- FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins [Internet]. AHRP. 2003 [cited 2018 Dec 31]. Available from: http://ahrp.org/fda-warning-letter-re-fatal-experiment-hexamethonium-inhalation_johns-hopkins/
- Savulescu J, Spriggs M. The hexamethonium asthma study and the death of a normal volunteer in research. Journal of Medical Ethics. 2002 Feb 1;28(1):3–4. Available from: https://jme.bmj.com/content/28/1/3
- Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE Seeding Trial: A Review of Internal Documents. Annals of Internal Medicine. 2008 Aug 19;149(4):251. Available from: http://annals.org/article.aspx?doi=10.7326/0003-4819-149-4-200808190-00006
- Hochhauser M. Is this a Seeding Trial? Journal of Clinical Research Best Practices [Internet]. 2009 Jun [cited 2019 Jan 4];5(6). Available from: https://firstclinical.com/journal/2009/0906_Seeding.pdf
- U.S. Food and Drug Administration. Drug Study Designs - Information Sheet [Internet]. [cited 2019 Jan 7]. Available from: https://www.fda.gov/RegulatoryInformation/Guidances/ucm126501.htm
- World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2018 Nov 30]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- Titanji BK. TEDxGoodenoughCollege: Ethical riddles in HIV research [Internet]. 2012 [cited 2019 Feb 26]. Available from: https://www.ted.com/talks/boghuma_kabisen_titanji_ethical_riddles_in_hiv_research/transcript
- Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation. N Engl J Med. 2011 Jun 30;364(26):2507–16. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3549296/
- Harmon A. New Drugs Stir Debate on Rules of Clinical Trials. The New York Times [Internet]. 2010 Sep 18 [cited 2019 Jan 5]; Available from: https://www.nytimes.com/2010/09/19/health/research/19trial.html
- FDA Approves Vemurafenib for Advanced Melanoma [Internet]. Medscape. [cited 2019 Jan 5]. Available from: http://www.medscape.org/viewarticle/748420
- The Canadian Institutes of Health Research (CIHR) and Queen’s University at Kingston. Module 6: Fairness and equity. In: TCPS 2: CORE (Course on Research Ethics) [Internet]. Government of Canada; Available from: https://tcps2core.ca/welcome
- Humphreys K, Weisner C. Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies. Am J Psychiatry. 2000 Apr;157(4):588–94. Available from: https://www.ncbi.nlm.nih.gov/pubmed/10739418
- Wilson JM. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Molecular Genetics and Metabolism. 2009 Apr 1;96(4):151–7. Available from: http://www.sciencedirect.com/science/article/pii/S109671920800499X
- ClinicalTrials.gov. Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency [Internet]. NIH U.S. National Library of Medicine. 1999 [cited 2019 Jan 9]. Available from: https://clinicaltrials.gov/ct2/show/study/NCT00004498
- Genetics Home Reference. Ornithine transcarbamylase deficiency [Internet]. NIH U.S. National Library of Medicine. [cited 2019 Jan 9]. Available from: https://ghr.nlm.nih.gov/condition/ornithine-transcarbamylase-deficiency
- Recombinant DNA Advisory Committee. Minutes of Symposium and Meeting, December 8-10, 1999 [Internet]. U.S. Department of Health and Human Services, National Institute of Health; 1999. Available from: https://osp.od.nih.gov/wp-content/uploads/2014/01/1299rac.pdf
- Steinbrook R. The Gelsinger Case. In: The Oxford Textbook of Clinical Research Ethics [Internet]. 1st ed. New York: Oxford University Press; 2011. p. 110–20. Available from: https://www.uab.edu/ccts/images/steinbrook_Gelsinger_-_Oxford_Textbook_08_3.pdf
- Savulescu J. Harm, ethics committees and the gene therapy death. Journal of Medical Ethics. 2001 Jun 1;27(3):148–50. Available from: https://jme.bmj.com/content/27/3/148
Module 3: Background review and research design