ethics timeline (1932–present). Research Triangle Park, North Carolina: National Institute of Environmental Health Sciences (www.niehs,nih.gov/research/resources/bioethics/timeline).

  23. Shuster E (1997) Fifty years later: the significance of the Nuremberg Code. N Engl J Med 337(20):1436–40.

  24. Turbes S, Krebs E, Axtell S (2002) The hidden curriculum in multicultural medical education: the role of case examples. Acad Med 77(3):209–16.

  25. World Health Organization (1995) Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series No. 850). Geneva; 97–137.

  26. World Medical Association (1964) Declaration of Helsinki—ethical principles for medical research involving human subjects. Ferney-Voltaire.

  27. Zalta EN, editor (2014) Stanford Encyclopedia of Philosophy. Stanford, California: Center for the Study of Language and Information, Stanford University (plato.stanford.edu/).

 

   Learning Objective 1.4:

  1. Alahmad G, Al-Jumah M, Dierickx K (2012) Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC Med Eth 13(1):34 (http://www.biomedcentral.com/1472-6939/13/34).

  2. Bekelman JE, Li Y, Gross CP (2003) Scope and impact of financial conflicts of interest in biomedical research. JAMA 289(4):454–65.

  3. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (2010) Tri-Council policy statement: ethical conduct for research involving humans. Ottawa.

  4. Chor JS, Ngai KL, Goggins WB, Wong MC, Wong SY, Lee N, et al. (2009) Willingness of Hong Kong healthcare workers to accept pre-pandemic influenza vaccination at different WHO alert levels: two questionnaire surveys. BMJ 339:b3391.

  5. Cohen D, Carter P (2010) WHO and the pandemic flu “conspiracies”. BMJ 340:c2912.

  6. Council for International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Ferney-Voltaire.

  7. Department of Health and Human Services (1991) Public welfare, Part 46 (Protection of human subjects), subparts A–E. US Code of Federal Regulations. Rockville, Maryland.

  8. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20):2701–11.

  9. Henderson GE (2007) Applying research ethics guidelines: the view from a sub-Saharan research ethics committee. J Empir Res Hum Res Eth 2(2):41–8.

  10. Hunter D (2007) Proportional ethical review and the identification of ethical issues. J Med Eth 33(4) 241–5.

  11. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L (2004) Ethical review of health research: a perspective from developing country researchers. J Med Eth 30(1):68–72.

  12. International Committee of Medical Journal Editors (2013) Uniform requirements for manuscripts submitted to biomedical journals: recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals (www.icmje.org).

  13. Jefferson T (2006) Public health: influenza vaccination: policy versus evidence. BMJ 333(7574):912.

  14. Kinlaw K, Barrett DH, Levine RJ (2009) Ethical guidelines in pandemic influenza: recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention. Disaster Med Public Health Prep 3(Suppl 2):185–92.

  15. Kotalik J (2005) Preparing for an influenza pandemic: ethical issues. Bioethics 19(4):422–31.

  16. Longini IM, Halloran ME (2005) Strategy for distribution of influenza vaccine to high-risk groups and children. Am J Epidemiol 161(4):303–6.

  17. Millum J, Wendler D, Emanuel EJ (2013) The 50th anniversary of the Declaration of Helsinki: progress but many remaining challenges. JAMA 310(20):2143–4.

  18. Nyika A (undated) The Trovan trial case study: After profits or to save lives? Dar es Salaam: African Malaria Network Trust, Tanzania Commission for Science and Technology (http://www.slideserve.com/bluma/the-trovan-trial-case-study-after-profits-or-to-save-lives-available-at-amanet-trust).

  19. Okonta PI (2014) Ethics of clinical trials in Nigeria. Niger Med J 55(3):188.

  20. Thompson DF (1993) Understanding financial conflicts of interest. N Engl J Med 329:573.

  21. World Health Organization (2007) Ethical considerations in developing a public health response to pandemic influenza. Geneva.

  22. World Health Organization (2009a) Research ethics in international epidemic response. Meeting report of a WHO technical consultation group. Geneva (http://www.who.int/ethics/gip_research_ethics_.pdf).

  23. World Health Organization (2009b) Pandemic influenza preparedness and response: a WHO guidance document. Geneva: Global Influenza Programme.

  24. World Health Organization (2014) Ethical considerations for use of unregistered interventions for Ebola viral disease. Report of an advisory panel to WHO (WHO/HIS/KER/GHE/14.1). Geneva.

  25. World Medical Association (2008) Declaration of Helsinki—principles of medical research involving human subjects. Ferney-Voltaire.

 

Module 2

 

Learning Objective 2.1:

  1. Edwards SJL (2009) The rationale for ethics review of research by committee. Res Eth Rev 5(4):147–50. Hodge JG, Gostin LO (2004) Public Health Practice vs. Research. Atlanta, Georgia: Council of State and Territorial Epidemiologists (http://www.vdh.virginia.gov/OFHS/policy/documents/2012/irb/pdf/Public%20Health%20Practice%20versus%20Research.pdf, accessed 22 September 2014). 

  2. Klitzman R (2012) Institutional review board community members: who are they, what do they do, and whom do they represent? Acad Med 87(7):975–81.

  3. Limkakeng AT  Jr, de Oliveira LL, Moreira T, Phadtare  A, Garcia Rodrigues C, Hocker MB, et al. (2013) Systematic review and metasummary of attitudes toward research in emergency medical conditions. J Med Eth; doi:10.1136/medethics-2012-101147.

  4. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC: Department of Health, Education, and Welfare.

