GOG 152 IRB APPLICATION

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Protocol No.

Institutional Review Board (IRB)

REQUEST FOR REVIEW OF INVESTIGATION
INVOLVING USE OF HUMAN SUBJECTS

The human subjects regulations (45 CFR Part 46) define research as “a systematic investigation, including
research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45
CFR 46.102(d)]. A human subject is “a living individual about whom an investigator (whether professional or
student) conducting research obtains (1) data through intervention or interaction with the individual or (2)
identifiable private information” [45 CFR 46.102(f)].

Weill Cornell Medical College (WCMC) and federal policies require review of each protocol by the WCMC’s IRB
with respect to the: 1) Rights and welfare of subjects; 2) adequacy of methods used to secure informed consent;
and 3) risk and potential benefits of the research to the subject. Read these instructions carefully and then type and
complete each item. If an item is not applicable, indicate this by "NA" DO NOT leave anything blank; Obtain
required signatures. The completed application and required attachments must be submitted as a single PDF file
bookmarked via email to submit2IRB@med.cornell.edu.

1. Principal
Investigator Degree

2. Academic Title Telephone

3. Email Fax

4. Department Division

5. Mailing
Address Room

6. Research
Coordinator Telephone / Email

7. New Protocol

Amendment to Approved Amendment
Protocol Number/Version :

8. Project title (if applicable, use same title as externally-funded research):

Purpose of Project (one or two
9. sentences):

10. Expected dates of (post IRB approval) to
study
Expected duration of study for individual subjects
(days/months)

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11. Source of funds (name of agency, institution, or industry
sponsor)

12. For IRB protocols associated with a grant proposal

Proposal: a. Not b. will be c. has been submitted to funding agency (date):
applicable submitted
d. Proposal is under consideration for funding by the Sponsor and Just-in-Time documentation is
required (i.e.,Sponsor notified Grants and Contracts that the grant application is under
consideration for funding and requires a 310 form and/or a grant approval memo to certify IRB
approval of the project’s proposed use of human subjects and/or evidence of compliance with the
education in protection of human research participants requirement). Please submit the grant
(including any supplemental revisions submitted to the Sponsor) along with the protocol
submission for review by the IRB.

13. Proposal (Grant) Title (If different from project title)

14. Please specify the agency Grant number (If known):

15. If project will be funded to another investigator, give Principal Investigator’s name and grant title

16. Co-investigators:
Name;Degree Role in the Study(Use key Department Telephone #
below; Enter numbers for
all that apply)*
A.
B.
C.
D.
E.
F.
*1. Conduct informed consent process; 2. Screen subjects; 3. Collect demographics; 4. Evaluate
Inclusion/Exclusion Criteria and Medical History; 5. Perform Physical Examination; 6. Perform other study
specific interventions; 7. Assess Adverse Events; 8. Record Concomitant Medications; 9. Review/Sign CRFs
and/or DCFs; 10. Protocol design; 11. Supervision of study personnel; 12. Other (please specify)
Please note, independent monitors (if indicated in section D14) should not be listed as co-investigators.

17. Student No Yes, complete the items below
Research:

List Student
Name(s):

Indicate the role of the student(s) and who will supervise the student(s):

18. Where will study be conducted? (be specific, i.e., WCMC, New York Presbyterian Hospital, Specific clinics
within WCMC or NYPH.)

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19. Is this a multi-site study? If yes, please indicate which is the coordinating/lead site. If WCMC will be the
coordinating site for this study, please contact the IRB at 646-962-8196 for guidance on additional
information that will be required for this protocol application.

20. Required Summary: Please write a brief descriptive summary of this study (200 words or less), in Layman
Terms (8th grade language), that would be useful as a public awareness mechanism.

SECTION A. NON TECHNICAL RESEARCH PLAN

For the following questions, state concisely, and in language that can be understood by a non-scientist, the
design, aims and specific objectives of the research, and the procedures to be used to accomplish these aims.
Since the Board includes lay persons, this non-technical research plan must avoid or clearly explain highly
technical language. Describe what will happen to subjects and what they will be expected to do. State specific
interventions and procedures which would not otherwise be performed for your intended subject population except
for the purposes of this study, as well as any standard of care procedures that would be done as part of the research.
Do not include the technical summary from the NIH grant or sponsor’s protocol as this will unnecessarily
slow the approval process.
A1. Study Design (For example, the hypothesis, research question, standard and experimental procedures, special
or unusual equipment of procedures.) Include specifics on all study interventions and their frequency (e.g.,
administration of study drug, surgical intervention, blood draws, clinical assessments, etc)

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 List together in a group all procedures that are part of standard of care treatment if being administered
as part of the research, and list together in a group all procedures that are investigative, separating and
labeling the two groups. Tables and/or charts are helpful and encouraged):
 For randomized studies, provide the above information for each study group.

A2. Rationale and justification for the study (for example, historical background, investigator’s personal
experience, pertinent medical literature):

A3. Primary study endpoint:

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A4. Primary objective:

A5. Secondary objectives:

A6. Inclusion/Exclusion criteria:

A7.Tissue collection: (include amount and frequency of samples of blood and other bodily fluids in chart
below)
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Bodily Fluid Amount Frequency Total
Blood

Urine
Other________
_

A8. Statistical considerations (e.g. justification for sample size or “n”; Please include the total number of
subjects to be recruited at WCMC, the total number of subjects at all sites (if a multisite protocol), expected
total screening failures/dropouts at WCMC (if applicable), etc.):

A9. Relative importance/value of the trial, considering “standard” therapy and published/competing trials.

SECTION B. SUBJECT POPULATION
Please note: Subjects are considered to be enrolled in the study once they have signed the consent form.
The numbers below should include those subjects who will sign the consent form but may ultimately not
participate in the study due to screen failure, not meeting inclusion/exclusion criteria, etc.

