IRB Library of Reference Materials

To check out any of these items, contact PNNL's IRB Program Manager, Kathy Ertell.

Title	Author	Year Published	Summary
Institutional Review Board: Management and Function, Second Edition	Elizabeth A. Bankert	2006	This comprehensive reference covers three separate areas related to IRBs: administration, daily management, and ethical issues. This instruction 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.
Study Guide for Institutional Review Board Management and Function	Amy Davis/Elizabeth A. Bankert, etc.	2006	Published in partnership with the Applied Research Ethics Association (ARENA), this study guide companion to the Institutional Review Board: Management and Function, Second Edition, facilitates the application of knowledge acquired from the textbook. Written by IRB people for IRB people, this study guide is a useful resource that promotes the professional development of people working in the field of human subjects protection.
Institutional Review Board Member Handbook	Robert J. Amdur	2003	Institutional Review Board Member Handbook is designed to give IRB members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. Chapters are short and to the point with the goal of presenting practical advice on what IRB members should do before and during full-committee meetings. A large portion of the book is devoted to topic-specific chapters that list the criteria IRB members should use to determine how to vote on specific kinds of studies. This handbook is an excellent accompaniment to Institutional Review Board: Management and Function that IRB members can access and refer to quickly and easily.
Planning Ethically Responsible Research - A Guide for Students and Institutional Review Boards	Joan E. Sieber	1992	This book was written to provide social scientists, their students, and members of research ethics committees with the theory and practical knowledge needed to plan ethically responsible social and behavioral research. It interprets current viewpoints on what ethical research is, especially those views presented in The Belmont Report (National Commission, 1978), a document set forth by the National Commission on the Protection of Human Subjects of Biomedical and Behavioral Research. It is also a practical handbook on how to translate ethical principles into valid research methods and procedure that satisfy both scientific and ethical standards. Part of each chapter provide guidelines for satisfying federal regulations governing human research and for working with one's Institutional Review Board (IRB), or Human Subjects Committee.
Protecting Study Volunteers in Research - A Manual for Investigative Sites	Cynthia McGuire Dunn, MD& Gary Chadwick, Pharm.D., MPH	1999	The intent of this manual is to aid researchers in understanding the regulatory requirements and ethical principles upon which they are based. The manual will also identify issues that require sensitivity when designing or conducting human research studies. Ultimately the safety and welfare of human subjects rests in the hands of the investigators. We hope this manual will aid all members of the research community in promoting ethical scientific discovery.
Clinical Ethics - Fourth Edition	Albert R. Jonsen, Mark Siegler, William J. Winslade	1998	We have two purposes in writing this book: first, to offer an approach that facilitates thinking about the complexities of the problems that clinicians actually face and, second, to assemble concise representative opinions about typical ethical problems that occur in the practice of medicine. Our book is intended not only for clinicians and students who provide care to patients, but also for others whose work requires an awareness and sensitivity to the ethical issues raised in clinical care, such as hospital chaplains, administrators, hospital attorneys, members of institutional ethics committees, quality reviewers, and administrators of health plans.
A Short History of Medical Ethics	Albert R. Jonsen	2000	A physician says, "I have an ethical obligation never to cause the death of a patient," another responds, "My ethical obligation is to relieve pain even if the patient dies." The current argument over the role of physicians in assisting patients to die constantly refers to the ethical duties of the profession. References to the Hippocratic Oath are often heard. Many modern problems, from assisted suicide to accessible health care, raise questions about the traditional ethics of medicine and the medical profession. However, few know what the traditional ethics are and how they came into being. This book provides a brief tour of the complex story of how medical ethics evolved over centuries in both Western and Eastern culture. It sets this story in the social and cultural contexts in which the work of healing was practiced and suggest that, behind the many different perceptions about the ethical duties of physicians, certain themes appear constantly, and may be relevant to modern debates. The book begins with the Hippocratic medicine of ancient Greece, moves through the Middle Ages, Renaissance and Enlightenment in Europe, and the long history of Indian and Chinese medicine, ending as the problems raised in modern medical science and technology challenge the settled ethics of long tradition. Two chapters record the growth of medical ethics in the environment of American medicine. The final chapter chronicles the events in medical science and technology that began to transform medical ethics into bioethics.
