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Bibliography (page 9 of 11)

Scherer, D. G., J. L. Brody, et al. (2005). "Financial compensation to adolescents for participation in biomedical research: Adolescent and parent perspectives in seven studies." The Journal of Pediatrics 146(4): 552.
     This empirical paper studies the implications of payment to the participants in pediatric asthma research using protocol scenarios. They concluded that financial compensation was not a major motivator. However, there were significant differences in estimates that raise interesting questions about coercion.
http://www.sciencedirect.com/science/article/B6WKR-4FW7GVF
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Ballard, H., L. Shook, et al. (2004). "Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period." J Perinatology 24(7): 409-15.
     This article evaluates the effectiveness of the informed consent process for a study in a NICU. They were somewhat concerned about both the knowledge of the procedures and the purpose on the part of the parents, especially the fathers. I believe, however, that they did as well as others. Some people really don't want to learn the details.
http://www.nature.com/jp/journal/v24/n7/full/7211142a.html

Regidor, E. (2004). "The Use Of Personal Data From Medical Records And Biological Materials: Ethical Perspectives And The Basis For Legal Restrictions In Health Research." Social Science & Medicine 59(9): 1975.
      Personal medical information is essential when carrying out many kinds of human research. When clinical databases are mined in the US and elsewhere, the protocol must be extremely precise, the data extracted limited, and a waiver of informed consent obtained from an IRB. The author discusses the preconceptions utilized in passing these restrictive rules and indicates that they lack an effective logical rationale. Interesting reading, especially for those who have been hamstrung by HIPAA.
http://www.sciencedirect.com/science/article/B6VBF-4C6KPJX
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Joffe, S. and J. Weeks (2002). "Views Of American Oncologists About The Purposes Of Clinical Trials." J Natl Cancer Inst 94(24): 1847-53.
      This study raises serious questions about the preparation of oncologists for carrying out clinical trials. A large proportion of clinical oncologists believed that the purpose of the trial was to improve therapy for the individual participants rather than to produce generalizable knowledge about cancer treatment to advance future therapy. That is inconsistent with the principles of clinical research.

Roberts, L. W. (2002). "Informed Consent and the Capacity for Voluntarism." Am J Psychiatry 159(5): 705-712.
      The author proposes considering four domains of influences on voluntariness that apply to everyone and must be considered in the determination of whether fully informed consent is possible: 1) Development factors; 2) illness-related considerations; 3) psychological issues and cultural/religious values; 4) External features and purposes. She discusses how these affect the informed consent process, especially in psychiatric patients.

Biros, M. H. (2003). "Research without consent: Current status, 2003." Annals of Emergency Medicine 42(4): 550.
      A review of the status of the 1996 ruling by the NIH and FDA on the allowance of research in resuscitation and emergency medicine without prior informed consent. Very little research had been done under that rubric and the article reviews the reasons why and makes some suggestions.

Pucci E, B. N., Borsetti G, Rodriguez D, Signorino M. (2001). "Information and competency for consent to pharmacologic clinical trials in Alzheimer disease: an empirical analysis in patients and family caregivers." Alzheimer Dis Assoc Discord 15(3): 146-54.
      The authors studied the competency to give informed consent was compared in Alzheimer's disease patients and their caregivers. The Mini-Mental State Examination was useful in determining competence. They request support on methods to enroll Alzheimer's patients.

Wendler, D. (2004). "Can We Ensure That All Research Subjects Give Valid Consent." Arch Intern Med 164: 2201-4.
      This article raises the question of the degree to which study participants actually understand the consent form they are signing. It proposes post-decision questionnaires to improve understanding.


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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


Chapter 2 Download (PDF)