|Revised Human Subject Regulations: Delayed||
On January 17th, 2018 the Department of Health and Human Services announced the delay of the revisions to the Federal Policy for the Protection of Human Subjects. Therefore, all current human subject protection policies and procedures will remain as they have been to date while the University evaluates the impact of the delay and considers next steps. (View Rutgers Announcement; View HHS Announcement)
|NIH’s New 'Certificates of Confidentiality' (CoC)||
Previously, NIH provided protections through the issuance of Certificates only upon receipt and approval of an application. The NIH will now provide Certificates automatically to any NIH-funded recipients conducting research applicable to this Policy. (Read Guidance) (Read NIH’s CoC FAQs)
|New GCP Course For Social Behavioral Researchers||
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.