Human Subjects Protection Progam

Our Role

The HSPP operates in accord with the Federal Wide Assurance (FWA). The FWA is a binding written agreement with the OHRP which states that HackensackUMC is guided by the ethical principles of the Belmont Report and will comply with Federal Regulations 45 Code of Federal Regulation Part 46, (45CFR 46), for all federally funded human subjects research. View the HackensackUMC FWA here

  • Provides oversight and regulation protection for all human subject research projects at HackensackUMC.
  • Assures compliance with the Federal Wide Assurance, a mandate assuring compliance with Health & Human Services regulations pertaining to the protection of human subjects.
  • Assures HackensackUMC policies and procedures are effectively applied in accordance with New Jersey State and U.S. Government Federal laws and regulations, including: the FWA, OHRP, FDA, NIH, OCR and any other applicable Federal Agency.
  • Interprets and applies Federal regulations to all human subjects’ research.
  • Develops, implements, and interprets HackensackUMC HSPP policies and procedures.
  • Supports and facilitates the HackensackUMC IRB, Data Safety Monitoring Board, Conflicts of Interest in Research, and Institutional Biosafety Committees.
  • Supports and facilitates the transfer of studies to and from Western IRB (WIRB) and the NCI Central IRB (CIRB).
  • Provides ongoing educational training programs and activities for investigators, key study personnel, HIRB Committee members and HackensackUMC staff.
  • Verifies and maintains mandatory research investigators training records (CITI Program).
  • Collects confidential yearly financial disclosure statements from research staff members.
  • Mentors and trains new institutional staff as needed, including HSPP staff, Investigators, and key study personnel on human subject protection updates and the HIRB process.
  • Provides eIRB and research application support to staff, as needed.

For more information on the roles and responsibilities of the HSPP, please contact us at: 551-996-2255 or email us at: eirb@humed.com.

 


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