TY - BOOK AU - Mazur,Dennis John TI - Evaluating the science and ethics of research on humans: a guide for IRB members SN - 0801885019 AV - R853.H8 M39 2007 U1 - 174.28 22 PY - 2007/// CY - Baltimore PB - Johns Hopkins University Press KW - Human experimentation in medicine KW - Moral and ethical aspects KW - Medical ethics KW - Medicine KW - Research KW - Ethics Committees, Research KW - organization & administration KW - Human Experimentation KW - ethics KW - standards KW - Ethical Review KW - United States N1 - Includes bibliographical references (pages 239-245) and index; Introduction/what can the new IRB member expect? --; 1; What is an IRB, and what does it do? --; 2; Basic terms and concepts used in IRB work --; 3; What is risk? --; 4; Prescreening of proposals --; 5; The scientific protocol --; 6; The informed consent form --; 7; Recruitment, selection, and compensation of study participants --; 8; Research involving questionnaires and surveys --; 9; Protection of participants' privacy in research data and specimens --; 10; The ethical issues of informed consent --; 11; Continuing review, communication, and feedback --; 12; Where are IRBs making mistakes, and how can we minimize mistakes? --; 13; Strategies for managing the IRB workload and supporting IRB decision making --; 14; Decision-making capacity and accountability in research --; Summary : the IRB's key role --; App. 1; A check list for reviewing a scientific protocol --; App. 2; A check list for reviewing an informed consent form N2 - "Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes.Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process."--Publisher description UR - http://www.loc.gov/catdir/enhancements/fy0668/2006012326-b.html ER -