Human Subjects Protection Program (HSPP)

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ANNOUNCEMENTS

Revised "Common Rule" For Human Subject Regulations: Jan 2019

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). This new rule will take effect on January 21, 2019.
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RUTGERS BEGINS AAHRPP ACCREDITATION PROCESS

Looking to validate and strengthen its protections for its research subjects, Rutgers University has initiated the AAHRPP (Association for the Accreditation of Human Research Protection Programs) accreditation process. AAHRPP promotes high-quality research through an accreditation process for organizations worldwide. In order to earn accreditation, organizations must provide tangible evidence of their commitment to scientifically and ethically sound research and to continuous improvement. (View Announcement)

General Data Protection Regulation (GDPR) Compliance Date 5/25/18

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) will become effective in 28 member states of the EU and the three additional countries (Iceland, Liechtenstein, and Norway) that also are members of the European Economic Area (EEA). The GDPR not only applies to organizations located within the EU but it will also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behaviour of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location. (View RU Guidance)
 
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.