Institutional Review Board Management and Function

ISBN-10: 0763730491

ISBN-13: 9780763730499

Edition: 2nd 2006 (Revised)

List price: $303.95 Buy it from $267.04
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Description:

nbsp; This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. nbsp; The updated Second Edition includes seven new chapters: bull; bull; IRB Closure of Study Files bull; Internet Research bull; Research in Public Schools bull; Phase I Clinical Trials in Healthy Volunteers bull; Vulnerability in Research bull; Balancing the Risks and Potential Benefits bull; HIPAA
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Book details

List price: $303.95
Edition: 2nd
Copyright year: 2006
Publisher: Jones & Bartlett Learning, LLC
Publication date: 11/8/2005
Binding: Paperback
Pages: 530
Size: 8.75" wide x 11.25" long x 1.50" tall
Weight: 3.652
Language: English

Foreword : Jesse's intent
Preface
An ethics primer for institutional review boards
Reflections of an outsider
A unified human-research protection program
A shared responsibility for protecting human subjects
A brief history of public responsibility in medicine and research and institutional review board education
The institutional review board : definition and federal oversight
The limits of institutional review board authority
Administrative reporting structure for the institutional review board
Documentation, policies, and procedures
Tracking systems using information technology
Support staff
Audit systems
Charging for institutional review board review
Reflections on chairing an institutional review board
The institutional review board chair
The institutional review board administrative director
The role of an attorney
Committee size, alternates, and consultants
Length, frequency, and time of institutional review board meetings
Institutional review board subcommittees
Social science versus biomedical institutional review boards
Exempt from institutional review board review
Expedited institutional review board review
Identifying intent : is this project research?
Compassionate use and emergency use exemption
Waiver of consent in emergency medicine research
Overview of initial protocol review
Evaluating study design and quality
The study population : women, minorities, and children
Community consultation to assess and minimize group harms
Privacy and confidentiality
Recruitment of research subjects
Advertisements for research
Paying research subjects
Provisions for data monitoring
Conflict of interest : researchers
Conflict of interest : recruitment incentives
Conflict of interest : institutional review boards
Administrative tasks before each instutional review board meeting
Guidelines for review, discussion, and voting
Administrative tasks after each institutional review board meeting
The institutional review board's role in editing the consent document
The consent document
Exculpatory language in informed consent documents
Requiring a witness signature on the consent form
Deception of research subjects
Research without consent or documentation thereof
Selecting a surrogate to consent to medical research
Research-related injuries
Informing subjects about research results
Explaining the cost of research participation
Improving informed consent
Informed consent evaluation feedback tool
Revisions to an approved study
Protocol renewal
Institutional review board review of adverse events
Data and safety monitoring
Noncompliance, complaints, deviations, and eligibility exceptions
Institutional review board closure of study files
Health insurance portability and accountability act and research
Office for human research protections federalwide assurance
International conference on harmonisation
The role of the institutional biosafety committee : human gene transfer research
Understanding the Food and Drug Administration's investigational new drug process
Differences between Department of Health and Human Services and Food and Drug Administration regulations
Veterans Administration research guidelines
State law
Institutional review board member liability
Certificates of confidentiality
Training institutional review board members
Investigator training
Accreditation of human research protection programs
Certification of institutional review board professionals
Preparing for a Food and Drug Administration audit
Preparing for an office for human research protections site visit
Vulnerability in research
Research in public schools
Phase I clinical trials in healthy adults
Requiring birth control to participate in research
Research involving fetuses and in vitro fertilization
Research involving pregnant women
Research involving children
Research involving adults with decisional impairment
Regulatory issues of research involving prisoners
Research involving college students
When are research risks reasonable in relationship to anticipated benefits?
Internet research : a brief guide for institutional review boards
Qualitative social science research
Ethnographic research
Health services research
Epidemiology/public health research
Survey research
Research involving a medical device
Humanitarian use devices
Banking of human biological materials for research
The placebo-controlled clinical trial
Treatment-withholding studies in psychiatry
Phase I oncology trials
Research involving genetic testing
International research
Alternative medicine research
Ethical codes
The Nuremberg Code
The Belmont Report
Selected U.S. government regulations
Code of Federal Regulations : Title 45, Part 46
Code of Federal Regulations : Title 21, Part 50
Code of Federal Regulations : Title 21, Part 56
Expedited review criteria
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