Submission Guidelines

Complete Your Advarra Application at the Advarra CIRBI™ Website once the myResearch IRB submission has been reviewed and released per the local submission guidelines for studies reviewed by an external IRB.

The email notification from the Office of Research Compliance confirming institutional
sign off for Advarra to complete the protocol review for SBU must be included in the
initial submission to Advarra.

The Center for IRB Intelligence (CIRBI)  is Advarra's web-based electronic platform, which supports the entire IRB process, from initial submission and review to study closeout.

• All users must register prior to accessing the CIRBI system. To register, go to cirbi.net and click on "Sign Up". A temporary password will be sent to the e-mail account specified at the time of registration. Users are required to change their password when logging into CIRBI for the first time.
• All study-related contacts must also be registered in the CIRBI system prior to completion of an online protocol application. Therefore, it is recommended that any individual who intends to use CIRBI immediately register in order to facilitate future research submissions.
• To submit a research proposal follow the directions/prompts found within CIRBI and the Smart Form: CIRBI uses Smart Form technology, which directs users to complete only those sections of the application that are directly applicable to the research study. Users will be prompted to upload all required study documents into the Smart Form. The Smart Form may be completed in one session or multiple sessions by saving the form and accessing it later.
• First-time CIRBI users are encouraged to contact the Advarra Customer Service Team via email to intitutions@advarra.com with any questions or concerns.

NOTE #1: At the time of your initial protocol submission to Advarra, please include the Sponsor's template Informed Consent Form with the Office of Sponsored Programs approved injury language included in track changes. Advarra will then convert the Sponsor's Consent Document into the Advarra/SBU approved ICF by incorporating additional mandatory language on your behalf.

NOTE #2: If Advarra is a central IRB (cIRB) for an established study, SBU may join the study with an investigator application. Please ensure Lu-Ann Kozlowski, Lu-Ann.Kozlowski@stonybrook.edu is listed as institutional contact to ensure communication with the local ORC office.  

Stony Brook University has executed a Master Service Agreement that allows SBU IRB to rely on WIRB - Copernicus Group (WCG) for IRB review. Stony Brook Investigators may utilize WCG for industry initiated/sponsored studies, SITE review for protocols when WCG is acting as a Central IRB for a sponsor initiated/funded clinical trial, or when WCG is acting as the mandated sIRB for federally funded research.

Note:

• The research activity must be submitted in myResearch for local review and acknowledgment before submission to WCG. The Reliance Administrator will copy the PI and Primary Contact when the study is released to WCG via an email to the Account Manager, Jon Gellert.
• The study team must update the informed consent document with injury language approved by the Office of Sponsored Programs (OSP) and required local context language before submission to WCG.
• Sign into or create an account on Connexus to complete submissions to WCG and review the User Guide at https://connexus.wcgirb.com/resources for tutorials and demonstrations of selected tasks on the Connexus submission platform.

Initial Review Instructions - Submitting to Western IRB (WIRB)

• Find out if WIRB has already reviewed the research.
  • Ask the sponsor, WIRB Client Services, or WIRB Account Manager Jon Gellert. They will send you the WIRB approved Sponsor Template ICF, and add you to the Connexus Study Workspace by request.
• If WIRB has already reviewed the research:
  • Select this option on the Initial Review Submission Form:

• Since WIRB already has the research on file, you only need to submit site specific documents:
  • Initial Review Submission Form
  • PI’s CV & Medical License (only for their first submission)
  • ICF
  • Any Site-Specific Subject Facing Materials (Ads, Diaries, etc.)

• If WIRB has NOT reviewed the research:
  • Select this option on the Initial Review Submission Form:

• Since WIRB hasn’t reviewed the research, you will also need to submit:
  • Protocol/Grant (final/clean copy)
  • IB/Package Insert/Instructions for Use Manual (if applicable)
  • Any Subject Facing Materials (Ads, Diaries, etc.)

• Submit via Connexus

Stony Brook University participates in the National Cancer Institute’s Central IRB Adult and Pediatrics Initiative. All participation in research activity reviewed under NCI-CIRB must first be approved by the Cancer Center Protocol Review Committee (PRMC). Once approval by the PRMC committee has been granted, complete the NCI-CIRB investigator worksheet on the NCI-CIRB Website.

Stony Brook University Informed Consent and HIPAA Authorization Policy for studies under NCI-CIRB Oversight

Overview

This Quickguide outlines the process of how a study is reviewed, including central review of the study and local context review.

 

When NCI-CIRB has approved the research and local site investigator, submit the study in myResearch for local administrative review. The submission package must include all the required documentation outlined in the submission guidelines in addition to:

• Main protocol approval letter with expiration date and IRB determinations.
• Local Investigator Approval Letter
• Master template, track changed and clean final copies of the Informed Consent Form.
  • NCI-CIRB has specific guidelines for any word alterations/substitutions to the informed consent document. Please review the permitted boilerplate language
• Final HIPAA Authorization Form 

NOTE:

• The translation of the informed consent form is the responsibility of the local institution.

From www.ncicirb.org:
“…Revisions/changes to the local consent form other than those described above require full board review at the local level, facilitated review may not be used, and the CIRB cannot serve as the IRB of record for the protocol at the local site."

 From www.ncicirb.org: “…the local IRB may add stipulations or local requirements to protocols, particularly to increase subjects' safety, to clarify procedures, etc., but may not delete or contradict any protocol contents…”

Certain research supported by the Federal Government mandates a single IRB for review of multi-site and collaborative research activities.  This guidance may be used to identify when a sIRB is required.

Single Institutional Review Board (sIRB)

Effective Date: January 25, 2018

sIRB is mandated by the NIH and the revised Common Rule for the following types of non-exempt research:  

The NIH Single IRB Policy for Multi-Site Research

Applies to: NIH funded studies in which two or more sites are using the same research protocol to conduct the same human subject research activities at each site. These will typically be clinical trials, but can include observational studies. 

Exceptions to the Requirement: International sites, or sites involving tribal nations.

Details:Single IRB Policy for Multi-site Research

The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards.  

The Common Rule’s Cooperative Research Provision

Effective Date: January 20, 2020

Applies to: Federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020.  That is, studies that involve more than one institution conducting research with human subjects (regardless of if each institution is not carrying out the same human subject research activities).

Reviewing IRB: will be identified by the Federal department or agency supporting or conducting the research OR proposed by the lead institution (subject to the acceptance of the Federal department or agency supporting the research).

Exceptions to the Requirement: International sites, sites involving tribal nations, or studies that received initial IRB approval prior to January 20, 2020.

Details: The Revised Common Rule’s Cooperative Research Provision

Single IRB Help

• Stony Brook requires completion of a request in order to determine whether or not a study qualifies for Single IRB review and agree to be the sIRB or rely on the chosen IRB of Record.
• Currently SBU IRB will only cede review or serve as the single IRB for federally funded research studies in order to comply with the Single IRB mandate.

Guidance to Determine if a Study Qualifies for a sIRB and Process to Request SBU rely on an External IRB. (Click here for external sIRB flow chart)

Steps to Request SBU IRB as the sIRB (Click here to find SBU sIRB Flow Chart).

Investigators should contact the Reliance Administrator in the Office of Research Compliance, lu-ann.kozlowski@stonybrook.edu,  early in the multi-site grant/contract process to discuss possible sIRB options.