  5. Nuffield Council on Bioethics (2002) The ethics of research related to healthcare in developing countries. London (www.nuffieldbioethics.org).

  6. Nuffield Council on Bioethics (2005) The ethics of research related to healthcare in developing countries, follow-up discussion paper. London (www.nuffieldbioethics.org).

  7. Petrini C. Ethics of clinical science in a public health emergency: reflections on the role of research ethics boards. Am J Bioeth 2013;13(9):27–9.

  8. Sims CA, Isserman JA, Holena D, Sundaram LM, Tolstoy N, Greer S, et al. Exception from informed consent for emergency research: consulting the trauma community. J Trauma Acute Care Surg 2013;74(1):157–65. 

  9. Stephens SW, Williams C, Gray R, Kerby JD, Wang HE. Preliminary experience with social media for community consultation and public disclosure in exception from informed consent trials. Circulation 2013;128(3):267–70.

  10. Sumathipala A, Jafarey A, De Castro LD, Ahmad A, Marcer  D, Srinivasan S, et al. Ethical issues in post-disaster clinical interventions and research: a developing world perspective. Key findings from a drafting and consensus generation meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007. Asian Bioeth Rev 2010;2(2):124–42.

  11. World Health Organization (2010) Research ethics in international epidemic response. Meeting report. Geneva (http://www.who.int/ethics/gip_research_ethics_.pdf).

 

Learning Objective 2.2: 

  1. Edwards SJL (2009) The rationale for ethics review of research by committee. Res Eth Rev 5:147–50.

  2. Goodman KW, Meslin EM (2014) Ethics, information technology and public health: duties and challenges in computational epidemiology. In: Magnuson JA, Fu PC, editors. Public health informatics and information systems, 2nd Edition, London: Springer-Verlag; 191–209. 

  3. Hodge JG, Gostin LO (2004) Public health practice vs. research: a report for public health practitioners including cases and guidance for making distinctions. Atlanta, Georgia: Council of State and Territorial Epidemiologists (http://www.cste2.org/webpdfs/CSTEPHResRptHodgeFinal.5.24.04.pdf).

  4. Lee L, Heilig C, White A (2012) Ethical justification for conducting public health surveillance without patient consent. Am J Public Health 32(1):38–44.
  5. Meslin EM, Goodman KW (2010) Bank on it: an ethics and policy agenda for biobanks and electronic health records. Science Progress (http://www.scienceprogress.org/2010/02/bank-on-it).

  6. World Health Organization (2010) Research ethics in international epidemic response. Meeting report of a WHO technical consultation group. Geneva.

 

Learning Objective 2.3: 

  1. Angell M (1997) The ethics of research in the third world. N Engl J Med 12:847–9.

  2. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (2010) Tri-Council policy statement: ethical conduct for research involving humans. Ottawa (http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_ Web.pdf, accessed 29 August 2014).

  3. Council for International Organizations of Medical Sciences (2009) International ethical guidelines for epidemiological studies. Geneva.

  4. Curry RD, Waldman RJ, Caplan AL (2014) An ethical framework for the development and review of health research proposals involving humanitarian contexts. A project report, 2014. London: Enhancing Learning and Research for Humanitarian Assistance (http://www.elrha.org/uploads/FINAL%20R2HC%20Ethical%20Framework_Final%20Report_24%20January%202014_1.pdf)

  5. Edwards SJL (2013) Drug discovery at the bedside: ethics of clinical science during a pandemic. Am J Bioeth13(9):1–14, with response to open peer commentaries: Am J Bioeth 2013;13(9):W1–3.

  6. Kilpatrick DG (2004) The ethics of disaster research: a special section. J Trauma Stress 17(5):361–2.

  7. Limkakeng AT Jr, de Oliveira LL, Moreira T, Phadtare A, Garcia Rodrigues C, Hocker MB, et al. (2013)

  8. Systematic review and metasummary of attitudes toward research in emergency medical conditions. J Med Eth; doi:10.1136/medethics-2012-101147.

  9. Missouri Department of Health (2009) Missouri ESSENCE policies and procedures. Jefferson City: Senior Services Public Health Event Detection and Assessment Program (http://health.mo.gov/data/essence/pdf/ policiesprocedures.pdf).

  10. O’Mathúna D (2012) Roles and challenges for IRBs with disaster research. Res Pract 167–74.

  11. Schopper D (2011) Research ethics governance in disaster situations. In: Disaster Bioethics Symposium. Geneva: Brocher Foundation (http://disasterbioethics.com/symposium/).

  12. Sims CA, Isserman JA, Holena D, Sundaram LM, Tolstoy N, Greer S, et al. (2013) Exception from informed consent for emergency research: consulting the trauma community. J Trauma Acute Care Surg 74(1):157–65.

  13. Siriwardhana C, Hewage S, Deshabandu R, Siribaddana S, Sumathipala A (2012) Psychosocial and ethical response to disasters: a SWOT analysis of post-tsunami disaster management in Sri Lanka. Asian Bioeth Rev 4(3):171–82.

  14. Sumathipala A, Fernando B. Ethical issues in global mental health trials. In: Thornicroft G, Patel V, editors. Global mental health trials. Oxford: Oxford University Press; 123–38.

  15. Sumathipala A, Jafarey A, De Castro L, Ahmed A, Marcer D, Srinivasan S, et al. Ethical issues in post-disaster clinical interventions and research: a developing world perspective. Key findings from a drafting and consensus generation meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007. Asian Bioeth Rev 2(2):224–42.

