IRB Electronic Submission Process

For the purposes of the Downstate IRB, the Downstate workforce includes individuals who act on behalf of Downstate, including, but not limited to:

• Faculty members, employees, and staff who are paid by Downstate,
• Employees, staff, or contractors paid by the Research Foundation for SUNY, working on behalf of Downstate,
• Individuals with a Downstate Voluntary Faculty appointment with medical privileges (credentialed by University Hospital SUNY Downstate),
• Retired Downstate faculty member with emeritus status,
• Residents, Fellows, or Medical Students who are sponsored by Downstate
  • A sponsored Resident or Fellow is any Resident or Fellow who is part of a Downstate residency/fellowship training program who goes through the Downstate GME Office, regardless of rotation site or employment status.
  • A sponsored Medical Student is someone who is sponsored through one of the Downstate colleges or through an affiliation agreement.
  • If the sponsored individual is paid by another institution, (s)he should check to see if their IRB or Institution has any additional requirements for their review and/or whether they require an IRB Reliance Agreement (IRA) or Individual Investigator Agreement (IIA). However, even when an IRA or IIA is established for an investigator who is sponsored by Downstate, (s)he is still responsible for following Downstate policy and completing Downstate requirements for training and COI (if applicable).
• Students in a Downstate academic program,
• Temporary Employees or SUNY contractors working on behalf of Downstate, or
• Downstate Research Volunteers (officially approved by the Senior VP of Research Office).
  • All students and trainees who are NOT in a Downstate academic program MUST go through the Senior VP of Research Office to be onboarded as a Research Volunteer to become members of the Downstate Workforce.  Note:  Former external students covered under an existing executed Individual Investigator Agreement may continue to conduct research on existing studies.
  • External investigators who are not otherwise covered by an Individual Investigator Agreement or an IRB Reliance Agreement (see Step 5 below) must become Downstate Research Volunteers if they are conducting human research on the Downstate site or if they will have access to Downstate Protected Health Information or Downstate private identifiable information.

When Downstate is engaged in human research, the Downstate IRB requires a Downstate IRB application be submitted to the Downstate IRB, as indicated in Step 11  (below).   

A Downstate IRB application is required for the following situations: 

• When a member of the Downstate workforce, regardless of appointment or employment at another site, conducts human research using Downstate resources (e.g., salary, funding, equipment, computers, space) or conducts human research on behalf of Downstate.
• When a Resident, Fellow, or Medical Student is sponsored by Downstate, the Downstate IRB has jurisdiction over the research regardless of where the research takes place.

The Downstate IRB application is  not required for the following situations:

• An investigator who is a member of the Downstate workforce with a joint appointment/employment that is NOT using Downstate resources nor conducting the research on behalf of Downstate. 
• A resident who conducts research while moonlighting without using Downstate resources nor conducts the research on behalf of Downstate.

The following individuals are considered "External Investigators" or those who are not members of the Downstate workforce:

• External consultants (e.g., those paid by sponsors or other entities outside of Downstate),
• Individuals with Voluntary Faculty appointments at Downstate without medical privileges, and
• External residents, fellows, and students.
• Employees or agents of institutions that are not listed as components of the Downstate Federal Wide Assurance (FWA) on file with HHS OHRP, including
  • University Physicians of Brooklyn (UPB),
  • NYC Health + Hospital, Kings County Hospital,
  • Companies within the Downstate Biotech Park,
  • Other institutions, or
  • Private practices.

NOTE: An external investigator must establish an Individual Investigator Agreement (IIA) with Downstate or be covered under an IRB Reliance Agreement (IRA) between their institution and Downstate in order for the Downstate IRB to approve their research activities. See Step 5F below, for additional information.

External Investigators (those who are not part of the Downstate workforce) must follow their Institution’s requirements.

• For Exempt Review or IRB Determinations (e.g., not human research, not engaged, etc.), External Investigators must follow their Institution’s requirements and should not be included on the Downstate IRB application. If their Institution does not have an IRB to make these determinations, an IRA or an IIA may be established with the Downstate IRB to make these determinations.
• For Expedited or Full Board reviews, when External Investigators conduct human research activities that make their institution engaged in human research per OHRP guidance, they may use their Institution’s IRB or the Downstate IRB (if an IRA or IIA is established).
  
