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Research Ethics

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This page includes who's who, literature, sites and events concerning research ethics.
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¡Table of Contents
žWhat's New
žWHO
žLiterature (Various Writings)
žTheme Related Links
žEvents


>TOP
¡What's New

ŸApril 14, 2014 "STAP replication 'not conclusive'" (The Japan Times)
http://www.japantimes.co.jp/news/2014/04/14/national/stap-replication-not-conclusive/

ŸApril 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

ŸApril 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/

ŸApril 5, 2014 "Stem-cell row ea blow for sciencef" (The Japan Times)
http://www.japantimes.co.jp/news/2014/04/05/national/stem-cell-row-a-blow-for-science/

ŸApril 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/

ŸApril 1, 2014 "Stap cells: research paper on stem cell breakthrough was partly falsified" (theguardian)
http://mainichi.jp/english/english/newsselect/news/20140412p2a00m0na001000c.html

ŸApril 1, 2014 "New hope for embattled STAP cell researchers?" (Los Angeles Times)
http://mainichi.jp/english/english/newsselect/news/20140412p2a00m0na001000c.html

ŸApril 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/

ŸMarch 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/

ŸMarch 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/

ŸMarch 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/

ŸFebruary 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/

ŸJanuary 13, 2014 "Novartis drugfs 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/

ŸOctober 19, 2013 "Remedies for rigged research" (The Japan Times)
http://www.japantimes.co.jp/opinion/2013/10/19/editorials/remedies-for-rigged-research/

ŸSeptember 9, 2013 "Strengthening research ethics" (The Japan Times)
http://www.japantimes.co.jp/opinion/2013/09/09/editorials/strengthening-research-ethics/

ŸJuly 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

ŸAMADA Josuke
ŸARIZONO Masayo
ŸMATSUBARA Yoko
ŸMOCHIZUKI Akira
ŸNAGATA Atsumasa
ŸOTANI Izumi
ŸYAMAMOTO Takanori


>TOP
¡Literature (Various Writings)

Books
ŸBeecher HK@1970@Research and the Individual: Human Studies, Little Brown.

ŸFreund PA (Ed.) 1970 Experimentation with Human Subjects George Braziller.

ŸKatz 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.

ŸBeauchamp TL, Faden RR, Wallace RJ, Jr., Walters L (Eds.) @1982@Ethical Issues in Social Science Research Johns Hopkins University Press.

ŸSieber JE (Ed.) 1982 The Ethics of Social Research: Surveys and Experiments Springer-Verlag

ŸSieber JE (Ed.) 1982 The Ethics of Social Research: Fieldwork, Regulation, and Publication Springer-Verlag

ŸFaden RR, Beauchamp TL@1986@A History of Theory of Informed Consent Oxford University Press.

ŸLevine RJ@1988 The Ethics and Regulation of Clinical Research (2nd Edition)@Yale University Press.

ŸNational Research Council @1989@On Being a Scientist Natl Academy Pr.

ŸCommittee 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

ŸBeauchamp TL, Childress JF@1989@Principles of Bioethics (3rd Edition) Oxford University Press.

ŸVeatch RM@1989 Medical Ethics Jones and Bartlett.

ŸSieber JE@1992 Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards, Applied Social Research Methods Series, Vol.31, Sage Publications

Ÿ1993 Protecting Human Research Subjects: Institutional Review Board Guidebook@Office for Protection from Research Risks

ŸBeauchamp TL, Childress JF@1994 Principles of Biomedical Ethics (4th Edition) Oxford University Press.

ŸPenslar RL@1995@Research Ethics: Cases and Materials@Indiana University Press.

ŸCommittee 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)

ŸFaden R (Ed.) 1996 The Human Radiation Experiments@Oxford University Press.

ŸVanderpool HY@1996 The Ethics of Research Involving Human Subjects University Publishing Group.

ŸAssociation of American Medical Colleges@1997 Developing a Code of Ethics in Research: A Guide for Scientific Societies AAMC

ŸBrody BA@1998 The Ethics of Biomedical Research: An International Perspective Oxford University Press

ŸSugarman J, Mastroianni A, Kahn J. 1998 Ethics of Research with Human Subjects: Selected Policies and References University Publishing Group

ŸDunn C, Chadwick G@1999 Protecting Study Volunteers in Research: A Manual for Investigative Sites Center Watch

ŸRussell-Einhorn M (Ed.) 2000 IRB Reference Book Price Waterhouse Coopers.

ŸSteneck, Nicholas H@2000 ORI Introduction to the Responsible Conduct of Research (Revised Edition) U.S. Government Printing Office.

ŸBlock, Stephen; Wells, Frank & Farthing, Michael@2001@Fraud and Misconduct in Biomedical Reserch, Blackwell Publishing Ltd, Oxford.

ŸBankert E, Amudur RJ (Eds.) 2006 Institutional Review Board: Management and Function (2nd Ed.)@Jones & Bartlett Publishers.

ŸNational 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

ŸSteneck, 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

ŸAmdur, Robert J. & Bankert, Elizabeth A@200710@Institutional Review Board Member Handbook (2nd Edition) Jones & Bartlett Publishers.

ŸHester, Macah (Ed.) 2008 Ethics by Committee Rowman & Littlefield Publishers, Inc.

ŸCommittee 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

ŸAmdur, Robert J. & Bankert, Elizabeth A@201005@Institutional Review Board Member Handbook (3rd Edition) Jones & Bartlett Publishers.

Reports
ŸMATSUBARA 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)

ŸMOCHIZUKI Akira@2007@"Research Ethics as Communication" Research Series Human Service Research Series No.5 Considering Research EthicsF118-132CInstitute of Human Sciences of Ritsumeikan University
http://www.ritsumeihuman.com/hsrc/resource/05/open_reseach05.html (Japanese)

ŸAMADA Josuke@2007@"Some Difficulties over Research Practices: Conflicts, Friction, Cracks, Dissociation and Clashes" Research Series Human Service Research Series No.5 Considering Research EthicsF133-145CInstitute of Human Sciences of Ritsumeikan University
http://www.ritsumeihuman.com/hsrc/resource/05/open_reseach05.html (Japanese)

ŸNAGATA Atsumasa, ARIZONO Masayo, et al.@20101120@"yRound-table TalkzEthics 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 ¦

ŸYAMAMOTO 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

ŸAddressing Ethical Issues in Pandemic Influenza Planning (WHO)
http://www.who.int/ethics/influenza_project/en/index.html

ŸAmerican Society of Law, Medicine, and Ethics (ASLME)
http://www.aslme.org/

ŸBioethics Resource on the Web--National Institutes of Health
http://bioethics.od.nih.gov/

ŸCenterWatch
http://www.centerwatch.com/

ŸCFR (Code of Federal Regulations)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

ŸCFR - 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

ŸCFR - 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

ŸCFR - Code of Federal Regulations Title 21 Part 56 (Institutional Review Boards)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=56

ŸCommittee of Publication Ethics
http://publicationethics.org/

ŸConvention 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

ŸCouncil of Science Editors
http://www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=1

ŸDirective 2001/20/EC of the European Parliament and of the Council
http://www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf

ŸDirective 2004/23/EC of the European Parliament and of the Council
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0023:EN:HTML

ŸDrug Information Association
http://www.diahome.org/DIAHOME/Home.aspx

ŸErrata, 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

ŸEthical Considerations in Biomedical HIV Prevention Trials: UNAIDS/WHO Guidance Document
http://data.unaids.org/pub/Report/2007/jc1399_ethical_considerations_en.pdf

ŸEthical Principles of Psychologists and Code of Conduct (APA)
http://www.apa.org/ethics/code/index.aspx

ŸEuropean Association of Science Editors
http://www.ease.org.uk/

ŸEuropean Guidelines for Auditing Independent Ethics Committees
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard//appliedclinicaltrials/232002/21190/article.pdf

ŸFaculty Policies on Integrity in Science (Harvard Medical School)
http://hms.harvard.edu/public/coi/policy/integritypolicy.html

ŸFederal Policy for the Protection of Human Subjects ('Common Rule')
http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html

ŸFrequently 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

ŸGood Research Practice (Medical Research Council)
http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Researchpractice/index.htm

ŸGuidance for Auditing Quality Systems of Independent Ethics Committees in Europe
http://www.efgcp.be/downloads/EFGCP%20IEC%20Audit%20Guidance%2014%20October2008.pdf

ŸGuidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting--Improving Human Subject Protection
http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf

ŸGuidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127013.pdf

ŸGuidance for Institutional Review Boards Frequently Asked Questions--IRB Registration
http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm171256.pdf

ŸGuidances (Drugs) (FDA)
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm

ŸGuideline 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

ŸGuidelines for Investigators in Scientific Research (Harvard Medical School)
http://hms.harvard.edu/public/coi/policy/scientific.html

ŸGuidelines for Phase 1 Clinical Trials
http://www.abpi.org.uk/our-work/library/guidelines/Documents/phase1-trial-guidelines.pdf

ŸGuidelines 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

ŸGuidelines on Certificates of Confidentiality
http://www.hhs.gov/ohrp/policy/certconf.pdf

ŸHealth Insurance Portability and Accountability Act of 1996
https://www.cms.gov/hipaageninfo/downloads/hipaalaw.pdf

