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SUNY Downstate Health Sciences University

Office of Research Administration

IRB Electronic Submission Process:

 

COVID-19 PANDEMIC  

CALL FOR INFORMATION RELATED TO ANTICIPATED COVID-19 RESEARCH

The Downstate IRB is requesting information on all COVID-19 studies that are under development or anticipated at Downstate.  Please send the following information to the Executive Director of the IRB:

  • Principal Investigator
  • Title
  • Indicate any the following, if planned: a) External IRB, b) use of nasopharyngeal swab c) source of external funding

SUNY DOWNSTATE ORA COVID-19 WEBSITE (click here)

This web page contains important information that may have a potential impact to Researchers at Downstate.  Such information includes:

  • Ramp-Up Plan for SUNY Downstate Research Activities.
  • FDA app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. 
  • IRB Guidance for obtaining consent from a Legally Authorized Representative (LAR or Surrogate) or permission from a parent or legal guardian during the COVID-19 pandemic.
  • Triage for IRB reviews during the COVID-19 pandemic
  • FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
  • Sample IRBNet notice to confirm a sponsored study meets the criteria for temporary suspension
  • OHRP Guidance on COVID-19
  • Eliminating hazards associated with COVID-19
  • Lifting temporary suspension of research activities
  • Temporary suspension notice
  • Special IRB Update memo
  • Updates from Sponsored Programs Administration, including COVID-19 funding opportunities
  • Updates from IACUC and DCM.

NOTES:

1) If changes are needed to activate a study approved by an External IRB to meet the above request (e.g., procedures to mitigate risks of COVID-19), the External IB needs to approve these changes prior to implementation.

2) For extramurally funded studies (sponsored research) please work with the Director of Sponsored Programs to communicate with your sponsor if any changes impact the budget or if is determined by the Downstate Coronavirus Task Force or IRB that your existing and/or new study cannot continue as planned.

 

Below is a step by step process for preparing and submitting an IRB application along with all related materials to the IRB for approval of human research activities.   

The order of these steps is designed for a new investigator and are not meant to be prescriptive and many of the steps can take place in parallel to save time.  A more experienced investigator or coordinator who has a good grasp on the IRB process may wish to carry out the steps in a different order.

Note: For more information on whether an activity requires IRB approval, please refer to the Downstate IRB FAQs.To request an IRB determination letter for activities which do not require IRB approval, skip to step 11 (below) and review the information on the IRB Decision Aid form.

Click here if you looking for a for a specific form, template, policy or guidance document within the steps below... 

Click on the step below:  To find one of the following forms, templates, policies, or guidance: 
 Step 1:
  •  Policies and guidance
 Step 4 & 6:
  •  Guidance for training and conflict of interests
 Step 5:
  •  Agreements
 Step 7:
  • Data security
  • Protocol templates
 Step 8:
  • Obtaining legally effective informed consent and HIPAA research authorization
  • Consent Templates
  • Stand-alone HIPAA Authorization
  • Pregnancy follow-up consent
  • SUNY RF Payment Consent, Waiver, and Guidance
  • Assent
  • Recruitment authorization forms
  • Medical release form
  • HIPAA waiver/alteration form
  • Waiver of informed consent requirements form
 Step 9:
  • Obtaining legally effective informed consent and HIPAA research authorization
  • Short forms
  • Translation certificates
 Step 10:
  •  Additional IRB materials to submit with IRB application
 Step 11:
  •  IRB Application forms for initial review
 Step 12:
  •  IRBNet guidance
Step 13:
  • Scientific review guidance and forms
Step 20:
  • Post-IRB application forms

 

STEP 1: Review the Downstate IRB website, policies, and guidance.

Review the Downstate IRB website for instructions and details on how to submit an IRB application.

Refer to the Policy and Guidance to understand Downstate Policy IRB-01 and other applicable policies and IRB guidance.

STEP 2: Plan the project.

