SUNYDownstateMedicalCenterInstitutional Review Board
Submission Checklist(REQUIRED):
- All required applicable materials and all required signatures must be submitted or the IRB application package cannot be processed.IRB templates are available on theIRB website or on the “Forms and Templates” button on the left menu in IRBNet.See: “Local Research Context Guidance for External IRBs” for additional information.
- For additional policy requirements and tips for obtaining External IRB approval, please see pages 20-23 of IRB-01 located at
- If all of the materials are not available or approved by the External IRB, the SUNY Downstate IRB can grant conditional approval. The SUNY Downstate IRB will issue a final acknowledgement of external IRB approval once all requirements are satisfied.
required for all new submissions:
IRBNet Registration Form.
Application for External IRB (this form).
External IRB Approval Letter.
External IRB Approved Protocol
External IRB Approved Informed consent, Information Sheets (including HIPAA Authorization, when applicable), and Assent Documents, as applicable
Note: The SUNY DMC IRB will stamp the documents for the local use, if the external IRB does not stamp them; however, an IRB approval letter for the local materials from the external IRB must be provided.
IRB ReLIANCE AGREEMENT(Check one):
Note: Contact external IRB for their agreement. The SUNY Downstate Medical Center IRB only requires an IRB Reliance Agreement for Federal Funded or Supported research; however, the External IRB may require one regardless of funding or support.
Not required by External IRB and this is not a federally funded study (including pass through funds).
Fully executed IRB Authorization (Reliance) Agreement is on file with the IRB. Note: IRB Reliance Agreement on file for the BRANY IRB and NCI CIRB.
Fully executed IRB Authorization (Reliance) Agreement is attached.
Pending IRB Authorization (Reliance) Agreement is attached.
REQUIRED FOR NCI CIRB approved studies:
NCI CIRB Informed Consent Addendum. Only required for all NCI CIRB approved studies.
SUBMIT THE FOLLOWING IF APPLICABLE:
Recruitment materials. Note: The SUNY DMC IRB will stamp the documents for the local use, if the external IRB provides an approval letter for them.
Applicable HIPAA Research Authorization or HIPAA Waiver.
Other materials/information relevant to this project.
OCAS patient Referral Forms:
Note: These forms are available in IRBNet. If these are needed, please seek approval to use these forms from the External IRB.
Subject Recruitment Authorization Form (External Entity).
Subject Recruitment Authorization Form (Internal).
1)GENERAL INFORMATION
a)Protocol Title:
b)Principal Investigator (PI):PI Contact Information:
PI Phone # (required):
PI Email (required):
Alternate PI E-mail (optional): / Dept:
Check PI Status below (check all that apply):
(1)Faculty Member at SUNY Downstate who is a sseasoned investigator with a field-specific terminal degree
(2) Clinician with privileges at NYC H+H, Kings County. REMINDER: STAR approvalis also required for all NYC H+H research.
(3) Faculty member under recruitment to SUNY Downstate. Written memo or e-mail from a Dean is attached.
(4) Approved to be a PI by the Downstate Institutional Official (IO). Written memo or e-mail from the IO is attached.
(5) Qualify to be a PI at an external site AND this activity makes Downstate engaged (check all that apply):
Federal funding or support is provided to Downstate
Co-investigators or key personnel are (check all that apply):
Employee(s) of SUNY Downstate
Resident(s) or Fellow(s) trained under a GME program affiliated with SUNY Downstate
Student(s) in a Downstate Academic Program
c)(OPTIONAL) If someone, other than the PI, will be the main contact for this study, please provide his/her contact information below:
Name (if not PI):
Role on Study: / Phone: Email:
d)(OPTIONAL) If multiple Principal Investigators will be responsible for the scientific and technical direction for this study, complete the table below.
Rationale for using a multiple PI approach:
NOTE: Each PI must e-sign the initial IRB submission in IRBNet. The first PI listed in the IRB application will serve as the contact PI.
Additional PI Name / PI Status (for coding, see #s above) / Contact Information / Description of the roles, responsibilities and the working relationship to the primary PI.
(1), (2),(3),
(4),(5) / Phone #
Email :
(1), (2),(3),
(4),(5) / Phone #
Email :
Attach additional sheets if needed.
e)Who is providing funding for this study? (Check all that apply):
NOTE: IF THIS SECTION CHANGES AFTER INITIAL IRB APPROVAL, THE PI MUST SUBMIT AN AMENDMENT TO THE IRB.
Downstate Department: Specify Department:
Note: Check if using departmental funds, equipment, resources, or labor.
NYC +HH, Kings CountyREMINDER: STAR approvalis also required for all NYC H+H research.
Note: Check if using departmental funds, equipment, resources, or labor.
Industry Sponsor: Specify funding entity: Sponsor Award #:
Federal Sponsor. Provide additional information below:
Specify agency:
Investigator initiated? Yes No
Federal Award #
GCP training complete? Yes No
Check one: Grant materials are included for congruency review. Grant materials are pending and will be submitted as future amendment.