B1. Number being enrolled # of # of NonGender
at WCMC: Males: Females: Specific
enrollment

Specify Age of the subjects to be enrolled: to

B2. Type: Inpatients Patient Controls Patient Minors (up to 18 years)

Outpatients Normal Volunteers Volunteer Minors (up to 18 years)

B3. Special Groups (check applicable boxes):

Minors* Prisoners*

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Fetuses* Students and/or employees

Pregnant Women* Derived materials or data

Special racial or ethnic group (specify): Mentally/cognitively impaired (e.g. mentally ill,
mentally retarded, emotionally disturbed, senile
dementia)

* These special groups require additional protections under the law – see sections J, K and L at the end of this
application if these groups will be included as subjects and fill out the applicable section.

B4. Rationale for use of special groups, or subjects, whose ability to give voluntary informed consent may be in
question:

B5. Subject's state of physical health. Indicate if seriously or terminally ill.

B6. Indicate a) how subjects will be initially identified (medical records, physician referral, canvassing, classes,
etc.) AND b) how subjects will be recruited (bedside or clinic interview, ads, telephone, letter, etc.) If you will
be recruiting subjects from a specific clinic within WCMC/NYP, please indicate this here. BE SPECIFIC.

Note: For HIPAA purposes, if you will be reviewing patient medical records or appointment records/logs for
research recruitment purposes, please specify if the patients are those of the Principal Investigator or Co-
investigators, and submit a request for a HIPAA Partial Waiver to perform this action in accordance with
HIPAA Privacy Law as it applies to research.

B7. If there is more than one active trial being run by the PI/Co-Investigators or in the department/division (if
known) that the subjects would be eligible for, please provide an algorithm/schema or information on how it
will determined which study the subject will be offered. If there are no other studies that subjects would be
eligible for at this institution, please state not applicable.

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B8. Will the Clinical Translational Science Center be Yes No
used?
Pediatric Unit and/or Adult Unit

B9. Will subjects receive any inducements before, or rewards or compensation during or after the study?

No Yes If yes, how much and in what form? (Cash, taxi fares, medical care, meals, gifts, etc.):

SECTION C. HUMAN TISSUE

Is human tissue from patients at this institution being used in this study (for definition of human tissue and surgical
waste, see Human Tissue Section & Request Form at
http://www.med.cornell.edu/research/for_pol/ins_rev_boa.html).
No, proceed to Section D

Yes, complete the Human Tissue Section & Request Form. Submit completed form, a copy of the IRB
protocol application, and a copy of the consent form (if applicable) to:
submit2pathology@med.cornell.edu for departmental approval.

SECTION D. RISKS

The purpose of this section is to determine if subjects will be placed "at risk" – (i.e., exposed to the possibility of
physical, psychological, sociological, or other harm as a consequence of any activity proposed in the research
project)

RISK CLASSIFICATION: What is the overall risk classification of the research: (select the classification
that applies) Note: Final risk level is determined by the IRB.

Minimal risk Greater than minimal risk

NOTE: according to HHS/FDA regulations, no more than minimal risk means: “The probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily

Revised 3-2012 Page 8 of 36
encountered in daily life or during the performance of routine physical or psychological examinations or
tests.”

DOES THE RESEARCH PLANNED IN THIS PROJECT INVOLVE: Yes No
D1. Does the protocol involve any form of invasive procedure (minimally invasive or greater)?

D2. Will any of the invasive procedures be done for research purposes only?
D3. Administration of investigational drugs, chemical or biological agents; if yes, complete sections
H and I.
D4. Administration of approved drugs, chemical or biological agents (e.g., FDA approved drugs
used according to label, contrast agents, etc); if yes, please describe and complete sections H
and I.
D5. Use of radioisotopes or other sources of ionizing radiation (e.g., x-ray machine, etc.). If yes,
complete section F.

D6. Major changes in diet or exercise. If yes, explain in detail:

D7. Administration of physical stimuli other than auditory and visual stimuli associated with normal
classroom situations. If yes, explain in detail:

D8. Deprivation of physiologic requirements such as nutrition or sleep, manipulation of
psychological and/or social variables (e.g., sensory deprivation social isolation, psychological
stresses, deceptions, etc.)
If yes, explain in detail:

D9. Use of medical devices as defined by FDA regulations in 21CCFR812. If yes, complete
Section G.

D10. Use of deceptive techniques without the knowledge of subject.
If yes, please describe in detail:

D11. Possible invasion of privacy of subject or family, including use of personal or medical
information.
If yes, explain in detail:

D12. Any probing of information which might be considered personal or sensitive.

D13. Presentation to the subject of any materials which they might find to be offensive, threatening or

Revised 3-2012 Page 9 of 36
degrading.
If yes, explain in detail:

D14. List all study procedures (i.e., interventions done for research purposes only) and identify risk (see key below
for examples and attach additional sheets as necessary)

Possible Examples
Minimal Risk: Quality of Life Questionnaire, Electrocardiogram (ECG), MRI scan without contrast media or
sedation, DEXA scan, Venipuncture/Intravenous Catheter, Observation
Greater than minimal risk: Endoscopy; CT scans; MRI with contrast media and/or sedation. Phase I/II
intervention with Phase I/II protocol with substantial subject risk, blinded or multi-center study; Phase III
randomized or comparative clinical investigation (Note: Phase III trials require a DSMB)
Pilot clinical study; Investigational Device(s); Investigator-initiated IND(s); Gene transfer, Use of
investigational pharmaceutical agent(s), Research-associated high risk clinical procedure (e.g., dialysis,
bronchoalveolar lavage, studies done under sedation)

Procedures and/or drugs being administered Risk level for procedure (mark appropriate
column)
Minimal Greater than
minimal

D15. Will an Independent Medical Monitor be used?.
Yes, external to WCMC.