  • A Single IRB (sIRB) is required for oversight of any federally funded or conducted study. The PI must obtain approval in advance to use the sIRB and include sIRB fees in the award budget for the review of all sites.
  • CAUTION: The Downstate IRB cannot be used as a sIRB for a federal funded or conducted study.  See Step 5 below, for additional information.
• When an Application for External IRB oversight is submitted to the Downstate IRB, only the Downstate workforce can be included. External investigators (including KC and UPB) must consult their institution and the external IRB for guidance to be included in their approval process, as the Downstate IRB does not have jurisdiction over External Investigators approved by an External IRB.
• For applications for either Expanded Access for Treatment or a HUD for Clinical Purposes, Clinicians from Kings County or UPB may be included on the Downstate IRB application. Other External Clinicians should seek approval from their Institution’s IRB.

See “Step 5F” (below) for additional details for required agreements. However, please note that an IIA cannot be established with an external investigator who is determined to be an investigator for the purposes of COI.

Click on the link to review the flow chart for: Determining which IRB to Use, which Agreements are required, and which IRB fees to budget.

From the flowchart, determine the following:

• Determine, which IRB(s) will have oversight.  This decision is generally based on the following:
  • Funding source
  • Whether Single IRB (sIRB) review is required by NIH, Federal Department/Agency, Common Rule, or FDA (once the FDA implements new regulations).
  • Whether the sponsor or main PI of a multi-site study requires the use of a specific Central IRB of sIRB.
  • The policies that the Main (overall) PI and/or other external collaborating investigator(s) must follow at the at the site where they are employed or act as an agent, when conducting multi-site human research.
  • Whether investigators who are members of the Downstate workforce are conducting activities that are considered Not Research, Not Human Research or whether these activities make Downstate engaged in human research. 
• Determine which agreements are required for investigators who are not members of the Downstate workforce:
  • IRB Reliance Agreement(s) (IRA)
  • Individual Investigator Agreement(s) (IIA)

Note: See Step 5F below for more information about other agreements that may be required, such as: Data Agreement (DA), Data Use Agreement (DUA) for sharing Limited Data Sets (LDS), Clinical Trial Agreement (CTA), Material Transfer Agreement (MTA), Facilities Use Agreement (FUA), Confidentiality Agreement (CA), etc.  

•  Determine which IRB fees are required:
  • Consult the Downstate IRB Guidance: Fee Schedule.
  • Contact Sponsored Programs Administration (SPA) for information on the budget process and include all IRB fees in your budget.
    • Research budgets must include all IRB fees:
      • The PI is responsible for including all Downstate IRB fees in research budget based on whether fees are paid out of the research budget or if they will be invoiced directly to the sponsor. 
      • Industry sponsored research budgets are negotiated and approved by WCG Clinical on behalf of the RF.
    • Invoices for IRB fees:
      • WCG Clinical will automatically invoice for the local Downstate IRB fee for Industry sponsored research on behalf of the RF upon study start up.
      • The Downstate IRB will notify the RF to bill any other required Downstate IRB fee.
      • External Reviewing IRBs should invoice their IRB fees directly to the Industry Sponsor; however, the PI should confirm with the Sponsor and External Reviewing IRB, for each study.
      • External IRBs should invoice the PI for IRB fees related to sIRB review.
      • For questions about invoices for IRB fees, please contact Sponsored Research Programs.
  • Downstate IRB fees:
    • When an External IRB is the Reviewing IRB for an Industry sponsored study, the RF will invoice the sponsor a one time fee of $1,000 (as per budget).
    • When the Downstate IRB is the Reviewing IRB for sponsored research not otherwise overseen by another external IRB,  the RF will invoice the sponsor $4,000 (as per budget).  However, please note that the RF does not charge any Downstate IRB fees for Downstate or Kings County intramurally funded studies or for extramurally funded studies sponsored by the government, non-profit entities, public entities, professional associations, oncology groups, or SUNY.
  • In general, when an External IRB is the Reviewing IRB, the Reviewing IRB will bill an Industry Sponsor directly for their IRB fees.  Confirm this information with the Reviewing IRB and the Industry Sponsor.
  • A quote must be obtained from the WCG IRB for the following studies:
    • Industry sponsored clinical investigations, unless already covered as noted above.
    • Federally funded non-exempt human research which requires an sIRB, when Downstate is the Primary Awardee.  Note: For sIRB studies, the WCG IRB will invoice the PI to be charged to the federal award.