NOTE: The IRB will review the federal grant materials for congruency and issue a confirmation in the final IRB Approval letter, which the PI must submit to Pre-Awards for processing.
Inbound Subcontract (Specify funding entity): Date of anticipated funding:
Other: Specify:
f)What is the status of funding?
This project is fully funded.
Project is partially funded at this time. List approved sources of funding:
Pending: Potential sources: Date of anticipated funding:
NOTE: IF THIS SECTION CHANGES AFTER INITIAL IRB APPROVAL, THE PI MUST SUBMIT AN AMENDMENT TO THE IRB.
The IRB will use discretion as to whether the research may be approved when funding is pending. This may be particular important if sponsored funds are not available for research related injuries for some more risky studies.
g)Is this a “Qualifying/Deemed Clinical Trial” under the CMS regulations? Yes No
For more information, see:
h) Is this study considered an “Applicable Clinical Trial”?
Yes No
If yes was checked above:
h1) ClinicalTrials.gov NCT# or anticipated date for registration
h2) Confirm the exact following language is included in the informed consent document by placing an “X” in the following box: Confirmed
A description of this clinical trial will be available on as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
h3) Who is the responsible party for registering the trial and submitting results:
2) Please provide the following information:
Please provide a written justification to request the use of the External IRB:
Is the use of the External IRB required by a NIH grant? Yes No
Does the External IRB require any additional ancillary reviews, beyond those required by SUNY Downstate? Yes No
If additional ancillary reviews are required by the External IRB, indicate type:
Radiation Safety
Radiology
Other. List:
Please answer the following questions:
- Indicate the type of external IRB
NCI Central IRB
BRANY IRB
External IRB at an academic medical center. Name of the IRB:
Commercial IRB. Name of the IRB:
Single IRB for NIH funded multisite study. Name of the IRB:
- Is the external IRB accredited by AAHRPP? Yes No Pending Unknown
- Does the study involve any of the following:
- IDE for an investigational medical device Yes No
IF YES, STOP: The FDA Does not permit External IRB approval of studies with an IDE
- Phase 1 or Phase 2 clinical trial Yes No
- Recruitment of children Yes No
- Recruitment of neonates Yes No
- Recruitment of pregnant women Yes No
- Recruitment of prisoners Yes No
- Recruitment of students or employees Yes No
- Data from a NYC School Yes No
2)TABLE OF STUDY STAFF:
For training and conflict of interest disclosure requirements see:
a.Name & degree / b.
Role(s) on Project. Examples: Principal Investigator, Co-Investigator, Coordinator, Consultant, Fellow, Resident, Student, Research Staff, Healthcare Operations only, Access to de-identified data only, Specimen shipment, etc. / c.
Place of employment
REMINDER: STAR approvalis also required for all NYC H+H research. / d.
Will this person be obtaining verbal or written Informed Consent/Authorization / e.
Is this person an “Investigator for the purposes of COI reporting”?
THE PI IS ALWAYS CONSIDERED AN INVESTIGATOR FOR COI PURPOSES. / f.
Will this person aid the shipment of hazardous materials (e.g., dangerous goods, specimens) to be transported by a public carrier?
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
a.
Name & degree / b.
Role(s) on Project. Examples: Principal Investigator, Co-Investigator, Coordinator, Consultant, Fellow, Resident, Student, Research Staff, Healthcare Operations only, Access to de-identified data only, Specimen shipment, etc. / c.
Place of employment
REMINDER: STAR approvalis also required for all NYC H+H research. / d.
Will this person be obtaining verbal or written Informed Consent/Authorization / e.
Is this person an “Investigator for the purposes of COI reporting”?
THE PI IS ALWAYS CONSIDERED AN INVESTIGATOR FOR COI PURPOSES. / f.
Will this person aid the shipment of hazardous materials (e.g., dangerous goods, specimens) to be transported by a public carrier?
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
3)RECRUITMENT & ENROLLMENT
3a) From which locations will research participants be recruited and enrolled by the study team?
SUNY Downstate
NYC H+H, Kings County
Other Site (describe):
If other is checked, please provide documentation to indicate support from the external site.
3b) Will social media approved by the external IRB be used to recruit participants? YES NO
NOTE: Any Downstate representation on social media must be authorized by SUNY Downstate’s Office of Institutional Advancement after IRB approval is granted. See:
4) Additional Information:
Note: Some external IRBs (e.g., NCI CIRB) do not function as a HIPAA Privacy Board. If this is the case with the External IRB, the SUNY Downstate IRB will serve as the HIPAA Privacy Board.
a)Indicate whether you will obtain a HIPAA Authorization, a HIPAA waiver, or whether the study does not involve access, review, or disclosure of Protected Health Information (PHI) also known as Individually Identifiable Health Information (IIHI).
Will obtain a HIPAA Authorization (IIHI Authorization) combined with a consent document or information sheet (e.g., “What information will be kept private” section of templates)
Request a HIPAA Waiver (e.g., for retrospective review of PHI/IIHI, and/or waive or alter signature or other required elements, and/or to review of PHI/IIHI for recruitment purposes and obtain a HIPAA Authorization during enrollment, if applicable)
N/A - the study does not involve access, review, or disclosure of PHI/IIHI.
N/A – this study involves release of a limited dataset and a Data Use Agreement (DUA)
b)Check if you are using an Authorization Form to have clinicians refer their patients to the SUNY DMC study team?
Note: Template forms are available on IRB Net.
Subject Recruitment Authorization Form (External Entity).
Subject Recruitment Authorization Form (Internal).
c) Please provide any additional information that you would like for the Downstate Medical Center IRB to consider:
6) ANCILLARY REVIEWS:
Please review the following sections to determine if any ancillary reviews are required. If so, for any ancillary reviewer other than IBC, please share the IRBNet submission with the ancillary reviewer. Although the IRB may grant a “conditional approval” of the research when ancillary review is required, the research CANNOT begin until the IRB has granted final IRB approval.
a)UHB Pathology Laboratories:
Check the box below to indicate whether the research involves any of the following:
At least one box MUST be checked.
(6a1) Services or assistance of the UHB Pathology Laboratories (Clinical Laboratory, Histology Lab and/or Surgical Pathology).
(6a2) 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: )
(6a3) None of the above. UHB Pathology Laboratories ancillary review is not required.
If uncertain about the need for Pathology Review, please email Susan Gottesman & Caitlin Otto for a determination. If they state Pathology Ancillary review is not required, attach the e-mail determination to the IRB submission.
If box “6a1” or “6a2” is checked above, please do the following:
Step 1:
a)Refer to the UHB Pathology Instructions, Forms, and Fees posted in IRBNet/IRB Website.
Note: These will be posted on the Pathology website in the near future and removed from the IRB website.
b)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:
a)Complete and submit the IRB application after the UHB Pathology Laboratories approves the feasibility of using their services to obtain IRB approval.
b)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) approvalsare 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 External IRB. All amendments must be acknowledged by the SUNY Downstate IRB within 30 days of approval by the External IRB.
b)Biosafety:
- All research involving the use of Recombinant or Synthetic Nucleic Acid Molecules, infectious agents, human cells or body fluids, or hazardous substances must be reviewed and approved by the Institutional Biosafety Committee (IBC) to ensure that all applicable biosafety standards are met. Early submission of the protocol to the committee is advisable to allow time for any necessary clarification, revision and reconsideration, and approval. The IBC will determine if the study requires approval from the NIH Recombinant DNA Advisory Committee. For more Information:Please consult the IBC website or contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912 .
- Protocols involving work with human-derived biological materials that are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory are exempt from IBC review. However, any work on human-derived biological materials (including packaging and shipping) in Research laboratoriesat DMC issubject to IBC review.
- If your study requires Institutional Biosafety Committee approval or NIH Recombinant DNA Advisory Committee approval, your study cannot be approved by the IRB until you have received the applicable approvals.
(6b1): Does your study require approval from the Institutional Biosafety Committee (IBC)?
No to (6b1), this study does NOT involve recombinant or synthetic nucleic acid molecules, infectious agents, human cells or body fluids, or hazardous substances.
No to (6b1), this study involves infectious agents, human cells or body fluids, or hazardous substances; however, all materials are human-derived and are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
Yes to (6b1), this study involves the use of recombinant or synthetic nucleic acid molecules, infectious agents, human cells or body fluids, or hazardous substances and the materials are not collected nor handled by a (CLIA) certified laboratory.
If yes to (6b1), has the IBC approved the study or is the review pending?
Yes. If YES, please upload the approval letter within the new IRBNet Submission package.
PENDING IBC approval. Note: IBC review may take place in parallel; however, final IRB approval cannot be granted until IBC approval is granted.
(6b2): If Yes to (6b1), does this study involve the 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?
Yes No Ifyes, approval by both the IBC and the NIH Recombinant DNA Advisory Committee (RAC) is required, prior to IRB approval.
If yes to (6b2), has the NIH RAC approved the study or is the review pending?
Yes. If YES, please upload the approval letter within the new IRBNet Submission package.
PENDING NIH RAC approval. Final IRB approval cannot be granted until IBC approval is granted.
c)Pharmacy:
Does this study involve anydrugs or biologics at DOWNSTATE? Yes No
Note: For research at NYC H+H, Kings County, a Kings County Pharmacist may review the research, once it is entered in STAR.
If yes to above, please share this IRB Submission with the Downstate Research Pharmacist or designee, so that (s)he may electronically sign the submission and answer the following:
Check the types of patients that will be involved in the study: Inpatients Outpatients Other, specify:
What days of the week will participants be enrolled or recruited?
Weekdays Seven days per week Other, specify: