Human Subjects Protection Program (HSPP)

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 Announcements
  • ClinicalTrials.Gov Requirement Announcement: January 18, 2017 is the effective date to comply with Clinical Trials Reporting Final Rule. If you are an Investigator doing interventional research at Rutgers University, you may have to register/update your research study on ClinicalTrials.gov. View Announcement
  • IRB Announcement 1.6.17: Transition To Updated eIRB System February 1, 2017: View Announcement
  • IRB Announcement 12.1.16: Update Regarding ORED’s Excellence in Research Administration (ERA) Initiative: View Announcement; New Resources: New Site Cooperation Form; New Protocol Templates (3); New Student Research Manual;
  • New NIH Policy on GCP Training For NIH-Funded Clinical Trials: The NIH Policy on GCP Training takes effect January 1, 2017 which establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP). View Announcement
 
The mission of the Human Subjects Protection Program (HSPP) is to support the University's research enterprise by ensuring the protection of individuals who participate in research; ensuring compliance with all pertinent federal and state laws and regulations; fostering the ethical conduct of human subjects research; and providing education and other services to the University's researchers regarding regulatory requirements and best practices.
 
The Institutional Review Board (IRB) process is based on the rules and regulations of the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) which require an IRB to approve, require modifications in planned research prior to approval, or disapprove research.
 
The HSPP contains three Institutional Review Boards (IRBs) and a Quality Assurance and Development Unit.