Yes, an individual from WCMC. Please provide the name

D16. Will an external Data Safety Monitoring Board (DSMB) be used for the assessment of the safety data?
No – But the WCMC DSMB is needed.

No – And the WCMC DSMB is not needed. Please complete the remaining sections.

Yes
If yes, please describe the criteria for independence of this DSMB from the sponsor of the protocol. If
available, please provide roster of the DSMB, including the degree and affiliation of the members. If the
DSMB has not yet been established, please indicate this.

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The following section will request information related to the precautions which will be taken to minimize risks to
subjects. For information on appropriate monitoring plans, see “A Guide to Understanding Data and Safety Monitoring
Procedures” at http://weill.cornell.edu/research/forms_and_policies/dsmb_forms.html

D17. Is the protocol an NIH-funded Phase I, II or III Clinical Trial?
Yes – Provide a copy of the NIH-approved Data Safety Monitoring Plan (DSMP) and proceed to
Question D19

No – Please Proceed to Question D18

D18. a) Please describe the Data Safety Monitoring Plan (DSMP) in detail by answering the following: What is/are
the experimental intervention(s), agents(s) and/or device(s)?

b) Describe the anticipated adverse events and risks of study intervention(s), agent(s) and/or device(s) in detail
(e.g., known psychological risks; known physical risks). Assess their seriousness and incidence of
complications or adverse events when known. Include animal data if trials in humans have not been
performed.

c) What data will be collected during the course of the study to assess both safety and efficacy?

d) Given the anticipated risks you have identified above, describe what monitoring is needed to immediately
recognize the adverse events that do occur and who, if anyone in addition to the PI, will monitor the subjects
for adverse events. Please provide contact information for all medical monitors and note that medical
monitors who are co-investigators cannot be designated as independent.

e) If you are requesting independent monitoring by an Independent Medical Monitor (IMM) or a Data Safety
Monitoring Board (DSMB) in questions D15 or D16, please explain if the regulations require independent
monitoring of this study or if your request for independent monitoring is being made for another reason.
Studies for which a DSMB are generally appropriate are listed
athttp://weill.cornell.edu/research/forms_and_policies/dsmb_forms.html.

f) If a DSMB is desired, what do you think should be reported to the DSMB and how often do you think this
should be done?

g) Specify to whom you will be reporting interim data and at what intervals, if interim analyses are planned.
(E.g., The WCMC DSMB)

h) Describe the adverse event grading based on severity, attribution, and expectedness (including frequency), to
whom AEs will be reported and how often. (E.g., Use of Common Terminology Criteria for Adverse Events
(CTCAE) v 4.0 at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)

i) Other than the WCMC IRB, specify to whom you will be reporting unexpected adverse events promptly.
Please note, all adverse events, incidents and information that must be immediately reported to the WCMC
IRB are indicated in the reporting policy at
http://weill.cornell.edu/research/research_integrity/institutional_review_board/irb_adv.html

j) Describe what measures will be taken to minimize any negative impact on subjects resulting from study
closure or a subject being terminated from the study.
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k) Describe interim and complete stopping rules for this study (if applicable)

D19. Describe adverse events that may cause termination/dropout of a subject

D20. Describe other alternative and accepted procedures or methods of diagnosis and treatment, if any, that were
considered and why they will not be used.

D21. Assess potential benefits to subjects and to society which may accrue as a result of this research. Analyze
risk-benefit ratio, and why the risks are justified by the potential benefits :

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SECTION E. CONFIDENTIALITY OF DATA

E1. What specific safeguards will be employed to protect confidentiality of data, e.g., coding or removal of
identifiers as soon as possible, limitation of access to data, use of locked file cabinets, protection of computer-
based data systems, etc.? Will data which identifies individual subjects be published or in any way disclosed
to third parties other than project personnel? If so, explain here, and incorporate in the consent form and
HIPAA documentation (Please include that the IRB and Federal oversight agencies may have access to the
data.):

Revised 3-2012 Page 13 of 36
E2. Will subjects have access to their research records while they are enrolled in the study? The HIPAA
Authorization form should contain the same information as in this section.
Yes (skip to Question E3)

No – answer all questions below
a) Please explain in detail the basis of your request for the temporary suspension of subjects’ rights to access their
research records while they are enrolled in the study. (Example: This is a double-blind study and the subjects will not
have access to information about the arm of the study to which they were assigned.)

b) List the specific sections of the research record or specific information subjects will not have access to while
participating in the study. [Example (1): You will not have access to the information relating to the arm of the study
to which you are assigned. Example (2): You will not have access to genetic test results that have no clinical
significance.]

c) At what specific point in time will the suspension be lifted? [Example (1): Access to the information will be
reinstated when the blinds are lifted and the primary investigator knows the arm of the study to which the subject was
assigned. Example (2): When the genetic testing becomes clinically significant and subject wants to view there
research records.]

NOTE: If you check ‘no’, you must also add a paragraph in the IRB consent form explaining the following:
1. While enrolled in this research study there is a temporary suspension to access the research record.
2. The specific sections of the research record or specific information they temporarily will not have access to
as listed above.
3. The reasons for the suspension.
4. The specific point in time the suspension will be lifted.

E3. Will any data, tissue, and/or blood sample(s) be collected/stored for use in future research? The HIPAA
Authorization form should contain the same information as in this section.
No (skip to Section F)

Yes (answer all questions below)

If Yes, where will the data, tissue, and/or blood sample(s) be stored/sent? (check all that apply)

Weill Cornell Medical College (WCMC Research Repository/Database)

An outside agency, sponsor, or individual (Repository/database maintained by an outside entity)
Note: If the information or specimens will be given to an outside agency, sponsor, or individual, then you must
also add a paragraph to the IRB consent form stating the following:
"You may agree to allow your data, tissue, and/or blood sample(s) to be used for future research either within
or outside WCMC-NYPH. If information goes to an outside entity then the privacy rule may not apply."
**This sentence must be located in the IRB consent form before the subject is asked to make a choice about
the use of data, tissue, and/or blood samples for use in future research.

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SECTION F. ADDITIONAL REGULATORY INFORMATION

F1. USE OF IMAGING EQUIPMENT AND RADIATION PRODUCING EQUIPMENT AND
RADIOACTIVE MATERIALS

a.) Will this study involve diagnostic imaging or image guided interventions?

i. No; this study does not involve diagnostic imaging / image guided interventions (Please go to
section d)

ii. Yes; within NYPH Department of Radiology, Weill Cornell Imaging, and/or CBIC; if yes, please
submit the IRB protocol portfolio including all ancillary documents (except SSRs) to
radiology@med.cornell.edu for review by the Department of Radiology.

iii. Yes; elsewhere

b) Where ever such imaging will occur please indicate the type of imaging involved below:

i. Entirely Standard of Care (i.e., would be ordered in the course of clinical care for this condition
exactly as it is proposed in this study)

ii. Entirely Sponsored Research Imaging (e.g., an experimental imaging study, standardized imaging
exam but not routinely ordered at the proposed frequency or performed as specified in this study, etc.)

iii. Both Standard of Care and Sponsored Research Imaging in some combination

iv. Not sure which of the above is the correct response (please provide advice)

Weill Cornell Medical College requires formal interpretations of all research imaging (i.e., non-
standard of care imaging done for research purposes only) as such imaging may have clinical
impact. In the informed consent, please make sure the required language related to formal
interpretations of non-standard of care imaging is included, as provided in the informed consent
template. Below, please provide your plan for documenting subject notification of any incidental
findings (e.g. subject signs a copy of the report and that report would be entered into the research
record; a log book with the date the subject informed, etc).

c) Please explain plans for archiving, transfer, and review of all images / image-related data derived from
diagnostic imaging or image guided interventions (e.g., IDEAL, or no archiving or transfer of images are included
in this protocol as images will be stored in the clinical PACS):

Revised3-2012 Page 15 of 36
d) Will this study involve the use of radioisotopes or other sources of ionizing radiation for diagnostic or
therapeutic purposes (e.g. x-ray machines, CT, cardiac catheterization, radiation therapy, etc.) for purposes
other than standard of care either entirely or in part? (i.e., subjects would not be having these procedures
in the manner described in the protocol and informed consent if they were not enrolled in the study; or subjects
might have some of these procedures for standard of care and some of these procedures outside of normal
standard of care)

No; there is either no exposure to ionizing radiation or radioisotopes at all OR all such exposure is entirely
within standard of care (Please go to Section F2)

Yes (Please answer sections e and f below)

If yes, you must receive approval from the Radiation Safety Committee (RSC). Contact the RSC Chair:
Stanley Goldsmith, M.D. at 212-746-4588 or sjg2002@med.cornell.edu

e) Will radioactive drugs be administered to one or more research subjects for research purposes only?

Yes

If yes, the IRB must receive the following approval letter pertaining to radioactive drug research before it
can approve your protocol:

An IND approval letter from the FDA or an approval letter from the Radioactive Drug Research
Committee (RDRC) to indicate IND exemption. Contact: Shankar Vallabhajosula, PhD at 212-746-4533
or svallabh@med.cornell.edu;

f) Dosimetry Section (Please contact Peter Capetelli (pec2008@med.cornell.edu), the Radiation Safety
Officer, for assistance in calculating the dosimetry prior to submitting the protocol to the IRB or
Radiology for review):

i. What is the major organ dose (if more than one organ is affected, please specify for each major organ
affected)?
ii. What is the total body dose?
iii. What is the gonadal dose for females?
iv. What is the gonadal dose for males?
v. What is the bone marrow dose?
vi. Please specify for each type of exposure (radiopharmaceutical injection, imaging study or radiation
treatment) what modality will be used and how often each modality will be used in the protocol

vii. For CT, radiography, fluoroscopy, and radiation therapy please specify what body region(s) will be
exposed for each exam
viii. For CT, radiography, fluoroscopy, and radiation therapy please include the entrance skin dose, and any
critical organ doses not included above (e.g. lens of eye)
ix. What is the source of the above dosimetry data?
x. Does the study involve the use of PET / Nuclear Medicine radioactive drugs?
Revised3-2012 Page 16 of 36
No (Please go to section F2)

Yes; Please answer the following:

1. What is the name of radionuclide’s licensee, the number of the license, the date issued, and
does it cover human use?
2. What is the radionuclide(s) to be administered?
3. What is the Chemical form(s)?
4. What is the activity administered per procedure (in millicuries) for each radionuclide?

5. How many studies of each type will be performed per patient?
6. If complementary non-radioactive drugs will be administered as part of the radionuclide study,
what is the name of the drug and the dose schedule?

F2. BIOSAFETY REQUIREMENTS

Please answer both a and b.
a) Does this protocol involve human gene transfer? (I.e., Research involving the deliberate transfer of
recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects)

NO, this study does not involve human gene transfer. (Move to question b)

YES. Approval by the Institutional Biosafety Committee (IBC) is required before IRB approval can be
released. Proceed according to the Quick Guide for Conducting Human Gene Transfer Research at WCMC
at http://weill.cornell.edu/research/forms_and_policies/ins_bio_com.html. For assistance, contact the IBC
at ibc@med.cornell.edu. [Note: No human gene transfer trial is exempt from local IBC review, even if
exempt from NIH Recombinant Advisory Committee (RAC) review under Appendix M.]

b) Does this protocol involve the use of non-FDA-approved biological agents in human subjects? (i.e., Non-
FDA-approved viruses, bacteria or other etiological agents that are used as investigational new
drugs/vaccines in human subjects.)

