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Federal, State & Other Policies

Federal, State and other non-Penn State policies

Federal Policies and Other Guidance

information NIH Regulation Title 42, Part 50.604 - Financial Conflict of Interest Regulation
Institutional Responsibility Regarding Conflicting Interest of Investigators (for all PHS Funded Research)
information NIH Regulation Title 45, Part 94.4 - Financial Conflict of Interest Regulation
Institutional Responsibility Regarding Conflicting Interests of Investigators (for all PHS Funded Research)
information NSF Grant Policy Manual - Conflict of Interest Policy
Conflict of Interest Grantee Management Standards
information FDA Regulation Title 21, Part 54 - Financial Conflicts of Interest
Financial Disclosure by Clinical Investigators
information OHRP IRB Guidebook
United States Department of Health & Human Services, Office for Human Research Protections (OHRP) - IRB Guidebook
information Code of Federal Regulations - Title 45 CFR Part 46
Protection of Human Subjects
information Office for Human Research Protections (OHRP) - Policy Guidance
OHRP policy guidance by topic
information OHRP 2013 International Compilation of Human Research Standards
Office for Human Research Protections International Compilation of Human Research Standards
information NIH - Certificates of Confidentiality Kiosk
National Institutes of Health - Certificates of Confidentiality
information NIH Policy - Required Education in the Protection of Human Research Participants
National Institutes of Health Policy - Required Education in the Protection of Human Research Participants
information NIH FAQs Regarding Human Participant Research
National Institutes of Health frequently asked questions regarding human participant research
information FDA Guidance for IRBs and Clinical Investigators
Food and Drug Administration guidance for IRBs and clinical investigators
information Code of Federal Regulations - Title 21 CFR Part 50
Food and Drug Administration - Protection of Human Subjects
information Code of Federal Regulations - Title 21 CFR Part 56
Food and Drug Administration - Institutional Review Boards
information Code of Federal Regulations - Title 21 CFR Part 312
Food and Drug Administration - Investigational New Drug Application
information Code of Federal Regulations - Title 21 CFR Part 600
Food and Drug Administration - Biological Products: General
information Code of Federal Regulations - Title 21 CFR Part 812
Food and Drug Administration - Investigational Device Exemptions
information NIH Policy for Data and Safety Monitoring
National Institutes of Health Policy for Data and Safety Monitoring
information NIH Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
National Institutes of Health Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
information The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
information The Nuremberg Code
Directives for Human Experimentation
information Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects
information APA Ethical Principles of Psychologists and Code of Conduct
American Psychological Association - Ethical Principles of Psychologists and Code of Conduct With the 2010 Amendments
information Animal Welfare Act, last amended 2008
Animal Welfare Act, last amended 2008
information Public Health Service Policy on Humane Care and Use of Laboratory Animals, 2002
Public Health Service Policy on Humane Care and Use of Laboratory Animals, 2002
information Health Research Extension Act of 1985, "Animals in Research"
Health Research Extension Act of 1985, "Animals in Research"
information USDA Animal and Plant Health Inspection Service Animal Care Policy Manual, Updated March 2011
USDA Animal and Plant Health Inspection Service Animal Care Policy Manual
information AVMA Guidelines on Euthanasia, June 2007
AVMA Guidelines on Euthanasia, June 2007
information Guide for the Care and Use of Laboratory Animals: 1996
Guide for the Care and Use of Laboratory Animals: 1996
information Guide for the Care and Use of Laboratory Animals: Eighth Edition, 2010
Guide for the Care and Use of Laboratory Animals: Eighth Edition, 2010
information Guide for the Care and Use of Agricultural Animals in Research and Teaching: Third Edition, January 2010
Guide for the Care and Use of Agricultural Animals in Research and Teaching: Third Edition, January 2010
information Occupational Health and Safety in the Care and Use of Research Animals, 1997
Occupational Health and Safety in the Care and Use of Research Animals, 1997
information NIH Recombinant DNA Guidelines
NIH Recombinant DNA Guidelines
information OSHA Bloodborne Pathogen Standard (29CFR1910.1030)
OSHA Bloodborne Pathogen Standard (29CFR1910.1030)
information Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition, 2007
Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition, 2007
information Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research
AAMC/AAU 2008 Joint Report on Implementing COI Policies. See Chapter 2 for Institutional Information.
information Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research
AAMC 2002 Report of Institutional Conflicts of Interest
information Council on Governmental Relations (COGR) Publications on Conflict of Interest
2001 COGR Institutional COI Policy Recommendations