Human Subjects Protection Program (HSPP)

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ANNOUNCEMENTS

NJ ACTS Pilot Program Request for Applications (RFA)

One of the major objectives of NJ ACTS is to successfully translate biomedical discoveries to clinical applications by promoting creative and innovative science, which often requires pilot support for hypothesis generation and/or for team building to address questions in translational science. Also please note that all pilot require NCATS approval before an award can be made, and that projects with humans or animals require IRB/IACUC and the NCATS approval. For IRB Approval support Contact Us. For IACUC Approval support Contact Us. For all other inquiries visit: https://njacts.rbhs.rutgers.edu/. View Announcement (PDF).

Conversion of ArtSci IRB Paper Studies Into The eIRB System
Will Be Required Starting January 22, 2020
Arts and Sciences IRB Paper-based Full Board or Expedited studies due for continuing review on or after January 22, 2020 will be required to transition to eIRB (online submission system) rather than renewing in their current paper format. Please be advised the IRB requires that studies are submitted in eIRB approximately 90 days prior to the expiration date due to the time needed for the Committee review. (View Announcement; View Instructions)
Revised "Common Rule" For Human Subjects Regulations
Effective Monday January 21, 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 took effect on Monday, January 21, 2019.

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 nine Institutional Review Boards (IRBs) and a Quality Assurance and Development Unit.