Submissions Download HRPP SOPs Clinical Trials Find a Researcher BRANY IRBManager All Expedited and Full Board Initial Submissions should be submitted in BRANY IRBManager using BRANY IRB forms as well as: Continuing Reviews Modifications Interim Reports Closures In order to access BRANY IRBManager, Principal Investigators (PIs) and Study Personnel who need access to IRBManager must complete the “BRANY User Access Form” available here: https://www.brany.com/forms-and-downloads Sign in ink and submit either via email: sabramov@brany.com or fax: 516.706.5066 Click here to access BRANY IRBManager. Resources: Informed Consent Templates Merged BRANY-NJH Informed Consent/HIPAA Authorization Template - to be used for adult subjects with or without the capacity to consent (LAR signature provided), and parent permission for minor subject participation. NJH Standard Consent Statements - with content to assist you in drafting your consent documents Minor Assent Form - to be used for minor subjects ages 12-17 years old. Note that for younger subjects, ages 7-12, documentation of assent should be via a note in the subject’s research record regarding the assent process and child’s decision. Guidance for Submitting NEW Research to BRANY Guidance for Submitting CURRENT Research to BRANY BRANY Submission Checklist FDA NIH Protocol Template NJH Non-Clinical Protocol Template If you would like to speak with someone about any of the information addressed above, please contact the following individuals: Questions relating to BRANY IRB submissions: Raffaella Hart Office: 516.470.6909 Email: rhart@brany.com Kerri Friel Office: 516.622.2040 Email: kfriel1@brany.com NJH IRBManager Please continue to use NJH IRBManager for Exempt and Human Subjects Research Determination (HSR) submissions. These will be reviewed and approved by NJH HRPP. In addition, ALL non-exempt human subject research must be registered in NJH IRB Manager prior to submitting to an IRB for review. Click here to access NJH IRBManager Resources: NJH Ancillary Review Contact List NJH Human Subject Research Registration Checklist Initial Exemption Submission Checklist NJH Human Research Financial Interest Form NJH Exempt Research Information Sheet Template NJH Required Consent Language NJH Pharmacy Drug or Biologics Service Request Form NJH Pharmacy Exception Request Form Supplement Form H Request for Waiver or Alteration of HIPAA final NJH IRBManager: Intro Log In Dashboard - July 2019 IRBManager Tips for Use - August 2019 IRB Manager FAQs - October 2019 Questions relating to NJH Exempt and HSR submissions: Jenna Wall, PhD, CCRP HRPP Administrator Email: WALLJ@NJHealth.org Phone: 303-398-1670