  16. Tansey CM, Herridge MS, Heslegrave RJ, Lavery JV (2010) A framework for research ethics review during public emergencies. Can Med Assoc J 182(14):1533–7.

  17. World Health Organization (2010) Research ethics in international epidemic response. Meeting report of a WHO technical consultation group. Geneva.

 

Module 3

 

Learning Objective 3.1:

  1. Bernstein AB, Sweeney MH (2012) Public health surveillance data: legal, policy, ethical, regulatory, and practical issues. Morbid Mortal Wkly Rep 61(Suppl):30–9.

  2. Cash R, Wikler D, Saxena A, Capron A, editors (2009) Casebook on ethical issues in international health research. Geneva: World Health Organization; 62.

  3. Faden R (2007) Social justice and pandemic planning and response. In: Ethical and legal considerations in mitigating pandemic disease: workshop summary. Washington DC: National Research Council; 177–201.

  4. Field RI, Caplan AL (2008) A proposed ethical framework for vaccine mandates: competing values and the case of HPV. Kennedy Inst Eth J 18(2):111–24.

  5. Lee LM, Heilig CH, White A (2012) Ethical justification for conducting public health surveillance without patient consent. Am J Public Health 102(1):38–44.

  6. Nuffield Council on Bioethics (2007) Public health: the ethical issues. London (http://www.nuffieldbioethics. org/public-health).

  7. Pollack A (2009) Fear of a swine flu epidemic in 1976 offers some lessons and concerns today. New York Times, 9 May 2009 (www.nytimes.com/2009/05/09/health/09vaccine.html, accessed 18 September 2014).

  8. United Nations Commission on Human Rights (1984) The Siracusa principles on the limitation and derogation provisions in the International Covenant on Civil and Political Rights, 28 September 1984. New York (E/ CN.4/1985/4) (www.refworld.org/docid/4672bc122.html).

  9. Williamson J, Robinson M (2006) Psychosocial interventions, or integrated programming for well-being? Intervention 4(1):4–25.

 

Learning Objective 3.2: 

  1. Capron, AM (1974) Informed consent in catastrophic disease research and treatment. Univ Pa Law Rev
    123:340–438.

  2. Coleman CH, Selgelid MJ, Reis A, Reichman LB, Jaramillo E (2012) The role of informed consent in tuberculosis testing and screening. Eur Resp J 39(5):1057–9.
  3. Council of International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Geneva.

  4. Council of International Organizations of Medical Sciences (2009) Commentary on guideline 4 international ethical guidelines for epidemiological studies. Geneva; 42–4.

  5. Department of Health and Human Services (2009) Basic HHS policy for the protection of human research subjects. Rockville, Maryland.

  6. Gostin LO (2008) Surveillance and public health research: personal privacy and the “right to know”. In: Public health law: power, duty, restraint. 2nd Ed. Berkeley, California: University of California Press; 287–330.

  7. Mystakidou K, Panagiotou I, Katsaragakis S, Tsilika E, Parpa E (2009) Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries. J Soc Aspects HIV/AIDS 6:46–57.
  8. Nuremberg Military Tribunals (1949) Trials of war criminals before the Nuremberg military tribunals under
    Control Council Law No. 10, Vol. 2. 181–182. Washington DC, Government Printing Office.

  9. Parmet WE (2005) Informed consent and public health: Are they compatible when it comes to vaccines? J Health Care Law Policy 8(1):71–110.
  10. World Medical Association (2013) Declaration of Helsinki. Ferney-Voltaire (http://www.wma.net/
    en/30publications/10policies/b3/).

 

Learning Objective 3.3:

  1. Beauchamp TL, Childress JF (1994) Principles of Biomedical Ethics, 4th edition. New York: Oxford University Press.

  2. Boruch RF, Cecil, JS (1979) Assuring the confidentiality of social research data. Philadelphia: University of Pennsylvania Press.

  3. Mill JS (1859) On liberty. London: Electric Book Company.

  4. Upshur R (2002) Principles for the justification of public health intervention. Can J Public Health 93(2):101–3.

 

Learning Objective 3.4: 

  1. College of American Pathologists (2012) Informed consent for the donation, use, and disposition of human tissue for non-diagnostic purposes. Northfield, Illinois (http://www.cap.org/apps/cap.portal?_ nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrP tlt&cntvwrPtlt%7BactionForm.contentReference%7D=policies%2Fpolicy_appI.html&_state=maximized&_ pageLabel=cntvwr, accessed 5 September 2014).

  2. National Bioethics Advisory Commission (1999) Research involving human biological materials: ethical issues and policy guidance. Washington DC.

  3. National Bioethics Advisory Commission (2001) Ethical and policy issues in international research: clinical trials in developing countries. Washington DC.

  4. National Cancer Institute (2010) National Cancer Institute best practices for biospecimen resources, Appendix 4 sample material transfer agreement. Research Triangle Park, North Carolina (http://biospecimens. cancer.gov/bestpractices/Appendix4.pdf, accessed 12 September 2014).

 

Learning Objective 3.5:

  1. Brock D (1998) Quality of life measures in health care and medical ethics. In: Brock D, editor. Life and death. New York: Cambridge University Press; 268–324.

  2. Dworkin R (1978) Taking rights seriously. Cambridge, Massachusetts: Harvard University Press. 

  3. Harris J, Holm S (1995) Is there a moral obligation not to infect others? Br Med J 311:1215–7. 

  4. Mill JS (1859) On liberty. Indianapolis, Indiana: Hackett, reprinted 1979.

  5. Selgelid MJ (2007) Ethics and infectious disease. Bioethics 21(4):218–29.

 

Module 4

 

Learning Objective 4.1: 

  1. Baylis F, Kenney N, Sherwin S (2008) A relational account of public health ethics. Public Health Eth 1(3):196–209.

  2. Benatar S (2006) Facing ethical challenges in rolling out antiretroviral treatment in resource-poor countries:comment on “They call it ‘patient selection’ in Khayelitsha”. Cambridge Q Healthcare Eth 15:322–30.

  3. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (2010) Tri-Council policy statement: ethical conduct for research involving humans (TCPS2), December 2010. Ottawa (http://www.pre.ethics.gc.ca/eng/ policy-politique/initiatives/tcps2-eptc2/Default/).

  4. Daniels N, Sabin JE (1997) Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philosophy Public Affairs 26(4):303–50.

  5. Edwards SJL (2013) Ethics of clinical experimentation in a public health emergency: drug discovery at the bedside. Am J Bioeth 13(9):3–14

  6. Horrobin DF (2003) Are large clinical trials in rapidly lethal diseases usually unethical? Lancet 361:695–7.

  7. Naylor D, Basrur SH, Bergeron MG, Brunham RC, Butler-Jones D, Dafoe G, et al. (2003) Learning from SARS: renewal of public health in Canada. A report of the National Advisory Committee on SARS and Public Health. Ottawa: Health Canada (Publication No. 1210).

  8. Nyika A (undated) The Trovan trial case study: after profits or to save lives? Dar es Salaam: African Malaria Network Trust, Tanzania Commission for Science and Technology (http://www.slideserve.com/bluma/the- trovan-trial-case-study-after-profits-or-to-save-lives-available-at-amanet-trust, accessed 25 November 2014).

  9. O’Mathúna DP (2010) Conducting research in the aftermath of disasters: ethical considerations. J Evid Based Med 3(2):65–75 Pappworth MH (1967) Human guinea pigs. Boston, Massachusetts: Beacon Press.

  10. National Collaborating Centre for Aboriginal Health (2012) Population and public health ethics: cases from research, policy, and practice. Prince George, British Columbia (http://www.nccah-ccnsa.ca/en/publications. aspx?sortcode=2.8.10&publication=86#sthash.f3o1A5Zk.dpuf).

  11. Shah S (2002) Globalizing clinical research. The Nation, 13 June 2002 (http://www.thenation.com/article/globalizing-clinical-research?page=full).

  12. Veatch RM (2000) Doctor does not know best: why in the new century physicians must stop trying to benefit patients. J Med Philosophy 25(6):701–21.

  13. World Health Organization (2007) Ethical considerations in developing a public health response to pandemic influenza. Geneva (EPR Publications) (http://www.who.int/csr/resources/publications/WHO_CDS_EPR_GIP_2007_2c.pdf).

 

Learning Obejective 4.2: 

  1. Gostin L (2006) Public health strategies for pandemic influenza: ethics and the law. JAMA 295:1700–4. 

  2. Kass NE (2001) An ethics framework for public health. Am J Public Health 91:1776–82.

  3. Rawls J (1999) A theory of justice. Cambridge, Massachusetts: Belknap Press.

  4. Selgelid MJ (2009) A moderate pluralistic approach to public health policy and ethics. Public Health Eth 2(2):195–205.

  5. Upshur R (2002) Principles for the justification of public health intervention. Can J Public Health 93:101–3.

 

Learning Objective 4.3:

  1. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (2010) Tri-Council Policy Statement: ethical conduct for research involving humans (TCPS2), December 2010. http://www.pre.ethics.gc.ca/eng/policy-politique/ initiatives/tcps2-eptc2/Default/National

  2. Institute of Dental and Craniofacial Research (2013) Minimal risk protocol template (last updated July 2013). Bethesda, Maryland (http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/MinimalRisk ProtocolTemplate.htm).

 

Learning Objective 4.4:

  1. AVAC: Global Advocacy for HIV Prevention (2014) GPP blueprint for stakeholder engagement. Good participatory Practice tools. New York (http://www.avac.org/sites/default/files/resource-files/GPPBlueprint_%202014.pdf).

  2. Benatar SR (2002) Reflections and recommendations on research ethics in developing countries. Soc Sci Med 54:1131–41.

  3. Bhutta ZA (2004) Beyond informed consent. Bull World Health Organ 82(10):771–7.

  4. Beauchamp TL, Walters L, Kahn JP, Mastroianni AC (2014) Contemporary issues in bioethics. 8th Edition. South Melbourne, Victoria: Cengage Learning; 180, 556, 558.

  5. Bosely S, Smith D (2010) As doctors fought to save lives, Pfizer flew in drug trial team. The Guardian, 9 December 2010 (http://www.theguardian.com/business/2010/dec/09/doctors-fought-save-lives-pfizer- drug, accessed 12 September 2014).

  6. Council for International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Geneva.

  7. Dawson L, Kass NE (2005) Views of US researchers about informed consent in international collaborative research. Soc Sci Med 61:1211–22.

  8. Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA (2005) Community permission for medical research in developing countries. Clin Infect Dis 41(2):255–9.

  9. Dresden E, McElmurry BJ, McCreary LL (2003) Aproaching ethical reasoning in nursing research through a communitarian perspective. J Prof Nurs 19(5):295–304.

  10. Ekunwe EO, Kessel R (1984) Informed consent in the developing world. Hastings Center Rep 14:22–4.

  11. Ganguli Mitra A (2012) Off-shoring clinical research: exploitation and the reciprocity constraint. Dev World Bioeth 13:111–8.

  12. Hurst SA (2008) Vulnerability in research and health care: describing the elephant in the room? Bioethics 22(4):191–202.

  13. Luna F (2009) Elucidating the concept of vulnerability: layers not labels. Int J Feminist Approaches Bioeth 2(1):121–39.

  14. Marshall PA (2006) Informed consent in international health research. J Empirical Res Human Res Eth 1(1):25–42.

  15. Médecins sans Frontières (2011) Statement: Pfizer promoted misleading and false accusations of MSF’s involvement in unethical drug trials the company conducted in Nigeria in 1996. Geneva (http://www.msf.org/article/statement-pfizer-promoted-misleading-and-false-accusations-msfs-involvement-unethical-drug, accessed 12 September 2014).

  16. Molyneux CS, Peshu N, Marsh K (2005) Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med 61(7):1463–73.

  17. Murray S (2007) Anger at deadly Nigerian drug trials. BBC News, 20 June 2007 (http://news.bbc.co.uk/2/hi/africa/6768799.stm, accessed 12 September 2014).

  18. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC: Department of Health, Education, and Welfare.

  19. Nyika A (undated) The Trovan trial case study: After profits or to save lives? Dar es Salaam: African Malaria Network Trust, Tanzania Commission for Science and Technology (http://www.slideserve.com/bluma/ the-trovan-trial-case-study-after-profits-or-to-save-lives-available-at-amanet-trust, accessed 25 Novem- ber 2014).

  20. Okonta P (2014) Ethics of clinical trials in Nigeria. Niger Med J 55(3):188–94.

  21. Vreeman R, Kamaara E, Kamanda A, Ayuku D, Nyandiko W, Atwoli L, et al. (2012) A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya. BMC Med Eth 13:23.

 

Module 5

 

Learning Objective 5.1:

  1. Balasegaram M, Harris S, Checchi F, Hamel C, Karunakara U (2006) Treatment outcomes and risk factors for relapse in patients with early-stage human African trypanosomiasis (HAT) in the Republic of the Congo. Bull World Health Organ 84(10):777–82.
  2. Calain P, Fiore N, Poncin M, Hurst SA (2009) Research ethics and international epidemic response: the case of Ebola and Marburg hemorrhagic fevers. Public Health Eth 2(1):7–29.
  3. Committee on Publication Ethics (2011) Code of conduct and best practice guidelines for journal editors. London (http://publicationethics.org/files/Code_of_conduct_for_journal_editors_1.pdf).
  4. Gollogly L (2006) Ethical approval for operational research. Bull World Health Organ 84(10):766. 
  5. International Committee of Medical Journal Editors (2009) Recommendations for the conduct, reporting,
    editing, and publication of scholarly work in medical journals: roles and responsibilities of authors,
    contributors, reviewers, editors, publishers, and owners: protection of research participants. Rockville, Maryland: Institute of Medicine (http://www.icmje.org/roles_e.html).

  6. Langat P, Pisartchik D, Silva D, Bernard C, Olsen K, Smith M, et al. (2011)  Is there a duty to share? Ethics of sharing research data in the context of public health emergencies. Public Health Eth 4(1):4–11.
  7. Public Health Ontario (2011) An ethical framework for public health projects, discussion paper, Toronto. 
  8. Remme JHF, Adam T, Becerra-Posada F, D’Arcangues C, Devlin M, Gardner C, et al. (2010) Defining research
    to improve health systems. PLoS Med 7(11):e1001000.

  9. Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, Ahmad A, et al. (2009) Research ethics review in humanitarian contexts: the experience of the independent ethics review board of Médecins Sans Frontières. PLoS Med 6(7):e1000115.
  10. World Medical Association (2013) Declaration of Helsinki. Ferney-Voltaire (http://www.wma.net/
    en/30publications/10policies/b3/).

 

Learning Objective 5.2: 

  1. Banatvala N, Zwi AB (2000) Public health and humanitarian interventions: developing the evidence base. Br Med J 321:101–5.

  2. Bensimon CM, Upshur REG (2007) Evidence and effectiveness in decision-making for quarantine. Am J Public Health 97:S44–8.

  3. Bowen S, Zwi AB (2005) Pathways to “evidence-informed” policy and practice: a framework for action. PLoS Med 2(7):e166.

  4. Channel 4 News (2009) New doubts about Tamiflu. London (http://www.channel4.com/news/articles/science_technology/new+doubts+over+tamiflu/3454737.html).

  5. Cohen D (2009) Complications: tracking down the data on oseltamivir. BMJ 339:b5387.

  6. Delva V (2013) Do commercial interests impact clinical science during a public health emergency? Am J Bioeth 13(9):25–6.

  7. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E, et al. (2008) Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 3(8):e3081.

  8. Egger M, Smith GD (1995) Misleading meta-analysis. Br Med J 310:752–4.

  9. Godlee F, Clarke M (2009) Why don’t we have all the evidence on oseltamivir? BMJ 339:b5351.

  10. Godlee F, Loder E (2010) Missing clinical trial data: setting the record straight. Urgent action is needed to restore the integrity of the medical evidence base. BMJ 341:c5641.

  11. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K (2009) Publication bias in clinical trials due to statistical significance or direction of trial results (review). Cochrane Library 1:1–26.

  12. Ioannidis JPA, Manzoli L, De Vito C, D’Addario M, Villari P (2011) Publication delay of randomized trials on 2009 influenza A (H1N1) vaccination. PLoS One 6(12):e28346.

  13. Jefferson T, Jones M, Doshi P, Del Mar C (2009) Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and metaanalysis. BMJ 339:b5106.

  14. Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F (2003) Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 163:1667–72

  15. Knox Clarke P, Darcy J (2014) Insufficient evidence? The quality and use of evidence in humanitarian action. London: Active Learning Network for Accountability and Performance in Humanitarian Action (ALNAP, Overseas Development Institute.

  16. Kohatsu ND, Robinson JG, Torner JC (2004) Evidence-based public health: an evolving concept. Am J Prev Med 27(5):417–21.

  17. Mahoney MJ (1977) Publication prejudices: an experimental study of confirmatory bias in the peer review system. Cogn Ther Res 1(2):161–75.

  18. Rothstein HR, Sutton AJ, Borenstein M (2005) Publication bias in meta-analysis: prevention, assessment and adjustments. Chichester: John Wiley & Sons.

  19. Sackett DL (1979) Bias in analytic research. J Chron Dis 32:51–63.

  20. Stern JM, Simes RJ (1997) Publication bias: evidence of delayed publication in a cohort study of clinical research projects. Br Med J 315:640–5.

  21. World Health Organization (2007) WHO Rapid Advice Guidelines on pharmacological management of humans infected with avian influenza A (H5N1) virus. Geneva (http://www.who.int/medicines/publications/ WHO_PSM_PAR_2006.6.pdf?ua=1)

  22. World Health Organization (2013) WHO Model List of Essential Medicines. Geneva (http://www.who.int/medicines/publications/essentialmedicines/en/)

 

Learning Objective 5.3:

  1. Chan M, Kazatchkine M, Lob-Levyt J, Obaid T, Schweizer J, Sidibe M, et al. (2010) Meeting the demand for results and accountability: a call for action on health data from eight global health agencies. PLoS Med 7(1):e1000223.

  2. Channel 4 News (2009) New doubts about Tamiflu. London (http://www.channel4.com/news/articles/science_technology/new+doubts+over+tamiflu/3454737.html).

  3. Crowcroft NS, Rosells LC, Pakes BN (2014) The ethics of sharing preliminary research findings during public health emergencies: a case study from the 2009 influenza pandemic. Euro Surveill 19(24):pii=20831.

  4. Emanuel EJ, Ezekiel J, Wendler D, Grady C (2002) What makes clinical research ethical? JAMA 283:2701–11.

  5. Godlee F, Clarke M (2009) Why don’t we have all the evidence on oseltamivir? BMJ 339:b5351.

  6. Jefferson T, Jones M, Doshi P, Del Mar C (2009) Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and metaanalysis. BMJ 339:b5106.

  7. Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 163:1667–72.

  8. Kohatsu ND, Robinson JG, Torner JC (2004) Evidence-based public health: an evolving concept. Am J PrevMed 27(5):417–21.

  9. Langat P, Pisartchik D, Silva D, Bernard C, Olsen K, Smith M, et al. Is there a duty to share? Ethics of sharing research data in the context of public health emergencies. Public Health Eth 4(1):4–11.

  10. National Advisory Committee on SARS and Public Health (2003) Learning from SARS: renewal of public health in Canada. Ottawa (http://www.phac-aspc.gc.ca/publicat/sars-sras/pdf/sars-e.pdf).

  11. National Institutes of Health (2003) Final NIH statement on sharing research data. Bethesda, Maryland (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

  12. Pisani E, AbouZahr C (2010) Sharing health data: good intentions are not enough. Bull World Health Organ 88:462–6.

  13. Pisani E, Whitworth J, Zaba B, Abou-Zahr C (2010) Time for fair trade in research data. Lancet 375:703–5.

  14. Stanbrook MB, Hébert P (2010) Disseminate time-sensitive research faster. Can Med Assoc J 182(1):9. Taylor PL (2007) Research sharing, ethics and public benefit. Nature Biotechnol 25(4):398–401.

  15. Vanderpool HY (1996) The ethics of research involving human subjects. Frederick, Maryland: University Publishing Group.

  16. World Health Organization (2007) Avian and pandemic influenza. Best practice for sharing influenza viruses and sequence data. Geneva (http://apps.who.int/gb/ebwha/pdf_files/WHA60/A60_ID1-en.pdf).

Module 6

 

Learning Objective 6.1: 

  1. Melnychuk RM, Kenny NP (2006) Pandemic triage: the ethical challenge. Can Med Assoc J 175(11):1393–4.

  2. Persad G, Wertheimer A, Emanuel EJ (2009) Principles for allocation of scarce medical interventions. Lancet 373:423–31.

  3. Smith MJ, Viens AM (forthcoming) Critical care triage during a pandemic. In: Barrett DH, Bolan G, Dawson A, Ortmann L, Reis A, Saenz C, editors. Global perspectives on public health ethics: a casebook. Berlin: Springer.

  4. University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group (2005) Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza. Toronto: University of Toronto Joint Centre for Bioethics (http://www.jointcentreforbioethics.ca/people/documents/upshur_stand_ guard.pdf).

 

Learning Objective 6.2:

  1. Calain P, Fiore N, Poncin M, Hurst SA (2009) Research ethics and international epidemic response: the case of Ebola and Marburg hemorrhagic fevers. Public Health Eth 2(1):7–29.

  2. CBS News (2006) Eye to Eye: Dr. Anna Pou, 26 September 2006 (http://www.cbsnews.com/videos/eye-to- eye-dr-anna-pou/).

  3. Fink S. The deadly choices at Memorial. New York Times Magazine, 25 August 2009:28–46 (http://www. nytimes.com/2009/08/30/magazine/30doctors.html).

