Human Subjects Protection Program (HSPP)

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  • Major Changes to Regulations Governing Human Subject Research Start Effective January 19, 2018: The Federal Policy for the Protection of Human Subjects ('Common Rule') is a rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. The Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) was published by the U.S. Department of Health and Human Services (HHS) in January 2017 in the Federal Register. Learn more about the most significant Final Rule changes that affect research institutions, Institutional Review Boards (IRBs), and investigators: (Read More)
  • NIH’s New 'Certificates of Confidentiality' Policy in Effect as of 10/1/17: Previously, NIH provided protections through the issuance of Certificates only upon receipt and approval of an application. However, in order to comply with the requirement in subsection 301(d) of the Public Health Service Act to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements associated with applying for a Certificate, NIH will now provide Certificates automatically to any NIH-funded recipients conducting research applicable to this Policy. (Read Guidance) (Read NIH’s Blog Posting About This Topic)
  • The Electronic IRB (eIRB) Submission Process Goes Live For All Remaining Rutgers Campuses (Newark, Camden And Greater New Brunswick) On Monday, October 30th 2017: (View Announcement)
  • New GCP Course For Social Behavioral Researchers Added to CITI Training Website: To assist our Social Behavioral researchers in meeting the NIH mandate for GCP training for interventional studies, we have added the following to our CITI training menu: GCP – Social and Behavioral Research Best Practices for Clinical Research. (Read More)
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.