Responsible Conduct of Research

• Office of Science and Technology Policy
  • Federal Policy on Research Misconduct [Federal Register 12/6/00, Vol. 65, No. 235]
• DHHS's Office of Research Integrity
  • Policies, Regulations, and Statutes
  • Instruction in the Responsible Conduct of Research
  • ORI Introduction to RCR
• DHHS/PHS/NIH Guidelines
  • Protection of Research Misconduct Whistleblowers [Federal Register 11/28/00, Vol. 65, No. 229]
  • Responsibilities of NIH and Awardee Institutions for the Responsible Conduct of Research
  • Instruction in the Responsible Conduct of Research in NRSA Institutional Training Grants
  • Final Rule on Research Misconduct
    [Federal Register: May 17, 2005 (Volume 70, Number 94); 42 CFR Parts 50 and 93]
• NIH Resources
  • Bioethics Resources
  • Training in the Responsible Conduct of Research
• Columbia University
  • Medical Center's Course: Responsible Conduct of Research and Related Policy Issues
    • Article on Course in P&S Journal (Fall 1997)
  • CU Institutional Policy on Misconduct in Research

• Nuremberg Code (1947) (NIH)
  • Nuremberg Trial of Nazi Germany Doctors (USHMM)
• World Medical Association
  • Declaration of Helsinki
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
• Federal Policy for the Protection of Human Subjects (45 CFR 46)
• President's Council on Bioethics
• National Bioethics Advisory Commission
  • Reports
• Council for International Organizations of Medical Sciences (CIOMS)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
  • International Guidelines for Ethical Review of Epidemiological Studies (1991)
• International Conference on Harmonisation: Good Clinical Practice: Consolidated Guideline (Federal Register: Vol. 62; No. 90; 5/9/97)
• International Conference on Harmonisation
• Institute of Medicine Reports
  • Responsible Research: A Systems Approach to Protecting Research Participants (10/02)
  • Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (4/01)
• Ethical Issues in Research Involving Human Participants (Current Bibliographies - NLM)
• Jesse's Intent by Paul Gelsinger, presented 10/31/00
• Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
• Western IRB
• Dept. of Health and Human Subjects
  • Office for Human Research Protections (OHRP)
    • Policy Guidance
    • Education
    • Reference Documents
  • NIH's Intramural Research Program: Office of Human Subjects Research
  • NCI's Education Material
  • Comparison of FDA and HHS Human Subject Protection Regulations
  • NIH Guide
    • Required Education in the Protection of Human Research Participants
    • Data and Safety Monitoring for Phase I and II Clinical Trials
  • Food and Drug Administration
    • Good Clinical Practice (GCP) in FDA-Regulated Clinical Trials
    • Information for Clinical Investigators
      • Guidance for Institutional Review Boards and Clinical Investigators
      • Guidance for Industry: Good Clinical Practice Consolidated Guideline
    • Regulatory Information
    • Federal Policy for the Protection of Human Subjects (21 CFR 50)
    • Federal Policy for Institutional Review Boards (21 CFR 56)
    • Patient Misuse and Investigator Fraud in Clinical Trials: What Can Be Done? Part I
    • Who’s in Charge Anyway? Responsibility in Today’s Clinical Trial Environment
  • Office for Civil Rights - HIPAA
    Medical Privacy - National Standards to Protect the Privacy of Personal Health Information
• Department of Energy
  • Human Subjects Research Program: Protecting Human Subjects
    • Advisory Committee on Human Radiation Experiments and its Final Report (1995)
    • Human Radiation Experiments Associated with the U.S. Department of Energy and its Predecessors (1995)
• Columbia University Medical Center
  • CUMC Institutional Review Board and Human Research Protection Program, including links to ethical principles, government regulations, and policies and guidances

• NIH's Office of Laboratory Animal Welfare
  • Public Health Service Policy on Humane Care and Use of Laboratory Animals
    • "What Investigators Need to Know About the Use of Animals"
    • Tutorial
• U.D. Depatment of Agriculture
  • Animal and Plant Health Inspection Service (APHIS)
    • Animal Care
• Guide for the Care and Use of Laboratory Animals (NRC)
• Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)

• Department of Health and Human Services
  • Secretary of DHHS: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (5/5/04)
• PHS/NIH Guidelines for Objectivity in Research
  • Office of Extramural Research: Conflict of Interest
  • Conflict of Interest: Overview
  • Conflict of Interest Information Resources Available on the Web
  • Grants Policy Statement
  • NIH Review of Financial Conflict of Interest Policies of Grantee Institutions
  • NIH Guide
    • Reminder of Financial Conflict of Interest Requirements for All NIH-Supported Institutions (12/6/04)
    • Issues for Investigators and Institutional Review Boards (6/5/00)
    • Objectivity in Research Policy (7/14/95, Vol. 24, No.25)
  • Federal Register
    • Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (5/12/04, Vol. 69, No. 92, pp. 26393-26297)
    • Objectivity in Research; Investigatory Financial Disclosure Policy; Final Rule and Notice (7/11/95; Vol. 60; No. 132)
    • Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy (7/3/96; Vol. 61; No. 129)
  • Code of Federal Regulations
    • Grants (Title 42 CFR Part 50 Subpart F); "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought"
    • Contracts (Title 45 CFR Part 94); "Responsible Prospective Contractors"
• Tasks Forces and Reports
  • AAMC: Task Force on Financial Conflicts of Interest in Clinical Research
    • U.S. Medical School Policies on Individual Financial Conflicts of Interest: Results of an AAMC Survey (9/04)
    • Report on Institution's Financial Interests in Human Subjects Research (10/02)
    • Report on Individual Financial Interest in Human Subjects Research (12/01)
  • Council on Governmental Relations: Recognizing and Managing Personal Financial Conflicts of Interest (Winter 2002)
  • General Accounting Office: Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest (11/01)
  • Association of American Universities: Report on Individual and Institutional Conflict of Interest (10/01)
• Columbia University Medical Center
  • CUMC Conflict of Interest Policy; Faculty Handbook: Appendix L
  • CU Guidelines for Situations Involving Potential Conflicts of Interest Between Scholarly and Commercial Activities; Faculty Handbook: Appendix K
  • Statement of Columbia University Policy on Conflicts of Interest: Appendix J

