Submissions

IRB Manager

IRB Manager Website Text FAQs

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

Initial Submissions (Post January 21, 2019)

Initial Submission Form
Request for Determination of Exempt Status
Request for Human Subjects Research Determination
Supplement Form C - Research Involving Children as Subjects
Supplement Form J - Research Involving Prisoners as Subjects
Supplement Form P - Research Involving Pregnant Women
Supplement Form I - Research Involving Subjects with Impaired Decision Making Capacity
Supplement Form W - Request for Waiver Alteration and or Documentation of Consent
Supplement Form H - Request for Waiver or Alteration of HIPAA
Supplement Form D - Research Involving Drugs or Biologics
Supplement Form M - Research Involving Medical Devices
Supplement Form F - Storing Data or Specimens for Future Research
Supplement Form S - Collaborative Research
Initial, Expedited and FullBoard Checklist
Initial Exemption Submission Checklist
Radiology Study Protocol Form

Consent Documents

Consent Authorization Template Common Rule
Assent Template
ICF Standard Statements

Continuing Review for studies approved before January 20, 2019

Continuing Review Request Form

Completion for both studies approved before January 20, 2019 and after January 21, 2019

Closure Request Form

Informed consent posting guidance link

Amendments & Modifications for both studies approved before January 20, 2019 and after January 21, 2019

Modification Request Form

Conflict of Interest Form

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)