<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 6 of 11) Consents Dye, L., S. Hendy, et al. (2004). "Capacity To Consent To Participate In Research -- A Recontextualization." British Journal of Learning Disabilities 32: 144-50.       In order to be able to carry out research in people with learning disabilities the issue of how to consent becomes important. The authors suggest that consent exist in a continuum involving both assessments of capacity, degree of risk, availability of surrogates and assent, etc, rather than a dichotomous decision for each individual. Ross, L. F. (2004). "Children In Medical Research: Balancing Protection And Access--Has The Pendulum Swung Too Far?" Perspectives in Biology and Medicine 47(4): 519-36.       The author discusses the uncertain evolution of research in children from protection (paternalism) to access (autonomy) and the associated ethical dilemmas. It is largely a historical review. http://muse.jhu.edu/journals/perspectives_in_biology_and_medicine/v047/47.4ross.html Kovnick, J. A., P. S. Appelbaum, et al. (2003). "Competence to Consent to Research Among Long-Stay Inpatients With Chronic Schizophrenia." Psychiatr Serv 54(9): 1247-1252.       The authors did a study of the consenting capacity of a group of chronically hospitalized schizophrenics to see how many were competent and for what kind of research. While diminished competence was widespread some positive findings were demonstrable. http://ps.psychiatryonline.org/cgi/content/full/54/9/1247 Nelson, R. and J. F. Merz (2002). "Voluntariness of consent for research: an empirical and conceptual review." Med Care 40(9): V69-V80.       These authors discuss the concepts surrounding voluntariness in voluntary informed consent. They elaborate on the vulnerabilities of potential research subjects and proceed with the ways in which investigations can influence participation to the extent of coercion. These are evaluated as ethical conclusions in research. Bosk, C. (2002). "Obtaining voluntary consent for research in desperately ill patients." Med Care 40(9): V64-V68.       The author, in reflecting on the consent process for very seriously ill subjects, stresses the battle between hope (the therapeutic misconception) and reason (reading all the negative information provided). If we insist that reason prevails and the distinction between care and research be clear then some changes need to be made in the process of obtaining consent. Kim S Y Hcaine , E D, et al. (2001). "Assessing the Competence of Persons with Alzheimer's Disease in Providing Informed Consent for Participation in Research." Am J Psychiatry 158(5): 712-717.       This study used the MacArthur Competence Assessment Tool--Clinical Research Version to examine the consenting capability of 37 subjects with mild to moderate Alzheimer's disease in comparison to controls. They found 62% of the subjects to be incompetent by not exceeding the cutoff score on at least one domain. The validity of this way of determining competency was subject to discussion. Kuczewski, M. and P. Mashall (2002). "The decision dynamics of clinical research: the context and process of informed consent." Med Care 40(9): V-45-V54.       This very perceptive article elaborates on the informed consent process. They indicate that research on informed consent have concentrated on the form rather than dealing with recruitment that condition people about volunteering, the social and demographic characteristics of the potential volunteers, and the role of the primary care physician. Nelson K, G. R., Brown J, Mangione CM, Louis TA, Keeler E, Cretin S (2002). "Do patient consent procedures affect participation rates in health services research?" Med Care 40(4): 283-88.       These authors report on an experiment forced upon them when 7 of 15 IRBs required pre-permission to send a questionnaire to subjects in a health services research investigation. Pre-permission substantially reduced acceptance. They would prefer no advanced permissions but would accept an "opt out" solution. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links 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)