Includes index.

Rev. ed. of: Institutional review board / Robert J. Amdur, Elizabeth A. Bankert. c2002.

Includes bibliographical references (p. [519]-[520]) and index.

Differences between Department of Health and Human services and Food and Drug Admiistration 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 -- Pt. 9. Issues based on study population. Vulernability in research -- Research in public schools -- Phase I clinical trials in healthy adults -- Acquiring 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 --

Pt. 1. Background and overview topics. 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 -- Pt. 2. Organizing the office. 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 -- Pt. 3. Organizing the institutional review board committee. 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 --

Pt. 10. Institutional review board issues based on study design or category. 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 -- Pt. 11. Reference material and contact information. 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 -- Guidelines and resources -- Periodicals, IRB forum, and selected organizations.

Social science versus biomedical institutional review boards -- Pt. 4. Review categories. Exempt from institutional review board review -- Expedited institutional review board review -- Identifying intent: is this project research? -- Compassionate use and emergency use examptions -- Waiver of consent in emergency medicine research -- Pt. 5. Initial protocol review and the full-committee meeting. 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 institutional review board meeting -- Guidelines for review, discussion, and voting -- Administrative tasks after each institutional review board meeting -- Guidelines for review, discussion, and voting -- Administrative tasks after each institutional review board meeting -- Pt. 6. Informed consent.

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 -- Pt. 7. Continuing review. 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 -- Pt. 8. Administrative and regulatory issues. 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 Adminsitration's investigational new drug process --