FORM: Application for Human Research
/ Protocol Name: /
/ Principal Investigator: /
/ Primary Contact Name: / Contact Info: /
/ Date: /
/ Study Numbers (IF, GCO, HS): /
A. Elements of the Research (Does the research involve any of the following?)
No / Yes / Use of any external (non-MSSM) facilities or sites under the responsibility of the Principal Investigator/research team. If so, complete and submit Appendix A: External Site Approvals
No / Yes / Use of drugs or biologics other than the use of approved drugs/biologics in the course of medical practice
If so, complete and submit Appendix B: Drugs/Biologics
No / Yes / Use of a device to evaluate its safety or effectiveness.
If so, complete and submit Appendix C: Devices
No / Yes / Use of a Humanitarian Use Device (HUD) to evaluate its safety or effectiveness (If use is exclusively in course of medical practice, complete “FORM: Application for Humanitarian Use Device” instead; otherwise complete this form)
No / Yes / Submission of a protocol already approved by the MSSM 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. If so, follow modified submission instructions in Investigator Manual.
B. Additional Institutional Approvals Required Prior to Initiating Conduct of Research
Does this research involve any of the following?
Radiation being used for reasons other than clinical care? / No Yes / If YES, has Radiation Safety Committee approval been obtained? If not, explain current state: / No Yes
Use of materials requiring approval from the Institutional Biosafety Committee (e.g. biohazards, recombinant DNA)? / No Yes / If YES, has IBC approval been obtained?
If not, explain current state: / No Yes
Cancer research that requires approval from the Protocol Review & Monitoring Committee? / No Yes / If YES, has PR&MC approval been obtained?
If not, explain current state: / No Yes
Investigators or research personnel who disclosed a potential/actual financial conflict of interest regarding this research? / No Yes / If YES, has FCOIRC resolution been obtained for all personnel?
If not, explain current state: / No Yes
Pathological specimens that require approval from the Pathology department? / No Yes / If YES, has Pathology approval been obtained?
If not, explain current state: / No Yes
Human embryonic stem cells? / No Yes / If YES, has ESCRO approval been obtained?
If not, explain current state: / No Yes
Study of use/outcomes for a product sold to Mount Sinai at full price and sponsored by entity with economic interest in sale of product? / No Yes / If YES, has Registry Committee approval been obtained? If not, explain current state: / No Yes
A required submission to the Grants and Contracts Office? / No Yes / If YES, have you submitted to Grants and Contracts Office? If not, explain current state: / No Yes
A required submission to the Office of Clinical Research’s Division of Clinical Trials Budget and Billing? / No Yes / If YES, have you submitted the CTBB checklist and supporting documents to OCR? If no, explain current state: / No Yes
Use of the Investigational Drug Service? / No Yes / If YES, have you submitted the required IDS forms to the IDS for approval? If no, explain current state: / No Yes
Use of the Clinical Research Centers? / No Yes / If YES, have you submitted an application to the CRC Office? If no, explain current state: / No Yes
C. Funding Sources (add additional as necessary)
Name of Funding Source / Grant (or other) ID number(if applic) / GCO Number / Infoed Number
D. RESERVED
This section is reserved.
E. PERSONNEL: Names of all* personnel involved in design, conduct, or reporting of the research (All must complete a Financial Conflict In Research disclosure** regarding this research)
(Make copies of this page or add additional lines as needed)
Name / Primary Department
(use abbreviation) / Role in the research
(e.g. co-investigator, research coordinator, statistician, etc.) / Involved in interpersonal contact communication with subjects, or access to private identifiable data? / Involved in consent process? / Fulfilled all PPHS education requirements+? / Location of “evidence of qualifications”
provided to PPHS (e.g. protocol template #4, biosketch, CV, other document) / Indicated potential or actual financial interest related to this research on their completed FCOIR form*?
