Investigator Instructions Mount Sinai Beth Israel IRB

Investigator Instructions Mount Sinai Beth Israel IRB January 2015, replaces version 8/22/14

This information is provided as IRB forms are available for use.

The forms are as follows: a. HRP 211, Application for Human Research (formerly Application for New Research) b. HRP 503, Protocol template c. HRP 502 d and c, Consent form (Adult and Child), HRP 502h, Spanish Consent form (Jan 2015) d. HRP 212, Continuing Review/Final Review Progress Report e. HRP 213, Modifications (formerly Application for Addendum) f. HRP 214, Responses Required to Secure Approval (formerly Provisos) g.. Exemption Determination Form (Dec. 2014) h. HIPAA Waiver Form (Dec 2014 i. *HIPAA Research Authorization BI (Sept. 2013) j. *Instructions on how to Format HIPAA Research Authorization (Sept. 2013) k. *HIPAA Research Authorization BI Spanish (2013) *no changes to these forms, now available on website l. HRP-224 Reportable New Information (Dec 2014)

As is currently required, all submissions to the IRB must be submitted to: [email protected]

Reference the IRB # of the project and what you are submitting (e.g. IRB 112-15, Modification)

If you have questions for the Office of Grants and Research at MSBI, email [email protected]

***Key Changes***

AT MSBI, IRB NUMBER is required prior to submission. Email Keith King ([email protected]) for an IRB #. Please provide name of PI. How do I complete the “FORM HRP-211: Application for Human Research”?

Form Header (Basic Protocol Information) 1) Protocol Name

Enter the full protocol name and, where applicable, the protocol code or number in parentheses (such as a cooperative group or sponsored protocol). 2) Principal Investigator Name the person with overall responsibility for the conduct of the Human Research. There can be only one investigator with this overall responsibility. If the PI is new to the institution or the IRB application process, or if there has been a change in the PI’s contact information, include that information within the other submission materials. 3) Primary Contact Name Name the person who will receive a copy of all communications in addition to the principal investigator. Leave blank if there is no contact other than the principal investigator. There can only be one contact. If this person is new to institution or the IRB application process, or if there has been a change in their contact information, mention that within the other submission materials. 4) Contact Info Provide that person’s email and direct phone number in the area provided. 5) Date Revised Provide the date that the application form is being filled out. 6) Study Number Provide the IRB # assigned for the project. This must be on all forms at the time of submission. At MSBI, the IRB number follows this format: XXX-XX Number-Year

At ISMMS PPHS, the Human Subjects (HS) # is used with the format: XX-XXXX Year-Number.

On approval letters, only the HS# will be listed. The HS# and the IRB # are the same and therefore are referred to on applications as : IRB (HS#) #. For projects that are being opened with a submission of the 229 Form (used when IRB approval is already in place at one of the IRBs within the Mount Sinai System and you are seeking to extend IRB approval to another site within the Mount Sinai Health System), please contact the IRB to ensure you are using the IRB/HS numbers correctly. Page 3 of 10

Section A: Elements of the Research Check each applicable item to indicate whether the Human Research involves the following and complete the associated forms a) Use of any external (i.e. non-MSBI) sites at which Human Research activities will be conducted – For example, if you are conducting research in a school, nursing home, or other external facility or site, list it here. b) Use of drugs other than the use of approved drugs in the course of medical practice c) Use of a device to evaluate its safety or effectiveness d) Use of a HUD (Humanitarian Use Device) to evaluate its safety or effectiveness e) Submission of a protocol already approved by the MSBI IRB under a different principal investigator. Your intention is to activate the same protocol at a different site(s) for which you are taking separate and full responsibility.

