<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 2 of 11) Faden, R., S. Lederer, et al. (1996). "US Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code." JAMA 276(20): 1667-1671.       These authors reiterate, 50 years later, the impact of the Nuremberg trials documenting NAZI physicians'atrocities and proposing rules about performing research on humans. Clinical research in America and worldwide was designed to protect the rights of the individual subjects' to make uncoerced decisions about participation and to expect that the chance of benefit will generally outweigh the chance of harm. The subsequent research rules in the Belmont report and the Declaration of Helsinki were derived directly from the Nuremberg Report. Grizzle, W., W. Grody, et al. (1999). "Recommended policies for uses of human tissue in research, education, and quality control." Arch Pathol Lab Med. 123(4): 296-300.      As recipients of tissue and medical specimens, pathologists and other medical specialists regard themselves as stewards of patient tissues and consider it their duty to protect the best interests of both the individual patient and the public. The stewardship of slides, blocks, and other materials includes providing, under appropriate circumstances, patient materials for research, education, and quality control. The decision to provide human tissue for such purposes should be based on the specific (i.e., direct patient care) and general (i.e., furthering medical knowledge) interests of the patient and of society. The same standards of responsibility should apply to all medical professionals who receive and use specimens. This document proposes specific recommendations whereby both interests can be fostered safely, ethically, and reasonably. Gunsalus, C. K. (2003). "Human Subject Regulations: Whom Are We Protecting from What, and Why? Working to Align Incentives with Ethical Goals." Professional Ethics Report 16(2)      The author discusses the use of IRBs in research on humans outside of medicine. Social scientists are very concerned about overzealous IRBs severely curtailing what they consider to be harmless research. In frustration, they engage in "serial mind-reading" trying to produce protocols that will be acceptable to their IRBs. The problem is that IRBs are local and reflect local conditions so investigators are often not sure where they stand. The conference from which this report was generated was to produce a white paper asking for improvements in research regulation. Halpern, S. D., J. H. T. Karlawish, et al. (2002). "The Continuing Unethical Conduct of Underpowered Clinical Trials." JAMA 288(3): 358-362.      This important paper discusses the ethical implications of underpowered clinical trials, indicating that they are becoming more common and have garnered a degree of professional support. They are justified as ways of accumulating data for meta-analyses and for ways of determining efficacy or appropriate dosing. It is unethical to carry out studies on humans in which you can never reach a valid conclusion. It subjects them to risk and bother for no possible reward. Certainly, if that is the intention, participants should know about it and assess the value of their participation. However, clearly, in many cases under powering was not deliberate, but rather the consequence of difficulty recruiting or excessive dropouts. They suggest that underpowered trials are justifiable in treating rare diseases where a meta-analysis will provide statistical validity or in a phase 2 type dosing experiment. Small trials might also be used to develop a protocol. They believe that it is immoral to reach clinical conclusions from inadequate information. Hawkins, A. (2004). Obligation to human research participants goes far beyond regulatory compliance. Washington Fax. November 4, 2004.       This brief paper tries to answer the claim that today's scientists perceive no obligation to research subjects beyond compliance with the rules. Numerous individuals and government leaders are quoted, all coming to the conclusion that research integrity goes well beyond the rules, but we must have rules. The prevalence of major conflicts of interest mandates the existence of strong regulations. Henry, R. C. and D. E. Wright (2001). "When Do Medical Students Become Human Subjects of Research? The Case of Program Evaluation." Acad Med 76(9): 871-875.       This position paper reviews the ideas behind requiring medical students to fill out graduation questionnaires as an evaluative tool. Are they research subjects when they do this? And if it is required for graduation does that mean that their cooperation in research is coerced? The problem is that the results might be useful to others and therefore subject to publication. Other such "dual purpose activities" include clinical quality assurance studies. The authors conclude that students should know that faculty may publish the results of an educational questionnaire, but they do not go so far as to require the completion of an informed consent document. They do raise the question of when is it appropriate to ask for student consent, thus making the task voluntary. HHS (2002). Standards for Privacy of Individually Identifiable Health Information--Proposed Rule Modification. U. S. DHS. http://www.hipaacomply.com/changetoprivacy.htm << 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)