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>HOME [Japanese] 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 ◇What's New ◇WHO ◇Literature (Various Writings) ◇Theme Related Links ◇Events >TOP ■What's New ◆April 14, 2014 "STAP replication 'not conclusive'" (The Japan Times) http://www.japantimes.co.jp/news/2014/04/14/national/stap-replication-not-conclusive/ ◆April 12, 2014 "Japanese universities rush to tackle cheating in wake of STAP cell controversy" (Mainichi Daily News) http://mainichi.jp/english/english/newsselect/news/20140412p2a00m0na001000c.html ◆April 10, 2014 "Riken panel mulls steps to prevent misconduct" (The Japan Times) http://www.japantimes.co.jp/news/2014/04/10/national/riken-panel-mulls-steps-to-prevent-misconduct/ ◆April 5, 2014 "Stem-cell row ‘a blow for science’" (The Japan Times) http://www.japantimes.co.jp/news/2014/04/05/national/stem-cell-row-a-blow-for-science/ ◆April 2, 2014 "Hasty Riken STAP report draws fire" (The Japan Times) http://www.japantimes.co.jp/news/2014/04/02/national/hasty-riken-stap-report-draws-fire/ ◆April 1, 2014 "Stap cells: research paper on stem cell breakthrough was partly falsified" (theguardian) http://mainichi.jp/english/english/newsselect/news/20140412p2a00m0na001000c.html ◆April 1, 2014 "New hope for embattled STAP cell researchers?" (Los Angeles Times) http://mainichi.jp/english/english/newsselect/news/20140412p2a00m0na001000c.html ◆April 1, 2014 "Obokata falsified data in STAP papers: probe" (The Japan Times) http://www.japantimes.co.jp/news/2014/04/01/national/obokata-falsified-data-in-stap-papers-probe/ ◆March 29, 2014 "The truth is, we have gotten too used to lying" (The Japan Times) http://www.japantimes.co.jp/news/2014/03/29/national/the-truth-is-we-have-gotten-too-used-to-lying/ ◆March 15, 2014 "STAP papers discredited, but science may be sound" (The Japan Times) http://www.japantimes.co.jp/news/2014/03/15/national/despite-scandal-scientists-want-another-attempt-at-creating-stap-cells/ ◆March 11, 2014 "Lab may have to retract groundbreaking stem cell paper as questions arise" (The Japan Times) http://www.japantimes.co.jp/news/2014/03/11/national/co-author-urges-retraction-of-groundbreaking-stem-cell-study/ ◆February 27, 2014 "Diovan scandal traced to cozy doctor-drugmaker ties" (The Japan Times) http://www.japantimes.co.jp/news/2014/02/27/national/diovan-scandal-traced-to-cozy-doctor-drugmaker-ties/ ◆January 13, 2014 "Novartis drug’s data-tampering reflects unchecked collusion" (The Japan Times) http://www.japantimes.co.jp/news/2014/01/13/reference/novartis-drugs-data-tampering-reflects-unchecked-collusion/ ◆October 19, 2013 "Remedies for rigged research" (The Japan Times) http://www.japantimes.co.jp/opinion/2013/10/19/editorials/remedies-for-rigged-research/ ◆September 9, 2013 "Strengthening research ethics" (The Japan Times) http://www.japantimes.co.jp/opinion/2013/09/09/editorials/strengthening-research-ethics/ ◆July 31, 2013 "Another Japanese university finds data manipulation for Novartis drug" (The Japan Times) http://www.japantimes.co.jp/news/2013/07/31/national/another-japanese-university-finds-data-manipulation-for-novartis-drug/ >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/ ◆iThenticate http://www.ithenticate.com/ ◆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/April 14, 2014/April 15, 2014 Prepared & Translated by KATAOKA Minoru |