Ethics of Research with Human Subjects - Selected Policies and Resources	Jeremy Sugarman, Anna C. Mastroianni, Jeffrey P. Kahn	1998	This book should be useful for IRB members and administrators, scholars, students, researchers, and those responsible for research oversight in various settings. This book is divided into three parts. Part 1: Landmark Documents, contains materials that have in some way influenced policy development related to research with human subjects. Part 2: Selected Major Policies, presents important policies relating to this research. These include policies that address general issues arising in the context of research with human subjects, as well as those addressing particular subject populations and research settings. Part 3: Selected Bibliography, provides citations to resources that are intended to amplify understanding of policies for human subjects research and, perhaps more importantly, address gaps where policy guidance is lacking.
Ethics and Regulation of Clinical Research	Robert J. Levine	1988	The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analyses, and case studies in an attempt to answer these questions. His book is an essential reference for everyone - members of institutional review boards, scientists, philosophers, lawyers - addressing the ethical issues involved.
Beyond Consent - Seeking Justice in Research	Jeffrey P. Kahn, Anna C. Mastroianni, Jeremy Sugarman	1998	Beyond Consent examines the concept of justice, and its application to research with human subjects, through the lenses of research populations: children, the vulnerable sick (including those seeking emergency medical care), captive and convenient populations (such as prisoners), women, people of color, and subjects in emergency and international settings. To set the stage for this examination, an introductory chapter addresses the evolution of research policies. After a look at specific subject populations and settings, concluding chapters discuss the concept of justice with respect to research with human subjects and examines its implications for this research in the future. The editions, in addition to authoring chapters of their own, have assembled a team of eight other contributors, all of whom are leading experts in the ethics of research with human subjects.
Undue Risk - Secret State Experiments on Humans	Jonathan D. Moreno	2000	In Undue Risk, Moreno presents the first comprehensive history of the use of human subjects in atomic, biological, and chemical warfare experiments from World War II to the twenty-first century. From the courtrooms of Nuremberg to the battlefields of the Gulf War, Undue Risk explores a variety of government policies and specific cases, including plutonium injections into unwitting hospital patients, U.S. government attempts to recruit Nazi medical scientists, the subjection of soldiers to atomic blast fallout, secret LSD and mescaline studies, and the feeding of irradiated oatmeal to children. It is the first book to go behind the scenes and reveal the government's struggle with the ethics of human experimentation and the evolution of agonizing policy choices on unfamiliar moral terrain.
Acres of Skin - Human Experiments at Holmesburg Prison	Allen M. Hornblum	1998	At a time of increased interest and renewed shock over the Tuskegee syphilis experiments, Acres of Skin sheds light on yet another dark episode of American medical history. In this disturbing expose, Allen M. Hornblum tells the story of Philadelphia's Holmesburg Prison. From the early 1950s through the mid-1970s, Holmesburg's inmates were used, in exchange for a few dollars, as guinea pigs in a host of medical experiments. Acres of Skin argues that at Holmesburg the American medical establishment betrayed the ideals of the Hippocratic Oath and the Nuremberg Code. An array of doctors, in conjunction with the University of Pennsylvania and prison officials, established Holmesburg as a laboratory testing ground. Hundreds of prisoners were used to test products from facial creams and skin moisturizers to perfumes, detergents, and anti-rash treatments. Other experiments used the inmates as test subjects for far more hazardous, even potentially lethal, substances such as radioactive isotopes, dioxin, and chemical warfare agents. Based on in-depth interviews with dozens of prisoners as well as the doctors and prison officials who, respectively, performed and permitted these experimental tests, Hornblum paints a disturbing portrait of abuse, moral indifference, and greed. Central to this account are the millions of dollars many of America's leading drug and consumer goods companies made available for the eager doctors seeking fame and fortune through their medical experiments. Many of these doctors established their illustrious careers on the backs of the inmates who served as the ideal test subjects.
Oral History and the Law - Revised Edition - Oral History Association Pamphlet Series No. 1	John A. Neuenschwander	1993	Oral History and the Law first appeared in 1985; this edition is expanded and revised to reflect the increasing complexity of case law regarding oral history and other historical materials.
Title Using Oral History in Community History Projects - Oral History Association Pamphlet Series #4	Laurie Mercier and Madeline Buckendorf	1992	Because good planning is the key to a successful community oral history project, we provide a detailed, step-by-step guide to project planning and execution in Section 1. Section 2 addresses common pitfalls that may arise in an oral history project and suggests ways to avoid or minimize them. Section 3 describes the successful use of oral history in a number of community history projects. The final section is a bibliography of publications providing specific guidance about oral history methods and means of interpretation. In this pamphlet, we describe how an oral history project can be set up and carried out as part of a community history project. For some projects, oral history will be the primary means of gathering information; for other projects, oral history will be used as part of a larger data-gathering effort. The suggestions we provide are applicable in both cases. We hope that those who are new to community oral history projects can learn from the experiences of others who have already struggled around (and sometimes through) the quicksands associated with these endeavors. The suggestions presented here are based on such experiences.