TIPS:

  • Start early!
  • Establish the study team and meet often to keep the project flowing.
  • Investigators performing certain clinical interventions must have appropriate privileges, as determined by the Department Chair in accordance to the Downstate Medical and Dental By Laws of the Medical and Dental Staff.
  • Have a kick-off meeting.
  • Establish goals and critical milestones.
  • Assign tasks.
  • Conduct a literature search and keep a bibliography of references to include with the protocol. 
  • Consult with a mentor and other experts in the field, as needed.
  • Consult with a biostatistician, as needed.
  • When seeking funding, work with the Sponsored Programs Administration to establish the award.  This can be done in parallel; however, the research cannot begin until both the IRB has approved the study and it is funded.

STEP 3: Identify a Principal Investigator with "PI Status".

Effective on February 20, 2020, the IRB requires the PI to submit a current CV or NIH Bio-sketch with each new study submitted to the IRB.

The PI must have "PI Status" which is defined as:

  • Seasoned investigator with a field-specific terminal degree who is a Faculty Member at Downstate
  • Clinician with clinical privileges at NYC H + H, Kings County
  • Faculty member under recruitment to Downstate with written approval by a Dean
  • Individual approved to be a PI by written memo or e-mail from the Downstate Institutional Official
  • Individual who qualifies to be a PI at an external site, when the research makes Downstate engaged.  Downstate becomes engaged when:
    • Federal funding or support is provided to Downstate
    • Co-investigators or key personnel on the study are members of the Downstate workforce

Notes:

  1. In certain situations, multiple Co-PIs are permitted.  Consult Policy IRB-01 to determine if Co-PIs can be used for the particular project.
  2. The Site Principal Investigator for a study conducted at NYC H+H, Kings County must be a full-time, part-time or voluntary physician who is a member of the Medical Staff at Kings County and who has appropriate clinical privileges as defined in the Facility's Medical Staff Bylaws. This individual must also be approved by the reviewing IRB as personnel on the study.

STEP 4: Determine whether investigators are members of the Downstate workforce.

Understanding whether an Investigator (or Key Personnel) is a member of the "Downstate workforce" will help determine:

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 (approved by IO & Dean/Department Chair),
  • Residents, Fellows, or Medical Students who are sponsored by Downstate
  • Students in a Downstate academic program,
  • Temporary Employees or SUNY contractors working on behalf of Downstate, or
  • Downstate Volunteers (officially approved by the Downstate Volunteer Office).

 The following individuals 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
  • 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.

 

STEP 5: Determine which IRB to use and establish any required agreements.

Single IRB (sIRB) Mandate is now in effect

Federally funded research that takes place at multiple sites (cooperative research) must be reviewed by a single IRB (sIRB), with the following exceptions:

  • Exempt research.
  • Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
  • Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
  • Other exceptions as described within OHRP guidance or as determined by the federal department or agency that is funding the research.

Using the Downstate IRB  

 The Downstate IRB can be used for human research conducted by:

  • Investigators from the Downstate workforce (see above),
  • Investigators from an institution which has executed an IRB Reliance agreement, including University Physicians of Brooklyn (UPB) or NYC Health + Hospital, Kings County, and
  • Investigators from another institution, including Companies from the Downstate Biotech Park, through the establishment of either an IRB Reliance Agreement and/or Individual Investigator Agreement, as applicable for the study.

The Downstate IRB may serve as a sIRB for multi-sites on a case-by-case basis; however, this must be requested and approved in advance by the Downstate IRB and approved by the Federal Agency or Department funding the study.  Be sure to build sIRB fees into your award.

Determining which IRB to use for multi-site studies

In general, the Downstate IRB will be used whenever research takes place at Downstate. When a qualified External IRB (including sIRB) is used to approve the research; the Downstate IRB must acknowledge the External IRB approval and confirm the study meets Downstate requirements in order to activate the study at Downstate before it can begin.

When a single IRB (sIRB) must be used, the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research, will determine which sIRB to use.

One or more Tribal IRB(s) must be used when the research focuses on American Indians, Alaskan Natives tribes, or indigenous people, when required by (tribal) law.

Unless the Downstate IRB refers review to an external IRB, DO NOT use an external IRB for any research involving any of the following:

  • Downstate as a single site, unless a Tribal IRB MUST be used, or
  • Research previously disapproved by the Downstate IRB.

