<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 4 of 11) Lehman, C. R., G. (2001). "To IRB or Not to IRB?" Am J of Clin Pathology 115(2): 187-191.       This paper, which has become historical by now, deals with the issue of whether pathologists using tissue samples mainly for developing diagnostic test needed IRB approval. At this time, they frequently did not seek such approval and in an empirical study, identifiable tissue samples were often used. I believe that HIPAA has clarified those uncertainties and IRB approval or waiver is necessary when conducting studies of human tissues. Levine, R. J. (1999). "The Need to Revise the Declaration of Helsinki." N Engl J Med 341(7): 531-534.      This position paper reviews the Declaration of Helsinki (since revised) and points out that investigators routinely violate some of the provisions. He also claims that provisions violate contemporary ethical standards. He claims that the Declaration of Helsinki requires revision because it is defective in two important respects. First, it relies on a distinction between therapeutic and nontherapeutic research. Secondly, it includes several provisions that are seriously out of touch with contemporary ethical thinking. As a consequence, many researchers routinely violate its requirements. Such routine violations and their associated attitudes rob the declaration of its credibility. Marshall, E. (2000). "BIOMEDICAL ETHICS:HHS Plans to Overhaul Clinical Research Rules." Science 288(5470): 1315a-1316.       This report outlines the plans to strengthen the Office of Protection from Research Risks and DHHS. It will also establish serious penalties for clinical investigator lapses and ensure better oversight of research, better deal with conflicts of interest, etc. Strengthening IRBs, one of the goals of the initiative has been carried out but more needs to be done. Mello, M. M., D. M. Studdert, et al. (2003). "The Rise of Litigation in Human Subjects Research." Ann Intern Med 139(1): 40-45.       This is an important paper that identifies the rapidly increasing trend to sue institutions and individuals for bad results associated with clinical research. Litigation will get the profession to examine itself more rigorously, stultifying IRBs and perhaps inhibiting the development of drugs. Molloy, V. J. and D. R. Mackintosh (2003). "GCP Compliance Problems Encountered at Clinical Sites: Informed Consents, Physical Exams, and Adverse Events." SoCRa Source: 12-15. Nebeker, J. R., P. Barach, et al. (2004). "Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting." Ann Intern Med 140(10): 795-801.       Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies. Partridge, A. H. and E. P. Winer (2002). "Informing Clinical Trial Participants about Study Results." JAMA 288(3): 363-365.       Many informed consent forms now indicate that participants will receive information about the results of their trial. That is not always done. This paper addresses the issues involved in that area. Rising, J., P. Lurie, et al. (2003). Letter to HHS urging a federal investigation of medical schools conducting unethical research.       This letter to Bernard. Shwetz. Acting director of the Office for Human Subject Protections requested that all the medical schools in the US be investigated for requiring seniors to fill out a questionnaire about their medical school experience. These were compiled at the AAMC and utilized by individual schools and the profession to improve its performance. The students objected to the obligatory nature of the response and the failure to obtain consent. The argument was that it was research because someone could study the data and report it although it was intended as an educational quality assurance report. It also pointed out that the seniors would personally derive no benefit from the results. << 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)