• NIH Guidelines
  • Invention Reporting
    • A "20-20" View of Invention Reporting (full text)
    • Extramural Invention Reporting --- 20/20 View (short text)
    • Procedures for Handling Non-Election of Title to Patentable Biological Materials
    • Questions and Answers on Implementation of the NIH Proedures for Handling Non-Election of Title to Patentable Biological Materials
    • Implementation of Inventor Certification for Inventions Waived to the Inventor under the Bayh-Dole Act
• Code of Federal Regulations
  • Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements (37 CFR 401)
• Federal Register
  • Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice (12/23/99; Vol.64; No.246)
• Council on Government Relations
  • Informational Documents, Guidances, Tutorials, Reviews , and Other Educational Materials

• Council of Science Editors (CSE)
  • Authorship Task Force White Paper on Promoting Integrity in Scientific Journal Publications
  • Selected References on Authorship
  • Editorial Policies
• Uniform Requirements for Manuscripts Submitted to Biomedical Journals
  International Committee of Medical Journal Editors (ACP-ASIP Online)
• Committee on Publication Ethics (COPE)
  • Guidelines and Code of Conduct
• World Association of Medical Editors
  • Policy Statements
  • Recommendations on Publication Ethics Policies for Medical Journals
  • Ethics Resources
• Understanding Plagiarism tutorial (Prentice Hall)

• National Institutes of Health
  • Statement on Sharing Research Data
  • Frequently Asked Questions on Data Sharing
  • NIH Data Sharing Policy and Implementation Guidance
  • NIH Model Organism Sharing Policy
  • Sharing of Model Organism and Related Resources: Frequently Asked Questions (FAQs)
  • Principles and Guidelines on Obtaining and Disseminating Biomedical Research Resources: Final Notice
  • NIH Guide
    • NIH Policy on Sharing of Model Organisms for Biomedical Research (5/7/04)
    • Final NIH Statement on Sharing Research Data (2/26/03)
    • Public Health Service Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding (7/12/96)
  • Grants Policy Statement
    • The Freedom of Information Act
    • Access to Research Data
    • Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources
    • Record Retention and Access
• Federal Register
  • Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice (12/23/99; Vol.64; No.246)
• Council on Government Relations
  • Guidance to Campuses on NIH "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources" [2/15/00]
• Academic and Other Resources
  • UC San Francisco: New Investigators: A Quick Guide to Starting Your Research - Data Management: Research Records
  • Fox Chase Cancer Center: Scientific Recordkeeping
  • University of Florida: Good Record Keeping: Procedures for Academic Laboratory Settings
  • University of Florida: Good Record Keeping: Procedures for Academic Laboratory Settings
  • Making the Right Moves: A Practical Guide to Scientific Management for Postdocs and New Faculty - Chapter 8: Data Management and Laboratory Notebooks [HHMI and BWF (2006)]

• Compact Between Postdoctoral Appointees and Their Mentors [Association of American Medical Colleges (2006)]
• Training Scientists to Make the Right Moves: A Practical Guide to Developing Programs in Scientific Management [HHMI and BWF (2006)]
• Entering Mentoring A Seminar to Train a New Generation of Scientis [Wisconsin Program for Scientific Teaching and the HHMI(2005)]
• Enhancing the Postdoctoral Experience for Scientists and Engineers: A Guide for Postdoctoral Scholars, Advisers, Institutions, Funding Organizations, and Disciplinary Societies (National Academy of Sciences (2000)]
• Guide to Training and Mentoring in the Intramural Research Program at NIH (1999)
• Advisor, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering (National Academy of Sciences (1997)]

• Columbia University Medical Center
  • Medical Center's Course: Responsible Conduct of Research and Related Policy Issues
    • Article on Course in P&S Journal (Fall 1997)
• Ethical, Legal, and Social Implications (ELSI) Research Program
• Center for the Study of Bioethics (Med. Coll. of Wisconsin)
• Center for Bioethics (Univ. of Penn.)
• Poynter Center (Indiana Univ.)
• Online Ethics Center for Engineering and Science (CWRU)
• Research Ethics (UCSD)
• Scientific Integrity Bibliography (AAAS/NAS)
• Research Compliance Resources (AAMC)

• Ethical Issues in Research Involving Human Participants (Current Bibliographies - NLM)
• National Academy of Sciences' Publication: On Being a Scientist
  • HTML version
  • Image version
• ORI Introduction to RCR
• Science and Engineering Ethics
• Report on Research Compliance

• AAMC-ORI Responsible Conduct of Research (RCR) Program for Academic Societies
• Applied Research Ethics National Association (ARENA)
• Association for Practical and Profesional Ethics (APPE)
  • Responsible Conduct of Research Education Committee
• Council of Graduate Schools
  • Responsible Conduct of Research Initiatives
  • RCR Resources
• Public Responsibility in Medicine and Research (PRIM&R)