Ethical issues in research

Fisher, C.B., Hoagwood, K., and Jensen, P.S. (1996). Casebook on ethical issues in research with children and adolescents with mental disorders. In Hoagwood, K., Jensen P.S., and C.B. Fisher, eds., Ethical Issues in Mental Health Research with Children and Adolescents Mahwah, NJ Lawrence Erlbaum Associates, pp. 135-157. 

Zwait SD, et al. A network approach for distinguishing ethiced issues in research and development. Sci Eng Ethic. 2006 12 663-84. 

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

C., Hattab, J., Graham, P., Zametkin, A., Castellanos, F.X., McMahon, W., and Lechman, J.F. (1995) Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 34 929-939. 

Hoagwood, K., Jensen, P.S., and Fisher, C., eds. (1996) Ethical Issues in Child and Adolescent Mental Health Research. Mahwah, NJ Lawrence Erlbaum Associates. 

Vitiello, B. in press Ethical issues in pediatric psychopharmacology research. In Rosenberg, D., Gershon, S., Davanzo P., eds.. Pharmacotherapy for Child and Adolescent Psychiatric Disorders. 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

About the Author Dr. Bentley is an Associate Professor in the Department of Pharmacy Administration and Research Associate Professor in the Research Institute of Pharmaceutical Sciences at the University of Mississippi School of Pharmacy. He received a B.S. in pharmacy and an MBA from Drake University and an M.S. and Ph.D. in pharmacy administration from the University of Mississippi. In addition to statistics, Dr. Bentley s teaching interests focus on the organization, delivery, financing, and outcomes of health care. His research interests include understanding the role of pharmacy practice in how medications and the medication consumption experience affect quality of life, the use of quality-of-life measures as clinical tools, and empirical investigations of ethical issues in pharmacy and research. 

Brady RP, Newberry MS, Girard VW. The Food and Drug Administration s Statutory and Regulatory Authority to Regulate Human Pluripotent Stem Cells. In Ethical Issues in Human Stem Cell Research, vol. 1. Report and Recommendations of the National Bioethics Advisory Commission, Appendix D, pp. 93-8. 

Sorting out the ethical issues in relation to conducting research in disasters is a worthwhile starting point. Ownership of data can be an issue. If data are collected in a community that has just experienced a disaster, the data belongs to that community. They should have first call on the dissemination and implementation of findings. Just as in mainstream health care research where participants in the form of patient groups are heavily involved in research so too should be the case in disaster research. Nurses are in a prime position to develop this process whether they wish to use an action research approach or carry out projects that are immedi-... 

Bioethics is a relatively new field of study concerning the investigation of ethical issues in medicine, health care, and the life sciences. From the standpoint of bioethics, clinical pharmacy research presents no novel ethical questions however, the type and scope of issues involved differ from those faced by other practitioners. It is important for pharmacists to be aware of the ethical issues, give thoughtful consideration to them, and be sensitive to how they may affect their involvement in research. The current Code of Ethics for the practice of pharmacy virtually neglects issues encountered by pharmacists as they conduct clinical research. ... 

Louis, K. S., Swazey, J. P., and Anderson, M. S., University Policies and Ethical Issues in Graduate Research and Education Results of a Survey of Graduate School Deans, unpublished manuscript, University of Minnesota, St. Paul, and Acadia Institute, Bar Harbor, ME, 1991. 

Porton Down in the UK was a biochemical research facility. In the mid-1950s, part of its research activities were concerned with the effects of nerve gases. One young serviceman was asked to participate in an experiment to find a cure for the common cold. It is claimed that he was actually exposed to a nerve toxin, sarin, and subsequently died. As recently as 2002 the British High Court gave the go-ahead for a new inquest into the death. Ethical issues in medical research have a habit of not going away until there is complete resolution. 

Sclineiderman, N., Weiss, S. M., Kaufmann, P. G. (1989). Handbook of research methods in cardiovascular behavioral medicine. New York Plenum. Schuler, H. (1982). Ethische Probleme [Ethical issues]. In J. L. Patry (Ed.), Felt orschung (pp. 341-364). Bern, Switzerland Huber. 

McManus, J., et al., Informed Consent and Ethical Issues in Military Medical Research , Journal of Academic Emergency Medicine, 12 (2005), p. 1121. 

Levinson, R. Turner, S. (2001). Valuable Lessons The teaching of social and ethical issues in the school curriculum, arising from developments in biomedical research - a research study of teachers. London The Wellcome Tmst. 

The responsibilities of academic institutions for human subjects in research are found at http // www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. A good discussion of ethics issues in animal research is at http //www.ontineethics.org/cms/13119.aspx. 

The course. Responsible Research in Appropriate Technology, also raises issues in research ethics such as paternalism, informed consent (see especially Schrag 2006 for collective informed consent), and working to realize a community s capabilities (Nussbaum 2011). Moral imagination plays a central part in the design and execution of this course. 

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