NO, this study does not involve the use of non-FDA-approved biological agents in human subjects.

YES. Approval by the Institutional Biosafety Committee (IBC) is required before IRB approval can be
released. Complete the Application for the Use of Biological Agents in Human Subjects Research
(http://weill.cornell.edu/research/forms_and_policies/ins_bio_com.html) and submit it with your IRB
protocol (after all IRB-requested changes have been made) to submit2ibc@med.cornell.edu.

 Once the IRB has reviewed your protocol and only administrative issues remain (e.g., HRBAF form,
signatures, etc.), submit your protocol to the IBC for evaluation.
 Final IRB approval will not be issued until proof of IBC approval is provided.

Have a question about the IBC? Email ibc@med.cornell.edu or call 646-962-8192 for assistance.

F3. CONFLICT OF INTEREST

Conflicts of interest exist when investigators or the institution have financial interests that may compromise or
present the appearance of compromising an individual’s, group’s, or institution’s judgment in conducting,
reviewing, or reporting research. These relationships vary from those with negligible potential to those with
great potential to influence judgment, and not all relationships represent true conflicts of interest. A fully
informed consent is one in which all related financial interests are disclosed.

Does the Principal Investigator or co-investigator(s), or members of their families have a Financial Interest in a
business or outside entity, or an Intellectual Property interest, that relates to this project?
Revised3-2012 Page 17 of 36
No (Please move to question F3)

Yes

A signed electronic version of the WCMC Study Specific Report must be attached for the Principal
Investigator and co-investigator(s) involved in this study. WCMC investigators must complete the forms
online at conflicts.med.cornell.edu. External investigators (those who are not employed by WCMC) must
complete the external form available at http://weill.cornell.edu/research/rea_com/SSR_External.html

If you answered yes above, have you included a disclosure of the conflict of interest in the informed consent
document?

Yes (Please move to Section G)

No
please explain why you believe that disclosure to potential subjects is not necessary or not appropriate.

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SECTION G. MEDICAL DEVICES
NOTE: If this study involves an FDA regulated device, please submit any communications from the FDA
regarding IDE, or humanitarian use applications related to this submission.

Will any medical devices be used during the study?

No, proceed to Section H

Yes (Please indicate one of the following)
Is the device cleared/approved for use by the FDA
Yes (Please check one of the following)

The device is being used as in accordance with its cleared/approved labeling (Please
provide documentation of FDA approval or 510 clearance)

The device is approved for use as a Humanitarian Use Device under an HDE (Please
Answer G1 below)

The device is being used off label (If this study involves the experimental use of
medical and surgical diagnostic therapeutic devices of unproven safety and/or efficacy,
the investigator must determine the applicability of the Investigational Device
Exemption federal regulations to the study and answer questions G2-G7)

No (If this study involves the experimental use of medical and surgical diagnostic
therapeutic devices of unproven safety and/or efficacy, the investigator must
determine the applicability of the Investigational Device Exemption federal regulations
to the study, and must answer questions G2-G7):

Please answer for use of a device approved using and HDE
G1. Please provide the Name of the device, the HDE # and the holder of the HDE. Please submit any supporting
documentation from the FDA,

Please answer the following for approved/cleared devices to be used off label or for unapproved devices.
G2. Name of device and the Sponsor:

G3. Will device be custom-built? Yes No

G4. Is this a previously "banned" device Yes No

G5. Does the study involve a "significant risk" device (Go to G7), or a "non-significant risk” device (Go to
G6)
DEFINITION: Significant risk device means an investigational device that:
(a) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a
subject;
(b) Is purported or represented to be for use in supporting or sustaining human life and presents a
potential for serious risk to the health, safety, or welfare of a subject.
(c) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise
preventing impairment of human health and presents a potential for serious risk to the health, safety, or
welfare of a subject;
(d) Otherwise presents a potential for serious risk to the health, safety or welfare of a subject.

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DEFINITION: Non-Significant risk device: one that does not meet the definition for a significant risk
device)
For guidance on Significant vs. Non-Significant Risk Devices, go to
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf

G6. Non-Significant Risk Device (Complete if Applicable)

(a) Please explain the rationale for your designation of this device as “non-significant risk.” Include
information on prior investigations with this device and any documentation from the sponsor on how this
determination was made.

(b) Have you consulted the FDA to make this determination? ____Yes ____No
If yes, attach the official FDA correspondence documenting this determination.

G7. Significant Risk Device (Complete, if applicable)

a) Does sponsor intend to apply for an IDE?
i. _____Yes (Please answer the following)
FDA IDE#: ___________
Who is the holder of the IDE
_____ Industry sponsor (If using an industry IDE for an investigator initiated study,
please provide documentation showing that the PI has the right of reference to
the industry IDE)

_____ Investigator-initiated (If investigator initiated, please submit the IDE application
and all correspondence , including the IDE acknowledgement with the IDE
number from the FDA; please note that the IRB approval will not be released
until the IDE application and acknowledgement from the FDA is submitted; The
IDE acknowledgement will have to be specifically requested from the FDA).

ii._____ No (please justify)

b) Have you signed an agreement with the sponsor to participate in the study? _____Yes _____No

b) Please submit the Sponsor’s investigational plan and the results of any prior
investigations.

G8. Are there any medical tests/procedures (i.e. CAT scans, MRIs, X-Rays, etc.) that will be limited and/or not
permissible to the subject as a result of the device implantation?