The following examples are provided for clarification on which IRB to use:

  • When a member of the Downstate workforce has an appointment or employment at another site; the Downstate IRB has jurisdiction of the research at Downstate when Downstate resources (e.g., salary, funding, equipment, computers, space) are used in the research or when the individual is conducting research on behalf of Downstate. 
  • When a Downstate faculty member is also a paid clinician at NYC Health + Hospital, Kings County Hospital (KCH) and only conducts research at KCH without any Downstate resources, the Downstate IRB does not have jurisdiction over the research, unless the faculty member is also doing the research on behalf of Downstate.
  • If a resident conducts research while moonlighting without using Downstate resources, the Downstate IRB does not have jurisdiction, unless the resident is doing the 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.

Requesting the reliance of an External IRB  

The Downstate IRB MUST activate a research project conducted by members of the Downstate workforce via review of the IRB Application for External IRB Oversight when a qualified External IRB has approved a study. 

NOTE: The actual steps (or order) may be different depending on the specific process of the selected external IRB.

 

Step 1: Reliance Request (request to cede IRB review to an external IRB)  

CAUTION: When the Downstate Workforce collaborates with investigators from other sites, an IRB Reliance (Authorization) Agreement will need to be established with each site.  The investigators at the other sites must follow their own policies to establish their IRA.  For example, investigators from Kings County should contact the Facility Research Coordinator at Kings County Hospital for guidance.


  1. Determine whether Downstate has an existing IRB Reliance (Authorization) Agreement (IRA) in place.  Downstate has an IRA with the following IRBs
    1. National Cancer Center Central IRB, 
    2. Biomedical Research Alliance of New York (BRANY) IRB, or
    3. An external IRB that participates in the SMART IRB Reliance System
  2. If an existing IRA is not in place, the study team must first contact the external IRB to confirm it meets at least one of the following qualifying criteria:
    1. Have an active AAHRPP accreditation,
    2. Have completed a quality assessment within the last five years (e.g., OHRP’s Quality Assessment Program, internal audit, FDA inspection, ORHP inspection, or equivalent approach).
  3. Obtain the external IRB's Reliance Agreement, unless there is one on file with Downstate (as noted above).  If using an IRB within the SMART IRB network, contact the external IRB to determine which additional reliance steps are required.
  4. Submit the request to the Downstate IRB in IRBNet along with the Application for External IRB Oversight (check box A in Section A of the form).

Step 2: Clarification of local research requirements

Note:  in some cases, this may be combined with Step 1.

When required by the external IRB, include any documentation provided by the external IRB that the Downstate IRB that is required to complete as part of the local review (e.g., local context forms).

Upon request, the Downstate IRB will clarify any local research requirements for members of the Downstate workforce; however, the study team is encourage to share the Downstate IRB Guidance on Local Research Context for the External IRB

When collaborating with Kings County, the Facility Research Coordinator at Kings County Hospital should provide their local research context to the external IRB.

Step 3: Pre-Activation [Pre-Review of materials (e.g., model informed consent templates] by the Downstate IRB, prior to submission to the external IRB.  

Note:  In some cases, the external IRB may require this step be combined with Step 1 and/or 2.

  1. Ask the external IRB whether a Pre-Activation (Pre-Review) by the Downstate IRB is required.   This step is optional for the Downstate IRB but may be required by the external IRB or desired by the Downstate investigator. The Downstate IRB Office will issue a Pre-Activation letter after conducting an administrative review of the following as applicable to the request:
    • Model informed consent templates,
    • Other documents requested for Downstate review by the external IRB, and
    • Review of required training, conflict of interest disclosures, and ancillary reviews.
  2. If required or desired, please submit the request to the Downstate IRB in IRBNet along with the Application for External IRB Oversight (check box B in Section A of the form). 

Step 4: Obtain approval from the qualified External IRB  

Follow IRB approval process of the External IRB.

Step 5: Request activation by Downstate IRB

  1. Submit the request to the Downstate IRB in IRBNet along with the Application for External IRB Oversight (check box C in Section A of the form). 
  2. Include the IRB approval letter obtained from the external IRB.
  3. The Downstate IRB will confirm all institutional and local requirements are met for the Downstate workforce.
  4.  The Downstate IRB will stamp any approved consent materials if the materials are not stamped by the external IRB when these materials require stamping under Downstate IRB-01 policy.

