The Downstate Medical Center IRB uses an electronic IRB submission and reporting system (IRBNet) for the electronic submissions and management of human research activities and required reporting. Please refer to the guidance for the IRBNet (IRB Application and Reporting System) for more details on how to use the system. Application forms and template materials are provided below. Guidance and policy can be viewed by clicking on tab within the IRB Menu for Policies & Guidance. Information on required training and conflict of interest disclosures can be viewed by clicking on the tab within the IRB Menu for Training & Conflict of Interest.
Anyone associated with Downstate may create an IRBNet user name and password by following the instructions below:
Step 1: Create an IRBNet user account
Step 2: Activate your IRBNet user account
Note: With the exception of the "IRB Decision Aid", an IRBNet Registration Form is required for each new submission. This is created within IRBNet. If you are not sure how to create the IRBNet Registration, please review the guidance for the IRBNet (IRB Application and Reporting System).
Helpful Tip: Please be sure that all required training and conflict of interest disclosures are submitted in a timely fashion. For more information click on "Training and Conflicts of Interest."
There are 6 types of "Initial IRB Reviews." Use the applicable form in the table below to submit your application to the IRB:
TYPE OF REVIEW :
(indicates IRB review is NOT required)
Note: The exemption categories are described on the form.
Note: The criteria for expedited review can be viewed on the OHRP website, by clicking here.
Convened (Full) IRB Review
Use of a Humanitarian Use Device (HUD) for clinical purposes
External IRB Review
(some multi-site research)
Note: To share additional guidance with the External IRB, please see the Guidance: Local Research Context for External IRB.
The following materials must be submitted, when applicable for the research activity:
If a sponsor's protocol is not available, investigators are strongly encouraged to use one of the templates below to minimize the number of iterative changes required by the IRB.
Note: An e-tool is available on the NIH Clinical e-Protocol Writing Tool website.
Informed Consent, Information Sheet, Assent, and Short Form Templates
Translation Certificates for Short Form Templates
Note: These do not need to be submitted to the IRB, but are here to be saved to the research record or to be shared with a sponsor.
The following additional materials are required, when applicable to the study
HIPAA Waiver(s) NOTE: If PHI is involved, the IRB will accept the HIPAA waiver form to document a request to waive informed consent
Waiver of Informed Consent Requirements. Required when waiving documentation (e.g., signature) of informed consent or the entire process of informed consent.
Scientific Review Committee:
The SUNY Downstate IRB requires scientific or scholarly review of a protocol to evaluate the quality of the proposed research activity prior to submission of all materials to the IRB. Scientific Review Committee (SRC) Members from SUNY Downstate or KCHC or the SUNY Downstate Cancer Program/Institute are scientific experts charged by their Department Chair to critically scrutinize and critique the protocol to ensure they are based on sound science.
The Scientific Review Committee (SRC) Form is completed by an SRC reviewer for Exempt, Expedited, and Full Board reviews.
Note: SRC review is not required for Determination Letters or External IRB Review.
Ancillary Review Requirements:
Ancillary reviews by various departments may be required, depending on the nature of the study. To determine if a study requires ancillary review, please see details below or consult the instructions on the IRB application. At the discretion of the IRB, the IRB may consult with others or require ancillary review of a research application at any time. Ancillary reviewers may request modifications of the research; however, any such modification must also be approved by the IRB.
A conditional approval letter may be issued by the IRB, when a specific type of required ancillary review is pending prior to the final approval of the research; however, a final approval letter cannot be issued until all applicable required ancillary reviews are complete.
UHB Pathology Laboratories Services (Clinical Laboratory & Histology):
If the study involves Clinical or Anatomic Pathology services, please complete the following steps to determine the feasibility for using this service:
- Refer to the "UHB Pathology Instructions" and "Fee Schedule" for guidance.
- Complete and submit the “Step 1 Form" to Pathology.
- When submitting the IRB application in IRBNet, please share the IRBNet submission with the laboratory designee so that (s)he may e-sign the submission.
- Pathology E-signature is required before the IRB can grant final approval.
- After IRB approval is granted, complete and submit the “Step 3 Form" to Pathology.
Caution: If any changes to the IRB materials are require after final IRB approval, an amendment must be submitted to the IRB.
Institutional Biosafety Committee (IBC) Approval:
When IBC approval is required, the review process may take place in parallel. Conditional IRB approval may be granted before the IBC is complete; however, a copy of the IBC approval letter must be provided to the IRB in order to grant final IRB approval.
All studies involving a drug or biologic must be approved by the Research Pharmacy.
Department Chair(s) or Dean(s):
NYC Health + Hospitals, Kings County Requirements:
All research conducted at NYC H+H, Kings County must also be in compliance with H+H policy and approved in System to Track and Approve Research (STAR). IRB Approval is required before information can be entered in STAR. For more information refer to the NYC H+H, Kings County policies on the IRB policy tab.
For any questions about NYC H+H, Kings County policy, please contact:
Rich Sinert, DO, Professor of Emergency Medicine; Chair, Facility Research Review Committee, NYC Health + Hospitals/Kings County (718) 245-2973 or Richard.Sinert@nychhc.org
Bryce Petty, Facility Research Coordinator: (718) 245-2973 or Bryce.Petty@nychhc.org
Alyssa Conigliaro, Facility Research Coordinator (718) 245-5601 or email@example.com
(Dionne is the best person to contact with questions about STAR)
The following application forms are to be used for submitting applicable information to the IRB after the IRB has granted initial approval: