Research Ethics

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

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■WHO

◆AMADA Josuke
◆ARIZONO Masayo
◆MATSUBARA Yoko
◆MOCHIZUKI Akira
◆NAGATA Atsumasa
◆OTANI Izumi
◆YAMAMOTO Takanori

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■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 ※

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■Theme Related Links

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

◆American Association for the Advancement of Science, Integrity in Scientific Research Video Series
http://www.aaas.org/page/integrity-scientific-research-video-series

◆American Association for the Advancement of Science, Professional Ethics Report
http://www.aaas.org/page/integrity-scientific-research-video-series

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

◆Association of American Universities, Conflicts of Interest
https://www.aau.edu/policy/article.aspx?id=10090

◆Bioethics Research Library at Georgetown University
https://bioethics.georgetown.edu/

◆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

◆Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/read/5140/chapter/1

◆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/

◆Institute for Laboratory Animal Research
http://dels.nas.edu/ilar

◆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 Institute of Health, Ethics Program
https://ethics.od.nih.gov/

◆National Institute of Health, Human Subjects Research
http://grants.nih.gov/policy/hs/index.htm

◆National Institute of Health, Office of Extramural Research, Financial Conflict of Interest
http://grants.nih.gov/grants/policy/coi/

◆National Institute of Health, Office of Laboratory Animal Welfare - Public Health Service Policy on Humane Care and Use of Laboratory Animals
https://grants.nih.gov/grants/olaw/references/phspol.htm

◆National Library of Medicine
http://www.nlm.nih.gov/

◆National Whistleblower Center
http://www.whistleblowers.org/

◆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 for Human Research Protection (Department for Health and Human Services)
http://www.hhs.gov/ohrp/

◆Office of Biotechnology Activities
http://oba.od.nih.gov/oba/index.html

◆Office of Research Integrity
http://ori.hhs.gov/

◆Office of Research Integrity, Handling Misconduct
http://ori.hhs.gov/handling-misconduct

◆Online Ethics Center for Engineering and Science, National Academy of Engineering
http://www.onlineethics.org/

◆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

◆Resources for Research Ethics Education, University of California-San Diego
http://research-ethics.net/

◆Responsible Conduct of Research, Columbia University
http://ccnmtl.columbia.edu/projects/rcr/

◆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

◆Survival Skills and Ethics Program, University of Pittsburgh
http://www.pitt.edu/~survival/~survival.html

◆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 Poynter Center for the Study of Ethics and American Institutions
http://poynter.indiana.edu/

◆The Wellcome Library
http://library.wellcome.ac.uk/

◆U.S. Department of Health and Human Services, Code of Federal Regulations
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

◆U.S. Department of Health and Human Services, Office for Human Research Protections
http://www.hhs.gov/ohrp/

◆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/

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■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/June 10, 2014/January 6, 2015/March 31, 2016

Prepared & Translated by KATAOKA Minoru

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