Step 6: Follow all applicable policies:

  1. When using an external IRB, the research team must follow the procedures, policies, directives, and practices of the external IRB, the Downstate, the IRB Authorization (Reliance) Agreement, and the sponsor.
  2. The PI and research staff must comply with the determinations and requirements of the both the external IRB and the Downstate IRB. 
  3. Each institution involved in the multi-site project is responsible for ensuring compliance at their site.  Downstate is responsible for ensuring compliance with the IRB’s requirements at the Downstate. 
  4. Research staff from external sites must consult their own institutional policies to determine if other requirements apply.

 

Establish agreements  

  • Establish an (external) IRB Reliance Agreement to rely on an external IRB (see above).
  • Establish a SUNY Downstate IRB Reliance Agreement (IRA) when an external institution relies on the SUNY Downstate IRB for review and oversight of human research. 
    • The Downstate IRB has an IRB Reliance agreement in place to review research that takes place at UPB or NYC H+H, Kings County, so no new agreement is needed.
    • The Downstate IRB may also require the external site to provide information on their local research context. The Downstate IRB will contact the external site and provide them with the necessary application for this step. 
    • Please note however, that the Downstate IRB is not AAHRPP accredited, which may be a requirement of the external site.
  • Establish an Individual Investigator Agreement (IIA) for each investigator who is not a member of the Downstate Workforce when (s)he:
    • is not covered by an SUNY Downstate IRA, or
    • is from a site that does not have PHS compliant COI management process and/or COI training program.
  • Establish a Data Use Agreement (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.
  • Establish a Business Use Agreement (BAA) when activities involving business associates. 
  • Implement Confidentiality Agreements when required by the IRB or Sponsor, particularly if needed to address any data security requirements.
  • Establish a Clinical Trial Agreement or Facilities Use Agreement when required by Sponsored Programs Administration.  

 

 

STEP 6: Complete training and submit conflict of interest disclosures.

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.

A summary of required training is provided below; however, the training options will vary depending on which site the investigator is located:

  • CITI training (Group 1 or Group 2)
  • HIPAA compliance training
  • COI & research misconduct training (if investigator for COI purposes)
  • Dangerous Goods Shipping certification (if involved with shipping specimens, infectious substances, biological or hazardous substances
  • GCP training (if conducting NIH clinical trial or when required by sponsor)
  • Department of Defense training is required if receiving DoD funding.

Investigators who are determined by the PI to be if investigator for COI purposes, must submit Annual COI disclosures and Transactional Questionnaires for each study.  They must also update their Annual COI disclosure within 30 days of any new significant financial interest (SFI).  Management Plans must be established for any SFI.  Investigators who are not members of the Downstate workforce must follow their COI disclosure process at their institution and submit their COI adjudication (determination) with the IRB submission.

Download and complete the following forms if needed and submit directly to OCAS:

STEP 7: Develop the research protocol.

If this is an industry sponsored project, use the protocol provided by the sponsor. 

If the research is funded by a grant or an award, ensure the protocol is consistent with the funding documents.

Ensure the protocol is consistent with the IRB Guidance on Data Security.

Include the following in the protocol, as applicable:

  • Hypothesis, Aims, and Objectives
  • Methods
  • Procedures
  • Data collection
  • Power analysis
  • Statistical tests

The research team can use any format or template for their protocol; however, 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:

STEP 8: Develop consent materials or applicable waivers.

Review guidance for Obtaining Legally Effective Informed Consent and HIPAA Research Authorization.

Develop the informed consent templates and related materials or request a waiver, when applicable:

Note: Informed consent is not a requirement for exempt research applications; however, HIPAA authorizations (or waivers ) apply to exempt research involving PHI. 

STEP 9: Develop Short Forms, if applicable.

A short form written informed consent form stating that the required elements of informed consent required have been presented orally to the research participant or their legally authorized representative, and that the required key information was presented first, before other information, if any, was provided. The IRB shall approve a written summary (this can be the English version of the consent or a separate written summary) what is to be said to the research participant or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. 

Refer to IRB Guidance: Obtaining Legally Effective Informed Consent and HIPAA Research Authorization to determine if the Short Forms should be used for the study.

CAUTION: In general, written translation of the long form is expected over the use of the short-form process when the research anticipates the enrollment of five or more research participants with limited English proficiency of the same language (e.g., 6 Spanish speaking participants), for the following types of research:

  • Phase 0, 1,1/2, 2, 2a, 2b, or 2/3 Clinical trials which are determined to be greater than minimal risk without any anticipated therapeutic benefit for the research participants
  • Studies which are determined to be a minor increase over minimal risk, when there is no direct benefit to the research participant;
  • Complex clinical trials; or
  • When required by the sponsor.

Short Form Templates & Translation Certificates:

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.

Note: Use the versions below ONLY for an amendment to request the use of a Short Form with a 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 (e.g., study approved under pre-2018 version of the Common Rule).

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.

STEP 10: Determine if any additional materials are required. 

Effective on February 20, 2020, the IRB requires the PI to submit a current CV or NIH Bio-sketch with each new study submitted to the IRB.

 

The following additional materials are required, when applicable to the study:

 

  • Recruitment Materials, including, but not limited to:
    • fliers
    • brochures
    •  ads
    •  e-mails
    •  telephone or verbal script
    •  web site materials
    •  social media postings 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 an IDE:
    • Device Package Insert
    • IDE Letter or SR/NSR determination from the FDA or sponsor
  • When requested by the IRB, provide Credentials of study staff performing clinical interventions.
  • When requested by the IRB, provide the contract or agreement with the Sponsor.
    • IRB may need to confirm consistency of informed consent language regarding injuries, additional costs, EU GDPR disclosures, data security requirements, or other information.
  • HIPAA Preparatory to Research Certification Form

STEP 11: Determine which IRB Application Form to use for initial review.

Use the correct IRB Application form as indicated below.

Contact the IRB office if you are not sure which form to use.

IRB APPLICATION FORMS  

Most frequently used forms:

*To meet the requirements of the the April 4, 2020 Temporary suspension notice, for any new human research submitted to during the COVID-19 pandemic, please provide the following information as a response to Section D, item dd (page 9), within the application for External IRB Oversite.

1) Compelling reason to initiate new research:

2) Explain how the benefits of the research outweigh the risks of exposure of research participants and others (e.g., investigators, staff, family members of research participants) to COVID-19:

3) Procedures to mitigate the risk of COVID-19.  For guidance, see Eliminating hazards associated with COVID-19

Less Commonly used forms:

 

GUIDANCE: Which application should be used?  

Most frequently used forms:

Exempt Research:

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

There are two (2) versions of the IRB Exempt application. Use the DOJ/DIJ version for research funded by DOJ/DIJ.

Note: Some categories do not apply to research with Children or Prisoners.  See Policy IRB-01 or IRB application for details.

Form A1A: Application for Exempt Review

Form A1B: Application for Exempt Review - DOJ/DIJ Funded Research Only

 

Expedited or Full Review

Form A2: Application for Expedited or Full Review

Use Form 2 for any research which meets the criteria for expedited review.  Research which may be expedited includes research which is no greater than minimal risks and meets the criteria for expedited review.  These categories are outlined in the IRB application; however, please note that with the revision of the Common Rule in 2018, many types of research which were once "expedited" will now meet the criteria for exempt research (noted above). 

Examples of non-exempt research which may meet the criteria for expedited review 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
  • Initial review of research that meets the criteria for “expedited review” category #1 or #2:
    • If it involves biomedical interventions with children, pregnant women, neonates, prisoners, or cognitively impaired adults
    • If referred by the expedited reviewer

External IRB Oversight:

Form A3: Application for External IRB Oversight

In general, the PI can request the use of an external IRB for multi-site studies and must do this for research approved by a Tribal IRB.  The following is noted:

  • Requires an IRB Reliance Agreement (IRA) with the External IRB:
    • IRA on file: BRANY IRB, NCI CIRB, & those in the SMART IRB Network (over 667 participating sites)
    • Other IRAs determined on a case by case basis with approval of Downstate Institutional Official (IO)
  • Downstate IRB must acknowledge external IRB approval and confirm all local research requirements are met
  • Cannot be used for the following:
    • Downstate as a single site, unless a Tribal IRB is required
    • Research previously disapproved by the Downstate IRB
  • When completing a “Request for External IRB Oversight” application, include only Downstate Workforce to confirm local context

Regarding Form 3, see also: Guidance: Local Research Context for External IRB.

