Office of Research Administration

Institutional Review Board (IRB)

IMPORTANT ANNOUNCEMENT:

Please review this important IRB Update (click link for most recent update made on 12.28.2018) to keep informed of the transition to new forms, templates, guidance, and Policy IRB-01 to be in compliance with the revised Common Rule and IRB Policy, effective for new submissions that are approved by the IRB on or after January 21, 2019.

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 e-mail 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 web site.

 

There are several types of initial IRB reviews.  Use the applicable form in the table below to submit your application to the IRB:

 

TYPE OF REVIEW: LINK TO FORMS:

Determination Letter (indicates IRB review is NOT required). There are two (2) versions of the IRB Decision Aid. Use the version that applies to the project.

Note: Include all applicable attachments, including the Honest Broker Agreement (see below), when applicable.

A: This version is streamlined for the most common activities that do not require IRB approval.

Use form A for Health Care Operations Activities Only, when there is no intention of developing or creating generalizable knowledge, and the proposed activity is limited to one of the following:

  • Health care operations activity (e.g., performance improvement),
  • Case report or case series (up to three individuals)
  • Operational activity,
  • Pilot activity, feasibility activity, or evidence-based practice activity,
  • Training or educational activity, or
  • Not engaged in human research.

 

A: “IRB Decision Aid -Application for a Determination Letter to State IRB Approval is NOT Required - For Health Care Operation Activities Only"

(Posted 12.17.2018)

 

B: Use form B for any request.

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

(Posted 12.17.2018)

There are three (3) versions of the IRB Exempt application during the transition to the revised Common Rule.  NOTE:  The applicable exemption categories are described on each form.

A. CURRENT Application for Exempt Review (version date 3.14.2018; available until 1.21.2019)

  • Use for current research submissions.
  • On 1.21.2019, research on this form qualifies for the new exemption categories except exemption category #1.
  • For exemption under only category #1, it is best to use the NEW form (version 12.17.2018).
  • Note: The IRB will accept submissions (including DOJ/DIJ funded research) on the current form; however, additional information must be provided to qualify for approvals under category #1, effective 1.21.2019.

 

A. CURRENT: “Application for Exempt Review.”(version date 3.14.2018; available until 1.21.2019)

B. NEW Application for Exempt Review (version 12.17.2018)

  • This form has new expanded exemption categories under the revised Common Rule, effective 1.21.2019.
  • Use this version now only for exemption category #1 (including DOJ/DIJ funded research).
  • Use this version for all other exemptions research to be approved on or after 1.21.2019.

 

B.NEW: “Application for Exempt Review.” (version 12.17.2018)

C. DOJ/DIJ Application for Exempt Review - DOJ/DIJ Funded Research Only (version 12.21.2018)

  • Use this form now for DOJ funded research now.
  • DOJ has not a signatory to the revised Common Rule.

 

C. DOJ/DIJ: “Application for Exempt Review - DOJ/DIJ Funded Research Only.” (version 12.21.2018)

Expedited Review or Convened (Full) IRB Review

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

  • There is just one form for both types of review. 
  • The IRB will make the final determination as to the type of review performed.
  • Submit Full Board studies by designated deadline for the meeting.

“Application for Expedited or Full Review”

(Posted 12.17.2018)

 

External IRB Review

(some multi-site research)

“Application for External IRB Oversight”

(Posted 12.17.2018)

Note: Please share the following with the External IRB:

Guidance: Local Research Context for External IRB.

(Updated 12.21.2018)

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

(Including external IRB review of a multi-site activity)

“Application for HUD for Clinical Purposes”

(Posted 12.19.2018)

Expanded Access to Investigational Drug/Biologic For Treatment Use

(Including external IRB review of a multi-site activity)

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

(Posted 12.17.2018)

Honest Broker Agreement

(Include this form with an IRB Decision Aid or other IRB Application, as applicable to the project)

"Application for Independent Honest Broker Assurance Agreement"

(Posted 12.17.2018)

 

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.

