<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 3 of 11) Humphreys, K., J. Trafton, et al. (2003). "The Cost of Institutional Review Board Procedures in Multicenter Observational Research." Ann Intern Med 139(1): 77-.       This short letter examines costs of 9 IRBs and estimates supplemental IRB expenditures at $56000 per study, after home IRB approval. It chronicles poor communication and fear of punishment as the two main components of over-expenditure. This is a whopping sum that certainly needs to be diminished. Kaiser, J. (2001). "PATIENT PRIVACY: Researchers Say Rules Are Too Restrictive." Science 294(5549): 2070-2071.       This paper reports on the brouhaha associated with the proposed rules for HIPAA, prior to its activation. Some changes were made. Kaiser, J. (2002). "PATIENT RECORDS: Researchers Welcome Revised Privacy Rules." Science 297(5584): 1108b-1109.       The revised HIPAA rules are reported here. It includes a limited data set, which would permit medical record review without identifiability. It also liberalized the time that data could be kept. http://www.hhs.gov/ocr/hipaa Karlawish, J. H. T., D. J. Casarett, et al. (2002). "Alzheimer's Disease Patients' and Caregivers' Capacity, Competency, and Reasons to Enroll in an Early-Phase Alzheimer's Disease Clinical Trial." J Am Geriatr Soc 50(12): 2019-2024.       This is a valuable study of small number of persons with early Alzheimer's disease, age matched normal controls and care givers (15 of each). They used the MacArthur Competency Assessment Tool for Clinical Research and audiotaped the interviews for review. They found that all of the controls and 9 of the 15 Alzheimer cases were adjudged to be competent. They conclude that the instrument is very effective in selecting subjects who can sign for themselves rather than have a surrogate sign for them. Kaufman, J. L., R. Pelligra, et al. (2000). "Protection for Human Subjects in Medical Research." JAMA 283(18): 2387-2390.       This is the first of a series of letters to the editor of JAMA regarding the article by Woodward on protection of human research subjects. This supports the review by IRBs that were criticized by the author. Other letters in the group support positions taken by the NBAC, and criticize Dr. Woodward's view that there was movement afoot to weaken protections afforded to research participants. Korenman, S. and L. Shaker-Irwin (2003). Research Subject Advocacy--A New Way to Enhance Integrity in Clinical Research. Endocrine Society News. 1: 6-7.       The National Center for Research Resources provided General Clinical Research Centers funding to recruit and hire individuals to be Research Subject Advocates. The job description was somewhat vague. In this paper the authors describe their response to the charge to advocate for subjects and to oversee their research activities in a constructive manner. This describes how UCLA did it up to the date of the paper. This role has continued to evolve to include much more education, protocol monitoring, and face to face relationships with subjects and the research team. Korn, D. (2000). "Medical information privacy and the conduct of biomedical research." Acad Med 75(10): 963-8.       This constitutes a well thought out and somewhat pessimistic report on the expectations for medical research in the face of HIPAA. He sympathizes with the individual's need for privacy but wonders whether the individual would recognize the substantial benefits to be derived from the availability of medical data for examining and hopes that HIPAA does not close off the road toward chart-base research. By this time, many institutions have found their way to use the chart information needed while not violating HIPAA. Kulynych, J. and D. Korn (2002). "The New Federal Medical-Privacy Rule." N Engl J Med 347(15): 1133-1134.       It examines the new federal privacy rule (Federal Register 67: 53182-53273, 2002) by highlighting the differences and going into detail about the costs associated with its inception. http://content.nejm.org/cgi/content/full/347/15/1133 << 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)