What's New

FDA Final Guidance for Industry

The FDA has issued final guidance concerning Investigators’ Responsibilities for Protecting the Rights, Safety and Welfare of Study Subjects. Clinical investigators are advised to be especially careful when delegating clinical trial responsibilities.

View schedule of upcoming educational sessions on this topic.

Surrogate Consent Process

Guidelines and corresponding forms are now available on our forms page for investigators wishing to use a surrogate consent process for research studies.

Note that prior IRB approval is necessary before utilizing a surrogate.  If you have questions about the requirements or need help with the understanding the process, please call either your campus IRB office or the HSPP office for assistance.

Western Institutional Review Board (WIRB)

Effective February 1, 2009, in addition to the WIRB fee there will be a one-time Human Subjects Protection Program administrative submission service fee of $750 for initial applications.  Sponsors will be billed separately by HSPP.  UMDNJ researchers submitting WIRB initial review application of human subjects research will indicate the contact information for billing the HSPP service fee in the “Billing Information” section of the revised UMDNJ Application for Review by WIRB.