Section B: Approvals Required Prior to Initiating Research Check all additional approvals that are required: a) Radiation being used for reasons other than clinical care b) Use of materials requiring approval from the Institutional Biosafety Committee. This would include biohazards, toxins, infectious agents (of biological origin or otherwise), recombinant DNA, etc. Contact the IRB for more information if your project requires IBC review. c) Research from the Department of Medicine and its Divisions that requires approval from the Department of Medicine Clinical Trial Office. Check with the DOM CTO for the kinds of projects that require submission and approval from them PRIOR to IRB review. d) Investigators or research staff with a significant financial conflict of interest in the research. Refer to the FCOIR website: http://www.wehealny.org/services/coi_in_research/index.html or ISMMS equivalent (if applicable). e) Pathological specimens that require approval from the Pathology department. Check with the Department of Pathology for materials that require submission and approval. f) Human embryonic stem cells. Check with the IRB if you are planning to use human embryonic stem cells. g) Study of use/outcomes for a product sold to Mount Sinai Beth Israel at full price and sponsored by entity with economic interest in sale of product. Check with the [email protected] for more information on the “Registry Committee”. h) Submission required by the Grants and Contracts Office. Check with the OGARA regarding their submission requirements for this and coverage analysis (MCA) and approvals.

Section C: Funding Sources

List all funding sources. For each, list the associated grant number (if applicable) . Section E: Names of all research personnel involved in the design, conduct, or reporting of the research Page 4 of 10

• List all Human Research personnel involved in the design, conduct, or reporting of the Human Research and their roles. This includes all co-investigators, sub-investigators, coordinators, assistants, students, and collaborators who have a role in the design, conduct, or reporting of the Human Research. PERSONNEL DO NOT HAVE TO PRINT THEIR INITIALS ON THIS PAGE, just type their initials. • Indicate each person’s department(s). If personnel have multiple department appointments, list the department that may be related to the topic of this research first. • Indicate each person’s role in the research. • If this person is new to institution or the IRB application process, or if there has been a change in their contact information, submit that information with the other submission materials. • Check the box if the person will have contact with subjects or access to private identifiable data and whether the person will be involved in the consent process. • Check the box if the person has fulfilled their CITI education requirements. The research will not be approved if all individuals have not completed the requirements. Further information regarding WWW.CITIPROGRAM.ORG requirements is available from IRB staff. • Indicate the location of “evidence of qualifications”. The location may vary by role in the research. Typically investigators submit a copy of their CV or biosketch, and others provide a resume or a summary description of their qualifications. • Indicate whether the person has a significant financial interest related to the Human Research. The definition of “significant financial interest related to the Human Research” is included on the application and in the institutional Financial Conflict of Interest in Research policies.

Section F: Other Documents Provide the requested copies of additional documents. Section G: Principal Investigator signature Personally sign and date the application. Section H: Departmental/Designee Approval Have your department chair or their official designee sign and date the application. Follow any departmental procedures that are required in order to obtain their approval. Note: if the research involves personnel from multiple departments, the Chair of each department represented must sign and date the application. Note: if facilities/resources are required for this Human Research which the listed personnel do not have formal authority to provide (e.g. radiology scanning time), it is the PI’s responsibility to obtain permission for these resources prior to the IRB submission to assure the feasibility of the Human Research. Appendix A: External Site Approvals Page 5 of 10

If applicable, list any non-MSBI study sites/facilities in which human research activities will be conducted, and provide a contact name and contact information for each site. Indicate whether an authorized representative of the site has granted permission for you to conduct the Human Research and provide evidence of this permission when available. Indicate if the site’s IRB will review the Human Research (answer No if the site does not have an IRB). Answer whether the site will request to rely on our IRBs, or another IRB. Appendix B: Drugs/Biologics Complete Appendix B for the drug(s) or biologic(s) being used in the Human Research (FDA approved and unapproved). This form does not need to be completed for FDA-approved drugs or biologics whose use in a protocol is totally up to the discretion of an attending physician (not specifically prescribed by the protocol.) Each Appendix B form needs to be signed by the Research Pharmacy. Follow Research Pharmacy policy regarding their submission requirements. Appendix C: Devices Complete one Appendix C form for each device being evaluated for safety or effectiveness (approved and unapproved). Please obtain any necessary departmental approvals for device use/storage prior to the submission to the IRB.

Appendix D: Ionizing Radiation Please visit the website listed on the form for more information or contact the IRB should you have questions about completing this section.

How do I complete the “FORM HRP-503: Protocol Template”?

