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>HOME Japanese Page This page includes who's who, literature, sites and events concerning research ethics. If you have any information concerning research ethics that is not listed in this page, please e-mail us webmaster@arsvi.com. ■Table of Contents ◇WHO ◇Literature (Various Writings) ◇Theme Related Links ◇Events >TOP ■WHO ◆AMADA Josuke ◆ARIZONO Masayo ◆MATSUBARA Yoko ◆MOCHIZUKI Akira ◆NAGATA Atsumasa ◆OTANI Izumi ◆YAMAMOTO Takanori >TOP ■Literature (Various Writings) Books ◆Beecher HK 1970 Research and the Individual: Human Studies, Little Brown. ◆Freund PA (Ed.) 1970 Experimentation with Human Subjects George Braziller. ◆Katz J With the assistance of Alexander Morgan Capron and Eleanor Swift Glass 1972 Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process Russell Sage Foundation. ◆Beauchamp TL, Faden RR, Wallace RJ, Jr., Walters L (Eds.) 1982 Ethical Issues in Social Science Research Johns Hopkins University Press. ◆Sieber JE (Ed.) 1982 The Ethics of Social Research: Surveys and Experiments Springer-Verlag ◆Sieber JE (Ed.) 1982 The Ethics of Social Research: Fieldwork, Regulation, and Publication Springer-Verlag ◆Faden RR, Beauchamp TL 1986 A History of Theory of Informed Consent Oxford University Press. ◆Levine RJ 1988 The Ethics and Regulation of Clinical Research (2nd Edition) Yale University Press. ◆National Research Council 1989 On Being a Scientist Natl Academy Pr. ◆Committee on the Responsible Conduct of Research, National Research Council 1989 The Responsible Conduct of Research in the Health Sciences National Academies of Science ISBN-10: 0-309-06237-3 ISBN-13: 978-0-309-06237-4 http://www.nap.edu/catalog.php?record_id=1388 ◆Beauchamp TL, Childress JF 1989 Principles of Bioethics (3rd Edition) Oxford University Press. ◆Veatch RM 1989 Medical Ethics Jones and Bartlett. ◆Sieber JE 1992 Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards, Applied Social Research Methods Series, Vol.31, Sage Publications ◆1993 Protecting Human Research Subjects: Institutional Review Board Guidebook Office for Protection from Research Risks ◆Beauchamp TL, Childress JF 1994 Principles of Biomedical Ethics (4th Edition) Oxford University Press. ◆Penslar RL 1995 Research Ethics: Cases and Materials Indiana University Press. ◆Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine 1995 On Being a Scientist: A Guide to Responsible Conduct in Research (Second Edition) ◆Faden R (Ed.) 1996 The Human Radiation Experiments Oxford University Press. ◆Vanderpool HY 1996 The Ethics of Research Involving Human Subjects University Publishing Group. ◆Association of American Medical Colleges 1997 Developing a Code of Ethics in Research: A Guide for Scientific Societies AAMC ◆Brody BA 1998 The Ethics of Biomedical Research: An International Perspective Oxford University Press ◆Sugarman J, Mastroianni A, Kahn J. 1998 Ethics of Research with Human Subjects: Selected Policies and References University Publishing Group ◆Dunn C, Chadwick G 1999 Protecting Study Volunteers in Research: A Manual for Investigative Sites Center Watch ◆Russell-Einhorn M (Ed.) 2000 IRB Reference Book Price Waterhouse Coopers. ◆Steneck, Nicholas H 2000 ORI Introduction to the Responsible Conduct of Research (Revised Edition) U.S. Government Printing Office. ◆Block, Stephen; Wells, Frank & Farthing, Michael 2001 Fraud and Misconduct in Biomedical Reserch, Blackwell Publishing Ltd, Oxford. ◆Bankert E, Amudur RJ (Eds.) 2006 Institutional Review Board: Management and Function (2nd Ed.) Jones & Bartlett Publishers. ◆National Institutes of Health 200705 Guidelines for the Conduct of Research in the Intramural Research Programs at NIH (4th Edition) http://sourcebook.od.nih.gov/ethic-conduct/Conduct%20Research%206-11-07.pdf ◆Steneck, Nicholas H 200708 ORI Introduction to the Responsible Conduct of Research (Revised Edition) U.S. Government Printing Office http://ori.hhs.gov/documents/rcrintro.pdf ◆Amdur, Robert J. & Bankert, Elizabeth A 200710 Institutional Review Board Member Handbook (2nd Edition) Jones & Bartlett