Revised3-2012 Page 20 of 36
___________________ H. DRUG OR BIOLOGICAL PRODUCT____________________________

Most investigations of drugs or biologic products require submission of an Investigational New Drug (IND).
Exceptions are some investigations of already approved drugs or biologics, some in vitro diagnostic products that
are regulated as drugs or biologics, and some bioavailability or bioequivalence studies.
ANSWER THE QUESTIONS BELOW TO PROVIDE THE IND INFORMATION OR TO DETERMINE IF AN
IND IS NEEDED FOR THIS STUDY. Some of the questions require the exercise of scientific/medical judgment.
When judgment is required to answer a question, space is provided for you to explain how you reached your
conclusion. This information will enable the IRB to review your determination about the need for an IND.
FDA will not accept an IND for an exempt investigation (ref. §312.2(b)(4)). However, there is no penalty
associated with the submission of an unnecessary IND.

H1. Will any drugs, biological agents, or test articles (not including investigational devices) be administered
as part of this study (including bioavailability or bioequivalence studies)?
No (Proceed to Section J)

Yes (Please answer the appropriate section below (H2, H3, and/or H4, as it applies to your study) and
complete section I
f NYPH Investigational Pharmacy)use of investigational pharmacy)

H2. USE OF DRUG/BIOLOGICAL AGENT
Does this study involve the administration of a drug or biological product?
No (Proceed to Question H3)

Yes (Proceed to the next question below)
A. Is the drug or biological product already approved for marketing in the United States? (ref.
§312.2(b)(1))?

No (please answer question below)

Who is the holder of the IND?
Industry (Sponsor name and IND #: ) (If using an
industry IND for an investigator initiated study, please provide documentation showing that the PI has the
right of reference to the industry IND)

Investigator Holder of the IND and IND# ) (If investigator
initiated, please submit the IND application and all correspondence
regarding the IND application, including the IND acknowledgement
with the IND number from the FDA; please note that the IRB
approval will not be released until the IND application and
acknowledgement from the FDA is submitted; The IND
acknowledgement will have to be specifically requested from the
FDA).

Yes (Please answer question below)

Is the drug being used according to label?

Yes Move to question H3

Revised3-2012 Page 21 of 36
No (Please answer question below)

Will the study be conducted under an IND?

Yes (Please provide IND information below)

Who is the holder of the IND?
Industry (Name of sponsor and IND #: ) (If using an industry IND for
an investigator initiated study, please provide documentation showing that the PI has the right of reference
to the industry IND)

Investigator (Holder of IND and IND# ) (If investigator
initiated, please submit the IND application, and all correspondence regarding the IND application,
including the acknowledgement with the IND number from the FDA; please note that the IRB approval
will not be released until the IND application and acknowledgement from the FDA is submitted; The IND
acknowledgement will have to be specifically requested from the FDA).

No (Please answer questions i., ii., and iii below to determine if the study is exempt from the IND
regulations; these questions should only be answered if you are using an approved drug off label
and the study possibly qualifies for an IND exemption; If the study has already been determined
to be IND exempt by the FDA, please provide the documentation)
i. Is the study intended to support FDA approval of a new indication or a significant change in the
product labeling (ref. §312.2(b)(1)(i))?

Yes

Please explain your response:

ii. Is the study intended to support a significant change in the advertising for a prescription product
(ref. §312.2(b)(1)(ii))?

Yes

Please explain your response:

iii. Does the investigation involve a route of administration or dosage level or use in a patient
population or other factor that significantly increases the risks (or decreases the acceptability of the risks)
associated with the use of the product (ref. §312.2(b)(1)(iii))?

Yes
Revised3-2012 Page 22 of 36
No

Please explain response:

If you answered YES to one or more of the above questions, you must submit an IND application to FDA for
this study.

If you answered NO to all of the above questions, Proceed to section I. Please note, if the product will be
provided by the manufacturer, in order to remain IND exempt, the product must be commercial grade.
Please provide documentation from the manufacturer that the supplied product will be commercial grade. If
the manufacturer will be providing investigator-grade product, than you must submit an IND application.

H3. USE OF TEST ARTICLE AS AN IN VITRO DIAGNOSTIC
a. Is the test article an in vitro diagnostic biological product (ref. §312.2(b)(2))?
No (Go to Question H4)

Yes (Please answer the following questions)
i. Is the in vitro diagnostic biologic product one of the following types of product: (1) blood grouping serum; (2)
reagent blood cells; or (3) anti-human globulin (ref. §312.2(b)(2)(ii))?

Yes

ii. Will the diagnosis made with the in vitro biologic product be confirmed by another, medically established,
diagnostic product or procedure (ref. §312.2(b)(2)(i)(a))?
Yes

If you answered NO to one or more of the above questions, you must submit an IND application to FDA
for this study.

If you answered YES to all of the above questions, you do not need to submit an IND application to the FDA
for this study. You do not need to continue with this SECTION H AND CAN PROCEED TO SECTION I.

H4. IN VIVO BIOAVAILABILITY OR BIOEQUIVALENCE STUDIES

Are you conducting an in vivo bioavailability or bioequivalence study in humans (ref. 21 CFR 320.31)?
No (This checklist is complete. Please go to Section I)

Yes (Please answer the following questions)

Is the study one of the types of studies described below:

Revised3-2012 Page 23 of 36
a. A study involving a test product that contains a new chemical entity (ref. §320.31(a)(1) & 21 CFR
314.108(a))?

Yes

b. A study involving a radioactively labeled drug product (ref. §320.31(a)(2)?
Yes

c. A study involving a cytotoxic drug product (ref. §320.31(a)(3))?
Yes

d. A study involving a drug product containing an already approved, non-new chemical entity that is:

i. single-dose study in normal subjects where either the maximum single or total daily dose exceeds
that specified in the labeling of the drug product (ref. §320.31(b)(1))?

Yes

No
ii. A multiple-dose study in normal subjects where either the single or total daily dose exceeds that
specified in the labeling of the drug product (ref. §320.31(b)(2))?