        

 Informed consent templates and related materials:

  • Waiver of Informed Consent Requirements.  Required when waiving documentation (e.g., signature) of informed consent, the entire process of informed consent, or required elements of informed consent. (Updated 12.31.2018)

NEW Short Form Templates & Translation Certificates:(Posted 12.17.2018)

Note: Use the versions below for corresponding consent forms that used a Downstate consent form template dated on or after 12/17/2018 and for research initially approved by the IRB on or after January 21, 2019.

Note: Below are the translation certificates for the above short forms.  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.

NEW Certificates: (Posted 12.17.2018)

Short Form Templates & Translation Certificates:

Note: Use the versions below for corresponding consent forms that used a Downstate consent template from dated prior to 12/17/2018 and/or for research initially approved prior to January 21, 2019.

Note: Below are the translation certificates for the above short forms.  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.  Note: Refer to the "Training and Conflict of Interest Disclosure" guidance located on our Policy & Guidance web page.
  • 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.  This will no longer be required for IRB approvals on January 21, 2019.
  • HIPAA Preparatory to Research Certification Form

  • Data Use Agreement (DUA) - Establish a DUA for activities involving limited data sets.  Note: If SUNY DMC is the data holder and is disclosing a limited data set to an external recipient, our DUA template must be utilized.

    Downstate will only consider the review another facility's template if we are obtaining the data from them.

  • Business Use Agreement (BAA) -Establish a BAA when activities involving business associates.
  •  Recruitment Materials (including, but not limited to flyers, brochures, ads, e-mails, telephone or verbal script, web site materials, social media postings, etc). NOTE: Any Downstate representation on social media must be authorized by SUNY Downstate’s Office of Institutional Advancement after IRB approval is granted.  See: http://www.downstate.edu/policy/
  •  Questionnaires or Surveys.
  •  Data Collection Tools (or list of data to be collected).
  •  Clinical Investigations involving an IND: 
    • Investigator Brochure
    • FDA Form 1572
    • IND letter from FDA or sponsor
  • Clinical Investigations involving a medical device involving an IDE: 
    • Device Package Insert
    • IDE Letter or SR/NSR determination from the FDA or sponsor
  •  CV or Biosketch of PI.  Required for clinical trials that follow GCP.  Generally optional, unless the PI is new; however, the IRB may request CV to evaluate the PI’s qualifications, as required by the FDA and OHRP regulations.
  •  Credentials of PI or other study staff.  Generally not needed, unless the IRB needs to evaluate qualifications of research staff. 
  •  Sponsor contract (optional).  Generally not needed, unless the IRB needs to review language in the informed consent regarding injuries, additional costs, EU GDPR disclosures or to confirm additional data security requirements that follow EU GDPR.
  •  Delegation of e-signature
  •  Research Compliance Training Registration- COI Intake Form. NOTE: This is only required for independent investigators or external investigators who are considered "Investigators for the purposes of COI" when they are from a site that does not grant COI adjudication or have a COI policy.
  • SUNY Downstate IRB Reliance Agreement NOTE: This IRB Reliance Agreement is required when an external institution relies on the SUNY DMC IRB for review and oversight of federally funded or FDA regulated research.
  •  

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 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/Institute for review. For more information on the SRC, please click on the link below:

The Scientific Review Committee (SRC) Form is completed by an SRC reviewer, attached to the submission in IRBNet.  The SRC member must also e-sign the submission.  Please review form to determine when SRC review is required.(updated 01.16.2019)

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.  See Policy IRB-01 for more details. 

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 e-mail 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 web site.
  • 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:

  • Work on human-derived biological materials at Downstate which does not take place in a CLIA certified lab
  • Packaging and shipping of human-derived biological materials at Downstate
  • Hazardous substances
  • Infectious agents, or
  • Recombinant or synthetic nucleic acid molecules

For more information, please visit the IBC web site or contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912 or IBC@downstate.edu.

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 Motria is not available, please consult with Stanley Moy, PharmD, BCPS, BCIDP, at (718) 270-4121 or Stanley.Moy@downstate.edu

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

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

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

Other 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 follow the requirements of Policy IRB-01, including establishment of an IRB Reliance Agreement when applicable.  In addition, external employees should consult with and follow their own institution's policies. 

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