The Ethics of Research Involving Human Subjects - Facing the 21st Century	Harold Y. Vanderpool	1996	This book is about the current status and future directions of the ethics of research involving human subjects. Medical researchers, members and administrators of institutional review boards (IRBs) in academia and industry, ethicists, government officials, and informed citizens face a maze of changes and challenges over the ethics and regulation of biomedical research. These are the persons for whom this book is written. Its chapter depict where we are and envision where we are going. As is primary objective, this books seeks to make sense of an almost overwhelming body of literature and regulation on research ethics. Each of the book's contributors is a leader in his or her field of inquiry. Each author deals with a critical feature of contemporary research ethics. To capture current trends, many of the essays are arranged in a debate-like format. Different points of view are juxtaposed, and at points the authors of this volume address or oppose the positions of their fellow authors. Finally, this book serves as a bibliographical and document resource. Each chapter and introduction points to pivotal sources and background discussions. Each references the latest literature in its field of inquiry.
Research Ethics - Cases & Materials	Robin Levin Penslar	1995	Research Ethics is a comprehensive resource for classroom discussion of research ethics in the natural sciences, the behavioral sciences, and the humanities. The materials selected for inclusion here can speak to people in all disciplines, though the cases are drawn from biology, psychology, and history. They cover such topics as plagiarism, confidentiality, conflict of interest, fraud and misconduct, access to research materials, the obligations of mentors and teachers, the reporting of data, and the participation of human and animal subjects in research. Specific pedagogical suggestions for many of the cases are provided in the instructional notes. In addition, Research Ethics provides a discussion of ethical theory and pedagogy. An annotated bibliography will help instructors identify resources to use as supplements to cases, assist readers who are developing courses in research ethics, and aid further research.
Interpreting the Federal Code for Human Subjects Research - The Burden of Protection	See Summary	1991	Audio tapes featuring: (Tape 1) Workshop Overview: What are the Principles of the Belmont Report? (F. William Dommel, Jr.) and FDA Regulatory Update (FDA Representative); (Tape 2) Beneficence: Keynote Address (Charles R. McCarthy), Risk Assessment & Confidentiality (Ernest Kraybill), Vulnerable Subject Populations (Mario Perez-Reyes), and Justification for Expanded Availability of Drugs (FDA Representative); (Tape 3 - 2 tapes) Respect for Persons: Keynote (Steven Hauerwas), Modes of Consent (Thomas Wallsten), Recruitment Issues (Mark Hollins), and Clarity of Informed Consent & Deception (James Hunt); (Tape 4) Justice: Keynote (F. William Dommel), Institutional Interactions (Thomas Petrick), The Role of the IRB When Things Go Wrong (Susan Enringhaus), and Criteria for Exclusion/Inclusion of Subjects (Inge Corless); (Tape 5) IRB Membership & Composition (Tom Scott), IRB Role & Authorities (Clifford C. Sharke), IRB Review Procedures (Carl Shy), and IRB Recordkeeping Requirements (Susan Bauer); (Tape 6) Mock IRB Session Reviewing Protocols; (Tape 7) IRB's in the 1990's (Charles R. McCarthy).
The Spirit Catches You and You Fall Down	Anne Fadiman	1997	The Spirit Catches You and You Fall Down explores the clash between a small county hospital in California and a refugee family from Laos over the care of Lia Lee, a Hmong child diagnosed with severe epilepsy. Lia's parents and her doctors both wanted what was best for Lia, but the lack of understanding between them led to tragedy.
To Know Ourselves - The US Department of Energy and The Human Genome Project	Multiple Contributors	1996	Discusses the Human Genome Project undertaken in 1986 by the US Department of Energy.
Exploring Public Policy Issues in Genetics	Mark S. Frankel	1996	A compilation of presentations and resource materials prepared as part of a congressional seminar series on the human genome project.
Hanford Medical Monitoring Program: Background Consideration Document and ATSDR Decision	Robert F. Spengler, ScD	1997	In determining whether a medical monitoring program is appropriate for Hanford, the Agency for Toxic Substances and Disease Registry (ATSDR) first had to determine whether specific criteria had been met. This document presents the information that was used to determine if the criteria were met.
The Abuse of Casuistry - A History of Moral Reasoning	Albert R. Jonsen & Stephen Toulmin	1988	In this book we begin by exploring more deeply the implications of this distinction between science and prudence, intellectual theory and practical understanding. Taking this as our point of departure, we may then venture out to meet the attacks on casuistry and case ethics with greater confidence; and we can even go over to the counterattack. For (it turns out) the arguments by which Blaise Pascal and his successors have brought the enterprise of casuistry into disrepute contain, in turn, their own fundamental flaw, one that Aristotle would have recognized, only to deplore. Even now, we shall argue, the rejection of case ethics is a lingering expression of the intellectual dream that, after all, ethics may yet be transformed into a universal theoretical science. And that (we shall see) is precisely what, from the outset, Aristotle's distinction between episteme and phronesis, or between scientific understanding and practical wisdom, was designed to undercut.
Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity	National Bioethics Advisory Commission	1999	Volume II - Commissioned Papers by the National Bioethics Advisory Commission.
Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity	National Bioethics Advisory Commission	1998	Volume I - Report and Recommendations of the National Bioethics Advisory Commission.
Final Report - Advisory Committee on Human Radiation Experiments	Advisory Committee on Human Radiation	1995	The main part of the text is divided into four parts. Each part is preceded by an overview. Part I, "Ethics of Human Subjects Research: A Historical Perspective," which contains four chapters, explores how both federal government agencies and the medical profession approached human experimentation in the period 1944 through 1974. Part II, "Case Studies," approaches particular experiments from several angles, each of which raises overlapping ethical questions. Part III, "Contemporary Projects," reports the findings of our three inquiries into the present. Part IV, "Coming to Terms with the Past, Looking Ahead to the Future," reports the Committee's findings and recommendations.
Protecting Human Rights	National Institutes of Health and the Food and Drug Administration	1986	Video containing three parts: Evolving Concern - Protection for Human Subjects (traces the development of today's comprehensive program to protect human subjects of research out of earlier ethical codes and societal concerns); Balancing Society's Mandates - Criteria for Protocol Review (depicts an Institutional Review Board in action); and The Belmont Report - Basic Ethical Principles and Their Application (describes the basic ethical principles that underlie research involving human subjects: respect for persons, beneficence, and justice).
Protecting Human Subjects	National Institutes of Health and the Food and Drug Administration	1986	Video containing three parts: Evolving Concern - Protection for Human Subjects (traces the development of today's comprehensive program to protect human subjects of research out of earlier ethical codes and societal concerns); Balancing Society's Mandates - Criteria for Protocol Review (depicts an Institutional Review Board in action); and The Belmont Report - Basic Ethical Principles and Their Application (describes the basic ethical principles that underlie research involving human subjects: respect for persons, beneficence, and justice).
A Stampede of Zebras	The National Science Foundation	1996	Video - Scientific Integrity and Ethics of Research.
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries	National Bioethics Advisory Commission	2001	A binder containing both Volumes I and II. Volume I discusses the ethical issues that arise when research that is subject to US regulation is sponsored or conducted in developing countries. Volume II contains five expert papers, including three empirical studies of international perspectives that helpfully assisted the commission.
Creating an Ethical Framework for Studies That Involve the Worker Community	Human Subjects Research Program, Office of Biological and Environmental Research (SC-72), Office of Science, and US Department of Energy	2000	The purpose of An Ethical Framework for Studies That Involve the Worker Community is to raise the awareness of all stakeholders to the special needs and issues that apply to research using workers as study subjects.
1998 Program Book Supplement - Occupational Energy Research Program	Health-Related Energy Research Branch - Division of Surveillance, Hazard Evaluations and Field Studies	1998	This guide simply and effectively communicates the purpose, variety and content of the NIOSH/HERB Occupation Radiation Research Program. This resource identifies the major research issues within each project and also contains the name of the DOE sites or facilities where each study is being conducted.
Occupational Energy Research Program	Health-Related Energy Research Branch - Division of Surveillance, Hazard Evaluations and Field Studies	1998	Presents an overview of the occupational health research program conducted under the 1996 Memorandum of Understanding (MOU) between the Department of Energy (DOE) and the Department of Health and Human Services (DHHS). The reader will find information addressing studies conducted internally by NIOSH staff; studies conducted externally through NIOSH supported contracts, grants, and cooperative agreements; DOE worker surveillance projects with NIOSH involvement; and administrative and programmatic details within this document.
