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PubMed2006

Local perspective of the impact of the HIPAA privacy rule on research.

BACKGROUND: The operational and economic impact of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was evaluated. The setting was a natural experiment which involved a single-site, clinical research study that was initiated before the enactment of HIPAA and subsequently modified to be compliant with the new policy. METHODS: A formative assessment was conducted of the recruitment process to a clinical trial evaluating the efficacy of an educational strategy to inform Veterans about the National Cancer Institute/Department of Veterans Affairs cosponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT). Personnel time and costs were determined based on weekly accrual for study periods before and after the implementation of HIPAA. Root cause analysis was used to assess the recruitment protocol and to identify areas for improvement. RESULTS: The implementation of HIPAA resulted in a 72.9% decrease in patient accrual (7.0 patients/wk vs. 1.9 patients/wk, P < 0.001), and a threefold increase in mean personnel time spent recruiting (4.1 hrs/patient vs. 14.1 hrs/patient, P < 0.001) and mean recruitment costs (49 US dollars/patient vs. 169 US dollars/patient, P < 0.001). Upon review of the modified HIPAA-compliant protocol, revisions in the recruitment procedure were adopted. The revised protocol improved weekly accrual by 73% (1.9 patients/wk vs. 7.1 patients/wk, P < 0.001) and resulted in improvements in personnel time (5.4 hrs/patient) and recruitment costs (65 US dollars/patient). CONCLUSION: Enactment of HIPAA initially placed a considerable burden on research time and costs. Establishing HIPAA-compliant recruitment policies can overcome some of these obstacles, although recruitment costs and time are likely to be greater than those observed before HIPAA.

Confidentiality↗
PubMed2006

The privacy of T cell memory to viruses.

T cell responses to viral infections can mediate either protective immunity or damaging immunopathology. Viral infections induce the proliferation of T cells specific for viral antigens and cause a loss in the number of T cells with other specificities. In immunologically naive hosts, viruses will induce T cell responses that, dependent on the MHC, recognize a distinct hierarchy of virus-encoded T cell epitopes. This hierarchy can change if the host has previously encountered another pathogen that elicited a memory pool ofT cells specific to a cross-reactive epitope. This heterologous immunity can deviate the normal immune response and result in either beneficial or harmful effects on the host. Each host has a unique T cell repertoire caused by the random DNA rearrangement that created it, so the specific T cells that create the epitope hierarchy differ between individuals. This "private specificity" seems of little significance in the T cell response of a naive host to infection, but it is of profound importance under conditions of heterologous immunity, where a small subset of a cross-reactive memory pool may expand and dominate a response. Examples are given of how the private specificities of immune responses under conditions of heterologous immunity influence the pathogenesis of murine and human viral infections.

Animals↗
PubMed1994

The last invasion of human privacy and its psychological consequences on survivors: a critique of the practice of embalming.

In spite of the fact that it is required only occasionally for sanitary reasons and not legally mandatory, the practice of embalming is widespread in contemporary American society. This study explores the historical, cultural and psychological factors which gave rise to the practice of embalming and why the practice continues. Two case studies are presented in which delayed grief reactions were present; linkages with embalming are described. It is suggested that the frightening finitude of the self and a fear of death in modern society have led to practices in which the corpse is viewed as looking "natural," thus denying the reality of death. Embalming is seen as the final assault on the self, which can also carry with it problematic psychological consequences for the survivors.

Attitude to Death↗
PubMedDate not supplied

Privacy and therapy.

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Confidentiality↗