Lawrence O. Gostin – författare

In the realm of health care, privacy protections are needed to preserve patients'' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule.

In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine''s Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

In the realm of health care, privacy protections are needed to preserve patients'' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule.

In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine''s Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

The influenza pandemic caused by the 2009 H1N1 virus underscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communities across the United States.Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations draws from a broad spectrum of expertise—including state and local public health, emergency medicine and response, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication—to offer guidance toward establishing standards of care that should apply to disaster situations, both naturally occurring and man-made, under conditions in which resources are scarce.This book explores two case studies that illustrate the application of the guidance and principles laid out in the report. One scenario focuses on a gradual-onset pandemic flu. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event.Outlining current concepts and offering guidance, this book will prove an asset to state and local public health officials, health care facilities, and professionals in the development of systematic and comprehensive policies and protocols for standards of care in disasters when resources are scarce. In addition, the extensive operations section of the book provides guidance to clinicians, health care institutions, and state and local public health officials for how crisis standards of care should be implemented in a disaster situation.

The influenza pandemic caused by the 2009 H1N1 virus underscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communities across the United States.Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations draws from a broad spectrum of expertise—including state and local public health, emergency medicine and response, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication—to offer guidance toward establishing standards of care that should apply to disaster situations, both naturally occurring and man-made, under conditions in which resources are scarce.This book explores two case studies that illustrate the application of the guidance and principles laid out in the report. One scenario focuses on a gradual-onset pandemic flu. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event.Outlining current concepts and offering guidance, this book will prove an asset to state and local public health officials, health care facilities, and professionals in the development of systematic and comprehensive policies and protocols for standards of care in disasters when resources are scarce. In addition, the extensive operations section of the book provides guidance to clinicians, health care institutions, and state and local public health officials for how crisis standards of care should be implemented in a disaster situation.

Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion.

Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.