ŸHMS Faculty Policy on Conflicts of Interest and Commitment
http://hms.harvard.edu/public/coi/policy/coipolicy.html

ŸHuman Organ and Tissue Transplantation
http://www.who.int/ethics/topics/human_transplant/en/

ŸHuman Research Protections Program (Department for Health and Human Services)
http://ohsr.od.nih.gov/

ŸHuman Research Report
http://www.humansubjects.com/

ŸIHC
http://www.ich.org/

ŸInternational Bioethics Committee
http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/international-bioethics-committee/

ŸInternational Committee of Medical Journal Editors
http://www.icmje.org/

ŸInternational Declaration on Human Genetic Data
http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html

ŸInternational Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002
http://www.cioms.ch/publications/layout_guide2002.pdf

ŸInternational Guidelines for Ethical Review of Epidemiological Studies
http://www.dib.unal.edu.co/promocion/etica_epidemiologicos_en.pdf

ŸIRB Forum
http://www.irbforum.org/

ŸIRB Guidebook (Office for Human Research Protections)
http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm

ŸIRBs and Assurances
http://www.hhs.gov/ohrp/assurances/

ŸiThenticate
http://www.ithenticate.com/

ŸKennedy Institute of Ethics Jounral
http://muse.jhu.edu/journals/kennedy_institute_of_ethics_journal/

ŸMandate 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

ŸMedical Research Council
http://www.mrc.ac.uk/index.htm

ŸNational Council on Ethics in Human Research
http://www.ncehr-cnerh.org/

ŸNational Library of Medicine
http://www.nlm.nih.gov/

ŸNOT-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

ŸNOT-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

ŸNSF OIG
http://www.nsf.gov/oig/

ŸOffice of Biotechnology Activities
http://oba.od.nih.gov/oba/index.html

ŸOffice of Human Subject Research
http://ohsr.od.nih.gov/guidelines/nuremberg.html

ŸOffice of Research Integrity
http://ori.hhs.gov/

ŸOperational Guidelines for Ethics Committees that Review Biomedical Research
http://apps.who.int/tdr/svc/publications/training-guideline-publications/operational-guidelines-ethics-biomedical-research

ŸPanel on Research Ethics
http://www.pre.ethics.gc.ca/eng/index/

ŸPRIM&R
http://www.primr.org/

ŸPrinciples and Procedures for Dealing With Allegations of Faculty Misconduct (Harvard Medical School)
http://hms.harvard.edu/public/coi/policy/misconduct.html

ŸPubMed
http://www.ncbi.nlm.nih.gov/pubmed

ŸRecommendations 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

ŸRegistration of an Institutional Review Board
http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/download/self_regulation_98.pdf

ŸRegulations 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

ŸRelease 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/

ŸResearch Policy Handbook: Principles Concerning Research (RPH 2.1) (Stanford University)
http://rph.stanford.edu/2-1.html

ŸResearch Repositories, Databases, and the HIPAA Privacy Rule
http://rph.stanford.edu/2-1.html

ŸRoles and Responsibilities For the Protection of Human Research Participants (Vanderbilt University)
http://www.mc.vanderbilt.edu/irb/roles/

ŸRunning Clinical Trials
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

ŸSPIN
http://catalogue.wellcome.ac.uk:81/

ŸSteering Committee on Bioethics
http://www.coe.int/t/dg3/healthbioethic/cdbi/default_en.asp

ŸThe Amateur Academicfs Guide to the Nuremberg Code and Its Legacy
http://www.bachelorsdegreeonline.com/blog/2012/the-nuremberg-code-and-its-legacy/

ŸThe Bermont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

ŸThe Bioethics Research Library at Georgetown University
http://bioethics.georgetown.edu/

ŸThe Ethical, Legal and Social Implications (ELSI) Research Program
http://www.genome.gov/ELSI/

ŸThe Hastings Center
http://www.thehastingscenter.org/

ŸThe National Association of IRB Managers
http://www.naim.org/

ŸThe Nuremberg Code (HHS.gov)
http://www.hhs.gov/ohrp/archive/nurcode.html

ŸThe Wellcome Library
http://library.wellcome.ac.uk/

ŸUnited Nations Declaration on Human Cloning
http://www.nrlc.org/UN/UN-GADeclarationHumanCloning.pdf

ŸUniversal Declaration on Bioethics and Human Rights
http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/

ŸUniversal 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/

ŸWMA Declaration of Helsinki
http://www.wma.net/en/30publications/10policies/b3/

ŸWorld Association of Medical Editors
http://www.wame.org/


>TOP
¡Events

Ÿ2006@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)

ŸSeptember 5, 2009 "Considering Freedom and Ethics of Research: Over Life Sciences" (Japanese)@Kinugasa Campus, Ritsumeikan University

ŸJune 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Fhttp://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

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