Determine which investigators are members of the Downstate workforce, based on Step 4 and review the Flow Chart in Step 5A to determine when Individual Investigator Agreements (IIA) or IRB Reliance Agreements (IRA) are required, for investigators who rely on a reviewing IRB other than the IRB of their own institution (e.g, External Investigator relying on the Downstate IRB, Downstate Investigator relying on an External Reviewing IRB).

Note: External investigators must follow the policies of their own institution.  When a multi-site research project meets the criteria for Exempt Review, multiple IRBs are used to review the research at each site (e.g., each IRB with jurisdiction over their site's investigators reviews their research), as described in Step 5C2 below. Alternatively, an IIA may be established between the Downstate IRB and the external investigators in certain situations, as described within this step (below).  

• An Individual Investigator Agreement (IIA) (click link for form) may be executed between an external Investigator and the Downstate IRB, for Investigators who are NOT considered to be 'Investigators for the purposes of COI' under the Downstate Financial Conflict of Interest policy.
  
  • Typically, the investigator is at an institution without an IRB and/or acts independently from the institution (e.g., moonlighting resident, physician in private practice),  or their institution or IRB allows an IIA.
• An IRB Reliance Agreement (IRA) is set up between the Institution and the reviewing IRB.
  • When research is conducted by Investigators who are NOT members of the Downstate workforce and reviewed by the Downstate IRB, an IRA is generally required between the Downstate IRB and the external Institution, where the Investigator(s) is/are an employee or agent.  Alternatively, an IIA may be established with the Investigator(s) in certain situations, as described above.
    • The Downstate IRB has existing IRAs to serve as the reviewing IRB for all research conducted by Investigators from UPB and HHC, Kings County Hospital. Note: These institutions may also use other IRBs, based on their policies.
    • The Downstate IRB has an existing IRA with Maimonides Medical Center to review research conducted by Maimonides investigators under the following conditions:
      • PI is a member of the Downstate workforce, AND
      • Research is NOT federally funded, NOT industry sponsored, and NOT exempt.
    • An IRA may be executed between other external institutions and the Downstate IRB, to review NON-EXEMPT research, when the external institution is a HIPAA Covered entity, and has ALL of the following in place:
      • Federal Wide Assurance (FWA) on file with the Department of Health and Human Services, Office of Human Research Protections (OHRP),
      • PHS/NIH Financial Conflict of Interest compliant policy, 
      • A local IRB, Human Research Protection Program (HRPP), or office to confirm local research requirements, AND
      • A compliance (audit or QA) program.
  • When research is conducted by Investigators from the Downstate workforce and reviewed by a external IRB (e.g., sIRB, Central IRB, Commercial IRB), an IRA is generally required between Downstate and the external reviewing IRB. 
    • • Downstate has existing IRAs with the following IRBs:
        • WCG IRB
        • NCI CIRB
        • Biomedical Research Alliance of New York (BRANY) IRB
      • New IRAs may be established as needed with other qualified IRBs. To be qualified, the IRB must have at least one of the following criteria:
        • AAHRPP Accreditation,
        • CARE-Q Certification,
        • Member of the SMART IRB Reliance System, or
        • Successfully completed a quality assessment within the last 5 years (e.g., OHRP or FDA audit, self-assessment, peer review assessment).  Documentation must be provided upon request.
• IRAs and IIAs are processed by the Downstate IRB, following the specific  steps below:

1. Review the Flow Chart in Step A to confirm the Downstate IRB has jurisdiction over the research.
2. Review Step B to confirm the Downstate IRB may review IRB applications for external investigators or employees and execute any necessary IIA or IRA agreements.  
3. External investigators should contact their institution to determine their institutional requirements for review of human research.
4. Be sure to describe the data sharing between sites and security protections within the Downstate IRB application materials.
5. Ideally, identifiable data should not shared between sites; however, identifiable data could be shared when HIPAA and data security protections are in place, applicable disclosures are provided to participants, institutions agree to sharing identifiable the data, and applicable agreements are executed. 
6. External investigators covered by another IRB and consultants not conducting research should not be included on the Downstate Exempt IRB application; however, details of data sharing between sites must be included, as noted above.
7. Refer to the sections below for additional information based on the type of review:

 

CAUTION: This process is for the Downstate workforce only. Other investigators must follow the process of the External IRB and their institution. For example, when collaborating with Kings County, the Facility Research Coordinator at Kings County Hospital should provide their local research context to the external IRB.

The IRB, OCAS, and COI Committee may consider proposals for alternative IRB and COI review. Contact the Executive Director of the Downstate IRB if an alternative approach is proposed.

GENERAL INFORMATION:

• The Downstate IRB facilitates the process for agreements required in the research and may be requested to review the agreements for congruency with the IRB application materials.  The IRB does not approve or execute the agreements.  An overview of the process for execution of required agreements is described at the end of this section.
• Establish a Data Use Agreement (DUA) for activities involving limited data sets. Note: If SUNY Downstate 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 of another facility's template if we are obtaining the data from them.
  • Data Use Agreement (DUA) Template
  • Use of Limited Data Sets (HIPAA-27)
  • HIPAA De-Identification of Information (HIPAA-6)

• Establish a Business Use Agreement (BAA) when the study involves a non-Downstate workforce member who performs or assists in the performance of a function or activity involving the use, receipt or disclosure of protected health information, unless they are approved as an external investigator by the Downstate IRB when they are covered by a fully executed Individual Investigator Agreement or IRB Reliance Agreement.
  • BAA Template Form
  • Business Associate Agreements (BAA) Policy (HIPAA-3)
• Implement Confidentiality Agreements (CA) when required by the IRB or Sponsor, particularly if needed to address any data security requirements.  This is typically required for NIH funded studies. Include the Confidentiality Agreement with the IRB submission.
• Establish a Clinical Trial Agreement (CTA) or Facilities Use Agreement (FUA) when required by Sponsored Programs Administration or an external site.  NOTE: DO NOT include the CTA or FUA with the IRB submission.
• Establish a Materials Transfer Agreement (MTA) when required by the Office of Innovation and Partnerships (I&P). 
• CAUTION: Research activities covered by an agreement may not begin until any required agreement is fully executed by those with the authority to execute the agreement. Members of the study team are NOT authorized to sign any agreement on behalf of the SUNY RF or SUNY Downstate.

Note: In general, all data shared with external investigators under a multi-site study approved by an external IRB should be de-identified or coded in a manner where the key to the code is only available to investigators who are members of the Downstate workforce. This activity must be approved by the external IRB and subject to local site activation by the Downstate IRB.

EXECUTION OF AGREEMENTS FOR NON-FUNDED RESEARCH:

Send the agreement(s) to Shoshana Milstein, Associate VP, Compliance and Audit and Downstate Privacy Officer. Include any related materials associated with the request. Additional consultation with General Counsel may be required. Members of the study team may NOT sign the agreement. Executed agreements will be signed by the designated signatory official and returned to the PI.

Include the FULLY EXECUTED AGREEMENT(S) in IRBNet with the IRB submission; however, unsigned drafts many be included if not yet fully executed.

EXECUTION OF AGREEMENTS FOR FUNDED RESEARCH:

Send the agreement(s) to Ernest Purefied, Director, Contracts with a copy to Sharon Sealy, Executive Director, Deputy Operations Manager. Include any related materials associated with the request. Mr. Denny will review the documentation and prepare it for RF signature. Additional consultation with General Counsel and/or the Downstate Privacy Officer may be required. Members of the study team may NOT sign the agreement. Executed agreements will be signed by the designated signatory official and returned to the PI.

Include the FULLY EXECUTED AGREEMENT(S) in IRBNet with the IRB submission; however, unsigned drafts many be included if not yet fully executed.

