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Bibliography (page 8 of 11)

Foex, B. A. (2001). "The problem of informed consent in emergency medicine research." Emerg Med J 18(3): 198-204.
      This paper gives the ethical background and rationale for conducting research on emergency conditions without prior informed consent, citing mainly the importance to society.
http://emj.bmjjournals.com/cgi/content/abstract/18/3/198

Godard, B., J. Schidtke, et al. (2003). "Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective." European Journal of Human Genetics 11(Supplement 2): S88-122.
      This paper contains the results of a European meeting on DNA banking and review of applicable documents from around the world. It then reviewed the various ethical issues and ended up proposing standardizing policies for both the public and private sectors.
http://www.nature.com/ejhg/journal/v11/n2s/abs/5201114a.html

May, T. (2004). "Social Restrictions on Informed Consent: Research ethics and medical decision making." HEC Forum 16(1): 38-44.
      This philosophical paper deals with the question of the extent to which social and community considerations can and should play a role in the decision of an individual to participate in research. In many respects the IRB acts for the community but questions may arise that evade the IRB. In developing countries and in relation to minority populations, sensitivity to community morals, cultures, and cohesion is especially important.

Goodyear-Smith, F., B. Lobb, et al. (2002). "International variation in ethics committee requirements: comparisons across five Westernised nations." BMC Medical Ethics 3(1): 2.
     This study reviewed the IRB procedures employed in 5 countries that were jointly conducting a study about the believability of testimony regarding alleged child abuse. There were substantial differences and these were discussed.
http://www.biomedcentral.com/1472-6939/3/2

Hofman, N. (2004). "Toward critical research ethics: transforming ethical conduct in qualitative health care research." Health Care for Women International 25(7): 647-62.
      The author discusses the problems with the standard model of the ethical conduct of research when carrying out qualitative research on a vulnerable population, in this case female drug users conducting illicit sexual activity in the US. She draws the problem as a cognitive and emotional divide between relatively untrained middle class interviewers who focus on the science and impoverished underclass women who focus on their payment. Little is done to empower the participants or to explain their common ground in learning how to improve the participants' lives. Several useful suggestions for improving the situation are made.

Edwards, S. D. and M. J. McNamee (2005). "Ethical concerns regarding guidelines for the conduct of clinical research on children." J Med Ethics 31(6): 351-354.
      This focuses on the difference between the British and Declaration of Helsinki guidelines for research on children. They prefer the Helsinki guidelines because the subject can never be used as a means only but must also be an end in respect to the research.
http://jme.bmjjournals.com/cgi/content/full/31/6/351

Kahn, J. (2005). "Informed Consent in the Context of Communities." J. Nutr. 135(4): 918-920.
     The author revisits the change of IRB (and Federal) attention from protecting individuals (autonomy) to assuring equitable access (justice) and how involving communities complicates the issue. A very important set of concepts is examined here.
http://jn.nutrition.org/cgi/content/full/135/4/918

Casarett, D. J., J. H. T. Karlawish, et al. (2003). "Identifying ambulatory cancer patients at risk of impaired capacity to consent to research." Journal of Pain and Symptom Management 26(1): 615.
     Cancer patients might have a limited capacity to be research subjects, This study used a competency test and protocol scenarios and found that ability to consent was related not to the cancer but to cognitive impairment, education, and aging.
http://www.sciencedirect.com/science/article/B6T8R-4902FRW
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Chapter 2
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Research in Humans

History of Rules About Research in Humans

Definitions

Federal Mandate

Respect for Persons

Beneficence

Justice

Common Rule

IRB Mission

Cases

Bibliography


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