Yes

iii. A multiple-dose study on an extended release product on which no single-dose study has been
completed (ref. §320.31(b)(3))?

Yes

If you answered YES to any of the questions above, you must submit an IND application to the FDA for this
study and complete section I.

If you answered NO to all of the questions above, please answer the following question.

Are you conducting a bioavailability or bioequivalence study required for approval of an abbreviated new drug
application or supplemental new drug application other than the studies described in H4.. above (ref.
§320.31(d))?
Yes You do not need to submit an IND application to the FDA for this study as long as samples of the

Revised3-2012 Page 24 of 36
reference standard and test article are retained as described in §320.38 and §320.63 (ref. §320.31(d)(1)).

No You must submit an IND application to the FDA for this study and complete section I.

Revised3-2012 Page 25 of 36
SECTION I. USE OF NYPH INVESTIGATIONAL PHARMACY
NOTE: If this study involves an FDA regulated drug, please submit any communications from the FDA
regarding IND, or humanitarian use applications related to this submission.

If question H1 was answered “no”, this section does not need to be completed.

Except as specified below, all IRB-approved protocols that involve the administration of FDA-approved
medications and/or investigational medications MUST utilize the NYPH Investigational Pharmacy to dispense
the medications specified in the research protocol. Prior to submission of a new IRB application, investigators
must make arrangements with the Investigational Pharmacy and must have the Use of Drugs and Biological
Agents Form signed by an authorized member of the Department of Investigational Pharmacy. This will ensure
that all medications are accounted for and that studies budget properly for the utilization of the Investigational
Pharmacy.

1. Will this study require the services of the Investigational Pharmacy?

No, please check all that apply then proceed to Section J
Study will be performed at sites other than WCMC or NYPH (e.g., a physician’s private office).
Study performed at Weill Cornell Imaging at New York Presbyterian and /or Citigroup
Biomedical Imaging Center and involves standard-of-care agents being used according to FDA labeling
but are not part of the investigation. These agents are purchased via a pharmacy or directly from vendors.
Study involves the use of radio-isotopes, managed by the WCMC Radiopharmacy.

Yes, Please complete the Use of Drugs or Biological Agents Form. Submit completed form along with
a copy of the IRB protocol application and a copy of the consent form (if applicable) to
submit2rx@med.cornell.edu for departmental approval.

Note: A copy of the Use of Drugs or Biological Agents form must be placed in the patient’s medical chart
along with a copy of the signed and dated informed consent

Revised3-2012 Page 26 of 36
SECTION J – PEDIATRIC SUBJECTS

Does this study involve the enrollment of minor subjects (i.e., subjects under the age of 18)

No (Please move to Section K)

Yes (Please answer all of the questions below)

Please check the category below that best represents the degree of risk and benefit to which the children in this
study will be exposed. Note: More than one category may be indicated, such as when a protocol involves both a
study group and a control; in that case, please specify the group to which the category applies.

CHECK ONE OF THE FOLLOWING BELOW:

1. ____The proposed research is not greater than minimal risk (i.e., The probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological examinations or tests) For further
information, please see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. (45 CFR 46.404)

2. ____The proposed research poses a greater than minimal risk with the potential for direct benefit. (45 CFR
46.405) ; If checked, please answer the following:
2a. The risk must be justified by the benefit. Please explain:

2b. The risk/benefit assessment must be at least as favorable as that presented by alternative approaches.
Please explain:

3. ____The proposed research is greater than minimal risk with no prospect for direct benefit to individuals,
but is likely to yield generalizable knowledge about the subjects’ disorder or condition. (45 CFR
46.406) (Answer below)
NOTE: If your research is in this category, consent of both parents is required unless one parent is
deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal
responsibility for and custody of the child.

This research is approvable if 3(a) and 3(b)are both justified:

Revised3-2012 Page 27 of 36
3(a)The risk represents a minor increase over minimal risk (for example, the intervention or
procedures presents experiences to subjects that are reasonably commensurate with those inherent
in their actual or expected medical, dental, psychological, social or educational situations). Please
justify:

3(b) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder
or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or
condition. Please justify:

4. ____ Research involving minors that does not fit within the above categories but which presents an opportunity
to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, is
approvable only with approval of the Secretary of HHS, after consultation with a panel of experts. (45
CFR 46.407) Please go to http://www.hhs.gov/ohrp/policy/populations/guidance_407process.html for
further guidance. If this category applies, please consult the IRB office at 646-962-8196.

Assent of Minors

The federal regulations require that adequate provision be made for soliciting the assent of children when, in the
judgment of the IRB the children are capable of providing assent, taking into consideration the ages, maturity, and
psychological state of the children involved. Generally, the assent of a child could be sought when the child is
seven years of age or older, on an assent form that is written in language understandable to a child in the age
group involved. Please provide the age appropriate assent forms (7-11 and 12-17) for IRB review.

____ Assent form for ages 7-11 attached.

____ Assent form for ages 12-17 attached.

____ Requesting a waiver of assent (If you are requesting a waiver of assent, please provide the reason for the
request.)

Revised3-2012 Page 28 of 36
SECTION K. PREGNANT WOMEN, FETUSES AND NEONATES

Does this study involve the enrollment of pregnant woman or the use of neonates

No (Please move to Section L)

Yes (Please answer all of the questions below)

1. PREGNANT WOMEN AND FETUSES

(a) When appropriate, have studies been done on animals and non-pregnant individuals?
_____ Yes _____ No

If yes, please explain briefly the nature and findings of these previous studies:

(b) Does the research pose a greater than minimal risk to the woman or fetus? _____ Yes ______ No

If yes, please check the appropriate category and justify:

i. _____ The risk to the fetus is caused solely by interventions/procedures that hold out the prospect
of direct benefit for the woman or fetus. Please justify:

ii. _____ There is no prospect of direct benefit to either the woman or the fetus, but the risk to the
fetus is not greater than minimal and the purpose of the research is the development of important
biomedical knowledge that cannot be obtained by any other means. Please justify:

c) To be approvable, the risk must be the least possible for achieving the objectives of the research. Please
justify:

Revised3-2012 Page 29 of 36
If the research holds out the prospect of direct benefit to the woman and/or the fetus, or if the research presents no
more than minimal risk, consent of the woman must be obtained.