• For COI disclosure and COI training requirements, the PI determines who on the research team is an “Investigator for the Purposes of COI,” as defined in the Research Conflict of Interest Policy (RFDMC-01): The project director, Principal Investigator, co-Principal Investigator, personnel who are considered to be essential to work performance or any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research. The PI is responsible for identifying all Investigators involved in their research activities. If the role of an individual is unclear and that individual is listed as an Investigator, compliance with all training and filing requirements will be expected.
  • Transient staff and trainees, such as medical students, residents and fellows, who may recruit patients and/or collect and handle data under supervision, but are not key to the design, conduct or reporting of research are not considered Investigators for purposes of COI. In addition, staff or trainees who merely implement a protocol developed by an Investigator or enter data into an electronic data capturing system are also not considered Investigators for purposes of COI. However, if a medical student, resident and/or fellow is applying for a research grant, s/he is considered an investigator for COI purposes and, therefore, must complete COI requirements.
  • COI disclosures are required by HHC for Kings County investigators who are considered to be “Covered Individuals” as defined by HHC Policy 180-9. A “Covered Individual” means Principal Investigators, Sub-investigators, Collaborators, Consultants, and other Key Research personnel responsible for the design, conduct, or reporting of the research.
  • COI disclosures do not apply to other External Investigators, UNLESS the study has a PHS Award, as defined in the Downstate COI policy.
    • PHS Award(s)- Any grant, contract, award, or sub-award including SBIR/STTR Phase II applicants/awardees, but not Phase I SBIR/STTRs, issued or awarded by the United States Public Health Service and its agencies: Agency for Healthcare Research and Quality; Agency for Toxic Substances and Disease Registry; Centers for Disease Control and Prevention; Food and Drug Administration; Health Resources and Services Administration; Indian Health Service; National Institutes Health; and the Substance Abuse and Mental Health Services Administration; and their sub-agencies.
    • External Investigators should contact their employer to determine if they have any additional COI disclosure requirements.

Anyone determined to be an “Investigator for the Purposes of COI” must complete their required COI disclosures as outlined in the Guidance on COI Requirements.

For sponsored projects use the protocol provided by the sponsor.

For non-sponsored projects, please follow the guidance and instructions in one of the following templates as applicable to the research:

• Downstate Protocol Template (for Downstate Investigator-Initiated research that involves a clinical intervention).
• Downstate Protocol Template (With Guidance) - use for non clinical intervention and exempt research.
• Downstate Protocol Template (Shell Only) - use for non clinical intervention and exempt research.
• NIH/FDA Phase 2 or 3 Clinical Trial Protocol template with guidance.
• NIH Electronic Protocol Writing Tool.
• NIH Behavioral and Social Clinical Trials Template.

 

The Central Methodology Review Committee (CMRC) has been appointed by the Downstate Institutional Official on behalf of the Downstate President to certify certain human research protocols meet acceptable standards for study methods, research design, and statistical analysis. The types of protocols reviewed by the CMRC are limited to those outlined on the CMRC Request Form.

The CMRC must certify the protocol before it is submitted to the Downstate IRB.

For current submissions, the types of protocols reviewed by the CMRC are limited to those outlined on page 2 of the CMRC Review Request Form.

Click on the links below for more information: 

• CMRC Membership Roster
• CMRC Consultants
• CMRC Review Request Form
• CMRC Process (includes FAQs and instructions for completing e-forms in Adobe Reader)
• CMRC Reviewer and Certification Form

NOTE: The Departmental and College level Scientific Review Committee (SRC) is NOT required by Downstate IRB for any study undergoing CMRC review, including those reviewed during the pilot phase. SRC review may be valuable for other types of studies and may or may not be required by the Department Chair or Dean. The PI should consult with the Department Chair or Dean if they have any questions about their requirements for SRC review.

Questions about the CMRC may be sent to the CMRC mailbox.

See Tip 5 G (above) to include the proper project description.

Most frequently used forms:

Exempt Review:

Use "Form 11-A1: Application for Exempt Review".

The details of the exemption categories are described on the IRB application form. In general, use the exempt form for non-DOJ funded research that includes the following types of research:

1. Normal educational practices in established educational settings
2. Educational tests, surveys, interviews, or observation of public behavior
3. Benign behavioral interventions with adults with prospective agreement
4. Secondary research for which consent is not required (includes retrospective chart reviews with HIPAA waiver)
5. Federal research and demonstration projects
6. Taste and food quality evaluation and consumer acceptance studies

Note: Use Form A1B: Application for Exempt Review - DOJ/DIJ Funded Research Only (see below)

Expedited or Full Review

Use "Form 11-A2: Application for Expedited or Full Review".

