Responsible Conduct of Biomedical Research

Web Links


Please note:  the links on this web page were taken from the 2004 version of the text book, and some may be out of date. 
If you find a bad link, please let me know so I can update or delete it.

Office of Research Integrity (DHHS)

 
Rules of the Road Data Management Practices
Research Misconduct Mentor and Trainee Responsibilities
Protection of Human Subjects Collaborative Research
Welfare of Laboratory Animals Authorship & Publication
Conflicts of Interest Peer Review
 
Link

Source

Description

Rules of the Road

National Academy of Sciences, Committee on the Conduct of Science On Being a Scientist:  Responsible Conduct in Research, 2nd. ed., Washington, DC:  National Academy Press, 1995.
Association of American Medical Colleges Developing a Code of Ethics in Research: A Guide for Scientific Societies, Washington, DC: AAMC l997
National Institutes of Health Guidelines for the Conduct of Research in the Intramural Research Programs at NIH, 1997
Institute of Medicine The Responsible Conduct of Research in the Health Sciences, Washinton, D.C.: National Academies of Science, 1989
American Association for the Advancement of Science Integrity in Scientific Research, 2000 (information on 5 videos on integrity in research)
Bird, S. & Sper, R., eds. Science and Engineering Ethics, 1995 (includes articles on RCR)
Kalichman, M. The Online Resource for Instruction in Responsible Conduct of Research, 2003
National Institutes of Health Research Conduct and Ethics Instruction Materials, nd.
North Carolina State University Research Ethics Initiative, 2003
Office of Research Integrity Home page, 2003
Online Ethics Center for Engineering and Science Home page, 2003
Shamoo, A.E., ed. Accountability in Research:  Policies and Quality Assurance, 1994 ff.
Research Misconduct
National Science Foundation Research Misconduct, 45 CFR 689 (1987)
Office of Research Integrity ORI Model Policy and Procedures for Responding to Allegations of Scientific Misconduct, 1995, revised 1997
Public Health Service Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science
National Science Foundation Office of Inspector General, Home page
Office of Research Integrity Handling Misconduct, 2003
Protection of Human Subjects
Directives for Human Experimentation Nurember Code. 1949
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 1964, 2002
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979
United States. Congress, 99th Congress Health Research Extension Act of 1985, PL 99-158
National Institutes of Health Guidelines for the Conduct of Research Involving Human Subjects at the Natiuonal Institutes of Health, 1995
Food and Drug Administration Information Sheet:  Guidance for Institutional Review Boards and Clinical Investigators, 1998
National Institutes of Health. Standards for Clinical Research within the NIH Intramural Research Program, 2000
National Institutes of Health Bioethics Resources on the Web, 2003
National Institutes of Health, Office of Human Subjects Research Home page, nd
Welfare of Laboratory Animals
United States Congress Animal Welfare Act, PL 89-544, 1966
National Academy of Sciences. Institute of Laboratory Animal Resources Commission of Life Sciences Guide for the Care and Use of Laboratory Animals, 1996
Public Health Service Public Health Service Policy on Humane Care and Use of Laboratory Animals, 2002
U.S. Dept. of Agriculture Animal Care Policy Manual, 2002
National Institutes of Health U.S. Governament Principles for the Utilization and Care of Bertebrate Animals Used in Testing, Research, and Training
Association for the Assessment and Accreditation of Laboratory Animal Care Home page, nd.
Conflicts of Interest
Association of American Medical Colleges Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research, 1990
National Institutes of Health "Objectivity in Research," Federal Register 60, 132 , 1995
National Science Foundation "Investigator Financial Disclosure Policy"
US Congress. 105th Congress. First Session Federal Advisory Committee Act Amendments of l997, PL 105-153, 1997
Office of Management and Budget Circular A-21,Washington, DC: OMB, 2000
Association of American Universities Report on Individual and Institutional Financial Conflict of Interest, Washington, DC: AAU, 2001
Food and Drug Administration Guidance: Financial Disclosure by Clinical Investigators,  Washington, DC: FDA, 2001
