Office of Research Administration

Institutional Review Board (IRB)

Electronic Submissions and Management of Downstate IRB Activities:

The Downstate Medical Center IRB uses 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:

Note: Each user agrees to comply with the Individual User Terms of Use policy which may be found at https://www.irbnet.org/release/public/terms.jsp

Step 1: Create an IRBNet user account 

  • Go to www.irbnet.org and click the “New User Registration” link. Follow the online instructions. Complete all items with red asterisk (*).When asked to identify your “organization” type SUNY in the text box and then select “SUNY Downstate Medical Center, Brooklyn, NY”.
  • Remember to click on the “Register” button in order to finalize your “New User Registration.”
  • Press the “Continue” button on the “Registration is Complete” page and follow “Step 2” to activate your IRBNet user account.

Step 2: Activate your IRBNet user account 

  • After successful completion of “Step 1,” the User will receive an activation e-mail to the registered e-mail address. 
  • Sign-in to the email account that you entered into the system and click on the link within that e-mail to activate your IRBNet account. 
  • You may begin using IRBNet as soon as activation is complete.

If you forget your password, navigate to https://www.irbnet.org/release/public/login/hint.jsp and follow the instructions on the website.

 

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 :

REQUIRED FORM:

Determination Letter

(indicates IRB review is NOT required)

“IRB Decision Aid -Application for a Determination Letter to State IRB Approval is NOT Required"

 

Exempt Review

 

“Application for Exempt Review”

Note:  The exemption categories are described on the form.

 

Expedited Review

 

“Application for Expedited or Full Review”

Note: The criteria for expedited review can be viewed on the OHRP website, by clicking here.

 

Convened (Full) IRB Review

 

“Application for Expedited or Full Review”

 

Use of a Humanitarian Use Device (HUD) for clinical purposes

 

“Application for HUD for Clinical Purposes”

 

External IRB Review

(some multi-site research)

 

“Application for External IRB Oversight”

Note: To share additional guidance with the External IRB, please see the Guidance: Local Research Context for External IRB.

Expanded Access to Investigational Drug/Biologic For Treatment Use

(Including external IRB review of multi-site activity)

"Application for IRB Approval of Expanded Access to Investigational Drug/Biologic for Treatment Use"

 

The following materials must be submitted, when applicable for the research activity:

Protocol Templates:

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:

  • IRBNet Registration Form. 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).
  • Training and Conflict of Interest Disclosures must be complete.  For more information click on "Training and Conflicts of Interest."
  • Grant Application. NIH and Pre-Awards requires the IRB complete a congruency review and indicate this in the final IRB approval letter.  Be sure to include a PDF copy of your grant application.
  •  HIPAA Waiver(s) NOTE:  If PHI is involved, the IRB will accept the HIPAA waiver form to document a request a waiver of informed consent

  •  Questionnaires or Surveys.
  •  Data Collection Tools (or list of data to be collected).
  •  Investigator Brochure for study involving an IND for an investigational drug or biological agent.
  •  FDA Form 1572 for study involving an IND for an investigational drug or biological agent.
  •  IND letter for study involving an IND for an investigational drug or biological agent.
  •  Device Package Insert for IDE study.
  •  CV or Biosketch of PI (optional).  This is generally not needed unless the PI is new; however, the IRB may request this to evaluate the PI’s qualifications, as required by the FDA and OHRP regulations.
  •  Credentials of PI or other study staff (optional). 
  •  Sponsor contract (optional).  Generally not needed, unless the IRB needs to review language in the informed consent regarding injuries or additional costs.
  •  Letter of support from the external site (except KCHC) when not covered by an IRB Reliance Agreement or External IRB approval.
  •  Delegation of e-signature

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. Any research related to Cancer must be submitted to the SUNY Downstate Cancer Program/Instute for review. 

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:

Ancillary review by UHB Pathology is required when the the research involves any of the following:

  • Services or assistance of the UHB Pathology Laboratories (Clinical Laboratory, Histology Lab and/or Surgical Pathology).
  • Prospective collection of fresh specimens that require processing by UHB Pathology Laboratories, including tissue, blood and fluids (see UHB Exempt Tissue Policy:  “LAB3 Human Tissue Fluid and Foreign Matter Exempt From Submission for Pathology Examination”, which may be viewed or downloaded at: http://www.downstate.edu/pnp/lab/policies.html )   

 

If uncertain about the need for Pathology Review, please email Susan Gottesman & Caitlin Otto for a determination.  If they state Pathology Ancillary review is not required, attach the e-mail determination to the IRB submission.

 

Step 1:

  • Refer to the UHB Pathology Instructions, Forms, and Fees posted on the UHB Pathology Website.
  • Complete and submit “Step 1 Form: Preparation for Use of UHB Laboratory/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs Feasibility Determination” to Pathology.

 

Step 2: 

  • Complete and submit the IRB application after the UHB Pathology Laboratories approves the feasibility of using their services to obtain IRB approval. 
  • When submitting the IRB application in IRBNet, please share the IRBNet submission with the pathology representative so that (s)he may e-sign the submission.  E-signature is required before the IRB can grant final approval.

 

Step 3:  After IRB and Biosafety (if needed) approvals are granted, complete and submit the “Step 3 Form: Protocol of UHB Laboratory Use/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs.   Your pathology approval number will be then assigned.

Caution:  If any changes are required after final IRB approval, an amendment must be submitted to the IRB.

 

Institutional Biosafety Committee (IBC) Approval:

Ancillary review by the IBC is required when the the research involves any of the following:

  • All research involving the use of Recombinant or Synthetic Nucleic Acid Molecules, infectious agents, human cells or body fluids, or hazardous substances must be reviewed and approved by the Institutional Biosafety Committee (IBC) to ensure that all applicable biosafety standards are met.  Early submission of the protocol to the committee is advisable to allow time for any necessary clarification, revision and reconsideration, and approval.  The IBC will determine if the study requires approval from the NIH Recombinant DNA Advisory Committee.  For more information, please visit the IBC website or contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912 or IBC@downstate.edu.
  • Protocols involving work with human-derived biological materials that are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory are exempt from IBC review. However, any work on human-derived biological materials (including packaging and shipping) in Research laboratories at DMC is subject to IBC review.
  • If your study requires Institutional Biosafety Committee approval or NIH Recombinant DNA Advisory Committee approval, your study cannot be approved by the IRB until you have received the applicable approvals.

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.

 

Research Pharmacy:

All studies involving a drug or biologic must be approved by the Research Pharmacy. 

  • Please share this IRB Submission with the Research Pharmacist or designee, so that (s)he may review the application and electronically sign the submission.
  • For questions regarding Research Pharmacy review, contact Motria Mishko at (718) 270-4340 or motria.mishko@downstate.edu  If she is not available, please consult with LilyAnn Jeu, PharmD, BCPS, CPHQ at ljeu@downstate.edu or (718) 270-4065.

Department Chair(s) or Dean(s):

All studies must have the Department Chair or Dean approval.

  • If the research impacts multiple Departments or Colleges, each area where the research takes place needs to approve the study.
  • Please share the submission with the applicable Department Chair(s) or Dean(s) and request their electronic signatures in IRBNet.

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 alyssa.conigliaro@nychhc.org

  • Dionne Clarke, Facility Research Coordinator: (718) 245-5580 or clarked6@nychhc.org

          (Dionne is the best person to contact with questions about STAR)

External Sites:

When the Downstate IRB oversees human research carried out by employees from an external site (i.e., is not a legal entity of Downstate or NYC+Hospitals, Kings County) the external site must do one of the following:

  • If the study is federally funded or supported, either of the following must occur:
    • The external employees can seek IRB approval from their institution for their specific activities, or
    • The external institution may establish an IRB Reliance Agreement with the Downstate IRB.   
  • If the study is NOT federally funded NOR federally supported any of the following options apply:
    • The external employees may seek IRB approval from their institution.  Note: The external employees should consult with their institution’s policy.
    • The external institution may rely on the DMC IRB; however, either the external site or the DMC IRB may require the establishment of an IRB Reliance (Authorization) Agreement with the DMC IRB. 

 

The following application forms are to be used for submitting applicable information to the IRB after the IRB has granted initial approval: