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)
Sign in ink and submit either via email:
sabramov@brany.com or fax: 516.706.5066
Click here (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
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) 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