Human Subjects Protection Program (HSPP)

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ANNOUNCEMENTS

Revised "Common Rule" For Human Subjects Regulations

Goes Live 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 will take effect on Monday, January 21, 2019. Some of the changes made by the HSPP/IRBs include:
-Updated eIRB functionality
-Updated Research Protocol Templates
-Updated Consent Forms
-Updated Toolkit Checklists
NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule) The purpose of this notice is to provide guidance to the extramural research community regarding the NIH implementation of the Final Rule amending the Federal Policy for the Protection of Human Subjects (Common Rule). HHS, along with other Common Rule departments and agencies, published the Final Rule in the Federal Register on January 19, 2017 and subsequently amended the Final Rule to delay the general compliance date until January 21, 2019. (View NIH Announcement)

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.