SUNY Downstate Medical Center Institutional Review Board s2

SUNY Downstate Medical Center Institutional Review Board Application for Amendment

Please Note: All amendments must be approved by the IRB before they can be implemented.

1) GENERAL INFORMATION

A. Protocol Title:

B. Principal Investigator (PI): Dept: Box:

Downstate

Faculty Member

Kings County

Hospital Center Employee with Clinical Privileges

Other. Specify:

C. PI Contact Information:

Phone # (required): Email (required): Alternate E-mail (optional):

D. If someone, other than the PI, is the main contact for this study, please provide his/her contact information below:

Name (if not PI): Phone: Email: Application for Amendment (07.05.2017) Page 1 of 18 SUNY Downstate Medical Center Institutional Review Board

Role on Study:

2) SUMMARY OF CHANGES

A. Does this amendment come at the request of the sponsor?

Yes No If Yes to A, please upload documentation from the sponsor regarding the amendment.

B. Please provide a summary of the changes:

C. If adding staff, please explain the responsibilities of each new staff member (e.g. data collection, data analysis, recruitment, and the like):

D. Please explain why these proposed changes are necessary:

E. Please indicate the impact these changes will have on the participants:

3) CHANGES TO STUDY STAFF

Application for Amendment (07.05.2017) Page 2 of 18 SUNY Downstate Medical Center Institutional Review Board A. Are you making changes to the study staff? Yes No IF NO, Proceed to next section.

B. If Yes to A, please revise the IRB Registration form as follows: Locate the IRB Registration Form on the Designer page under “forms from previous packages” - > click the pencil symbol next to the form - > removing the names of those who are no longer part of the study team and / or add the names of those who are being added to the study team - > click Save & Exit.

C. If Yes to A, update any other documents that may be affected by this change and upload highlighted and clean versions of the forms to the Designer page of the package in IRBNet. These may include:

A.i. Protocol (if applicable, complete section 6 of this form)

A.ii. Abstract

A.iii. Informed Consent / Assent / Parental Permission form (if applicable, complete section 7 of this form)

A.iv. Flyer

D. If removing staff, please list the names of the those who are no longer part of the study team and the reason(s) they are being removed:

E. If adding multiple PIs responsible for the scientific and technical direction for this study, please complete the table below and provide the rationale for choosing a multiple PI approach:

Additional PI Name PI Status? Contact Information Description of the roles, responsibilities and the working relationship to the primary PI.

Application for Amendment (07.05.2017) Page 3 of 18 SUNY Downstate Medical Center Institutional Review Board Downstate Faculty Phone # Email : Member KCHC Employee with Clinical Privileges Other. Specify:

Downstate Faculty Phone # Email : Member KCHC Employee with Clinical Privileges Other. Specify:

Note: Attach additional sheets if needed. The first PI listed in the IRB application must be affiliated with the Downstate or KCHC and will serve as the contact PI. Each PI must electronically sign the initial submission.

F. If adding staff (even if listed in response to question E), complete the following chart with the new staff member’s information (If additional space is needed, please continue on a separate page using the same format):

a. b. c. d. e. f. Name & degree Role(s) on Project. Examples: Principal Will this Is this person an “Investigator Will this person aid the Investigator, Co-Investigator, person be for the purposes of COI shipment of hazardous Application for Amendment (07.05.2017) Page 4 of 18 SUNY Downstate Medical Center Institutional Review Board Coordinator, Consultant, Fellow, Place of employment obtaining reporting”? materials (e.g., Resident, Student, Research Staff, verbal or THE PI IS ALWAYS CONSIDERED AN dangerous goods, Healthcare Operations only, Access to de- written INVESTIGATOR FOR COI specimens) to be identified data only, Specimen shipment, Informed PURPOSES. transported by a public etc. Consent/Au carrier? thorization

SUNY Downstate Yes Yes No Yes No No KCHC

Other:

Application for Amendment (07.05.2017) Page 5 of 18 SUNY Downstate Medical Center Institutional Review Board

NOTE: 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- Training and COI Requirements” in the IRBNet Forms and Templates.

4) STUDY STATUS REVISED:

A. Are you making changes to the study status? Yes No IF NO, Proceed to the next section.

B. If Yes to A, please indicate the new status of your study by checking the appropriate box below:

Study is being re-open to enrollment. Reason:

Study is being closed to enrollment; however, follow-up of existing participants who have not completed all research related interventions

continues. Date enrollment closed:

Study is being permanently closed to the enrollment; all previously enrolled participants have completed all research-related interventions

and the research remains active only for long-term follow-up of participants. Date enrollment closed: Application for Amendment (07.05.2017) Page 6 of 18 SUNY Downstate Medical Center Institutional Review Board

The remaining research activities are limited to data analysis. (The study cannot be closed if data analysis is in progress)

Please Note: If your study has been completed, please, submit a final report form to the IRB for the purposes of closing the study.

5) ENROLLMENT / RECRUITMENT REVISION:

Instructions:  Number of participants enrolled = number of subjects who have signed the consent.  For Chart reviews: Number of subjects enrolled = number of charts and/ or specimen reviewed  This Site = Sites for which SUNY Downstate Medical Center Institutional Review Board is responsible

A. Are you making changes to the study enrollment numbers, screening numbers, or recruitment methods/materials?

Yes No IF NO, Proceed to the next section.

B. If Yes to A, are you making changes to the study Enrollment Numbers at this site? Yes No

i. If Yes to B, please provide the new enrollment #:

ii. If Yes to B, please explain reason for change:

C. If Yes to A, are you making changes to the study Screening Numbers at this site? Yes No

Application for Amendment (07.05.2017) Page 7 of 18 SUNY Downstate Medical Center Institutional Review Board i. If Yes to C, please provide the new screening #:

ii. If Yes to C, please explain reason for change:

D. If Yes to A, are you making changes to the study recruitment methods or recruitment documents for this site? 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: http://www.downstate.edu/policy/

i. If Yes to D, Select all that apply:

Flyer Information Brochure

Radio/TV Direct Subject Contact

Letters Referral

Printed Ad Radio/TV

Internet Posting: Website: Social Media; Describe:

Other:

ii. If revised, please upload a copy of the revised recruitment documents with tracked changes, underlined or highlighted to the Designer page of your IRBNet submission package

iii. If revised, please upload a clean copy of the revised or new recruitment documents.

6) STUDY SITE CHANGES:

A. Are you making changes to the list of sites taking part in this study?

B. If YES to A, what sites are being added?

C. If YES to A, what sites are being removed?

D. If YES to A, please update the IRB Registration form in IRBNet as follows: Locate the IRB Registration Form on the Designer page under “forms from previous packages” - > click the pencil symbol next to the form - > make the changes - > click Save & Exit.

7) PROTOCOL / ABSTRACT REVISION:

A. Are you making changes to the study Protocol or Abstract?

Yes, making changes to the study Protocol

Yes, making changes to the study Abstract

No IF NO, Proceed to the next section.

B. If Yes to A, will the changes affect the risks or potential benefits of the study? Yes No

i. If Yes to B, please explain:

Application for Amendment (07.05.2017) Page 9 of 18 SUNY Downstate Medical Center Institutional Review Board C. If Yes to A, and you are making changes to the study Protocol, what is the new version date of the revised Protocol?

D. If Yes to A, and you are making changes to the study Protocol, please upload a copy of the revised Protocol with tracked changes, underlined or highlighted to the Designer page of your IRBNet submission package.

E. If Yes to A, and you are making changes to the study Protocol, please upload a clean copy of the revised Protocol.

F. If Yes to A, and you are making changes to the study Abstract, please provide new abstract in the field below:

i) Abstract (Lay Summary):

Guidance: What the lay summary should include: 1. A statement of the problem of interest (background information). 2. General statement of how the problem will be studied . 3. Objective(s) and Hypothesis(es): State each of the main objectives and/or hypotheses in a single sentence (one sentence per objective/hypothesis). 4. Standard of Care (studies of treatment effects): What is the current standard of care, if any. 5. Potential Impact: how the research will advance scientific knowledge and/or human health.

Additional suggestions: • Technical terms need to be defined in simple language. • Abbreviations should be spelled out the first time used and defined in easily understood terms, if necessary. • It is not necessary to include a complete description of the study design in the lay summary-- a general idea of the strategy and/or techniques involved is sufficient • It is not necessary to include a complete description of the study design in this portion of the submission; rather, give a general sense of the strategy and/or techniques involved. • The summary should not exceed 2 pages

8) CONSENT / ASSENT / PARENTAL PREMISSION FORM REVISIONS:

A. Are you making changes to the study Informed Consent(s) / Information Sheet(s) / Assent(s) / Parental Permission form(s)?

B. If Yes to A, what is the new version date of the revised Informed Consent(s) / Information Sheet(s) / Assent(s) / Parental Permission form(s)?

C. If Yes to A, please upload a copy of the revised Informed Consent(s) / Information Sheet(s) / Assent(s) / Parental Permission form(s) with tracked changes, underlined or highlighted to the Designer page of your IRBNet submission package.

D. If Yes to A, please upload a clean copy of the revised Informed Consent(s) / Information Sheet(s) / Assent(s) / Parental Permission form(s).

9) INVESTIGATOR’S BROCHURE:

A. Has the sponsor made any changes to the study Investigator’s Brochure?

B. If Yes to A, what is the version date of the revised / new Investigator’s Brochure?

C. If Yes to A, should the consent form be revised based on this revision? Yes No

i. If Yes to C, please upload to the Designer page of your package in IRBNet the new version of the Informed consent with tracked changes.

ii. If Yes to C, please upload to the Designer page of your package in IRBNet a clean copy of the new version of the Informed consent.

Application for Amendment (07.05.2017) Page 11 of 18 SUNY Downstate Medical Center Institutional Review Board D. If Yes to A, please upload the new version of the Investigator’s Brochure to the Designer page in IRBNet.

10) FUNDING CHANGES:

A. Are you making changes to the study’s funding source or funding status? Yes No IF NO, Proceed to the next section.

B. If YES to A, please update the IRB Registration form in IRBNet as follows: Locate the IRB Registration Form on the Designer page under “forms from previous packages” - > click the pencil symbol next to the form - > make the changes - > click Save & Exit.

11) ADDITIONAL INFORMATION:

A. Are you making changes or adding any other materials not previously listed on this form (e.g. data collection tool, survey, focus group script, package insert, appointment card, recruitment sites, research sites, use of CTSA, etc. . .) Yes No IF NO, Proceed to the next section.

i. If you answered Yes to A, please indicate the type(s) of document(s) here (e.g. data collection tool, survey, focus group script, package insert, appointment card, etc. . .):

ii. If you answered Yes to A, please attach clean version(s) of the document(s) to the Designer page of this package.

iii. If you answered Yes to A, and these documents are revised, please attach tracked-changes version(s) of the document(s) to the Designer page of this package.

B. Does the research team plan to add the Downstate Clinical & Translation Science Center (CTSC) for any part of the research? For more information about CTSC resources, see: http://www.downstate.edu/ctsc/resources.html

No Yes If YES, please describe.

Application for Amendment (07.05.2017) Page 12 of 18 SUNY Downstate Medical Center Institutional Review Board C. If you wish to add additional information for the IRB to consider, please add it here:

12) ANCILLARY REVIEWS:

Please review the following sections to confirm or determine if any ancillary reviews are required. 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 after all required ancillary reviews are complete.

A. UHB Pathology Laboratories: NOTE: The criteria for the requirement of pathology ancillary review and approval were clarified on June 30, 2017.

Check the box below to indicate whether the research involves any of the following: At least one box MUST be checked.

(12a1) Services or assistance of the UHB Pathology Laboratories (Clinical Laboratory, Histology Lab and/or Surgical Pathology).

(12a2) 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 )

(12a3) 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 “12a1” or “12a2” is checked above, please indicate which past IRBNet package contains UHB Pathology Approval:

If box “12a1” or “12a2” is checked above and this project has not yet received UHB Pathology Approval, do the following:

Step 1: a) Refer to the UHB Pathology Instructions, Forms, and Fees posted in IRBNet/IRB Website. Application for Amendment (07.05.2017) Page 13 of 18 SUNY Downstate Medical Center Institutional Review Board 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) 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.

B. Biosafety Approval: NOTE: The criteria for the requirement of IBC ancillary review and approval were clarified on December 12, 2016.

 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 contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912 or [email protected].  Protocols involving work with human-derived biological materials that are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory are exempt from IBC review. However, any work on human-derived biological materials (including packaging and shipping) in Research laboratories at DMC is subject to IBC review.  If your study requires Institutional Biosafety Committee approval or NIH Recombinant DNA Advisory Committee approval, your study cannot be approved by the IRB until you have received the applicable approvals.

i. Does your study require approval from the Institutional Biosafety Committee (IBC)?

No to (B.i.), this study does NOT involve recombinant or synthetic nucleic acid molecules, infectious agents, human cells or body fluids, or hazardous substances.

No to (B.i.), 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.

Application for Amendment (07.05.2017) Page 14 of 18 SUNY Downstate Medical Center Institutional Review Board Yes to (B.i.), 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.

ii. If YES was selected to (B.i), please indicate the status of your IBC approval the study or is the review pending?

I have already received approval from the IBC and previously submitted said approval to the IRB for their records. Submitted in Package #:

I have already received approval from the IBC BUT I have not previously submitted said approval to the IRB for their records. Therefore, I am attaching said approval to this package.

I have not yet obtained approval from IBC approval. HOWEVER, I have an application pending with the IBC.

I have not yet obtained approval or applied for approval from the IBC. The IRB recognizes that the requirements for when IBC approval has changed on December 12, 2016. Check the following as it pertains to your study:

All of the research interventions with participants and specimens are complete and there are no interactions with research participants, no use of specimens, no storage or shipment of specimens, and no plans to publish in a journal that requires documentation of IBC approval. If this box is checked, please notify the IBC of this determination. Submit a copy of the IBC approval letter to the IRB for acknowledgment within 30 days of receipt of IBC approval.

Ongoing research still involves interactions with research participants, use of specimens, storage or shipment of specimens, or plans to publish in a journal that requires documentation of IBC approval. If this box is checked, please submit an application to the IBC for this research activity within 30 days and submit a copy of the IBC approval letter to the IRB for acknowledgment within 30 days of receipt of IBC approval.

NOTE: If IBC approval cannot be granted within 60 days of the IBC submission, the IRB recommends the PI voluntarily suspend the research until IBC approval is granted and notify the IRB and IBC of the suspension. Voluntary suspensions by the PI are not reportable to the US Office of Human Research Protections (OHRP); however, if the IRB determines lack of IBC approval is serious or continuing non-compliance or if the IRB must suspend or terminate IRB approval, the Downstate Institutional Official must report the event to OHRP, and when applicable report to the FDA and Sponsor.

If the above box was checked, indicate whether IBC approval will be requested?

Application for Amendment (07.05.2017) Page 15 of 18 SUNY Downstate Medical Center Institutional Review Board YES NO Comments:

iii. If Yes to (B.i), 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 If yes, approval by both the IBC and the NIH Recombinant DNA Advisory Committee (RAC) is required, prior to Final IRB approval.

iv. If yes to (b.iii), 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 or indicate which package this was

previously submitted: PENDING NIH RAC approval; however, conditional IRB approval is requested.

C. Ancillary review by Research Pharmacy: Note: For more information see SUNY Policy Number PHA-11: Investigational Drug/Dispensing and Utilization, which was revised Jan 2016. See: http://www.downstate.edu/regulatory/pdf/policies/PHA-11.pdf

i. Does this study involve drugs or biologics at Downstate? Yes No IF NO, proceed to question (D). Note: For research at NYC H+H, Kings County, a Kings County Pharmacist may review the research, once it is entered in STAR.

ii. If yes, to (C.i), please indicate the status of your Research Pharmacist approval:

I have already received approval (e-signature) from the Research Pharmacist or designee. The e-signature can be found in the IRB records. E-signature in Package #:

I have already received approval (e-signature) from the Research Pharmacist or designee BUT I have not previously shared and / or obtained e-signature from the Research Pharmacist or designee for the IRB for records. Therefore, I have shared this study with the research pharmacist and (s)he has e-signed this package.

I have not yet obtained approval from the Research Pharmacist or designee. If you selected this response, please share this IRB Submission with the Research Pharmacist or designee, so that (s)he may electronically sign the submission and answer the following:

Application for Amendment (07.05.2017) Page 16 of 18 SUNY Downstate Medical Center Institutional Review Board 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:

What hours of the day will participants be enrolled or recruited? 9am – 5pm Any time of the day Other, specify:

How much time does the Pharmacy have from randomization/enrollment to drug administration? (Hours)

Drug formulation: Injectable Oral Topical Other, specify:

If intravenous, for how many hours is the product stable for once prepared?

Who can randomize a patient into the study? PI Sub investigator/Co-Investigator Study coordinator Pharmacist Other, specify:

Who can receive drug treatment assignment via IVRS/IWRS? PI Sub investigator/Co-Investigator Study coordinator Pharmacist Other, specify:

What is the enrollment goal? (Number of research participants)

Anticipated quantity of drug shipped to site (if known): (Number of kits)

Size of kits (if known): (Dimensions)

D. Ancillary review by other multiple Departments:

i. Does this research impact or involve other Departments, other than those listed above? Yes No If NO, skip to section 13.

ii. If yes to (d.i), describe how each specific Department is involved or impacted:

Application for Amendment (07.05.2017) Page 17 of 18 SUNY Downstate Medical Center Institutional Review Board iii. If yes to (d.i), please indicate the status of your approval from the impacted or involved Department(s):

I have already received approval (e-signature) from the impacted or involved Department chair(s). The e-signature(s) can be found in the IRB records. E-signature(s) in Package #:

iv. I have already received approval from the impacted or involved Department chair(s), BUT I have not previously shared and / or obtained e-signature from the impacted or involved Department chair(s) for the IRB for records. Therefore, I have shared this study with the impacted or involved Department chair(s) and (s)he has e-signed this package.

v. I have not yet obtained approval from the impacted or involved Department chair(s). If you selected this response, please share this IRB Submission with the impacted or involved Department chair(s), so that (s)he may electronically sign the submission

13) SIGNATURES

The IRBNet package must be electronically signed by the PI before submitting the package to the IRB.

If additional PIs are added to the study, each new PI must e- sign the submission.

If Pharmacy, Pathology, or an additional Department Chair is conducting an ancillary review, please have the designated individual e-sign the submission.

If the IBC is reviewing the research, please provide a copy a copy of the IBC approval letter.

Application for Amendment (07.05.2017) Page 18 of 18