National Bioethics Advisory Commission -- Briefing Books

Republished by the LSU Medical Reseach Law Project

January 6-8, 1998 Crystal Gateway Marriott Arlington, Virginia	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Questionable Decisionmaking Capability: A Draft Report of the Human Subjects Committee, National Bioethics Advisory Commission Human Tissue Sample Collections in the United States Moral and Religious Perspectives Framework for Analysis Status of Current Policies Policy Options and Recommendations Model Consent Forms & Related Information on Tissue Banking for Routine Biopsies

February 5 - 6, 1998 Omni Los Angeles Hotel and Centre Los Angeles, California	Briefing Book As Adobe Acrobat Files: Draft Tissue Samples Report Report on Research Involving Persons with Questionable Decisionmaking Capacity

March 3 - 4, 1998 Mclean Hilton Tysons Corner, Virginia	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Disorders Affecting Decisionmaking Capacity Research Use of Human Biological Materials Report Chapter 1 - Overview Chapter 4 - Comparative Analysis... Chapter 5 - Framework for Analysis An Ethical Framework for Biological Samples Policy

May 19 - 20, 1998 Case Western Reserve University Cleveland, Ohio	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Mental Disorders Affecting Decisionmaking Capacity Cover Research Use of Human Biological Materials Report Cover Chapter 1 Overview and Introduction Chapter 2 Research Use of Human Biological Materials Chapter 3 Collection and Storage of Human Biological Materials In The United States Chapter 4 Ethical Perspectives on the Research Use of Human Biological Materials Chapter 5 Current Guidance on the Use of Human Biological Materials in Research Table x IRB Review for Research with Human Biological Materials Table y Informed Consent Requirements for Research with Human Biological Materials Appendix A Public Knowledge, Belief, and Feelings About Research Use of Human Biological Materials Appendix B Meeting Dates, Testimony, Acknowledgements Appendix C The Common Rule Appendix D Comparison Table of Professional Standards

July 14 - 15, 1998 Portland Marriott Portland, Oregon	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Mental Disorders Affecting Decisionmaking Capacity Research Use of Human Biological Materials Report Cover and Table of Contents Chapter 1 Overview and Introduction Chapter 2 Collection, Storage and Use of Human Biological Materials in the United States Chapter 3 Ethical Perspectives on the Research Use of Human Biological Materials Chapter 4 Current Guidance on the Use of Human Biological Materials in Research Appendix A Public Knowledge, Belief, and Feelings About Research Use of Human Biological Materials Appendix B Meeting Dates, Testimony, Acknowledgements Appendix C The Common Rule Appendix D Professional Standards

September 16 - 17, 1998 Embassy Suites Alexandria Old Town Alexandria, Virginia	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity Research Use of Human Biological Materials Report Cover and Table of Contents Chapter 1 Overview and Introduction Chapter 2 Collection, Storage and Use of Human Biological Materials in the United States Chapter 3 Ethical Perspectives on the Research Use of Human Biological Materials Chapter 4 Current Guidance on the Use of Human Biological Materials in Research Chapter 5 Conclusions and Recommendations Charts: Proposed Process for Research Using Human Biological Materials Human Subject, Defined IRB Review for Research with Human Biological Materials Informed Consent Requirements for Research with Human Biological Materials Appendices: Appendix A Public Knowledge, Belief, and Feelings About Research Use of Human Biological Materials Appendix B Meeting Dates, Testimony, Acknowledgements Appendix C The Common Rule

October 20, 1998 Holiday Inn-National Airport Arlington, Virginia	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Mental Disorders that may Affect Decisionmaking Capacity Appendix I -- History of Regulatory Efforts in the United States

November 17 - 18, 1998 Mayfair House Coconut Grove, Florida	Briefing Book As Adobe Acrobat Files: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity Research Use of Human Biological Materials Report Cover Table of Contents Chapter 1 Overview and Introduction Chapter 2 Collection, Storage and Use of Human Biological Materials in the United States Chapter 3 Ethical Perspectives on the Research Use of Human Biological Materials Chapter 4 Current Guidance on the Use of Human Biological Materials in Research Chapter 5 Conclusions and Recommendations Charts: Proposed Process for Research Using Human Biological Materials Human Subject, Defined Appendices: Appendix A Public Knowledge, Belief, and Feelings About Research Use of Human Biological Materials Appendix B Meeting Dates, Testimony, Acknowledgements Appendix C The Common Rule

