FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Contact Info:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
A. Elements of the Research (Does the research involve any of the following?)
Use of any external (non-MSSM) facilities or sites under the responsibility of the Principal Investigator/research team.
No
Yes If so, complete and submit Appendix A: External Site Approvals
Use of drugs or biologics other than the use of approved drugs/biologics in the course of medical practice
No
Yes If so, complete and submit Appendix B: Drugs/Biologics
Use of a device to evaluate its safety or effectiveness.
No
Yes If so, complete and submit Appendix C: Devices
Use of a Humanitarian Use Device (HUD) to evaluate its safety or effectiveness (If use is exclusively in course of
No
Yes medical practice, complete “FORM: Application for Humanitarian Use Device” instead; otherwise complete this form)
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,
No
Yes
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
No
If YES, has Radiation Safety Committee approval been
No
clinical care?
Yes obtained? If not, explain current state:
Yes
Use of materials requiring approval from the
No
If YES, has IBC approval been obtained?
No
Institutional Biosafety Committee (e.g.
Yes If not, explain current state:
Yes
biohazards, recombinant DNA)?
Cancer research that requires approval from the
No
If YES, has PR&MC approval been obtained?
No
Protocol Review & Monitoring Committee?
Yes If not, explain current state:
Yes
Investigators or research personnel who
If YES, has FCOIRC resolution been obtained for all
No
No
disclosed a potential/actual financial conflict of
personnel?
Yes
Yes
interest regarding this research?
If not, explain current state:
Pathological specimens that require approval
No
If YES, has Pathology approval been obtained?
No
from the Pathology department?
Yes If not, explain current state:
Yes
No
If YES, has ESCRO approval been obtained?
No
Human embryonic stem cells?
Yes If not, explain current state:
Yes
Study of use/outcomes for a product sold to
No
If YES, has Registry Committee approval been
No
Mount Sinai at full price and sponsored by entity
Yes obtained? If not, explain current state:
Yes
with economic interest in sale of product?
If YES, have you submitted to Grants and Contracts
A required submission to the Grants and
No
No
Contracts Office?
Yes Office? If not, explain current state:
Yes
If YES, have you submitted the CTBB checklist and
A required submission to the Office of Clinical
No
No
Research’s Division of Clinical Trials Budget and
supporting
documents
to
OCR
? If no, explain
Yes
Yes
Billing?
current state:
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Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
C. Funding Sources (add additional as necessary)
Name of Funding Source
Grant (or other) ID number(if applic)
D. PPHS Pre-Review Services
Check to indicate that you wish to bypass the optional PPHS pre-review process.
GCO Number / Infoed
Number
(By default, PPHS staff members will conduct pre-reviews of certain protocol submissions to make an initial and unofficial determination
of which regulatory criteria appear to be met, which appear not to be met, and which would appear to be met if the investigator modified
the protocol as requested by the pre-reviewer. This pre-review process is intended to improve the likelihood that the protocol will be
approved when officially reviewed by the IRB.)
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Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
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)
Ex: Sally Smith, MD
Ex: Jerry Miranda
PS
OB
Co-Investigator
Research Coordinator
Location of
“evidence of
qualifications”
provided to
PPHS (e.g.
protocol template
#4, biosketch,
CV, other
document)
Biosketch
Protocol Template #4
*Refer to Financial Conflict of Interest in Research (FCOIR) website or the Sinai Central module for details
** Refer to PPHS website for Educational Requirements for details
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Revised 8/25/10
Indicated potential
or actual financial
interest related to
this research on
their completed
FCOIR form*?
Fulfilled all PPHS
education requirements**?
Involved in consent
process?
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?
Name
Primary Department
(use abbreviation)
(Make copies of this page or add additional lines as needed)
Yes
No
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Contact Info:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
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):
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FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
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 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:
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:
1
Not allowed for Veterans Administration (VA) research
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Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
Appendix B: Drugs/Biologics
(Make or download additional copies of this page as needed)
(Complete this form for each drug/biologic whose use is specifically prescribed in the research. 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.)
1. A. Generic Name of Substance:
B. Brand Name of Substance:
2. Is this a controlled substance? YES *
NO
Indicate Schedule II , III, IV, or V:
Research License #(s) License Class:
Name of Licensee:
If "Yes", complete the following:
None
DEA #:
NYS #:
Date of Expiration:
Date of Expiration:
* Please refer to Mount Sinai Controlled Substance Policy at http://www.mssm.edu/grants/pdfs/contsubs.pdf
3. Manufacturer’s name or source of substance:
4. A. Form:
5.
B. Strength:
Is the drug/biologic being administered under an IND? YES
6. Is this substance FDA approved?
YES
NO
(Proceed to #8) NO
(Proceed to #6)
(Proceed to #7a-h)
(STOP: Either an IND or an FDA exemption is required for each unapproved
drug/biologic to be used in your research. If you answered “No” to questions #5 and #6, the IRB
cannot approve the research until an IND or exemption has been received. Please provide a copy
of correspondence with the FDA along with this document.)
7. For studies of approved drugs without an IND:
a) Is this investigation intended to be reported to FDA as a well-controlled study in support of a new indication for use or
intended to be used to support any other significant change in the labeling for the drug?
YES
NO
If "Yes", please provide information about the intended change:
b) Will dose, frequency, or duration of use differ from what is indicated on the product label?
YES
NO
If "Yes", specify dose/frequency/duration:
c) Will the substance be administered by a route NOT indicated on the product label?
YES
NO
If "Yes", specify route:
d) Will the substance be used for a population (e.g. children) NOT indicated on the label?
YES
NO
If “Yes”, Please specify population and age range:
e) Could the manner in which the substance will be used in this study significantly increase the
risks (or decrease the acceptability of the risks) associated with use of the drug product?
YES
NO
If "No", please indicate why not:
If "Yes", please provide information about the potential change in risk:
g) If YES is marked in any question #7 above, an IND or an IND exemption from the FDA will be required. Apply to the
FDA; you will get a determination in 30 days. Please provide a copy of your correspondence with the FDA along with this
document.
h) Is there a Black Box Warning associated with the labeling of this substance?
YES
NO
If Yes, a) Please insert exact text of Black Box Warning here:
b) Please indicate what information regarding this risk has been included in the consent document
given the context of the research study?
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Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Then proceed to question #9.
If No, proceed to question #9.
Contact Info:
8. Studies that need to be conducted under an IND:
a) Is there an active IND or has an IND been applied for?
YES
NO
If "Yes", answer the following:
What IND number(s) are associated with the research?
Provide documentation that references the IND number (e,g. protocol imprinted with the IND#, sponsor
correspondence or FDA correspondence; if this is an investigator-held IND, submit a copy of FDA
correspondence documenting the IND number.)
Who is the holder of the IND (should match 1571 form/FDA correspondence)?
Has the FDA indicated a clinical hold or requested any revisions to the study?
Please provide information concerning any pending applications:
If “No”, the IRB cannot approve the research until an IND or exemption has been received. Please provide a
copy of your correspondence with the FDA along with this document. Please explain:
b) Has the substance ever been safely administered previously to humans?
YES
NO
Please provide data:
c) Indicate method of administration:
d) Indicate dosage:
e) Indicate previous known medical use:
f) Indicate known or anticipated adverse events:
g) Provide references of published papers on product safety (include studies of appropriate animal literature):
h) Indicate pharmacologic, therapeutic properties, cautions and contraindications:
i) Is there a Black Box Warning associated with this substance?
YES NO
If Yes, a) Please insert exact text of Black Box Warning here:
b) Please indicate what information regarding this risk has been included in the consent document
given the context of the research study?
Then proceed to question #9.
If No, proceed to question #9.
9.
Total number of subjects to be studied: Across all sites:
At sites covered by the Mount Sinai IRB review:
10. Indicate where study substance will be administered:
a) HOSPITAL AREAS**
INPATIENT HOSPITAL
OUTPATIENT CLINIC (HOSPITAL)
(**Please note: JCAHO medication management section 7.42 states when a hospital operates a pharmacy, the pharmacy must control the
storage, dispensing, labeling and distribution of investigational medication. Research taking place in hospital areas must use the Mount
Sinai pharmacy services to control the drug/biologic)
b) NOT DESIGNATED HOSPITAL AREAS
OUTPATIENT (FPA)
PRIVATE OFFICE (SCHOOL OF MEDICINE OR OFFSITE LOCATION)
Indicate which of the following will be storing/dispensing the drug/biologic:
i)
The MSH Pharmacy
ii) The Principal Investigator and his/her authorized personnel
Describe your plan to store, handle, and control distribution of the drug/ biologic so that it will only be
administered by authorized investigators and will only be used in subjects that have agreed to take part in the
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Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Contact Info:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
research:
iii) An entity other than the MSH Pharmacy or the PI and his/her authorized personnel
Describe who the entity is, and the plan to store, handle, and control distribution the drug/ biologic so that it will
only be administered by authorized investigators and will only be used in subjects that have agreed to take part in
the research:
11. Requested Pharmacy services:
STORAGE
REPACK
LABEL
SITE VISITS
RANDOMIZATION
DILUTE/COMPOUND
DESTRUCTION
Other:
12. Will the substance be supplied without cost (by the sponsor or study fund)?
YES
NO
a) If applicable, will a placebo be provided without cost?
YES
NO
If No, please provide a fund number below for the procurement or manufacturing of agent
13. Dispensing fee per order (to be determined by Pharmacy and billed quarterly)
FUND NUMBER TO BE CHARGED:
---
$25
$60
N/A
$120
---
14. Investigator Information:
Role
Name
Hospital #
Office Phone #
Home Phone #
Prin. Invest.
Investigator
Investigator
15. PHARMACY ONLY:
If a Black Box Warning is present, has the risk been described appropriately in the consent document? If not, how does the
Pharmacy think it should it be modified?___________________________________________________________________
Other Pharmacy comments/decisions: ____________________________________________________________________
16. PRINCIPAL INVESTIGATOR SIGNATURE: The signature below indicate that the information above, including any
modifications made by the Pharmacy regarding fees, risks, INDs, and any other required modifications, have been agreed to by
the Principal Investigator (if necessary, via phone call) and the Pharmacy.
________________________________________________
SIGNATURE, PRINCIPAL INVESTIGATOR
________________
Date
17. RESEARCH PHARMACY SIGNATURES [Required only when using the Mount Sinai Pharmacy to store, handle or dispense]
________________________________________________
SIGNATURE, RESEARCH PHARMACY REPRESENTATIVE
______________________________________________________
PRINTED NAME OF RESEARCH PHARMACY REPRESENTATIVE
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Revised 8/25/10
________________
Date
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
Note: Each Appendix B form must be carefully completed and signed by the PI prior to submitting to the Department of Pharmacy Office in
Annenberg B2-12. In order for the form to be reviewed by the Department of Pharmacy, it must be accompanied by the protocol, protocol
template, Investigators Brochure (if applicable) and the proposed informed consent document. If the research required PR&MC review, the
PR&MC approval letter should be included. Forms are reviewed on a rolling basis and you will be contacted when the signed forms are
available for pick-up or if there are questions about the proposed Human Research. If there are omissions or errors in the submission, this will
prevent a timely Pharmacy review. Please factor the Pharmacy review time in your submission planning. Please be aware that item #13 will be
filled out after submission to the Department of Pharmacy; costs are based on a variety of factors including drug/biologic handling complexity.
When planning Human Research involving drugs/biologics, it is strongly advised that you consult with the Research Pharmacy very early in the
process, in order to assess the feasibility of providing the drug/biologic or service that may be requested, costs, and other related matters.
Direct questions to the Department of Pharmacy at 212-241-2493.
9
Revised 8/25/10
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
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?
Yes
If Yes, skip to question #8.
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
Yes
use in the specified population)?
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
Yes
product or procedure?
No
*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.
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?
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?
7. Does the protocol include a justification as to why the device is not a significant risk device?
If No to either question #6 or #7, proceed to question #8.
If Yes to both questions, skip to question #11.
10
Revised 8/25/10
Yes
No
Yes
No
Yes
No
FORM HRP-211: Application for Human Research
Protocol Name:
Principal Investigator:
Primary Contact Name:
Date:
Study Numbers (IF, GCO, HS):
Contact Info:
Studies that Require an IDE
8. If the device has an approved IDE please provide the IDE #:
and identify the Sponsor (holder of
the IDE): (choose one) MSSM Investigator: (provide specific name):
Provide documentation of the IDE number (e,g. protocol imprinted with the 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
Yes
include the hospital covering the costs of the device)?
No
a. If No, please provide detailed information of who will cover the costs and how the cost level was
determined:
Departmental Approval:
If departmental approval is required regarding research involving devices, the PI should obtain
those approvals prior to submission to the PPHS.
Please attach the following items, if applicable:
Device brochure that includes the following:
 Description of device and its use
 Reports of prior investigations with device
 Proposed investigational plan
 Participant selection criteria description
 Monitoring procedures
IDE application/ FDA’s device risk assessment or notification
Documentation that the device meets criteria to be Exempt from the regulations
Non-significant risk supporting documentation
Determinations made by other IRBs
Signature of Principal Investigator
Date
Printed Name
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