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被験者を用いた研究の倫理と規制 第2版

The Ethics and Regulation of Research with Human Subjects, 2nd Edition

Carl H. Coleman, Jerry A. Menikoff, Jesse A. Goldner, Efthimios Parasidis

1 vol. xlvi, 970pp. Paperbound. 2015年7月刊(Ethics and Regulation of Research with Human Subjects)

Matthew Bender. ISBN: 9780769847320

¥16,622

在庫あり

新薬や医療機器に開発における被験者を用いた研究の倫理と規制に関する論点を取り上げた教科書。

【主な内容】

第1部:被験者を用いた研究の歴史、連邦および州による規制、審査委員会(IRB)、利益相反

第2部:リスク・ベネフィット評価、インフォームドコンセント、被験者の募集および報酬、女性およびマイノリティの参加、守秘義務、継続研究のモニター、研究での負傷への補償

第3部:子ども、意思決定能力のない成人、囚人、胎児および胚、遺伝子やナノテクノロジー技術を含む研究、国際的研究

【Table of Contents】

Part I BACKGROUND AND REGULATORY CONTEXT

Chapter 1 HISTORICAL ANTECEDENTS

Chapter 2 THE CHANGING FACE OF RESEARCH: NEW REGULATIONS, NEW PLAYERS,NEW PLACES, NEW AGENDAS

Chapter 3 THE FEDERAL AND STATE REGULATORY STRUCTURE

Chapter 4 INSTITUTIONAL REVIEW BOARDS

Chapter 5 CONFLICTS OF INTEREST

Part II REVIEWING RESEARCH PROPOSAL: GENERAL CONSIDERATIONS

Chapter 6 RISK-BENEFIT ASSESSMENT

Chapter 7 INFORMED CONSENT

Chapter 8 RECRUITING AND PAYING SUBJECTS

Chapter 9 RESEARCH AND JUSTICE: PROMOTING THE INCLUSION OF WOMEN AND MINORITIES

Chapter 10 CONFIDENTIALITY

Chapter 11 MONITORING OF ONGOING RESEARCH

Chapter 12 COMPENSATION FOR RESEARCH INJURIES

Part III REVIEWING RESEARCH PROPOSALS: SPECIAL SITUATIONS

Chapter 13 RESEARCHES WITH CHILDREN

Chapter 14 ADULTS WHO LACK DECISION-MAKING CAPACITY

Chapter 15 PRISONERS

Chapter 16 MEMBERS OF THE ARMED SERVICES

Chapter 17 FETUSES AND EMBRYOS

Chapter 18 RESEARCHES INVOLVING EMERGING TECHNOLOGIES

Chapter 19 INTERNATIONAL RESEARCH

 

Appendix A U.S. CODE OF FEDERAL REGULATIONS TITLE

45—PUBLIC WELFARE AND HUMAN SERVICES PART 46—PROTECTION OF HUMAN SUBJECTS

Appendix B DEPARTMENT OF HEALTH AND HUMAN SERVICES CATEGORIES OF RESEARCH THAT MAY BE REVIEWED BY THE INSTITUTIONAL REVIEW BOARD (IRB)THROUGH AN EXPEDITED REVIEW PROCEDURE

Appendix C FOOD AND DRUG ADMINISTRATION SIGNIFICANT DIFFERENCES IN FDA AND HHS REGULATIONS FOR PROTECTION OF HUMAN SUBJECTS

Appendix D NUREMBERG CODE Appendix E DECLARATION OF HELSINKI Appendix F THE BELMONT REPORT ETHICAL PRINCIPLES & GUIDELINES FOR RESEARCH INVOLVING HUMAN SUBJECTS Table of Cases Index