Human Subjects Resources

• CSULB IRB Manual

DHHS/USPHS/NIH:

• Office for Human Research Protections (OHRP)
• 45 CFR Part 46, et al
• Institutional Review Board Guidebook -- BIOMEDICAL AND BEHAVIORAL RESEARCH: AN OVERVIEW
• NSF Frequently Asked Questions on Human Subjects Research
• OHRP Guidelines on Written IRB Procedures
• OHRP Procedures for Registering Institutional Review Boards and Filing Federalwide Assurances of Protection for Human Subjects
• Federal FAQ
• The Nuremberg Code
• OPRR Revised List (11-98) of Research Types Qualifying for Expedited Review
• Inclusion of Women and Minorities Policy
• NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects
• Decision Tree for the Participation of Children in Research

Training:

• IRB Forum
• NIH Training Requirement 6/5/2000
• NIH Computer-Based Training for Human Subjects Researchers
• Human Participant Protections Education for Research Teams (NIH)
• NIH Bioethics Resources

Clinical Trials:

• Clinical Trials
• NIH Policy for Data and Safety Monitoring
• Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials
• Further Guidance on Data and Safety Monitoring in Phase I and Phase II Clinical Trials
• Data Safety and Monitoring (NCI)
• U. Rochester / Centerwatch Clinical Trials Listing Service

Other:

• Human Subjects Research in Cyberspace
• Food and Drug Administration
• U. Minn. Informed Consent Orientation
• OHA Oral History Guidelines
• Ethical and Legal Aspects of Human Subjects Research on the Internet
• TO HUMAN SUBJECTS MODULE BEGINNING
• GO TO RESPONSIBLE CONDUCT OF RESEARCH PROGRAM BEGINNING

The CSU Long Beach Responsible Conduct of Research Orientation Program — Orientation to Research with Human Subjects , Copyright, 2000, California State University, Long Beach
All rights reserved.