Publishers. ◆Hester, Macah (Ed.) 2008 Ethics by Committee Rowman & Littlefield Publishers, Inc. ◆Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine 2009 On Being a Scientist: A Guide to Responsible Conduct in Research (Third Edition) ISBN-10: 0-309-11970-7 ISBN-13: 978-0-309-11970-2 http://www.nap.edu/catalog.php?record_id=12192 ◆Amdur, Robert J. & Bankert, Elizabeth A 201005 Institutional Review Board Member Handbook (3rd Edition) Jones & Bartlett Publishers. Reports ◆MATSUBARA Yoko (Ed.) 2007 Research Series Human Service Research Series No.5 Considering Research Ethics Institute of Human Sciences of Ritsumeikan University http://www.ritsumeihuman.com/hsrc/resource/05/open_reseach05.html (Japanese) ◆MOCHIZUKI Akira 2007 "Research Ethics as Communication" Research Series Human Service Research Series No.5 Considering Research Ethics：118-132，Institute of Human Sciences of Ritsumeikan University http://www.ritsumeihuman.com/hsrc/resource/05/open_reseach05.html (Japanese) ◆AMADA Josuke 2007 "Some Difficulties over Research Practices: Conflicts, Friction, Cracks, Dissociation and Clashes" Research Series Human Service Research Series No.5 Considering Research Ethics：133-145，Institute of Human Sciences of Ritsumeikan University http://www.ritsumeihuman.com/hsrc/resource/05/open_reseach05.html (Japanese) ◆NAGATA Atsumasa, ARIZONO Masayo, et al. 20101120 "【Round-table Talk】Ethics Imposed on Research and Questions in Practice: What Are "Researchers" who Are Wandering among Participants / Involved Persons / People / Activists?" (Japanese) pp.222-293, YAMAMOTO Takanori & TAKAHASHI Shinichi (Eds.) 20101120 Dynamics of "Differences": Practical Challenges of Research and Methodology on Minority Report Issued by Research Center for Ars Vivendi of Ritsumeikan University, Vol.14, ISSN 1882-6539 ※ ◆YAMAMOTO Takanori 20101120 "Methods and Practices of Social Research: On Spectrum of Being a "Researcher" (Japanese) pp.294-318 YAMAMOTO Takanori & TAKAHASHI Shinichi (Eds.) 20101120 Dynamics of "Differences": Practical Challenges of Research and Methodology on Minority Report Issued by Research Center for Ars Vivendi of Ritsumeikan University, Vol.14, ISSN 1882-6539 ※ >TOP ■Theme Related Links ◆Addressing Ethical Issues in Pandemic Influenza Planning (WHO) http://www.who.int/ethics/influenza_project/en/index.html ◆American Society of Law, Medicine, and Ethics (ASLME) http://www.aslme.org/ ◆Bioethics Resource on the Web--National Institutes of Health http://bioethics.od.nih.gov/ ◆CenterWatch http://www.centerwatch.com/ ◆CFR (Code of Federal Regulations) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html ◆CFR - Code of Federal Regulations Title 21 Part 50 (Protection of Human Subjects) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=50 ◆CFR - Code of Federal Regulations Title 21 Part 54 (Financial Disclosure by Clinical Investigators) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=54 ◆CFR - Code of Federal Regulations Title 21 Part 56 (Institutional Review Boards) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=56 ◆Committee of Publication Ethics http://publicationethics.org/ ◆Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine http://conventions.coe.int/Treaty/en/Treaties/html/164.htm ◆Council of Science Editors http://www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=1 ◆Directive 2001/20/EC of the European Parliament and of the Council http://www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf ◆Directive 2004/23/EC of the European Parliament and of the Council http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0023:EN:HTML ◆Drug Information Association http://www.diahome.org/DIAHOME/Home.aspx ◆Errata, Retractions, Partial Retractions, Corrected and Republished Articles, Duplicate Publications, Comments (including Author Replies), Updates, Patient Summaries, and Republished (Reprinted) Articles Policy for MEDLINE http://www.nlm.nih.gov/pubs/factsheets/errata.html ◆Ethical Considerations in Biomedical HIV Prevention Trials: UNAIDS/WHO Guidance Document http://data.unaids.org/pub/Report/2007/jc1399_ethical_considerations_en.pdf ◆Ethical Principles of Psychologists and Code of Conduct (APA) http://www.apa.org/ethics/code/index.aspx ◆European Association of Science Editors http://www.ease.org.uk/ ◆European Guidelines for Auditing Independent Ethics Committees http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard//appliedclinicaltrials/232002/21190/article.pdf ◆Faculty Policies on Integrity in Science (Harvard Medical School) http://hms.harvard.edu/public/coi/policy/integritypolicy.html ◆Federal Policy for the Protection of Human Subjects ('Common Rule') http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html ◆Frequently Asked Questions- Human Subjects Research - Requirement for Education (U.S. Department of Health and Human Services) http://grants.nih.gov/grants/policy/hs_educ_faq.htm ◆Good Research Practice (Medical Research Council) http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Researchpractice/index.htm ◆Guidance for Auditing Quality Systems of Independent Ethics Committees in Europe http://www.efgcp.be/downloads/EFGCP%20IEC%20Audit%20Guidance%2014%20October2008.pdf ◆Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting--Improving Human Subject Protection http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf ◆Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127013.pdf ◆Guidance for Institutional Review Boards Frequently Asked Questions--IRB Registration http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm171256.pdf ◆Guidances (Drugs) (FDA) http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm ◆Guideline on Strategies to Identify and Mitigate Risks for First-in-human Clinical Trials with Investigational Medicinal Products http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf ◆Guidelines for Investigators in Scientific Research (Harvard Medical School) http://hms.harvard.edu/public/coi/policy/scientific.html ◆Guidelines for Phase 1 Clinical Trials http://www.abpi.org.uk/our-work/library/guidelines/Documents/phase1-trial-guidelines.pdf ◆Guidelines for the Conduct of Research in the Intramural Research Programs at NIH http://sourcebook.od.nih.gov/ethic-conduct/Conduct%20Research%206-11-07.pdf ◆Guidelines on Certificates of Confidentiality http://www.hhs.gov/ohrp/policy/certconf.pdf ◆Health Insurance Portability and Accountability Act of 1996 https://www.cms.gov/hipaageninfo/downloads/hipaalaw.pdf ◆HMS Faculty Policy on Conflicts of Interest and Commitment http://hms.harvard.edu/public/coi/policy/coipolicy.html ◆Human Organ and Tissue Transplantation http://www.who.int/ethics/topics/human_transplant/en/ ◆Human Research Protections Program (Department for Health and Human Services) http://ohsr.od.nih.gov/ ◆Human Research Report http://www.humansubjects.com/ ◆IHC http://www.ich.org/ ◆International Bioethics Committee http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/international-bioethics-committee/ ◆International Committee of Medical Journal Editors http://www.icmje.org/ ◆International Declaration on Human Genetic Data http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html ◆International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002 http://www.cioms.ch/publications/layout_guide2002.pdf ◆International Guidelines for Ethical Review of Epidemiological Studies http://www.dib.unal.edu.co/promocion/etica_epidemiologicos_en.pdf ◆IRB Forum http://www.irbforum.org/ ◆IRB Guidebook (Office for Human Research Protections) http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm ◆IRBs and Assurances http://www.hhs.gov/ohrp/assurances/ ◆Kennedy Institute of Ethics Jounral http://muse.jhu.edu/journals/kennedy_institute_of_ethics_journal/ ◆Mandate of the European Group on Ethics in Science and New Technologies (2011-2016) http://ec.europa.eu/bepa/european-group-ethics/welcome/mandate-2011-2016/index_en.htm ◆Medical Research Council http://www.mrc.ac.uk/index.htm ◆National Council on Ethics in Human Research http://www.ncehr-cnerh.org/ ◆National Library of Medicine http://www.nlm.nih.gov/ ◆NOT-OD-00-039: Required Education in the Protection of Human Research Participants