Research Ethics Consultation: A Casebook by Marion DanisResearch Ethics Consultation: A Casebook by Marion Danis

Research Ethics Consultation: A Casebook

byMarion Danis, Emily Largent, Christine Grady

Paperback | April 18, 2012

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Interesting and important ethical questions confront researchers, regulators, institutional review boards, support personnel, and research participants committed to the ethical conduct of human subjects research at all stages of research. Questions encompass - but are not limited to - studydesign, enrolling participants, balancing the clinical needs of participants against the research agenda, ending trials, discharging post-trial obligations, and resolving conflicts. Straightforward solutions to these types of questions are often not found in regulations, ethics codes, or thebioethics literature. These resources may leave room for interpretation, offer conflicting guidance, or simply fail to address particular questions. Ethics consultation, which has been offered in clinical care settings with regularity since the 1980s, has since the turn of the century increasingly been sought in the clinical research context. Because there has only lately been recognition that ethics consultants can play a valuable role helpingthe research community conduct research in the most ethically informed way, there are many open questions in the field of research ethics consultation including the appropriate role of consultants and the best methods of consultation. The Clinical Center Bioethics Consultation Service has been serving the NIH community of researchers, administrators, healthcare providers, and research participants for more than a decade, conducting nearly 1,000 consultations in that time. In this book, members of the Bioethics ConsultationService reflect on this long track-record and unparalleled range of research ethics consultations to share a collection of their most interesting and informative research ethics consultations and to start a dialogue on remaining open questions. Although the NIH experience is unique, this book focuses on cases - and associated lessons - that are generalizable and valuable for the entire clinical research community. This book will be valuable to ethics consultants, clinical investigators, students and teachers, and others desiring insightinto clinical research ethics and ethics consultation.
Marion Danis is Head of the Section on Ethics and Health Policy in the Dept. of Bioethics at the National Institutes of Health. Emily Largent is Post-baccalaureate Fellow in the Dept. of Bioethics, Clinical Center at the National Institutes of Health. Christine Grady is Acting Chief in the Department of Bioethics and Head of the Secti...
Title:Research Ethics Consultation: A CasebookFormat:PaperbackDimensions:288 pages, 9.25 × 6.12 × 0.68 inPublished:April 18, 2012Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199798036

ISBN - 13:9780199798032

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Table of Contents

ForewordIntroduction1. Sarting Research1.1 Assessing Social Value1.2 Assessing Social Value for Local Populations1.3 Assessing Scientific Validity1.4 Placebo Controlled Trials1.5 Standard of Care1.6 Reconciling Different Judgments Reached by Multiple IRBS2. Enrolling Research Participants2.1 Use of Non-Medical Criteria in Determinations of Study Inclusion or Exclusion2.2 Exclusion of an Individual Based on a New Co-Morbidity2.3 Enrolling Staff Members in Clinical Studies2.4 Identification of Potential Study Participants Through Publicly Available Records2.5 Enrollment of Research Participants in Multiple Protocols2.6 Obtaining Informed Consent From Individuals Who Are Blind, Illiterate, or do not Understand the Language in Which Consent Documents are Written2.7 Assessing Whether Study Procedures are Coercive or Unduly Influential3. Protecting Research Participants3.1 Justification of Research Risks3.2 Evaluation of Evolving Risks3.3 Respecting Participant Preferences While Minimizing Risk3.4 Addressing Medical Error3.5 Reconciling Confidentiality and the Duty to Warn3.6 Risks to Third Parties4. Conducting Research with Vulnerable Populations4.1 Exposing Children to Risk When There is no Prospect of Direct Benefit4.2 Informing a Minor of his Diagnosis4.3 Assignment of a Surrogate Decision Maker by a Cognitively Impaired Research Participant4.4 Consent for Research in an Emergency4.5 Research with the Terminally Ill4.6 Caring for the Economically Disadvantaged5. Balancing Clinical Research and Clinical Care5.1 Fulfilling Ancillary Care Obligations5.2 Disclosure of Incidental Findings5.3 Obligations to Individuals Tangentially Related to Research5.4 Withholding Care for Reasons of Scientific Validity5.5 Meeting Clinical Needs Without Compromising Scientific Validity5.6 Access to Experimental Drugs Outside a Study Protocol5.7 Non-Compliance6. Navigating Interpersonal Difficulties6.1 Obligations to Prevent Harm and Protect Confidentiality6.2 Excluding a Non-Compliant Participant from a Study with the Prospect of Direct Benefit6.3 Excluding a Non-Compliant Participant from a Study with no Prospect of Benefit6.4 Discharging an At-Risk Participant6.5 Futile Care6.6 Conflict Between the Research Team and Family Members6.7 Conflict Between the Research Team and Surrogate Decision Maker6.8 Respecting Medical Beliefs7. Ending Research7.1 Study Discharge After Violation of Rules7.2 Discharge to Less Optimal Care7.3 Managing Participants Post-Trial Expectations7.4 Fulfilling Post-Trial Obligations to Uninsured Participants7.5 Planning for Post-Trial Consequences of Trial Intervention7.6 Addressing a Request for Withdrawal of Tissue Samples7.7 Questions About Discontinuation of a Trial by the DSMB7.8 Assigning AuthorshipAppendices:Consultations Organized by SubjectEvaluation of the Ethics Consultation ServiceClinical Center Policy M77-2: Informed ConsentClinical Center Policy M-92-7: Advance DirectivesNIH Advanced Directive for Healthcare and Medical Research ParticipationClinical Center Policy M87-4: Research Involving Adults Who Are or May Be Unable to ConsentSelected Publications Inspired or Informed by the Work of the Bioethics Consultation Service