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