Use Form 2 for any research which meets the criteria for expedited review or full board review.  Examples of non-exempt research which may meet the criteria for expedited review, when they are no greater than minimal risk included the following:

• Clinical studies of drugs and medical devices only under specific conditions (no IND or IDE)
• Collection of blood samples
• Biological specimens obtained by non-invasive means
• Collection of data through non-invasive means

The following types of research must be reviewed by the full board:

• Studies involving greater than minimal risk
• Clinical Trials involving IND, IDE, or HUD
• If referred by the expedited reviewer
• Initial review of research that meets the criteria for “expedited review” category #1 or #2:
  • If it involves biomedical research interventions with children, pregnant women, neonates, prisoners, or cognitively impaired adults

Note: The term “biomedical research intervention” is interpreted to be an intervention that involves the research of a drug, biologic, and/or medical device as the object(s) of the study.  This term is not meant to be interpreted as a medical procedure, such as a blood draw or the use of an FDA approved medical device to measure what the device is intended to measure.  Nor is it intended to include the use of an FDA approved/licensed agent that is used per clinical indications in a clinic nor the review of medical records about an agent.  All other criteria for expedited review must apply for the study to be reviewed by expedited review.

External IRB Oversight:

Use "Form 11-A3: Application for External IRB Oversight".

In general, the PI can request the use of an external IRB for multi-site studies and when the research is approved by a Tribal IRB.

IRB Decision Aids:

Use "Form 11-A4" to request a determination letter to indicate IRB review is NOT required for activities that are not research, not human research, not engaged) use Form 11-A4.

Less commonly used forms:

Exempt Research conducted or supported by Department of Justice:

Use "Form A1B: Application for Exempt Review - DOJ/DIJ Funded Research Only" when applicable, based on funding.

Expanded Access:

Use "Form A5: Application for IRB Approval of Expanded Access to Investigational Drug/Biologic for Treatment Use"

The terms expanded access, compassionate use, pre-approval access, access, and treatment use are used interchangeably to refer to an investigational drug/biologic when the primary purpose is to diagnose, monitor, or treat a disease or condition rather than obtain any information that is generally derived from clinical trials (e.g., safety or effectiveness data).

Clinical Use of a HUD (HDE):

Use "Form A6: Application for HUD for Clinical Purposes"

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or manifests in fewer than 4,000 individuals in the United States per year. A physician may request approval to use a HUD for clinical purposes.

For additional guidance see the FDA guidance for IRB review of a HUD; however, be aware that this FDA guidance is under review to be in accordance with the 21^st Century Cure’s Act.

NOTE: There is a distinction between “clinical use” (non-research use) of a HUD and “investigational use/clinical investigation” of a HUD. If a HUD will be used for a clinical investigation (e.g., safety and effectiveness data is collected for a FDA Pre-market Approval), a full board IRB application must be completed and reviewed under an HDE if it is SR device study. An informed consent document is always required for a clinical investigation of a HUD/HDE.

Honest Broker:

Form A7: Application for Independent Honest Broker Assurance Agreement

An independent honest broker is a Downstate employee who has access to desired research data or specimens by virtue of his or her responsibilities as a member of the workforce providing the coded data or coded specimens for a project but who is not a member of the research team. An honest broker CANNOT serve as investigator or key personnel on the same project, because (s)he has access to the key to the code and can identify the participants. The Downstate IRB does not permit the use of this agreement with business associates or individuals who are not members of the Downstate workforce.

An honest broker can access protected health information and provide an investigator with coded data, de-identified data or a limited data set, once approved by the IRB. Submit this form with an IRB Decision Aid or IRB application, as applicable to the project.

Refer to IRB Submission Tip #2 towards the top of this web page for details.

The Downstate IRB & Privacy Board uses IRBNet for the electronic submissions and management of human research activities and required reporting.

