Human Subjects Protection Program (HSPP)

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 Announcements
  • IRB Announcement:Update Regarding ORED’s Excellence in Research Administration (ERA) Initiative 12/1/2016; View Announcement;
  • 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), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). The NIH’s recent response also clarifies, “institutions should not regard the policy’s effective date as a deadline by which we would expect all staff involved in the conduct, oversight, and management of clinical trials to be GCP trained. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be taken in a timely fashion after the effective date.” (Enter the NIH Training Website)
 
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 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 IRBs and a Quality Assurance and Development Unit.