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Federal Policies and Other Guidance

Federal policies related to human participants research.

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 Code of Federal Regulations - Title 45 CFR Part 46
Protection of Human Subjects
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 Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects
information FDA Guidance for IRBs and Clinical Investigators
Food and Drug Administration guidance for IRBs and clinical investigators
information NIH - Certificates of Confidentiality Kiosk
National Institutes of Health - Certificates of Confidentiality
information NIH FAQs Regarding Human Participant Research
National Institutes of Health frequently asked questions regarding human participant research
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 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 Policy for Data and Safety Monitoring
National Institutes of Health Policy for Data and Safety Monitoring
information Office for Human Research Protections (OHRP) - Policy Guidance
OHRP policy guidance by topic
information OHRP 2010 International Compilation of Human Research Protections
Office for Human Research Protections International Compilation of Human Research Protections
information OHRP IRB Guidebook
United States Department of Health & Human Services, Office for Human Research Protections (OHRP) - IRB Guidebook
information The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
information The Nuremberg Code
Directives for Human Experimentation
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Staff Directory and About Us...
814-865-1775 •
The Human Research Protection Program in the Office for Research Protections ensures compliance with Federal, state, and local regulations as well as institutional policies and procedures regarding the use of humans as participants in research.