Human Subjects Protection Program (HSPP)

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ANNOUNCEMENTS

WIRB Commerical IRB Presentation July 31, 2018
A WIRB representative will be on-site Tuesday, July 31st to discuss clinical trials that are sent to WIRB for review. He will cover the types of studies that Rutgers University usually sends to WIRB, the submission process, and he will provide an overview of their online submission system, Connexus. (View Announcement)
Revised Human Subject Regulations: Delayed
On June 18, 2018: HHS and 16 Other Federal Departments and Agencies Issue a Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period. The Final Rule delays the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019. (View HHS Announcement)
On April 20 2018, HHS Issued an NPRM to Delay the Revised Common Rule: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period: (View HHS Announcement)
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)

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)
NIH's Single IRB Policy for Multi-site Research
For NIH grant applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects. (Read More @ NIH.gov)
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. (View NIH's Notice) (View 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.