 

IRB Decision Aids:

To request a Determination Letter to indicate IRB review is NOT required, use one of the two (2) versions of the IRB Decision Aid. Use the version that applies to the project.

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

 

Use Form A4A when Downstate is not engaged in human research. 

 

Use Form A4A 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

 

Use Form A4B for any request, such as:

  • Any activity described for Form 4A above, particularly if the activity also includes other activities like those listed below,
  • Secondary data or materials (data collected for another purpose) which has been de-identified,
  • Use of data or specimens from deceased individuals
  • Specimens or commercial cell lines that cannot be linked to an individual by the investigator,
  • De-identified or coded materials,
  • Use of a limited data set under a Data Use Agreement,
  • Preparatory to research activities,
  • Referring others from Downstate to a new study,
  • Pilot activity, feasibility activity, or evidence-based practice that does not involve human research as defined in Policy IRB-01, or
  • Training or educational activity that does not involve human research as defined in Policy IRB-01.

 

Less Commonly used forms:

 

Exempt Research conducted or supported by Department of Justice:

Form A1B: Application for Exempt Review - DOJ/DIJ Funded Research Only

Please refer to above guidance for exempt research in more commonly used forms.

 

Important notes for forms A5 and A6: 

1) There are exceptions of certain emergencies where prior IRB approval is not required under applicable FDA regulations, as outlined in Policy IRB-01.   In the case of “emergency use”:

  • FDA authorization is required prior to use, and
  • The IRB must be notified within 5 working days of emergency use.

 2)  Because this is generally considered an option for treatment use, the standard requirements for typical IRB applications are generally waived and considered optional.  Scientific Review Committee, Training documents, and Ancillary Reviews, except Pharmacy review are not required, unless subsequently requested by the IRB.

 3) Conflict of Interest (COI) Disclosures are required if a clinician on the IRB application has or declares a conflict of interest. 

Expanded Access:

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):

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 21st 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.  

GUIDANCE: Submitting PDF fillable forms  

The Downstate IRB is in the process of converting the fillable WORD forms to fillable PDF forms.  In order to use a fillable PDF form, please do the following:

  1. Download the form on to your computer.
  2. Open the form within Adobe Reader DC
    1. Contact the Downstate IT HELP desk if you need to download the software on a Downstate computer.
    2. To update existing Adobe software, click on the "Help" menu within the Adobe Reader DC application and then choose "Check for Updates..." and/or "Repair Installation."  This may take multiple rounds, if there are multiple updates or repairs.
  3. Use the "Fill & Sign" tool with Adobe Reader DC to complete the fillable sections of the form.
  4. Save the completed form on your computer with a new name.
  5. Upload the completed form to the IRBNet submission.

 

STEP 12: Upload all application materials.

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

STEP 13: Obtain Scientific/Scholarly Review, when required.  

Scientific/Scholarly Review (SR) is required prior to IRB approval of the following types of research projects:

  • Downstate Full Board Applications, and
  • Downstate Expedited Review Applications that qualify for research reviewed under categories (1A) or (1B) (e.g., studies involving a drug, biologic, or medical device).

Unless otherwise required by the Department Chair or Dean, the IRB does NOT require Downstate SR review on the following activities:

  • Application for Exempt Review,
  • Application for Expedited Review, unless the research reviewed under categories (1A) or (1B)
  • IRB Decision Aid – Application for a Determination Letter to State IRB Approval is NOT Required,
  • Application for Humanitarian Use Device (HUD) for Clinical Purposes,
  • Application for Expanded Access to Investigational Drug/Biologic for Treatment Use,
  • Application for External IRB Oversight, unless local SR is required by the external IRB, or
  • Application for Independent Honest Broker Assurance Agreement.