The Protocol Template should be used in the following cases: 1) If you are submitting a sponsored project to the IRB, please complete this template as an addition to the Sponsor’s protocol. It will be used as the former “protocol summary”. OR 2) If you are submitting a non-sponsored project to the IRB, please complete this template as the study protocol.

Use the “HRP-503a: Template Protocol” as a starting point for drafting a new protocol, and reference the instructions in italic text for the information the IRB looks for when reviewing protocols. Here are some key points to remember when developing a protocol: • For any items described in a “sponsor’s protocol” or other documents submitted with the application, investigators may simply reference the page numbers of these documents within the protocol template rather than repeat information. • When writing a protocol, always keep an electronic copy. You will need to modify this copy when making changes to the protocol. Page 6 of 10

• If you believe your activity may not be Human Research, contact the IRB office prior to developing your protocol. • Note that, depending on the nature of your research, certain sections of the protocol template may not be applicable. Indicate this as appropriate by marking “N/A” after each section heading.

How do I complete the “FORM HRP-502 d and c: Consent Form Template”?

Use the “HRP-502 d and c TEMPLATE CONSENT DOCUMENT” to create a consent document.

d: standalone consent for adult subjects

c: standalone consent for a parent consenting to enroll a child

Note that all consent documents must contain all of the required and all additional appropriate elements of informed consent disclosure. We require that you date the revisions of your consent documents to ensure that you use the most recent version approved by the IRB with prospective subjects, and to fulfill your researcher record- keeping responsibilities. You should continue using the standalone HIPAA Research Authorization currently approval for Mount Sinai Beth Israel. If the project will only occur at Mount Sinai Beth Israel, you may delete references to Mount Sinai St. Luke’s and Mount Sinai Roosevelt and vice versa, but this is not required. Template Spanish consents are available as of January 2015 (HRP 502h).

How do I document consent? Use the signature block approved by the IRB on the last page of the consent document. Complete all items in the signature block and including dates. The following are some requirements for consent documentation: • The subject or representative signs and dates the consent document. • The individual obtaining consent signs and dates the consent document. • Whenever required by the IRB, the subject’s or representative’s signature is to be witnessed by an individual who signs and dates the consent document. • For subjects who cannot read, and whenever required by the IRB or the study sponsor, a witness to the oral presentation signs and dates the consent document. • A copy of the signed and dated consent document is to be provided to the subject. The footer of the consent template should NOT be edited and is solely for IRB use.

How do I complete the “FORM HRP-212: Continuing Review/Final Review Progress Report”? Page 7 of 10

Complete the “FORM HRP-212: Continuing/Final Review Progress Report,” attach all requested supplements and have the formed signed by the individuals listed in the form. Maintain electronic copies of all information submitted to the IRB. If the continuing review involves modifications to previously approved research, submit those modifications as a separate request for modification using the “FORM HRP-213: Modification of Approved Human Research.” If the continuing review application is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application has been received. If the approval of Human Research expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing Human Research procedures is a violation of federal regulations. If current subjects will be harmed by stopping Human Research procedures that are available outside the Human Research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping Human Research procedures that are not available outside the Human Research context, immediately contact the IRB immediately and provide a written list of the currently enrolled subjects and why they will be harmed by stopping Human Research procedures. A"FORM HRP-212: Continuing/Final Review Progress Report” should be submitted within 30 days of the completion of the study.

How do I close out a study? Complete the “FORM HRP-212: Continuing/Final Review Progress Report,” attach all requested supplements, have the formed signed by the individuals listed in the form, and submit the documents to the PPHS office. Maintain electronic copies of all information submitted to the IRB.

How do I complete the “FORM HRP-213: Modifications”? Complete the “FORM HRP-213: Modification of Approved Human Research,” attach all requested supplements and have the formed signed by the individuals listed in the form. Maintain electronic copies of all information submitted to the IRB. Please note that research must continue to be conducted without inclusion of the modification until IRB approval is received.

How do I complete the “FORM HRP-214: Responses Required to Secure Approval”? Response to IRB Required to Secure Approval: Made when IRB members require specific affirmations or modifications to a protocol before approval can be finalized. This was formerly referred to as “ Provisional Approval” and the responses required were “Provisos”. Additionally, a form wasn’t formally required for proviso submission. This form should be completed for every Page 8 of 10 response to the IRB that mentions provisos or RRSAs: Response required to secure approval. The response time for RRSA is 30 days.

What will happen after IRB review?

The IRB will provide you with a written decision indicating that the IRB has approved the Human Research, requires modifications to secure approval, or has disapproved the Human Research.

Possible IRB Decisions: • If the IRB has approved the Human Research. • If the IRB requires a response to secure approval and you are agreeable to the modifications or confirmations required, make the requested modifications or confirmations and submit them to the IRB within 30 days using “FORM HRP-214: Response to IRB” If all requested modifications or confirmations are made, the IRB will issue a final approval. Research cannot commence until this final approval is received. If you do not respond to the IRB within 30 days, the offer of approval with the requested responses will be withdrawn. If you do not accept the requested modifications or confirmations, write up your response and submit it to the IRB within 30 days.

• Tabled: The project may be tabled when the IRB cannot approve the research at a meeting for reasons unrelated to the protocol, such as loss of quorum. When taking this action, the IRB automatically schedules the protocol for a subsequent meeting. • Deferred: Made when the IRB determines that the board is unable to approve a protocol and the IRB suggests modifications the might make the research approvable. When making this motion, the IRB describes its reasons for this decision, describes modifications that might make the research approvable, and gives the investigator an opportunity to respond to the IRB in person or in writing.

How do I submit an Exempt Determination Form? To submit an project for exempt determination: a. Obtain IRB # b. Submit PI certification form to [email protected] c. Submit exempt determination form, HIPAA waiver if applicable, additional materials if applicable (e.g. anonymous survey), and description of what the exempt research entails. Email all items [email protected] In the subject line of the email, write “Request for exemption and IRB # . Page 9 of 10

How do I submit a HIPAA Waiver of Authorization? Use with exempt application if applicable (If you are looking at PHI and recording it in a de-identified manner, you DO need to submit this waiver to be permitted to review identified PHI). Also use with expedited submission requesting waiver/alteration of HIPAA authorization. If you are looking at already de-identified PHI or aggregate data in a retrospective data review, you do NOT need to submit this waiver. Or If you are conducting clinical trial and will be screening PHI to find eligible subjects, even within your own department, your initial submission to the IRB should include this waiver request. How to I submit HRP-224: (Reportable New Information) Form?

The HRP-224 Reportable New Information Form is used to submit new information to the IRB. Page 2 of this form indicates the information items that must be reported to the IRB. Use this form to determine if an information item is reportable to the IRB.

All information must be reported to the IRB within 5 business days of the date the PI became aware of the information.

This form is to be used to report any information listed on page 2 of the form.

Only information that falls under the categories on page 2 must be reported to the IRB. For information that DOES NOT fall into one of those categories, report that information to the IRB at the TIME OF CONTINUING REVIEW along with HRP-212. Page 10 of 10

If any changes to the protocol or consent are required based on the information being reported, HRP-213 (Modification Form) must also be submitted.

This form is in effect as of 1/14/2015. Previous submissions to the IRB of:  DMSB reports  IND safety reports and IND tracking Sheet  **SAE reports on MSBI research subjects involved in clinical trials of drugs. Previously, MSBI IRB required reporting all deaths and SAEs that were unanticipated and at least possibly related. This requirement has changed. PIs must report: Any harm experienced by a subject or other individual that in the opinion of the investigator is unexpected and at least probably related to the research procedures. The death of subject need only be reported if it was unexpected and at least probably related.  Investigator’s brochures with minimal changes not associated with a new submission or a modification to the project  Protocol deviations  Monitoring Reports  Memos from sponsor about anticipated modifications or other safety updates; enrollment closures; change in sponsor, etc  Breaches of confidentiality  Manufacturer Device Reports  Scheduled audit or audit report findings

 Any other information that’s “new” and that is not being submitted as modification SHOULD ALL BE SUBMITTED USING THE HRP-224 FORM!!