Clarifying the concept of the “Social” in risk assessments for human subjects research

References

• Arendt, H. 1958. The Human Condition. Chicago, IL: University of Chicago Press.
   Google Scholar
• Bhagianadh, D., S. Bandekar, D. Ravindran, and S. Nikarge. 2010. This is no low risk game: Social science researchers reflect on their work. Indian Journal of Medical Ethics 7 (1):54–55.
   PubMedGoogle Scholar
• Bosk, C. L., and R. G. De Vries. 2004. Bureaucracies of mass deception: Institutional review boards and the ethics of ethnographic research. Annals of the American Academy of Political and Social Science 595:249–63. (ArticleType: research-article/Issue Title: Being Here and Being There: Fieldwork Encounters and Ethnographic Discoveries/Full publication date: Sep., 2004/Copyright © 2004 American Academy of Political and Social Science) doi:10.1177/0002716204266913.
   Web of Science ®Google Scholar
• Churchill, L. R., D. K. Nelson, G. E. Henderson, N. M. King, A. M. Davis, E. Leahey, and B. S. Wilfond. 2003. Assessing benefits in clinical research: Why diversity in benefit assessment can be risky. IRB; a Review of Human Subjects Research 25 (3):1–8.
   Google Scholar
• Committee, A. 2000. Institutional review boards and social science research. American Association of University Professors, Washington, DC. http://www.aaup.org.AAUP/comm/rep/A/protecting.htm.
   Google Scholar
• Committee, A. 2006. Research on human subjects: academic freedom and the institutional review board, Washington, DC. http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm.
   Google Scholar
• Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: World Health Organization.
   Google Scholar
• Cunningham-Burley, S. 2006. Public knowledge and public trust. Community Genetics 9 (3):204–10.
   PubMedGoogle Scholar
• Dressler, L. G. 2009. Disclosure of research results from cancer genomic studies: State of the science. Clinical Cancer Research 15 (13):4270–76. doi:10.1158/1078-0432.CCR-08-3067.
   PubMed Web of Science ®Google Scholar
• Enserink, M. 2011. Dutch univeristy sacks social psychologist over faked data. Science Magazine. http://www.sciencemag.org/news/2011/09/dutch-university-sackssocial-psychologist-over-faked-data.
   Google Scholar
• Emanuel, E. 2012. The systematic assessment of research risks: Does it depend upon culture or context? In 2nd Asia Pacific Research Ethics Conference. Singapore, Singapore: National Health Group of Singapore.
   Google Scholar
• Facio, F. M., S. Brooks, J. Loewenstein, S. Green, L. G. Biesecker, and B. B. Biesecker. 2011. Motivators for participation in a whole-genome sequencing study: Implications for translational genomics research. European Journal of Human Genetics 19 (12):1213–17. doi:10.1038/ejhg.2011.123.
   PubMed Web of Science ®Google Scholar
• Godlee, F., J. Smith, and H. Marcovitch. 2011. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 342:c7452. doi:10.1136/bmj.c7452.
   PubMed Web of Science ®Google Scholar
• Grayson, J. P., and R. Myles. 2005. How research ethics boards are undermining survey research on Canadian university students. Journal of Academic Ethics 2 (4):293–314. doi:10.1007/s10805-005-9005-x.
   Google Scholar
• Gunsalus, C. K. 2004. The Nanny state meets the inner lawyer: Overregulating while underprotecting human participants in research. Ethics and Behavior 14 (4):369–82. doi:10.1207/s15327019eb1404_7.
   PubMed Web of Science ®Google Scholar
• Gunsalus, C. K., E. Bruner, N. C. Burbules, L. Dash, M. Finkin, J. P. Goldber, W. T. Greenough, G. A. Miller, M. G. Pratt, and D. Aronson. 2005. The illinois white paper: Improving the system for protecting human subejcts: Counteracting IRB ‘Mission Creep’. Qualitative Inquiry 13 (5):617–49. doi:10.1177/1077800407300785.
   Web of Science ®Google Scholar
• Haggerty, K. D. 2004. Ethics creep: Governing social science research in the name of ethics. Qualitative Sociology 27 (4):391–414. doi:10.1023/B:QUAS.0000049239.15922.a3.
   Google Scholar
• Hammersley, M. 2009. Against the ethicists: On the evils of ethical regulation. International Journal of Social Research Methodology 12 (3):211–25. doi:10.1080/13645570802170288.
   Web of Science ®Google Scholar
• Hayek, F. A. 1967. Studies in philosophy, politics, and economics. Chicago, IL: University of Chicago Press.
   Google Scholar
• Hayek, F. A. 1988. The fatal conceit: The errors of socialism. Chicago, IL: University of Chicago Press.
   Google Scholar
• Heeney, C., N. Hawkins, J. De Vries, P. Boddington, and J. Kaye. 2011. Assessing the privacy risks of data sharing in genomics. Public Health Genomics 14 (1): 17–25.
   PubMed Web of Science ®Google Scholar
• Hero, R. E. 2007. Racial diversity and social capital: Equality and community in America. Cambridge, UK: Cambridge University Press.
   Google Scholar
• Hoedemaekers, R., B. Gordijn, and M. Pijnenburg. 2007. Solidarity and justice as guiding principles in genomic research. Bioethics 21 (6):342–50. doi:10.1111/biot.2007.21.issue-6.
   PubMed Web of Science ®Google Scholar
• Ioannidis, J. P. A. 2012. Why science is not necessarily self-correcting. Perspectives on Psychological Science 7 (6):645–54. doi:10.1177/1745691612464056.
   Web of Science ®Google Scholar
• Jordan, S. R., and K. Q. Hill. 2012a. Editor’s perceptions of ethical and managerial issues in political science journals. PS: Political Science and Politics 45 (4):724–27.
   Web of Science ®Google Scholar
• Jordan, S. R., and K. Q. Hill. 2012b. Ethical assurance statements in political science journals. Journal of Academic Ethics 10 (3):243–50. doi:10.1007/s10805-012-9163-6.
   Google Scholar
• Kaiser, K. 2009. Protecting respondent confidentiality in qualitative research. Qualitative Health Research 19 (11):1632–41. doi:10.1177/1049732309350879.
   PubMed Web of Science ®Google Scholar
• Kleinig, J. 1978. Crime and the Concept of Harm. American Philosophical Quarterly 15 (1):27–36.
   Web of Science ®Google Scholar
• Levine, R. J. 1975. The nature and definition of informed consent in various research settings. Preliminary paper prepared for the National Commission for the Protection of Human Subjects of Biomedical Behavioral Research, U.S. Department of Health, Education and Welfare, Washington, D.C.
   Google Scholar
• Manasco, P. K. 2005. Ethical and legal aspects of applied genomic technologies: Practical solutions. Current Molecular Medicine 5 (1):23–28. doi:10.2174/1566524053152816.
   PubMed Web of Science ®Google Scholar
• McGuire, A. L., R. Fisher, P. Cusenza, K. Hudson, M. A. Rothstein, D. McGraw, S. Matteson, J. Glaser, and D. E. Henley. 2008a. Confidentiality, privacy, and security of genetic and genomic test information in electronic health records: Points to consider. Genetics in Medicine 10 (7):495–99. doi:10.1097/GIM.0b013e31817a8aaa.
   PubMed Web of Science ®Google Scholar
• McGuire, A. L., J. A. Hamilton, R. Lunstroth, L. B. McCullough, and A. Goldman. 2008b. DNA data sharing: Research participants’ perspectives. Genetics in Medicine 10 (1):46–53. doi:10.1097/GIM.0b013e31815f1e00.
   PubMed Web of Science ®Google Scholar
• McKnight, C. 2003. Medicine as an essentially contested concept. Journal of Medical Ethics 29 (4):261–62. doi:10.1136/jme.29.4.261.
   PubMed Web of Science ®Google Scholar
• Miller, D. 1999. Principles of Social Justice. Cambridge, MA: Harvard University Press.
   Google Scholar
• Miller, F. G., and S. Joffe. 2009. Limits to research risks. Journal of Medical Ethicsx 35 (7):445–49. doi:10.1136/jme.2008.026062.
   PubMed Web of Science ®Google Scholar
• Miller, P. B., and C. Weijer. 2000. Moral solutions in assessing research risk. IRB: Ethics and Human Research 22 (5):6–10. doi:10.2307/3564222.