The Scientific Review Committee (SRC) is a scholarly and scientific review committee charged with reviewing research at Downstate. The purpose of the SRC is to evaluate the quality of the proposed activity when required by the IRB, Department Chair, Dean, or PI to ensure the research meets an acceptable standard of scientific rigor to improve the likelihood of yielding valid and meaningful information.

Please share the IRBNet submission with the SRC member to obtain their review and approval via e-signature. 

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.

 

STEP 14: Obtain ancillary reviews, when required.  

Ancillary reviews by various departments or committees may be required as an administrative process for Downstate policy or at the discretion of the IRB for any human research protection concern. Examples of Ancillary Reviews may include Scientific Review Committee (SRC) (see above), Institutional Biosafety Committee (IBC), Radiation Safety, Radiology, Pharmacy, and UHB Pathology.

To determine if an ancillary review is required prior to IRB approval of a specific project, other than noted below, please consult the IRB website, contact the IRB, or refer to the policies of the above committees or departments.  The IRB requires the following ancillary reviews in advance of granting IRB approval for the specific conditions noted below:

UHB Pathology Laboratories Services

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”, 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.

 

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 Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

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.

Institutional Biosafety Committee (IBC)

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.

Downstate Research Pharmacy

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.

 Other ancillary reviews

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.

When an ancillary review is required by Downstate or another institution, but NOT required as a condition for Downstate IRB approval, the investigator must document approval of any pending required ancillary review within the research record prior to starting the research or enrolling any research participants, as applicable.  The IRB may provide a copy of the approval letter to the corresponding department or committee that should complete the ancillary review.  If an ancillary reviewer requires or recommends any modifications to the previously IRB approved research, any such modification must be subsequently approved through an IRB amendment, prior to implementation of changes.  If desired, by the PI or sponsor, the PI may submit a copy of the documentation of ancillary approval not requiring any modifications to the IRB for the IRB to acknowledge; however, this is not a requirement of this policy.

STEP 15: Obtain Downstate Department Chair or Dean Approval.

The Downstate Department Chair of Dean must review and approve the following types of applications, prior to IRB approval:

  • IRB Applications for Exempt review, Expedited review, Full Board review, or External IRB Oversight
  • Application for a HUD for Clinical Purposes
  • Application for Expanded Access to Investigational Drug/Biologic for treatment

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.

The IRB will ensure notification of the Downstate Department Chair or Dean of approvals when an IRB Decision Aid (Application for Determination Letter to State IRB Approval is NOT required), if (s)he did not previously perform an ancillary review of the application.

A Department Chair or Dean may delegate this authority to another person through the Delegation of e-Signature Form.

STEP 16: Submit final application in IRBNet.

Within IRBNet, click on the “Submit this Package” button on the left menu and follow the instructions. 

Note: Once the IRB Application package is submitted it is locked. If any changes are needed to the package, contact the IRB to request the package be unlocked.

STEP 17: Respond to IRB within deadlines.

The IRB process is iterative in nature.  The IRB submission is automatically withdrawn if response is not timely; however, PI the may request more time if needed.

There are two types of revisions.

  • The IRB will pre-review the package and may unlock it to request minor revisions via expedited review. 
    • Revise the package as requested and lock package and mark revisions complete.
  • The IRB will require the submission of a revised package when major modifications are required.
    • Submit a follow-up package in IRBNet.
    • Include a point-by-point response cover letter.

 

STEP 18: Complete requirements for external sites.

NYC Health + Hospitals, Kings County Requirements:

  • Follow policies of both NYC H+H and Downstate.
  • All research conducted at NYC H+H, Kings County must follow 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:
    • Michele Follen, MD, PhD, MBA; Director of Research and Chair, Facility Research Review Committee, NYC Health + Hospitals/Kings County (718) 613-8401 or follenm@nychhc.org
    • Bryce Petty, CCRC, Facility Research Coordinator: (718) 613-8185 or Bryce.Petty@nychhc.org (Bryce Petty is the best contact for STAR)

Note: The Site Principal Investigator for a study conducted at NYC H+H, Kings County must be a full-time, part-time or voluntary physician who is a member of the Medical Staff at Kings County and who has appropriate clinical privileges as defined in the Facility's Medical Staff Bylaws. This individual must also be approved by the reviewing IRB as personnel on the study.