From Paper to People: After IRB Approval of Research Studies	Dr. Susan Rose	2004	Demonstrates the continuing, collaborative role and the responsibility of an Institutional Review Board (IRB) in working with principal investigators, sponsors, study subjects, the community, and others to promote ethical research. It also emphasizes the interactive and dynamic nature of the review process in contrast to the widely-held misperception that such a review is just a perfunctory response to regulatory requirements.
Health Insurance Portability & Accountability Act (HIPAA)	Public Responsibility in Medicine and Research	2003	An educational CD-ROM, based on a program offered January 27, 2003 in Washington, DC. HIPAA regulates the use and transfer of private medical information.
The Basics of HIPPA			A 43-minute VCR tape.
From Paper to People: After IRB Approval of Research Studies	DOE Office of Science Human Subjects Research Program Office of Biological and Environmental Research		From Paper to People demonstrates the continuing, collaborative role and the responsibility of IRBs, principal investigators, sponsors, study subjects and the community, to promote ethical research. It also emphasizes the interactive and dynamic nature of the review process in contrast to the widely-held misperception that such a review is just a perfunctory response to regulatory requirements.
Demystifying Central Review Boards	Robert J. Levine, M.D., Louis Lasagna, M.D., and Sanford Chodosh, M.D.	1998	A properly functioning Central Review Board (CRB) should be able to save time and decrease paperwork, with a more rapid initiation of research without jeopardizing human research subjects. This report deserves attention and critique, with the hope that improvements in the status quo can be achieved.
The Journal of Law, Medicine & Ethics; Symposium: Human Subjects: Ethical, Legal, and Regulatory Challenges	Jesse A. Goldner	2002	Several symposiums articles: Obtaining Informal Consent for Research: A Model for Use with Participants who are Mentally Ill; Oversight of Gene Transfer Research, Financial Conflicts of Interest; Institutional Conflicts; The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection; Professionalism in Forensic Bioethics; Solid Organ Donation between Strangers, etc.
Science Meets Reality: Recruitment and Retention of Women in Clinical Studies, and the Critical Role of Relevance	A Report of the Task Force sponsored by the NIH Office of Research on Women's Health	2003	During the years since the establishment of the Office of Research of Women's Health (ORWH), there has been a significant increase in the attention and resources devoted to women's health and women's health research. One of the major areas of progress has been an increased focus on research studies that include women as participants and a greater ability to monitor the inclusion of women as study participants in NIH-supported clinical trials. That progress and the challenges that remain constitute the theme for this meeting and report.
Ethical and Policy Issues in Research Involving Human Participants	National Bioethics Advisory Commission	2001	Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. This report views the oversight as a whole, provides a rationale for change, and offers an interrelated set of recommendations to improve the protection of human participants and enable the oversight system to operate more efficiently.
Scientific Research: Continued Vigilance Critical to Protecting Human Subjects	United States General Accounting Office	1996	Today's oversight of tens of thousands of HHS-funded research and FDA-regulated drug studies appears to have reduced the likelihood that serious abuses of human subjects, comparable to past tragic events, will occur. The conspicuous activity of local institutional review boards and human subject protection efforts by federal agencies have heightened the research community's awareness of ethical conduct standards, increased compliance with federal regulations, and served as deterrents to abuse of subjects' rights and welfare. However, little data exist that directly measure the effectiveness of human subject protection regulations.
Clinical Ethics- Fifth Edition	Albert Jonsen, Mark Siegler, William Winslade	2002	Provides an approach to addressing ethical problems associated with clinical research using four topics (1) medical indications, (2) patient preferences, (3) quality of life, and (4) contextual features, defined as the social, economic, legal, and administrative context in which the case occurs.
Protecting Study Volunteers in Research - A Manual for Investigative Sites - Second Edition	Cynthia McGuire Dunn, M.D. & Gary L. Chadwick, Pharm.D., MPH, CIP	2002	Education and raising awareness is still an important and vital, if only partial solution, because most violations in research ethics have been due to a lack of awareness rather than malice. The authors hope that this material will continue to help research professionals stay abreast of current issues in order to address the ethical dilemmas that are raised on an almost daily basis. Rigorous compliance with ethical standards and practices will reassure the public trust, safeguard the welfare of human subjects and promote scientific discovery.
Study Guide for Institutional Review Board - Management and Function	Susan Kornetsky, MPH, CIP; Amy Davis, JD, MPH; Robert J. Amdur, MD	2003	The Applied Research Ethics National Association (ARENA study guide companion to the book Institutional Review Board: Management and Function. ARENA is a membership organization for professionals whose responsibilities include the protection of human and animal research subjects.