Office for Human Research Protections. Public Health Service Draft Interim Guidance:  Financial Relationships in Clinical Research: Issues For Institutions, Clinical Investigators, And IRBs to Consider When Dealing With Issues of Financial Interest And Human Subject Protection, Washington, DC: OHRP, 2001
Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research Protecting Subjects, Preserving Trust, Promoting Progress II:  Principals and Recommendations for Oversight of an Institution's Financial Interest in Human Subject Research, Washington, DC: COGR, 2002
Council on Government Relations Recognizing and Managing Personal Conflicts of Interest, Washington, DC: COGR, 2002
Drazen, JM, Curfman, GD Financial Associations of Authors, The New England Journal of Medicine 346, 24, 2002
Institute of Medicine.  National Academies of Science Study Conduct:  Bias and Conflict of Interest, Washington, DC: IOM, nd.
Association of American Universities Conflict of Interest and Misconduct, nd
Association of University Technology Managers Home page, nd
Institute of Medicine.  National Academies of Science.  Office of Extramural Research Conflict of Interest. nd
Data Management Practices
Council on Government Relations. Policy Considerations:  Access to and Retention of Research Data, Washington, DC: 1995
University of Pittsburgh Guidelines on Data Retention and Access, Pittsburgh, PA, University of Pittsburgh, 1997
American Statistical Association Ethical Guidelines for Statistical Practice, Alexandria, VA: American Statistical Association, 1999
Harvard University Medical School.  Office Technology Licensing Record-Keeping Procedures, 2000
United States. Congress USA Patriot Act of 2001, PL 107-56, 2001
Food and Drug Administration Good Laboratory Practices for Designing Toxicology Studies for Petition Submissions and Notifications, 21 DFR Part 58, 2002
Society for Clinical Data Management Good Clinical Data Management Practices, Version 2, Hillborough, NJ: Soiciety for Clinical Data Management, 2002
National Institutes of Health NIH Data Sharing Policy and Implementation Guidance, 2003
National Institutes of Health.  Office of Extrmural Research NIH Data Sharing Policy, Washington, DC: National Institute of Health, nd.
Society for Clinical Data Management Home page, 2003
Mentor and Trainee Responsibilities
Institute of Medicine The Responsible Conduct of Research in the Health Sciences, Washington, DC: National Academies of Science, 1989
Gottesman, MM A Guide to Training and Mentoring in the Intramural Reserch Program at NIH, Bethesda, MD, National Institutes of Health, 1999
National Science Foundation Intergrative Graduate Education and Research Traineeship (IGERT) Program, Washington, DC: NSF, 2002
Association for Women in Science and Engineering Home page, 2003
MentorNet. The E-Mentoring Network for Women in Engineering and Science, 2003
National Postdoctoral Association Home page, 2003
Gadlin, H, Jessar, K Preempting Discord:  Prenuptial Agreements for Scientist.  The NIH Catalyst, 2002
University of Michigan.  Horace H. Rackham School of Graduate Studies How to Mentor Graduate Students:  A Guide for Faculty in a Diverse University, Ann Arbor, MI, University of Michigan, 2002
Collaborative Research
National Institutes of Health Principles And Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 FR 72090, 1999
Office of Management and Budget OMB Circular A-110, Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations, Washington, DC OMB, 1999
Davis, TP, ed Management of Biomedical Research Laboratories:  Proceedings of a National Conference, Tucson, AS: University of Arizona, 1999
Gottesman, MM Funding of Intramural Research Program/Extramural Research Program Collaborations, 1999
Macrina, FL Dynamic Issues in Scientific Integrity:  Collaborative Research, Washington, DC: American Society for Microbilogy, 1995
Schwartz, J Silence is not Golden:  Making Collaborations Work, Bethesda, MD: National Institutes of Health, nd
Authorship & Publication
Society for Neuroscience Responsible Conduct Regarding Scientific Communication, SN, 1996
Michigan State University Michigan State University Guidelines on Authorship, East Lansing, I: MSU, 1998
International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 2001
Council of Biology Editors Scientific Style, CBE, 2002
Peer Review
National Institutes of Health NIH Guide - Objectivity in Research, Bethesda, MD: NIH, 1995
University of Michigan Medical School Guidelines for the Responsible Conduct of Research: Right and Responsibilities of Peer Review, Ann Arbor, MI: UM, 1999
International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 2001

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