Submissions Download HRPP SOPs Clinical Trials Find a Researcher IRBManager Click below to access IRB Manager. What is IRBManager? IRBManager is the product selected to be used for the entire lifecycle of human subjects research, from the development and submission of protocol applications by researchers to the review of the applications by the NJH HRPP/IRB through approval, amendment, renewal, and eventual closure. IRBManager, despite its name, allows for the full suite of compliance processes to be handled in one system. After the rollout for NJH IRB is complete, implementation for the NJH IBC and NJH IACUC processes will begin. When did the use of IRBManager start? All NJH IRB Submissions after 01 September 2019 MUST be submitted through the IRBManager system. Please contact NJH HRPP/IRB office for more information on access and training. I have questions that are not answered here. Whom shall I contact? Questions about using the IRBManager System or about the IRB Protocol approval process should be directed to the NJH HRPP/IRB staff. Manuals: Intro Log In Dashboard - July 2019 How To - New Protocol Submission - July 2019 How To - Revise Submission - July 2019 How To - Request for Change or Renewal - July 2019 IRBManager Tips for Use - August 2019 IRB Manager FAQs - October 2019 Initial Submissions (Post January 21, 2019) IRB fees are required for industry funded protocols, whether or not they are industry-initiated. Please contact the NJH HRPP/IRB Office for guidance on IRB fees. Archived forms available upon request. Initial, Expedited and FullBoard Checklist Initial Exemption Submission Checklist Radiology Study Protocol Form Biobank Application Protocol Templates FDA NIH Protocol Template NH Non-Clinical Protocol Template Consent Documents Consent Authorization Template Common Rule Assent Template ICF Standard Statements Continuing Review for studies approved before January 20, 2019 Archived forms available upon request. Completion for both studies approved before January 20, 2019 and after January 21, 2019 Archived forms available upon request. Amendments & Modifications for both studies approved before January 20, 2019 and after January 21, 2019 Archived forms available upon request. Conflict of Interest Form Supplement Form H Request for Waiver or Alteration of HIPAA final Guidance for Modification Request Form Download Boilerplate Supplemental Access to NJH Repositories (updated 20 Nov 2018) Download Boilerplate HIP 020 Partial Waiver of HIPPA Authorization (updated 20 March 2019) HIP 020 Partial waiver of HIPPA Authorization (updated 25 April 2019) Supplemental Access to NJH Repositories (updated 25 April 2019)