Yes / No
Ex: Sally Smith, MD / PS / Co-Investigator / Biosketch
Ex: Jerry Miranda / OB / Research Coordinator / Protocol Template #4
*Refer to Financial Conflict of Interest in Research (FCOIR) website and the Sinai Central module for details
** CRC/CRU and Ruttenberg Cancer Center nurses need not be listed on this form
+Refer to PPHS website for Educational Requirements for details
F. OTHER DOCUMENTS
Provide one copy of the following documents as applicable: (See Investigator Manual for additional instructions)
· FORM: Application for Human Research, including as applicable:
o Appendix A: External Site Approvals
o Appendix B: Drugs/Biologics
o Appendix C: Devices
· Evidence of qualifications of the key personnel related to their role in this research (biosketch, resume, CV, other description)
· Protocol Template (If this is the activation of a previously approved protocol at a new site or sites that will be overseen by a principal investigator who will take separate and full responsibility for that site or those sites, include only site-specific information.)
· Grant application
· Complete sponsor protocol (including DHHS-approved protocols such as an NIH-sponsored multi-site study or Cooperative Group Clinical Trial protocol)
· HIPAA forms
· Data collection instruments (questionnaires, etc.; do not submit case report forms)
· All written material to be provided to or meant to be seen or heard by subjects, including:
o Evaluation instruments and surveys
o Advertisements (printed, audio, and video)
o Recruitment materials and scripts
o Consent documents
· If consent will not be documented in writing, a script of information to be provided orally to subjects
· DHHS-approved sample consent document (e.g., sample consent from NIH-sponsored Cooperative Group Clinical Trial)
· Current investigator brochure for each investigational drug
· Current package insert for each marketed drug
· Current product information for each medical device being evaluated for safety or effectiveness.
· If the research is conducted or funded by the Department of Energy, a completed “Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with DOE Requirements”
G. Principal Investigator Acknowledgement
I agree to conduct this Human Research in accordance with applicable regulations and the organization’s policies and procedures.
Principal Investigator Signature / Date
Department: / Division (if applicable):
H. Department Chair/Designee Approval (only required for New project submissions)
I have reviewed this application and determined that all departmental requirements are met and that the investigator has adequate resources to conduct the Human Research in terms of time, facilities, staff, access to a subject population, and resources for care that subjects may need.
Department Chair/Designee Printed Name: / Date
Department Chair/Designee Signature:
Division Chair/Designee Printed Name (if applic): / Date
Division Chair/Designee Signature (if applic):
Appendix A: External Site Approvals
(Make or download additional copies of this page as needed)
Complete for each external site for which the Mount Sinai Principal Investigator will bear responsibility for the conduct of research (including research affiliates)
Site name:
Contact name:
Contact phone & email
Yes / No
Has the site granted permission for you to conduct the research? Attach when available.
Will the site get federal funding passed through from your grant?
Will the site’s IRB review the research? Answer No if the site does not have an IRB.
Will the site request to rely on the MSSM IRB[1] for review?
Will the site request to rely on another IRB1 for review? If yes, describe:
Site name:
Contact name:
Contact phone & email
Yes / No
Has the site granted permission for you to conduct the research? Attach when available.
Will the site get federal funding passed through from your grant?
Will the site’s IRB review the research? Answer No if the site does not have an IRB.
Will the site request to rely on the MSSM IRB1 for review?
Will the site request to rely on another IRB1 for review? If yes, describe:
Site name:
Contact name:
Contact phone & email
Yes / No
Has the site granted permission for you to conduct the research? Attach when available.
Will the site get federal funding passed through from your grant?
Will the site’s IRB review the research? Answer No if the site does not have an IRB.
Will the site request to rely on the MSSM IRB1 for review?
Will the site request to rely on another IRB1 for review? If yes, describe:
Appendix B: Drugs+/Biological Products++
(Make or download additional copies of this page as needed)
(Complete this form for all drugs+ and biological products++ whose use is specifically prescribed in the research. This form does not need to be completed for approved drugs whose use is totally up to the discretion of an attending physician as part of medical care. Contact the PPHS if unsure.)
SECTION 1
Does the protocol include drugs and/or biologics as routine care, and these are supplied through the hospital pharmacy or U.S. commercial pharmacy supply?
No Yes
SECTION 2
List all drugs and biologics being used in the research not as routine care.
This includes approved drugs that are supplied or paid for by the company for this research, approved drugs that are not given under routine care guidelines, and all investigational drugs:
Generic / Brand Name / IND # (or None) / Name of IND holder
For each drug/biologic with an IND number, ensure that the application includes one of the following:
· Sponsor protocol with the IND number ·Communication from the sponsor or the FDA with the IND number
To receive IRB approval you must obtain the following the signature below to indicate that Investigational Drug Service of the Hospital Pharmacy has reviewed and approved the control of drugs and biologics in this study. Changes made to the approved plan for control of drugs and biologics require a new IDS approval.
______
SIGNATURE, IDS PHARMACY REPRESENTATIVE Date
Drug/Biologic Control Provided Under: (Pharmacy Initials)
______Research Pharmacy Plan: ______
PRINTED NAME OF IDS PHARMACY REPRESENTATIVE Investigator (or 3rd party) Plan: ______
Hospital Pharmacy Plan: ____
+Dietary supplements, nutraceuticals, and other compounds, when intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
(including studies for that purpose) are considered drugs. Drugs also include “articles (other than food) intended to affect the structure or any function of the
body of man or other animals” including endogenous compounds used to provoke or blunt a physiologic response.
++ Live organisms may be both a biological product and a drug.
Please see the PPHS and other institutional websites for further guidance about drugs and biological products, Investigational New Drug regulations,
and the responsibilities of investigators who become IND sponsor-investigators.
Appendix C: Devices
Please complete one form for each device whose safety or effectiveness is being evaluated in the research
(Make or download additional copies of this page as needed)
Name of Device:
Manufacturer:
Description of Device (include a brief description of the device, its purpose, how it is used and how it differs from existing devices):
FDA status:
1. Is this study being done under an IDE?
If Yes, skip to question #8. / Yes No
2. Is this device FDA approved? / Yes No
3. Is this device to be used in accordance with its PMA or 510(k) approval letter (approved for use in the specified population)? / Yes No
If Yes to questions #2 and #3, skip to question #9.
4. Is this a diagnostic device AND
· is noninvasive* and
· does not require an invasive sampling procedure that presents significant risk and
· does not by design or intention introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure?
*The FDA defines the term noninvasive as the use of a diagnostic device or procedure that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive. / Yes No
5. Is this device test limited to:
· consumer preference testing, or
· testing of a modification, or
· testing of a combination of devices if the device(s) are legally marketed device(s)
AND the testing is not for the purpose of determining safety or effectiveness AND does not put subjects at risk? / Yes No
If Yes to either question #4 or #5, skip to question #11.
· If there is an IDE exemption, or existing correspondence with the FDA, please provide documentation.
If No to both of these questions, continue to #6.
Abbreviated IDE Requirements
6. Is the sponsor claiming that this device is not a significant risk device? / Yes No
7. Does the protocol include a justification as to why the device is not a significant risk device? / Yes No
If No to either question #6 or #7, proceed to question #8.
If Yes to both questions, skip to question #11.
Studies that Require an IDE
8. If the device has an approved IDE please provide the IDE #: and identify the name of investigation’s IDE holder (IDE sponsor listed on current FDA corresondence):
Provide documentation of the IDE number (e,g. protocol imprinted with the IDE#, IDE sponsor correspondence or FDA correspondence. If this is an investigator-held IDE, submit a copy of FDA correspondence documenting the IDE number.
Manufacturing and Control:
9. If the device is Investigator-Manufactured, explain what arrangements and precautions have been taken to ensure proper manufacturing of the device and compliance with 21 CFR 812, 21 CFR 814 and Good Manufacturing Practice: Not Applicable
10. Describe the policies and procedures for storage, handling and control of distribution of the investigational device so that the device will only be administered by authorized investigators and will only be used in subjects that have agreed to take part in the research:
Coverage of Costs:
11. Will the sponsor provide the device at no cost for the research subjects (this does not include the hospital covering the costs of the device)? / Yes No
a. If No, please provide detailed information of who will cover the costs and how the cost level was determined:
Departmental Approval: