Office of Research Administration

Institutional Review Board (IRB)

Electronic Submissions

Electronic Submissions and Management of Downstate IRB Activities:

The Downstate Medical Center IRB uses an electronic IRB submission and reporting system (IRBNet) for the electronic submissions and management of its IRB activities.   Please refer to IRB guidance on electronic IRB submissions and reporting system for more details on how to use the system.  All guidance, policy, forms, and templates are located within the IRBNet "Forms and Templates" Library.  Anyone can obtain a User Name and Password for access to IRBNet by following the instructions below:

To create an IRBNet user name and password, do the following:

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.

 

Note: An IRBNet Registration Form is required for each new submission.  This is created within IRBNet.

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 :

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”

 

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

Protocol Templates

 

 

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

  • Grant Application or Grant Cover sheet Required for all federally funded/supported studies. Include the NIH application section “Key Personnel” and “Human Subjects section and Research Methodology” for federally (e.g., HHS, NIH, NCI etc.) funded studies.
  •  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.

  •  HIPAA Preparatory to Research Certification Form
  • Subject Recruitment Authorization Form - Internal
  • Subject Recruitment Authorization Form - External
  •  Recruitment Materials (including, but not limited to flyers, brochures, ads, e-mails, telephone script, etc).
  •  Questionnaires/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.

 

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:

Step 1:

  • Refer to the UHB Pathology Instructions, Forms, and Fees posted in IRBNet. Contact UHB Pathology Laboratory Administration (x1689) to be directed to the proper laboratory director/supervisor. 
  • Complete and submit the following form to Pathology:  “Step 1 Form: Preparation for Use of UHB Laboratory/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs Feasibility Determination.”

 

Step 2: 

  • Complete and submit this 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 laboratory designee so that (s)he may e-sign the submission.  E-signature is required before the IRB can grant final approval.

 

Step 3:  After IRB approval is granted, complete and submit the “Step 3 Form: Protocol of UHB Laboratory Use/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs.

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:

  • 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 Alan Hui, PharmD, BCPS at (718) 270-4238.

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 need to approve the study.
  • Please share the submission with the applicable Department Chair(s) or Dean(s) and request their electronic signatures in IRBNet.

 

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