Evaluating the science and ethics of research on humans : a guide for IRB members / Dennis J. Mazur.

Format:

Book

Author/Creator:

Mazur, Dennis John.

Language:

English

Subjects (All):

Human experimentation in medicine--Moral and ethical aspects.

Human experimentation in medicine.

Medical ethics.

Medicine--Research--Moral and ethical aspects.

Medicine.

Ethics Committees, Research--organization & administration.

Medicine--Research.

United States.

Human Experimentation--ethics.

Ethical Review.

Human Experimentation--standards.

Medical Subjects:

Ethics Committees, Research--organization & administration.

United States.

Human Experimentation--ethics.

Ethical Review.

Human Experimentation--standards.

Physical Description:

xi, 252 pages ; 23 cm

Place of Publication:

Baltimore : Johns Hopkins University Press, 2007.

Summary:

Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices must be the top priority. The need for the committees that regulate and oversee such research-institutional review boards, or IRBs-is growing. Evaluating the Science and Ethics of Reseach 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 human participants in research. 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: the systematic review of scientific protocols and informed consent forms and thorough adherance to applicable federal regulations. New members will gain understanding of how proposed research 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 amy have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accesible and informative guide will give IRB members the tools they need to protect human lives and facilitate the reseacrh process.

Contents:

What is an IRB, and what does it do?

Basic terms and concepts used in IRB work

What is risk?

Prescreening of proposals

The scientific protocol

The informed consent form

Recruitment, selection, and compensation of study participants

Research involving questionnaires and surveys

Protection of participants' privacy in research data and specimens

The ethical issues of informed consent

Continuing review, communication, and feedback

Where are IRBs making mistakes, and how can we minimize mistakes?

Strategies for managing the IRB workload and supporting IRB decision making

Decision-making capacity and accountability in research.

Notes:

Includes bibliographical references and index.

ISBN:

0801885019

0801885027

OCLC:

66524999

Online:

Contributor biographical information

Publisher description