Abstract
Your IRB conducts ethical review of biomedical investigations. To evaluate a study you must have a reasonable understanding of the science, since the ethics of a protocol flow from its particularities; those details will lead you to approve, modify, or reject it.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Advisory Committee on Human Radiation Experiments. Final report of the advisory committee on human radiation experiments. New York: Oxford University Press; 1996.
Amdur R. Evaluating study design and quality. In: Amdur R, Bankert EA, editors. Institutional review board member handbook. 3rd ed. Sudbury, MA: Jones and Bartlett; 2011. p. 91–5.
Atanasov PD. Double risk aversion. (2010). http://Papers.Ssrn.Com/Sol3/Papers.Cfm?abstract_id=1682569.
Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274:1355–60.
Curran WJ. Governmental regulation of the use of human subjects in medical research: the approach of two federal agencies. Daedalus. 1969;98(2):542–94.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11.
Fitzgerald MH, Phillips PA, Yule E. The research ethics review process and ethics review narratives. Ethics Behav. 2006;16(4):377–95.
Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, Goldberg JP, et al. The Illinois white paper: improving the system for protecting human subjects: counteracting IRB “Mission creep”. Qual Inq. 2007;13(5):617–49.
Ingelfinger FJ. Informed (but uneducated) consent. N Engl J Med. 1972;287:465–6.
Khan ST, Kornetsky SZ. Overview of initial protocol review. In: Bankert EA, Amdur RJ, editors. Institutional review board: management and function. 2nd ed. Sudbury, MA: Jones & Bartlett; 2005. p. 119–25.
Klitzman RL. The myth of community differences as the cause of variations among IRBs. AJOB Prim Res. 2011a;2(2):24–33.
Klitzman RL. The ethics police?: IRBs’ views concerning their power. PLoS One. 2011b;6(12):e28773.
Levine RJ. Ethics and regulation of clinical research. Baltimore, MD: Urban & Schwarzenberg; 1981.
Mazur DJ. Evaluating the science and ethics of research on humans: a guide for IRB members. Baltimore, MD: Johns Hopkins University Press; 2007.
Meyer MN. Three challenges for risk-based (research) regulation: heterogeneity among regulated activities, regulator bias, and stakeholder heterogeneity. In: Cohen IG, Lynch HF, editors. Human subjects research regulation: perspectives on the future. Cambridge, MA: MIT Press; 2014. p. 313–26.
National Research Service Award Act of 1974.
Rajczi A. Making risk‐benefit assessments of medical research protocols. J Law Med Ethics. 2004;32(2):338–48.
Ramsey P. The patient as person: explorations in medical ethics. New Haven: Yale University Press; 1970.
Rhodes R. Rethinking research ethics. Am J Bioeth. 2005;5(1):7–28.
Stark L. Morality in science: how research is evaluated in the age of human subjects regulation [PhD dissertation]. Princeton University; 2006
Stark L. Behind closed doors: IRBs and the making of ethical research. Chicago; London: The University of Chicago Press; 2012.
Weijer C. The ethical analysis of risk. J Law Med Ethics. 2000;28(4):344–61.
Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits? Nat Med. 2004;10(6):570–3.
Wendler D, Miller FG. Assessing research risks systematically: the net risks test. J Med Ethics. 2007;33(8):481–6.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Whitney, S.N. (2016). Evaluating Biomedical Research. In: Balanced Ethics Review. Springer, Cham. https://doi.org/10.1007/978-3-319-20705-6_4
Download citation
DOI: https://doi.org/10.1007/978-3-319-20705-6_4
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-20704-9
Online ISBN: 978-3-319-20705-6
eBook Packages: Social SciencesSocial Sciences (R0)