  4. Levin D, Cadigan RO, Biddinger PD, Condon S, Koh HK, on behalf of the Joint Massachusetts Department of Public Health–Harvard Altered Standards of Care Working Group (2009) Altered standards of care during an influenza pandemic: identifying ethical, legal, and practical principles to guide decision making. Disaster Med Public Health Preparedness 3(Suppl 2):S132–40.

  5. Selgelid M (2005) Module four: standard of care and clinical trials. Dev World Bioeth 5(1):55–72.

 

Learning Objective 6.3: 

  1. Buseh AG, Underwood SM, Stevens PE, Townsend L, Kelber ST (2013) Black African immigrant community leaders’ views on participation in genomics research and DNA biobanking. Nurs Outlook 61(4):196–204.

  2. Dauda B, Dierickx K (2013) Benefit sharing: an exploration on the contextual discourse of a changing concept. BMC Med Eth 2013;14(1):36.

  3. Fidler D (2010) Negotiating equitable access to influenza vaccines: global health diplomacy and controversies surrounding avian influenza H5N1 and pandemic influenza H1N1. PloS Med 7(5):e1000247.

  4. Garrett L, Fidler DP (2007) Sharing H5N1 viruses to stop a global influenza pandemic. PLoS Med 4(11):e330.

  5. Holbrooke P, Garrett L (2008) “Sovereignty” that risks global health. Washington Post, 10 August 2008 (http://articles.washingtonpost.com/2008-08-10/opinions/36864341-1).

  6. Nuffield Council on Bioethics (2002) Research in developing countries: the ethics of research related to healthcareindevelopingcountries.London (http://www.nuffieldbioethics.org/research-developing-countries).

  7. Nuffield Council on Bioethics (2005) Research in developing countries: follow-up. 2005. London (http://www.nuffieldbioethics.org/research-developing-countries-follow).

  8. Schroeder D (2007) Benefit sharing: It’s time for a definition. J Med Eth 33(4):205–9.

  9. Sedyaningsih ER, Isfandari S, Soendoro T, Supari SF (2008) Towards mutual trust, transparency and equity in virus sharing mechanism: the avian influenza case of Indonesia. An Acad Med Singapore 37:482–8.

  10. Simm K (2007) Benefit sharing: a look at the history of an ethics concern. Nature Rev Genet 8:496.

  11. UNESCO (2005) Universal Declaration on Bioethics and Human Rights. Paris (http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/).

  12. United Nations Environment Programme (1992) Convention on Biological Diversity. Montreal, Quebec (http://www.cbd.int/).

  13. United Nations Environment Programme (2010) Nagoya Protocol on Access and Benefit-sharing. Montreal, Quebec (http://www.cbd.int/abs/).

  14. World Health Organization (2011) Pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits. Geneva (http://www.who.int/influenza/pip/).

  15. World Medical Association (2013) Declaration of Helsinki. Ferney-Voltaire (http://www.wma.net/en/30publications/10policies/b3/).

 

Learning Objective 6.4: 

  1. Cookson R, McCabe C, Tsuchiya A (2008) Public healthcare resource allocation and the rule of rescue. J Med Eth 34(7):540–544.

  2. Edwards SJL (2006) Restricted treatments, inducements, and research participation. Bioethics 20(2):77–91.

  3. Edwards SJL (2013) Ethics of clinical science in a public health emergency: drug discovery at the bedside. Am J Bioeth 13(9):3–14.

  4. Feldmann H, Jones SM, Daddario-DiCaprio KM, Geisbert JB, Ströher U, et al. (2007) Effective post-exposure treatment of Ebola infection.PLoS Pathog 3(1):e2.

  5. Gonzalvo-Cirac M, Roqué MV, Fuertes F, Pacheco M, Segarra I (2013) Is the precautionary principle adaptable to emergency scenarios to speed up research, risking the individual informed consent? Am J Bioeth 13(9):17–19.

  6. Günther S, Feldmann H, Geisbert TW, Hensley LE, Rollin PE, Nichol ST, et al. (2011) Management of accidental exposure to Ebola virus in the biosafety level 4 laboratory, Hamburg, Germany. J Infect Dis 204(Suppl 3):S785–90.

  7. Kass N (2014) Ebola, ethics, and public health: What next? Ann Intern Med 161(10):744–5.

  8. Mullin KJ (2009) Did Ebola vaccine protect German researcher? Digital J (online) (http://digitaljournal.com/article/270419).

  9. Schuklenk U (2013) And there we go again: the ethics of placebo-controlled RCT in case of catastrophic illness. J Med Eth doi:10.1136/medethics-2013-101653.

  10. Solomon S (2013) Public health emergencies: research’s friend or foe? Am J Bioeth 13(9):21–3.

  11. Tuffs A (2009) Trial vaccine may have saved Hamburg scientist from Ebola fever. BMJ 338:b1223.

  12. Van der Tweel I, van der Graaf R (2013) Issues in the use of stepped wedge cluster and alternative designs in the case of pandemics. Am J Bioeth 13(9):23–4

  13. Wages N, Tait C (2014) Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents. J Biopharm Stat (e-pub ahead of print).

  14. World Health Organization (2014) Ethical considerations for use of unregistered interventions for Ebola virus disease—report of an advisory panel to WHO. Geneva (http://www.who.int/csr/resources/publications/ ebola/ethical-considerations/en/).

Module 7

 

Learning Objective 7.1:

  1. Benatar S (2006) Facing ethical challenges in rolling out antiretroviral treatment in resource-poor countries comment on “They call it ‘patient-selection’ in Khayelitsha”. Cambridge Q Healthcare Eth 15(3):322–30.

  2. Kenny N, Giacomini M (2005) Wanted: a new ethics field for health policy analysis. Health Care Anal 13(4):247–60.

  3. McDougall C (2010) Ethical questions during a pandemic: case studies. Montreal, Quebec: National Collaborating Centre for Healthy Public Policy, National Institute of Public Health Quebec (http://www. ncchpp.ca/docs/Ethics_CaseStudies_EN.pdf).

  4. Naylor D, Basrur SH, Bergeron MG, Brunham RC, Butler-Jones D, Dafoe G, et al. (2003) Learning from SARS: renewal of public health in Canada. A report of the National Advisory Committee on SARS and public health. Ottawa: Health Canada (Publication No. 1210) (http://www.phac-aspc.gc.ca/publicat/sars-sras/naylor/).

  5. Nuffield Council on Bioethics (2007) Public health: ethical issues. London (http://www.nuffieldbioethics.org/public-health).

  6. Public Health Leadership Society (2002) Principles of the ethical practice of public health (poster). New Orleans, Louisiana (http://phls.org/CMSuploads/PHLSposter-68526.pdf).

  7. Schwartz L, Hunt M, Sinding, C, Elit L, Redwood-Campbell L, Adelson, N, et al. (2012) Models for humanitarian health care ethics. Public Health Eth 5(1):81–90.

  8. Thomas JC (2004) Public health ethics. Chapel Hill, North Carolina: Gillings School of Global Public Health, University of North Carolina (http://oce.sph.unc.edu/phethics/modules.htm).

  9. Williams JR (2009) World Medical Association medical ethics manual. 2nd Edition. Ferney-Voltaire: World Medical Association.

  10. World Medical Association (2013a) WMA international code of medical ethics. In: Handbook of World Medical Association policies. Ferney-Voltaire (http://www.wma.net/en/30publications/10policies/HB-E_ print_-2013-1.pdf).

  11. World Medical Association (2013b) Declaration of Helsinki—Ethical principles for medical research involving human subjects. In: Handbook of World Medical Association policies. Ferney-Voltaire (http://www.wma.net/ en/30publications/10policies/HB-E_print_-2013-1.pdf).

 

Learning Objective 7.2:

  1. Appelbaum PS, Roth LH, Lidz C (1982) The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5:319–29.

  2. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Centre Rep 17(2):20–4.

  3. Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care40(9Suppl):v55–63.

  4. Miller FG (2009) Consent to clinical research. In: Miller FG, Wertheimer A, editors. The ethics of consent:theory and practice. New York: Oxford University Press.

  5. Morris A, Lundgren JD, Masur H, Walzer PD, Hanson DL, Frederick T, Huang L, Beard CB, Kaplan JE (2004) Current epidemiology of Pneumocystis Pneumonia. Emerg Infect Dis. 10(10):1713-20.

  6. Saito T, Kunimitsu A (2011) Public health response to the combined great east Japan earthquake, tsunami and nuclear power plant accident: perspective from the Ministry of Health, Labour and Welfare of Japan. West Pac Surveill Response J 2(4):7–9.

  7. World Health Organization (2012) Dengue and severe dengue. Fact sheet No. 117. Geneva (http://www. who.int/mediacentre/factsheets/fs117/en/).

  8. Zhu T, Korber BT, Nahmias AJ, Hooper E, Sharp PM, Ho DD (1998) An African HIV-1 sequence from 1959 and implications for the origin of the epidemic. Nature 391: 594–7.

 

Learning Objective 7.3:

  1. Cash R, Wikler D, Saxena A, Capron A, editors (2009) Chapter VIII. What to do when loyalties are divided? How should research misbehaviour be defined and policed? In: Casebook on ethical issues in international health research. Geneva: World Health Organization.

  2. Conflicts of Interest Coalition (2012) Statement of concern (http://coicoalition.blogspot.com).

  3. Ezeome ER, Simon C (2010) Ethical problems in conducting research in acute epidemics: the Pfizer meningitis study in Nigeria as an illustration. Dev World Bioeth 10(1):1–10.

  4. London L, Matzopoulos R, Corrigall J, Myers JE, Maker A, Parry CDH (2012) Conflict of interest: a tenacious ethical dilemma in public health policy, not only in clinical practice/research. S Afr J Bioeth Law 5(2):102–8.

  5. MacDonald C, McDonald M, Norman W (2002) Charitable conflicts of interest. J Bus Eth 39(1):67–74.

  6. Potvin M (2012) The strange case of Dr. B and Mr. Hide: ethical sensitivity as a means to reflect upon one’s actions in managing conflict of interest. J Bioeth Inq 9(2):225–7.

  7. Smith D (2011) Pfizer pays out to Nigerian families of meningitis drug trial victims. The Guardian, 12 August 2011 (http://www.theguardian.com/world/2011/aug/11/pfizer-nigeria-meningitis-drug-compensation).

  8. Stell LK (2011) Conflict of interest in diabetic research. J Diabetes 2(1):5–6.

  9. Stephens J (2000) Where profits and lives hang in balance. The Washington Post, 17 December 2000 (http://www.washingtonpost.com/wp-dyn/content/article/2007/07/02/AR2007070201255.html).

  10. Weinfurt KP, Dinan MA, Allsbrook JS, Friedman JY, Hall MA, Schulman KA, et al. (2006) Policies of academic medical centers for disclosing conflicts of interest to potential research participants. Acad Med 81(2):113–8.

  11. Williams-Jones B (2011) Beyond a pejorative understanding of conflict of interest. Am J Bioeth 11(1):1–2.