Abstract
Research policies, aimed at excellence in research, are designed and implemented to ensure that good research practices are pursued in balance with ethical considerations. As there is increasing overlap between good research practices and research ethics, and given that there are other chapters in this book that include detailed discussion of conflicts of interest, research misconduct and related topics, this chapter mainly focuses on the ethical aspects of research policies aimed at protecting human subjects in research. The history and development of the Declaration of Helsinki, International Conference on Harmonization: Good Clinical Practice (ICH-GCP) guidelines, and Council for International Organizations of Medical Sciences (CIOMS) guidelines, as well as ethical principles specified in these documents, were examined. Problems and challenges faced by different layers of research policies, for instance international guidelines, national laws/regulations, and institutional policies and procedures, are discussed. We conclude that lessons should be learnt from history and all stakeholders involved in human subject research bear the responsibility to develop new research policies. However, the diversity and uniqueness of a particular context should be considered seriously during the process of policy making, and once a research policy is developed, it still needs regular re-examination to ensure that any required updates are undertaken.
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Further Readings
Emanuel, E., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–2711.
Faden, R., Kass, N., Goodman, S., Pronovost, P., Tunis, S., & Beauchamp, T. (2013). An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Center Report, 43(s1), S16–S27. doi:10.1002/hast.134.
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Zhang, H., Cong, Y. (2016). Research Policy. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-09483-0_378
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DOI: https://doi.org/10.1007/978-3-319-09483-0_378
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