Sites of Interest

Federal Policies and Guidance
Food and Drug Administration
Data Safety and Monitoring
Ethics and Human Participants in Research
Additional Training Resources
Related Sites
Other IRBs

Federal Policies and Guidance

• IRB Guidebook
• Code of Federal Regulations - 45 CFR
• Office for Human Research Protections - OHRP | En Español
• Office for Human Research Protections (OHRP) 2007 International Compilation of Human Research Protections (PDF)
• Certificates of Confidentiality Kiosk - National Institutes of Health
• NIH Required Education in the Protection of Human Participants
• National Institutes of Health - FAQs regarding Human Participant Research

Food and Drug Administration

• Guidance for IRBs and Clinical Investigators
• Protection of Human Subjects
• Institutional Review Boards
• Investigational New Drug Application
  • Drug Application Form 1571
  • Drug Application Form 1572
• Biological Products
• Investigational Devise Exemptions
• FDA Centers
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Devices and Radiological Health (CDRH)

Data Safety and Monitoring

• Generic Monitoring Plan for Trials Requiring a Data Safety Monitoring Board
• NIH Policy for Data and Safety
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

Ethics and Human Participants in Research

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki
• American Psychological Associations Code of Ethics

Additional Training Resources

• NIH: On-line Tutorial for Research Investigators
• Office for Human Research Protections - Educational Materials
• Protecting Human Subjects of Research at Penn State Hershey Medical Center and Penn State College of Medicine

Related Sites

• AAHRPP
• NHRPAC
• Secretary's Advisory Committee on Human Research Protections (SACHRP)
• Penn State's General Clinical Research Center at the Hershey Medical Center
• Penn State's General Clinical Research Center at University Park
• Penn State's Statistical Consulting Center (SCC)
• FIRSt Families
• Get Research Smart (for potential research participants)

Other IRBs

• Penn State's College of Medicine at the Hershey Medical Center
• University of Iowa: Human Subject Office
• University of Michigan: Medical School Institutional Review Board (IRBMED)
• Indiana University: Office of Research and University Graduate School
• University of Minnesota: Research Subjects Protection Programs
• University of Washington: Grants and Contracts Services, Human Subjects Division
• Duke University: Human Subjects in Research
• University of Kentucky: ORI Research Integrity Human Research
• University of Chicago: BSD/UCH Institutional Review Board
• Michigan State University: Human Research
• Northwestern University: Office for the Protection of Research Subjects
• Ohio State University: Office of Responsible Research Practices
• Purdue University: Committee on the Use of Human Research Subjects
• University of Wisconsin-Madison: Human Research Protections Program