Chesapeake Research Review, Inc. IRB Services
Effective April 1, 2013, SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies must use the IRB services provided by our associate, Chesapeake Research Review Inc. (CRRI). All other studies (e.g.investigator-initiated, etc.) must be reviewed by the local SBU IRB's (CORIHS).
There are two exceptions to this requirement. If one of the following criteria are met, review will need to be conducted by our local IRB's (CORIHS):
- when the study in question is part of the SUNY-REACH initiative, or
- when the industry sponsor will not accept direct invoicing from CRRI and/or allow direct payments to CRRI.
Directions for use of CRRI are as follows:
The Center for IRB Intelligence (CIRBI) is Chesapeake IRB's web-based electronic platform, which supports the entire IRB process, from initial submission and review to study close-out.
All users must register prior to accessing the CIRBI system. To register, go to www.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 at a later date.
First-time CIRBI users are highly encouraged to contact our CRRI Project Coordinator, Rick Cruise, for assistance. Rick can be reached at 443-283-1624 or via firstname.lastname@example.org. Additional CRRI contact information can be found below.
NOTE #1: At the time of your initial protocol submission to CRRI, please include the Sponsor's template Informed Consent Form. CRRI will then convert the Sponsor's Consent Document into the CRRI/SBU approved ICF.
NOTE #2: In assessing CRRI deadlines and meeting dates (available on CRRI's website at www.chesapeakeirb.com, the investigator must factor in two working days for ORC review/processing. ORC does not assume responsibility for making a particular CRRI review deadline.
2. Satisfy SBU application requirements for CRRI studies (using IRBNet)
If you are not already registered and/or if you have not yet created a study on IRBNet, please follow the directions available on our website.
Create a study, complete initial fields, and when it's time to download, complete, and upload documents back into your study designer, do so with the following documents from the forms and documents library of IRBNet:
Registration Form for Expedited or Full CORIHS Review: This is a short ‘smart’ or ‘wizard’ form that quickly captures critical, searchable data pertaining to your study. To access this document:
- Go to your project’s Designer
- Select ‘Add New Document’
- In the lower shaded ‘On-Line Document’ box, select ‘Registration Form for Expedited or Full Committee Review’, then hit the ‘Add’ button
- Begin completing the Registration Form. You do not need to complete the whole form in one sitting; you can ‘save and exit’, and then go back and update the document by clicking the pencil icon next to the document listed in the designer.
- When you are done completing the registration form, click “Preview” to see what the completed form looks like, and confirm that all the information provided is accurate. Once you are satisfied in this regard, Click "Save and Exit", and then continue constructing your project package to completion:
- SBU IRB/Institutional Fee Invoice Authorization Form
- SBU Scientific Merit Review Form: The application materials must be endorsed as scientifically meritorious by either the department chair or departmental review committee of all departments impacted by the proposed activity.
- SBU University Hospital Form: This form is necessary to assess impact of the proposed activity on UH patients, services and facilities.
- The Study Protocol
Make sure you share, and obtain e-signatures from all appropriate parties, as detailed in sections V and VI of the IRBNet link above.
3. Contact the Office of Research Compliance
Send an e-mail to Judy.Matuk@Stonybrook.edu with the subject heading: CRRI study submitted on CIRBI [Insert PI name here]
4. What are SBU Responsibilities re: CRRI-Reviewed Protocols
- SBU Responsibilities Prior to Protocol Submission to CRRI
When the e-mail referenced in Step 3 is received:
- Eligibility to use CRRI, and proper fee authorization will be certified,
- Departmental chair/committee scientific merit assessment will be confirmed
- Institutional processes for financial disclosure/ COI management requirements, budget review and contract negotiation will be confirmed as initiated, in process or completed with notification to appropriate University officials for tracking and compliance purposes.
Once 1, 2 and 3 are reviewed and determined to be satisfied, CRRI will be notified to commence review of the submitted protocol. Concurrent with this notification may be reminders of special considerations for local context that should be considered during IRB review.
- SBU Responsibilities Concurrent with Protocol Review by CRRI
Concurrent with CRRI IRB review will be ORC's review of local compliance and administrative local requirements. Often, CRRI, SBU and the sponsor will need to negotiate together to confirm compliance with federal regulations and SBU best practices.
SBU University Policy P209, including the investigator disclosure form process, and following thresholds for determining significant financial interest in a pharmaceutical company are applicable to investigators submitting to CRRI for IRB review. Where there is human subject involvement in a sponsored activity, recommendations of the SBU COI Committee will be forwarded to ORC, who will retain responsibility for forwarding the management plan (as applicable) to CRRI.
- SBU Responsibilities: Post CRRI IRB Approval
SBU's ORC retains on-site monitoring responsibility for all studies, reviewed locally or by CRRI. Reports of site monitoring activities which have any finding that potentially impact human subject protections will be shared with CRRI.
Similarly, the ORC will be provided with any reports of CRRI's on-site monitoring activities.
5. Report Unanticipated Problems to both, SBU Office of Research Compliance and CRRI
Investigators approved through CRRI's IRB must still report Unanticipated Problems to the SBU Office of Research Compliance, in addition to CRRI reporting requirements
The form is available in the IRBNet project designer of your study.