<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 5 of 11) Shalala, D. (2000). "Protecting Research Subjects -- What Must Be Done." N Engl J Med 343(11): 808-810.       The Secretary of HHS, responding to serious criticism of the clinical research activities of the government and academic health centers proposed supporting a much strengthened oversight office with considerable powers. Oversight of research would be greatly enhanced. Sieber, J. P., S; Rubin, Philip. (2002). "How (Not) to Regulate Social and Behavioral Research." Professional Ethics Report 15(2): 1-8.       The authors deal with apparent craziness on the part of IRBs, used to dealing with medical research, attributing harm to social science studies and delaying or stopping research proposals for what seems to be ridiculous reasons. Good arguments; however, social scientists also are frequently oblivious of the harm they may do in their studies, for example, stigmatizing a group. Siegler, M. (1998). "Ethical issues in innovative surgery: should we attempt a cadaveric hand transplantation in a human subject?" Transplantation Proceedings 30(6): 2779.       The author discusses the ethical and scientific validity of conducting the first cadaveric hand transplant. He applies criteria that Francis Moore has proposed years ago that includes good science, institutional probity, openness, and community discussion and decides that it is o.k. Since we have seen two face transplants by now, we can see that surgical innovation will continue apace. Slater, E. E. (2005). "Today's FDA." N Engl J Med 352(3): 293-297.       The author, with considerable personal experience reviews the successes and deficiencies of the FDA. She recommends much strengthening post-marketing surveillance, getting proper leadership approved, improving the review process to more nearly match the strength of the pharmaceutical houses, and bringing down the costs of drugs by getting them generic sooner and transferring more agents to over-the-counter status. This is a very good article. Steinbrook, R. (2004). "Peer Review and Federal Regulations." N Engl J Med 350(2): 103-104.       The author addresses the issue of peer review of information quality that the Federal government utilizes to make substantive policy decisions. The superficially good idea was questions as to the need that it fulfills in that the data seem to be good in the first place. Secondly, the selection of peer reviewers could politicize the process, especially if conflicted individuals were selected. Finally, some thought the whole idea was political, to get rid of troublesome findings. This is a very interesting discussion. Woodward, B. (1999). "Challenges to Human Subject Protections in US Medical Research." JAMA 282(20): 1947-1952.       United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research--including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself. Theseare creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. This review is designed to sensitize the reader to the great difficulty of the task of protecting subjects in this environment. (2004). Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. DHHS. Services, Federal Register. 69 (92): 26393-7.       This federal guideline asks IRBs and institutions to consider a variety of means to eliminate, document, disclose, and manage conflicts of interest. It is not overly prescriptive but it expects institutions to actively and effectively deal with conflicts of interest both of individual investigators and of IRB members. Conflict of interest committees distinct from IRBs are expected to be developed. Required reading for research administrators. Shalowitz, D. I. and F. G. Miller (2005). "Disclosing Individual Results of Clinical Research: Implications of Respect for Participants." JAMA 294(6): 737-740.       This discussion piece should be read by everyone conducting research in which testing is done that may be of relevance to subjects. They claim that, in addition to informed consent, respect means that individuals have the right to learn about tests done on them as individual if they want the information. That obligation is not set down in any research rules as yet. http://jama.ama-assn.org/cgi/content/full/294/6/737 << 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)