Anyone associated with Downstate may create an IRBNet user name and password by following the instructions below:

Notes:

1. Each user agrees to comply with the IRBNet Individual User Terms of Use.
2. All members of the Downstate workforce MUST use their Downstate e-mail address when setting up their account.

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.

NOTE: To request a forgotten password enter IRBNet Username or e-mail address here.

OPTIONAL: If desired, the submission may be shared with an IRB Administrator to request and obtain their pre-review for any additional feedback.

Please refer to the guidance for the IRBNet (IRB Application and Reporting System) for more details on how to use the system.

Ancillary review by UHB Pathology is required when 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.” 

If uncertain about the need for Pathology Review, please e-mail Dr. Jenny Libien for a determination. If she states 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.

UHB pathology approval is required prior to IRB approval when patient material obtained for research will affect the clinical care of a patient (e.g., if the research proposes a surgical sample is divided for research and clinical purposes), as determined on a case by case basis by either the IRB or UHB Pathology.

Note: UHB pathology approval may be required for other activities, prior to starting the research. Refer to UHB policy or IRB guidance on the IRB application or IRB website for additional details.

NIH NExTRAC review is required for any study that involves human gene therapy or any deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into one or more human research participants.

Ancillary review by the IBC is required when 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
• Recombinant or synthetic nucleic acid molecules
• Any study that requires NIH NExTRAC review

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.

Note: IBC approval may be required for other activities, prior to starting the research. Refer to IBC policy or IRB guidance on the IRB application or IRB website for additional details.

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

• Please share this IRB Submission with the Research Pharmacist or designate, 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

Downstate Pharmacy approval is required prior to IRB approval for clinical investigations at Downstate that involve an IND.

Note: Downstate Pharmacy reviews for other studies involving a drug, including biologic can take place after IRB approval; however, cannot start until the Research Pharmacy approves the study. Refer to Downstate Pharmacy policy or IRB guidance on the IRB application or IRB website for additional details.

The IRB may require other types of ancillary review when the IRB determines there is a human research protection concern that requires the ancillary review. Examples may include review by the following groups:

• Radiology or Radiation Safety (i.e., for concerns with the risk or level of radiation exposure of a research participant).
• Biostatician (i.e., for concerns with possible design flaws or concerns with the data analysis plan).
• Consultant (i.e,, when there is not sufficient expertise on the IRB to evaluate the study).
• Privacy Officer or Data Security Officer (i.e., to address any concerns with HIPAA regulations, GDPR regulations, privacy, confidentiality, or information security).
• Ethics Consult.
• IBC (i.e. for any biosafety concern when IBC review is not otherwise required).
• Biomedical engineering (i.e., to review equipment used in the research, if there is a safety concern or unknown risk of using the equipment).
• Office of Regulatory Affairs.
• Office of General Counsel.

1. Log into IRBNet.
2. Click on the “My Projects” tab, and then select the study.
3. After opening the study, click on “Create a New Package” (last tab under Project Administration). CAUTION: DO NOT CLICK "Create New Project" in error.
4. Click on “Designer” tab on left menu.
5. To Create a "SUNY Downstate - Registration Form for DMC/IRB Review," do the following:
   1. On the “Designer” page select “Start a Wizard”
   2. Select the “SUNY Downstate Registration Form for DMC/IRB Review.”
   3. You will then be prompted to either create a new wizard from scratch or you may clone an existing wizard. Make a selection and choose “Continue.” With an existing project you will most likely wish to select clone an existing wizard.
   4. Follow the instruction and click “Next” to move through the document.
   5. At the end of the form, you must press the “Save and Exit” button.
6. If you need to update the existing "SUNY Downstate - Registration Form for DMC/IRB Review," click on the pencil icon for “SUNY Downstate – Registration Form for DMC/IRB Review”
   1. Using the drop down menu at the top of the page, jump to the section that needs to be edited, for example “Project Personnel”
   2. Edit this section of the form as needed (e.g., for example, when changing research staff click “X” to remove personnel or click “Add Another Individual” at the end of the form.
   3. Once you are finished filling out the form, you must press the “Save and Exit”. The registration form is automatically saved on the designer page.
   4. This action will bring you back to the “Designer” page where you can begin to add as many documents as you require for this IRB submission.
7. To attach completed applications or documents, click on "Attach New Document" on the Designer page. Attach the required document(s). Be sure to edit the document type for each attachment. Once the document is added, you will be given the option to select the document type.
8. To delete a document, click on the "RED X" next to the document on the Designer page.
9. To share the submission with the PI or others (e.g, to request e-signature), click “Share this Project” and follow prompts.
   1. Once shared, the PI (or others) may e-sign the submission by clicking “Sign this Package” tab.
10. Once all signatures are obtained, click “Submit this Package” and follow prompts.

REMINDERS:

1. 1. If adding staff, please ensure all required training and applicable conflict of interest disclosures have been completed. For more information, please see the IRB Guidance on Training and COI Requirements, in Step 6 (above).
   2. For information on how to use IRBNet, see Step 12 (above).
   3. The PI must electronically sign the package.
   4. Each new PI must e- sign the submission, when adding co-PIs.
   5. If a PI changes, the Department Chair or Dean must e-sign the submission.

Acknowledgments:

• Submit Form 20-B1: Application for Acknowledgment to request acknowledgment by the IRB (e.g., notices from an external IRB, external reportable events, new training documents, etc.).

Amendments (2 Types):

• Submit Form 20-B2A: Application for Amendment to request approvals for all changes. All amendments must be approved by the IRB before they can be implemented.
• Submit Form 20-B2B: Application for Amendment- STAFF CHANGES ONLY to change study staff. This amendment must be approved by the IRB before any new staff can do research on the study.

Reportable Events:

• Submit Form 20-B3: Application Form for Reportable Event for any reportable event within the required deadline(s) outlined in Policy IRB-01.

Continuing Review/Check-In/Study Closure/ Re-Activation:

Please Note: If the study is completed or only de-identified data is undergoing data analysis, please consider submission of an Application For Final (Study Closure) to the IRB for the purposes of closing the study.

Submit Form 20-B4: Application for Continuing Review/Check-In/Study Closure/Re-Activation

IMPORTANT NOTES:

• Securely retain data in accordance to Policy IRB-01, IRB approved documents, and sponsor requirements. Do not destroy any research data until required retention periods have passed.
• Only include data for sites that have oversight by the Downstate IRB. If this is a multi-site study, do not include data for sites outside of the jurisdiction of the SUNY Downstate IRB.
• If the study is completed or only de-identified data is undergoing data analysis, please consider submission of a final report form to the IRB for the purposes of closing the study.

 

When seeking continuing review and approval from an external Reviewing IRB,  the Principal Investigator (PI) should concurrently submit Form 20-B4 to the Downstate IRB. This practice promotes the concurrent review by the Reviewing IRB and the administrative review of local requirements by the Downstate IRB Office.

Upon receipt and pre-review, the Downstate IRB may either unlock the submission or issue a Conditional Activation letter to the Principal Investigator (PI), which will include a request for a copy of the Reviewing IRB’s approval notice.

Once the PI has provided the Reviewing IRB's approval notice and the Downstate IRB has verified that all local research requirements have been met, the continuing approval of the study will be officially activated.

Overview of Joint Continuing Review and Approval Process:

1. Follow the process required by the Reviewing IRB to secure continued IRB approval.
2. The PI should submit Form 20-B4 to the Downstate IRB.
   1. This can be done before receiving the continuing approval notice from the Reviewing IRB.
   2. Form 20-B4 should not be submitted to the Reviewing IRB.
3. Following pre-review of the Downstate submission, the Downstate IRB will either unlock the submission or issue a Conditional Activation letter to the PI.
4. After receiving the continuation approval notice from the Reviewing IRB and ensuring all local requirements specified by the Downstate IRB have been met, the PI must update the IRB submission to the Downstate IRB and lock the submission so that the review and activation process may continue.
5. The Downstate IRB will activate the study for continuation after the Downstate IRB confirms the Reviewing IRB has issued the continued approval of the study and all local Downstate research requirements have been satisfied.
6. Simultaneous compliance with both the Downstate IRB and the Reviewing IRB is essential for an efficient review process, particularly when the Reviewing IRB review might be delayed.

 

For any queries or assistance, please don't hesitate to contact the IRB Office.