Protocol Name:
Principal Investigator: / Phone: / Email:
Primary Contact Name: / Phone: / Email:
Date:
Study Numbers (IF, GCO, HS): / IF: HS: GCO:
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 Ionizing Radiation (including for routine care).
If so, complete and submit Appendix D: Ionizing Radiation
B. Additional Institutional Approvals Required Prior to Initiating Conduct of Research
Prior to submission of this application to the PPHS office, visit Mount Sinai’s online Grant Application Resource Center (GARC) and complete the Research Wizard ( to ensure you have a clear understanding of which institutional reviews are required, at what time in the review process.
All relevant institutional reviews and approvals must be obtained prior to final IRB approval of human research.
C. Funding Sources (add additional as necessary)
Name of Funding Source ( or “Mount Sinai") / Grant (or other) ID number(if applic) / GCO/InfoEd Number
D. RESERVED
This section is reserved.
E. PERSONNEL: Names of all[1]ISMMS/MSH personnel involved in design, conduct, or reporting of the research (All must complete a Financial Conflict In Research disclosure[2] 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? / NOTE: Prior to submission of this application to the PPHS office, all personnel must complete all PPHS required education requirements, and must complete a disclosure under the IF# assigned to this study submission.
A CV, resume, or biosketch for each person listed on the left must be included as part of this submission.
Ex: Sally Smith, MD / PS / Co-Investigator
Ex: Jerry Miranda / OB / Research Coordinator
Principal Investigator
F. OTHERDOCUMENTS
Provide one copy of the following documents as applicable: (See Investigator Manual for additional instructions)
- FORM HRP-211: Application for Human Research, including as applicable:
- Appendix A: External Site Approvals; Appendix B: Drugs/Biologics; Appendix C: Devices; Appendix D: Radiation procedures (may require Dosimetrychart)
- Completed e-Submission Checklist (
- Evidence of qualifications of the key personnel related to their role in this research (biosketch, resume, CV, other description)
- ProtocolTemplate (Including site-specific information for each site under ISMMS PI’s oversight)
- 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:
- Evaluation instruments and surveys
- Advertisements (printed, audio, and video), Recruitment materials and scripts
- 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 (required for New project submissions and co-I, PI changes)
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 (eg Elmhurst)
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[3] for review[4]?
Will the site request to rely on another IRB 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 IRB for review?
Will the site request to rely on another IRB 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 IRB for review?
Will the site request to rely on another IRB 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?
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)
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.
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:
- 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)?
- 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
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
Appendix D: USE OF IONIZING RADIATION
(Complete Section 1 and/or 2 of this form as appropriate)
(Does not apply to MRI, laser or ultrasonography)
For Laser, contact Radiation Safety Officer: x 42271
SECTION 1: For Projects Utilizing Ionizing Radiation-Based Imaging/Procedures
As Standard of Care
For protocols whichemploy ionizing radiation-basedimaging or procedures, the inclusion of which isconducted in accordance with standard practice both from the perspective of the actual procedure and the frequency of the procedure, please indicate which of the following will be used:
Choose as applicable:CT imaging
Nuclear medicine
Radiography
Fluoroscopy
Radiation-based therapy
PET/CT
OTHER:
ATTESTATION FOR PROCEDURES/IMAGING OBTAINED AS STANDARD OF CARE:
"I attest that any procedures presented above as standard of care would be obtained in this subject/patient population regardless of whether they take part in this research protocol, and as such these procedures do not require review and approval by the Mount Sinai Radiation Safety Committee."
______
Signature of Principal Investigator or Clinical Co-Investigator
SECTION 2: For Projects that Involve Radiological Procedures Performed for Research
Select Type / Complete Appendix C: Devices / Indicate Authorized User and Credentialed Reader (below) / RSC Subcommittee Review required / Complete Dosimetry Wizard*
RADIATION USAGE DIFFERING FROM STANDARD OF CARE
Radiologic procedures that are administered in addition to those that the participant would receive as part of standard care (radiation above and beyond standard of care) / X
Radiological procedures that are administered solely for experimental or research purposes (radiation would NOT be otherwise administered) / X
Standard of care radiological procedures that are being altered or performed differently for research / X
Use of radiologic procedures that are the subject of the investigation (comparison studies) / X
INVESTIGATIONAL IMAGING, AGENTS OR THERAPY
Use of an investigational radiopharmaceutical, or
Use of an approved radiopharmaceutical for an investigational purpose / X / X
Use of investigational radiotherapy, or
Use of approved radiotherapy for an investigational purpose / X / X
Use of fluoroscopy / X / X
Radiation exposure to children or pregnant women / X / X
Radiation exposure tohealthy subjects (ADULTS) / X / X / X
Use of an investigational radiologic device (such as an experimental scanner), or
Use of an approved device for an investigational purpose / X / X / X
For investigational imaging, agents or therapy, or use on pregnant, child or healthy subjects (as defined above):
The procedures will be supervised by the following Authorized User[5]:
All scans will be read by the following individual credentialed & qualified to read this type of scan:
* After completing the Dosimetry spreadsheet, incorporate the appropriate consent language provided into the consent, and save two versions: 1) an Excel version (for your use); and 2) a PDF version (for submission to PPHS Office).
1
Revised: 9/2/14
[1] CRC/CRU and Ruttenberg Cancer Center Nurses need not be listed on this form
[2] Refer to Financial Conflict of Interest in Research (FCOIR) website and the Sinai Central module for details
[3] Not allowed for Veterans Administration (VA) research
[4] Additional paperwork is required. Please contact the PPHS office.
[5] “An "Authorized User" is an individual approved by MSMC’s Radiation Safety Office to administer radiation and radioisotopes to humans. An Authorized User must supervise these activities in this study. For information or assistance contact the Radiation Safety Office at (212) 241-2269 (