In connection to the webinar organised by IndiaBioscience on 28 June 2022, we bring you a list of resources that may be useful for you to develop a deeper understanding of bioethics:
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ScandalsTragediesofResearchwithHumanParticipants.pdf (virginia.edu)
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World Medical Association (WMA). Declaration of Helsinki (2013):https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
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International Ethical Guidelines for Health-related Research Involving Humans (2016):https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/
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Wendler D, Emanuel EJ, and Lie RK. The Standard of Care Debate: Can Research in Developing Countries be Both Ethical and Responsive to Those Countries’ Health Needs? American Journal of Public Health 2004; 94 (6): 923-928.
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Emanuel E, Wendler D, & Grady C. What Makes Clinical Research Ethical JAMA 2000; 283 (20): 2701-2711.
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Morain SR, Joffe S, Largent EA. When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients? American Journal of Bioethics 2019;19(4):11-18.
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Joffe S & Miller F. Bench to Bedside: Mapping the Moral Terrain of Clinical Research. Hastings Center Report 2008; 38(2):30-42.
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Rid A, Emanuel E, Wendler D. Evaluating the Risks of Clinical Research. JAMA. 2010; 304(13):1472-1479.
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Grady C. Institutional Review Boards: Purpose and Challenges. Chest. 2015 Nov 1; 148(5):1148- 55.
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Common Rule, 45 CFR 46 (2018) 2018 Requirements (2018 Common Rule) | HHS.gov (This link also has the Belmont Report)
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Strauss DH, White SA, Bierer BE. Justice, Diversity, and Research Ethics Review. Science 2021;371(6535):1209-1211.
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Grady C. Enduring and Emerging Challenges of Informed Consent, NEJM, 2015;372 (9):855-62.
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Scott Y. H. Kim. Chapter 8: Capacity to Consent to Research, from Evaluation of Capacity to Consent to Treatment and Research. Oxford University Press 2010
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NIH Policy - Research Involving Adults Who Lack Decision-making Capacity to Consent to Research Participation 2021 https://policymanual.nih.gov/3014-403
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President’s Commission for the Study of Bioethical Issues. Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-toConsumer Contexts. 2013. Executive Summary, pages 1-20, available at https://bioethicsarchive.georgetown.edu/pcsbi/node/3183.html
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All of Us Research Program Investigators, et al. The “All of Us” Research Program. NEJM. 2019; 381(7):668-676.
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Garrison NA, Hudson M, Ballantyne LL, Garba I, Martinez A, Taualii M, Arbour L, Caron NR, Rainie SC. Genomic Research Through an Indigenous Lens: Understanding the Expectations. Annual Review of Genomics and Human Genetics 2019;20:495-517.
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Grady C. Ethics of Vaccine Research. Nature Immunology 2004;5(5):465-8. Grady C, Shah S, Miller F, Danis M, Nicolini M, Ochoa J, Taylor HA, Wendler D, Rid A. So Much at Stake: Ethical Tradeoffs in Accelerating SARSCoV-2 Vaccine Development. Vaccine 2020; 38(41): 6381-6387.
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Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of Controlled Human Infection to Address COVID-19. Science 2020;368(6493):832-834.
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Langford A. Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic. Journal of Health Communications 2020; 25(10): 780-789.
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Jamrozik E, Littler K, Bull S, Emerson C, Kang G, Kapulu M, Rey E, Saenz C, Shah S, Smith PG, Upshur R, Weijer C, Selgelid MJ; WHO Working Group for Guidance on Human Challenge Studies in COVID-19.Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group Vaccine 2021, 39(4): 633-640.
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ICMR - Bioethics Unit (ncdirindia.org) (Please read under Resources)