 

External Sites:

  • Follow policies of both the external site and Downstate
  • Follow requirements of IRB and/or IIA

STEP 19: Complete Post-IRB Requirements Before Starting the Research.

  • Upon approval by the IRB, the study team should do the following:
    • Review the IRB approval letter for accuracy and appropriate determinations.
    • Check the approval date and expiration date in letter and approved documents (consent, recruitment materials, etc.). An expiration date is NOT needed for recruitment materials
    • Contact the IRB if there are any discrepancies, errors, or questions.
    • Share applicable documents with sponsor.
    • File documents in study binder.
    • Ensure the study meets Applicable Clinical Trial Requirements (ACT) of the FDA and the ACT website is updated within the required deadlines.  The FDA requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
    • Understand and ensure the requirements of sponsor.
    • Understand reporting requirements to the IRB, sponsor, and FDA.
    • Do not use laboratory reports from research laboratories for diagnosis, treatment and prevention of disease, unless the research laboratory is properly certified or accredited.
    • Complete any required ancillary reviews that are still pending approval.
    • Finalize clinical trail agreements, facilities use agreements, with Sponsored Programs Administration, as applicable for the study.

STEP 20: Submit required updates after IRB approval.

Submit applicable application forms to the IRB after the IRB has granted initial approval.

POST-IRB APPROVAL APPLICATION FORMS

GUIDANCE: Which application should be used?

Acknowledgments:

  • Submit Form 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 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 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 B3Application Form for Reportable Event for any reportable event within the required deadline(s) outlined in Policy IRB-01.

 

Check-In Report/Progress Report(Continuing Review):

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 one (1) of the four (4) types of reports as applicable to the types of research:

  • Form B4AApplication for Check-In Report: ;

    Provide the check-in report for studies, which do not require continuing review, at least three (3) weeks in advance of the IRB check-in expiration date.

  • Form B4BApplication for Progress Report (Continuing Review): Submit this progress report and all required materials, when annual review is required, at least three (3) weeks in advance of the scheduled meeting for which the convened (full board) review must take place. When eligible for expedited review, submit this report at least three (3) weeks in advance of the IRB approval expiration date.

    Consider submitting any of the following with the current progress report submission:

    • Proposed amendments or notification of any changes (i.e., change in funding status)
    • Reportable events, including deviations for lapse of continuing review (i.e. expired IRB approval) or any reportable events that must be reported to the IRB during this reporting period (e.g., summary of minor deviations).

    If submitting an Amendment or Reportable Event at the time of continuing review, please consider whether such application(s) should be bundled with this Continuing Review application, particularly if the continuing review must go to the full board.  A delay in approval of a bundled report (i.e., if IRB needs additional information to approve an amendment or reportable event) may cause a lapse in continuing IRB approval, which would lead to an expiration, and all research must stop.

  • Form B4CApplication for Progress Report (Continuing Review) for External IRB Oversight: 

    Submit this progress report for research approved by an external IRB.  The progress report and all required materials must be provided and all required training and conflict of interest disclosures must be complete at least three (3) weeks in advance of the expiration date.

    WARNING: If the required training or conflict of interest disclosures are pending at the time of Downstate IRB review and acknowledgment, the investigators listed on the study may not conduct any research, until local Downstate requirements are met. 

  • Form B4D: Application for Progress Report (Continuing Review) for a HUD/HDE for Clinical Use Only.  Use this Progress Report only to request continuing approval by the IRB to use a HUD for clinical use only, within at least three (3) weeks in advance of the expiration date.

     

    CAUTION: If a HUD/HDE is part of a Clinical Investigation, please use the regular progress report form (B4B or B4C), rather than B4D.

     

Final Report (Study Closure):

  • Submit "Form B5: Application for Final Report (Study Closure)" at least three (3) weeks in advance of the expiration date of a study, when there are no plans to renew the study.

REMINDER: 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.

NOTES:  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.