http://grants.nih.gov/grants/guide/notice-files/not-od-00-039.html ◆NOT-OD-01-061: Required Education in the Protection of Human Research Participants http://grants.nih.gov/grants/guide/notice-files/not-od-01-061.html ◆NSF OIG http://www.nsf.gov/oig/ ◆Office of Biotechnology Activities http://oba.od.nih.gov/oba/index.html ◆Office of Human Subject Research http://ohsr.od.nih.gov/guidelines/nuremberg.html ◆Office of Research Integrity http://ori.hhs.gov/ ◆Operational Guidelines for Ethics Committees that Review Biomedical Research http://apps.who.int/tdr/svc/publications/training-guideline-publications/operational-guidelines-ethics-biomedical-research ◆Panel on Research Ethics http://www.pre.ethics.gc.ca/eng/index/ ◆PRIM&R http://www.primr.org/ ◆Principles and Procedures for Dealing With Allegations of Faculty Misconduct (Harvard Medical School) http://hms.harvard.edu/public/coi/policy/misconduct.html ◆PubMed http://www.ncbi.nlm.nih.gov/pubmed ◆Recommendations of the Commission on Professional Self Regulation in Science (Deutsche Forschungsgemeinschaft) http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/download/self_regulation_98.pdf ◆Registration of an Institutional Review Board http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/download/self_regulation_98.pdf ◆Regulations on Medical Research Involving Human Subjects (Medical Research (Human Subjects)) http://www.ccmo-online.nl/hipe/uploads/downloads_catw/Medical%20Research%20involving%20Human%20Subjects%20Act%20March%2001%202006.pdf ◆Release of the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or "TCPS 2" http://www.pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2010-12-07/ ◆Research Policy Handbook: Principles Concerning Research (RPH 2.1) (Stanford University) http://rph.stanford.edu/2-1.html ◆Research Repositories, Databases, and the HIPAA Privacy Rule http://rph.stanford.edu/2-1.html ◆Roles and Responsibilities For the Protection of Human Research Participants (Vanderbilt University) http://www.mc.vanderbilt.edu/irb/roles/ ◆Running Clinical Trials http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm ◆SPIN http://catalogue.wellcome.ac.uk:81/ ◆Steering Committee on Bioethics http://www.coe.int/t/dg3/healthbioethic/cdbi/default_en.asp ◆The Amateur Academic’s Guide to the Nuremberg Code and Its Legacy http://www.bachelorsdegreeonline.com/blog/2012/the-nuremberg-code-and-its-legacy/ ◆The Bermont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html ◆The Bioethics Research Library at Georgetown University http://bioethics.georgetown.edu/ ◆The Ethical, Legal and Social Implications (ELSI) Research Program http://www.genome.gov/ELSI/ ◆The Hastings Center http://www.thehastingscenter.org/ ◆The National Association of IRB Managers http://www.naim.org/ ◆The Nuremberg Code (HHS.gov) http://www.hhs.gov/ohrp/archive/nurcode.html ◆The Wellcome Library http://library.wellcome.ac.uk/ ◆United Nations Declaration on Human Cloning http://www.nrlc.org/UN/UN-GADeclarationHumanCloning.pdf ◆Universal Declaration on Bioethics and Human Rights http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/ ◆Universal Declaration on the Human Genome and Human Rights http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/ ◆WMA Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/ ◆World Association of Medical Editors http://www.wame.org/ >TOP ■Events ◆2006 Institute of Human Sciences of Ritsumeikan University "Research Ethics Working Group's Serial Events Considering Research Ethics," Kinugasa Campus, Ritsumeikan University http://www.ritsumei.ac.jp/acd/gr/gsce/2006/0709.htm (Japanese) ◆September 5, 2009 "Considering Freedom and Ethics of Research: Over Life Sciences" (Japanese) Kinugasa Campus, Ritsumeikan University ◆June 8, 2011 "Seminar for Getting Research Grant Part 2 Reseach Ethics," Kinugasa Campus, Ritsumeikan University http://www.ritsumei.ac.jp/ru_gr/g-support/ability/article/?id=18 (Japanese) Ustream：http://www.ritsumei.ac.jp/file.jsp?id=35672 (Japanese) UP:November 25, 2011 REV:December 20, 2012 December 25, 2012 Prepared & Translated by KATAOKA Minoru |