Submissions
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 (Opens in a new window) (Opens in a new window)
Sign in ink and submit either via email:
sabramov@brany.com or fax: 516.706.5066
Click here (Opens in a new window) (Opens in a new window) 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 - generally used for minor subjects ages 7-12 years old.
- 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
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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 (Opens in a new window) (Opens in a new window) to access NJH IRBManager
Resources:
- NJH Ancillary Review Contact List
- NJH Human Subject Research Registration Checklist
- NJH Initial Exemption Submission Checklist
- NJH Engagement Determination 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
- Request for Waiver or Alteration of HIPAA Authorization Form
- NJH Adverse Event Tracking Log
- NJH Deviations Log
- 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