January 19 - 20, 1999 Sheraton City Centre Hotel Washington, DC	Briefing Book As Adobe Acrobat Files: The Use of Human Biological Materials in Research Title Page (3kb) Table of Contents (16kb) Chapter 1 - Overview and Introduction (12kb) Chapter 2 - Collection, Storage and Use of Human Biological Materials In The United States (123kb) Chapter 3 - Ethical Perspectives on the Research Use of Human Biological Materials (55kb) Chapter 4 - Current Guidance on the Use of Human Biological Materials in Research (116kb) Chapter 5 - Conclusions and Recommendations (94kb) Chart 1 - Proposed Process for Research Using Human Biological Materials (12kb) Chart 2 - Human Subject, Defined (17kb) Appendix A - Public Knowledge, Belief, and Feelings About Research Use of Human Biological Materials (22kb) Appendix B - Acknowledgements (3kb) Appendix C - The Common Rule (11kb)

March 2 - 3, 1999 Sheraton Premiere at Tysons Corner Vienna, Virginia	Briefing Book As Adobe Acrobat Files: The Use of Human Biological Materials in Research Revised Chapter 5 Conclusions and Recommendations Research Involving Human Stem Cells Memo to NBAC from Eric M. Meslin, Ph.D. and Kathi E. Hanna, M..S., Ph.D., on Research Involving Human Stem Cells: Status of Work and Suggestions for Discussion, dated February 24, 1999 Memorandum to NBAC from Kathi E. Hanna, M.S., Ph.D., and J. Kyle Kinner, J.D., M.P.A. on Research on Human Fetal Tissue: Legal Analysis, dated February 24, 1999 Memo to Commissioners from Eric M. Meslin, Ph.D., regarding “Summary of Some Ethical Issues in Human Stem Cell Research,” dated February 24, 1999 Memo to Commissioners from Eric M. Meslin, Ph.D., regarding Staff Draft, “Points to Consider in Evaluating Basic Research Involving Human Stem Cells,” dated February 24, 1999 An Incremental Approach to NBAC Deliberation on Human Pluripotential Stem Cells (PSC) Research by John Fletcher, Draft Outline of Paper dated February 22, 1999

April 15 - 16, 1999 Omni Charlottesville Hotel Charlottesville, Virginia	Briefing Book As Adobe Acrobat Files: The Use of Human Biological Materials in Research Chapter 1 - Overview and Introduction Chapter 2 - Collection, Storage and Use of Human Biological Materials in the United States Box: Iceland's Health Records Database Chapter 3 - Current Guidance on the Use of Human Biological Materials in Research Chapter 4 - Ethical Perspectives on the Research Use of Human Biological Materials Chapter 5 - Conclusions and Recommendations Research Involving Human Stem Cells Research Involving Human Fetal Tissue: Legal Survey and Analysis -- J. Kyle Kinner, J.D., M.P.A. Deliberating Incrementally on Human Pluripotential Stem Cell Research -- John C. Fletcher, Ph.D.

May 11 - 12, 1999 Hilton Northbrook Northbrook, Illinois	Briefing Book As Adobe Acrobat Files: The Use of Human Biological Materials in Research -- Revised Chapters 4 and 5 Chapter 4 - Ethical Perspectives on the Research Use of Human Biological Materials Chapter 5 - Conclusions and Recommendations Commissioned Papers and Other Documents on Research Involving Human Stem Cells Third Draft Commissioned Paper: Deliberating Incrementally on Human Pluripotential Stem Cell Research Final Draft Commissioned Paper: "What Has the President Asked of NBAC?" Final Draft Commissioned Paper: International Persectives on Human Embryo and Fetal Tissue Research The Food and Drug Administration's Statutory and Regulatory Authority to Regulate Human Pluripotent Stem Cells Staff Draft: The Ethical Use of Human Stem Cells in Research Chapter 1: Introduction Chapter 2: Human Stem Cell Research and the Potential for Clinical Application Chapter 3: Legal and Regulatory Issues Chapter 4: Ethical Issues in Human Stem Cell Research Chapter 5: Conclusions and Recommendations

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