   PubMedGoogle Scholar
• O’Reilly, M., M. Dixon-Woods, E. Angell, R. Ashcroft, and A. Bryman. 2009. Doing accountability: A discourse analysis of research ethics committee letters. Sociology of Health and Illness 31 (2):246–61. doi:10.1111/j.1467-9566.2008.01132.x.
   PubMed Web of Science ®Google Scholar
• Office of Behavioral and Social Sciences Research (OBSSR). No date. BSSR (Behavioral and Social Sciences Research) Definitions.https://obssr.od.nih.gov/aboutus/bssr-definition/.
   Google Scholar
• Pitkin, H. F. 1998. Attack of the Blob: Hannah Arendt’s Concept of the Social. Chicago, IL: University of Chicago Press.
   Google Scholar
• Porter, T. 2008. Research ethics governance and political science in Canada. PS - Political Science and Politics 41 (3):495–99. doi:10.1017/s1049096508080852.
   Web of Science ®Google Scholar
• Presidential Commission for the Study of Bioethical Issues. 2011. Moral science: Protecting participants in human subjects research. Washington, D.C.: US Government Printing Office.
   Google Scholar
• Pritchard, I. A. 2011. How do IRB members make decisions? a review and research agenda. Journal of Empirical Research on Human Research Ethics 6 (2):31–46. doi:10.1525/jer.2011.6.2.31.
   PubMed Web of Science ®Google Scholar
• Putnam, R. D. 2000. Bowling alone: The collapse and revival of american community. New York, NY: Simon & Schuster.
   Google Scholar
• Rasmussen, L. M. 2008. Not all research is equal: Taking social science research into account. The American Journal of Bioethics 8 (11):17–18. doi:10.1080/15265160802513119.
   PubMed Web of Science ®Google Scholar
• Rasmussen, L. M. 2009. Problems with minimal-risk research oversight: A threat to academic freedom? IRB Ethics and Human Research 31 (3):11–16.
   PubMedGoogle Scholar
• Reddy, D. S. 2007. Good gifts for the common good: Blood and bioethics in the market of genetic research. Cultural Anthropology 22 (3):429–72. doi:10.1525/can.2007.22.3.429.
   PubMed Web of Science ®Google Scholar
• Resnik, D. B. 2010. Genomic research data: Open vs. restricted access. IRB Ethics and Human Research 32 (1):1–6.
   PubMedGoogle Scholar
• Rid, A., E. J. Emanuel, and D. Wendler. 2010. Evaluating the risks of clinical research. JAMA - Journal of the American Medical Association 304 (13):1472–79. doi:10.1001/jama.2010.1414.
   PubMed Web of Science ®Google Scholar
• Rid, A., and D. Wendler. 2011a. A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal 21 (2):141–79. doi:10.1353/ken.2011.0007.
   PubMed Web of Science ®Google Scholar
• Rid, A., and D. Wendler. 2011b. A proposal and prototype for a Research Risk Repository to improve the protection of research participants. Clinical Trials 8 (6):705–15. doi:10.1177/1740774511414595.
   PubMed Web of Science ®Google Scholar
• Schrag, Z. 2010. Ethical imperialism: Institutional review boards and the social sciences, 1965–2009. Baltimore, MD: Johns Hopkins University Press.
   Google Scholar
• Seligson, M. A. 2008. Human subjects protection and Large-N Research: When exempt is non-exempt and research is non-research. PS: Political Science and Politics 41 (3):477–82.
   Web of Science ®Google Scholar
• Sleeboom, M. 2005. The Harvard case of Xu Xiping: Exploitation of the people, scientific advance, or genetic theft? New Genetics and Society 24 (1):57–78. doi:10.1080/14636770500037776.
   PubMed Web of Science ®Google Scholar
• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1975. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research, ed. Education Department of Health, and Welfare. Washington, DC: US Government Printing Office.
   Google Scholar
• The 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—Appendix. ed. Education Department of Health and Welfare. Washington, DC: US Government Printing Office.
   Google Scholar
• United Kingdom Research Integrity Office. 2012. Code of practice for research. UK Research Integrity Office. http://ukrio.org/publications/code-of-practice-for-research/
   Google Scholar
• American Recovery and Reinvestment Act of 2009. 2009. Title XIII: Health Information Technology, ed. United States Congress, Washington, D.C.: Government Printing Office.
   Google Scholar
• US Department of Health and Human Services. 2011. ANPRM for revision to common rule: Information related to advance notice of proposed rulemaking (ANPRM) for revisions to the common rule. Federal register, Vol. 76, 44512–31.
   Google Scholar
• US Department of Health and Human Services. 2015. NPRM for federal policy for the protection of human subjects. Federal Register 80 (173):53933–4061.
   Google Scholar
• US Department of Health and Human Services. 2017. Final rule– federal policy for the protection of human subjects. Federal Register 82 (12):7149–274.
   PubMedGoogle Scholar
• Weijer, C. 1999a. The analysis of risks and potential benefits in research. NCEHR Communique = Communique CNERH 9 (2):16–20.
   PubMedGoogle Scholar
• Weijer, C. 1999b. Thinking clearly about research risk: Implications of the work of Benjamin Freedman. IRB: Ethics and Human Research 21 (6):1–5. doi:10.2307/3564450.
   Google Scholar
• Weijer, C. 2004. The ethical analysis of risk in intensive care unit research. Critical Care 8 (2):85–86. doi:10.1186/cc2822.
   PubMed Web of Science ®Google Scholar
• Weijer, C., and P. B. Miller. 2004. When are research risks reasonable in relation to anticipated benefits? Nature Medicine 10 (6):570–73. doi:10.1038/nm0604-570.
   PubMed Web of Science ®Google Scholar
• Weijer, C., and P. B. Miller. 2007. Refuting the net risks test: A response to Wendler and Miller’s “Assessing research risks systematically.” Journal of Medical Ethics 33 (8):487–90. doi:10.1136/jme.2006.016444.
   PubMed Web of Science ®Google Scholar
• Weijer, C. 2000. The ethical analysis of risk. Journal of Law, Medicine and Ethics 28 (4):344–61. doi:10.1111/j.1748-720X.2000.tb00686.x.
   PubMed Web of Science ®Google Scholar
• Wendler, D. 1998. When should “Riskier” subjects be excluded from research participation? Kennedy Institute of Ethics Journal 8 (3):307–27. doi:10.1353/ken.1998.0023.
   PubMed Web of Science ®Google Scholar
• Wendler, D. 2011. What we worry about when we worry about the ethics of clinical research. Theoretical Medicine and Bioethics 32 (3):161–80. doi:10.1007/s11017-011-9176-y.
   PubMed Web of Science ®Google Scholar
• Wendler, D., L. Belsky, K. M. Thompson, and E. J. Emanuel. 2005. Quantifying the federal minimal risk standard. Implications for pediatric research without a prospect of direct benefit. Journal of the American Medical Association 294 (7):826–32. doi:10.1001/jama.294.7.826.
   Web of Science ®Google Scholar
• Wendler, D., and E. J. Emanuel. 2005. What is a “minor” increase over minimal risk? The Journal of Pediatrics 147 (5):575–78. doi:10.1016/j.jpeds.2005.07.013.
   PubMed Web of Science ®Google Scholar
• Wendler, D., and F. G. Miller. 2007. Assessing research risks systematically: The net risks test. Journal of Medical Ethics 33 (8):481–86. doi:10.1136/jme.2005.014043.
   PubMed Web of Science ®Google Scholar
• Wendler, D., and S. Varma. 2006. Minimal risk in pediatric research. The Journal of Pediatrics 149 (6):855–61. doi:10.1016/j.jpeds.2006.08.064.
   PubMed Web of Science ®Google Scholar
• Wiles, R., V. Charles, G. P. Crow, and S. J. Heath. 2006. Researching researchers: Lessons for research ethics. Qualitative Research 6 (3):283–99. doi:10.1177/1468794106065004.
   Google Scholar
• Wiles, R., G. Crow, S. Heath, and V. Charles. 2008. The management of confidentiality and anonymity in social research. International Journal of Social Research Methodology 11 (5):417–28. doi:10.1080/13645570701622231.
   Web of Science ®Google Scholar
• Winickoff, D. E. 2001. Biosamples, genomics, and human rights: Context and content of Iceland’s Biobanks Act. Journal of Biolaw and Business 4 (2):11–17.
   PubMedGoogle Scholar
• Yanow, D., and P. Schwartz-Shea. 2008. Reforming institutional review board policy: Issues in implementation and field research. PS: Political Science and Politics 41 (3):483–94.
   Web of Science ®Google Scholar