If the research holds out the prospect of direct benefit solely to the fetus, the consent of the woman and the
father of the fetus must be obtained, unless the father is unavailable, incompetent, incapacitated, or if the
pregnancy resulted from incest or rape.

The PI must agree that no inducements, monetary or otherwise, will be offered to terminate a pregnancy.
_____ PI agrees _____ PI does not agree.

The PI must agree that individuals engaged in the research will have no part in any decisions as to the timing,
method, or procedures used to terminate a pregnancy.
_____ PI agrees _____ PI does not agree

The PI must agree that individuals engaged in the research will have no part in determining the viability of a
neonate.
_____ PI agrees _____ PI does not agree

2. NEONATES

For the purpose of human subject protection regulations, newborns are considered neonates until they are
determined to be viable. The regulations applicable to pediatric subjects would then apply. This section
applies to neonates of uncertain viability and nonviable neonates.

When appropriate, have preclinical and clinical studies been conducted and have they provided data for
assessing potential risks to neonates: ____ Yes ____ No

The PI must agree that individuals engaged in the research will have no part in determining the viability
of the neonate. ______ PI agrees ______ PI does not agree

(a) Neonates of uncertain viability.
To be approved, either:

The research must hold out the prospect of enhancing the probability of survival of the neonate to the
point of viability and any risk is the least possible for achieving that objective. Please justify:

The purpose of the research is the development of important biomedical knowledge which cannot be
obtained by other means and there will be no added risk to the neonate resulting from the research. Please
justify:

Revised3-2012 Page 30 of 36
Consent of either parent of the neonate of uncertain viability is required, or, if neither is able to consent, of the
legally authorized representative of either parent. Consent of the father or his representative is not required if the
pregnancy resulted from rape or incest.

(b) Nonviable neonates. After delivery, nonviable neonates may not be involved in research unless,

______ Vital functions of the neonate will not be artificially maintained,
______ The research will not terminate the heartbeat or respiration of the neonate,
______ There will be no added risk to the neonate resulting from the research, and
______ The purpose of the research is the development of important biomedical knowledge that cannot
be obtained by other means.
Consent of both parents of the nonviable neonate is required, unless either parent is unable to consent due to
unavailability, incompetence or incapacity. The consent of the father is not needed if the pregnancy resulted from
rape or incest. Consent of a legally authorized representative of either or both parents is not adequate.

Revised3-2012 Page 31 of 36
SECTION L. PRISONERS

Does this study involve the enrollment of Prisoners

No (Please move to Section M)

Yes (Please answer all of the questions below)

Because prisoners may be under constraints because of their incarceration which could affect their ability to make
a truly voluntary and uncoerced decision about whether or not to participate as subjects in research, the federal
regulations provide additional safeguards for the protection of prisoners as human subjects in research.

The IRB can only approve research that falls into one of the following categories and which has been approved by
the Secretary of HHS after consultation with a panel of experts.

Please check the one that applies and justify the research:

____ Cause and Effect: Study of the possible causes, effects, and processes of incarceration and of criminal
behavior and presents no more than a minimal risk. Please justify:

_____ Institutional Structures: Study of prisons as institutional structures or of prisoners as incarcerated persons,
provided it causes no more than a minimal risk. Please justify:

______ Conditions Affecting Prisoners as a Class: Research on conditions particularly affecting prisoners as a
class (e.g. vaccine trials and other research on hepatitis which is more prevalent in prisons; research on
social and psychological problems such as alcoholism, drug addiction and sexual assaults. Please justify:

Revised3-2012 Page 32 of 36
SECTION M. INFORMED CONSENT

Informed consent is necessary for all research involving human subjects and must be documented. The investigator
may determine which method of obtaining informed consent would best serve the interest of the subject population,
but the Board reserves the right to require alternative or more stringent means of securing consent. Recruitment of
subjects unable to give personal consent for reasons of age, mental state, legal or other such status, requires that
consent or assent be secured from parents or a legally authorized representative.

If a legally authorized representative will be used, please provide justification (in M1 below) to conduct
research on a subject unable to consent for him or herself. Include information about who will make the
determination that the subject does not have the capacity to give consent, how the capacity to give consent
will be determined and who will be allowed to be a legally authorized representative and consent for the
subject.

1. . Describe procedures used to obtain informed consent (and minor assent, if applicable), including how and where
informed consent (and assent, if applicable) will be obtained and what measures will be taken to ensure
subject’s understanding of the protocol is consistent with the protocol as written. If non-English speaking
subjects will be enrolled, please describe the consenting process and the use of a translator (Please go to our
website at http://weill.cornell.edu/research/rea_com/ins_rev_boa.html for the WCMC policy on consenting
non-English Speaking subjects). If you are requesting a waiver of informed consent, or an alteration in the
documentation of informed consent (i.e., oral consent), please justify.

2 Will you obtain written consent? Yes No
NOTE: This is always required when there is a definite physical, social, or psychological risk to the subject.
The document must embody all of the basic elements of informed consent. These are contained in the template
IRB Consent Form.
The Consent Form must be completed and attached and easily understood by a lay person.

3. Will you obtain only oral consent? Yes No
NOTE: Oral consent may be sufficient in the case of studies that the only record linking the subject and the
research would be the consent document and the principal risk would be potential harm resulting from
a breach of confidentiality or that the studies present no more than minimal risk to the subject and involves
no procedures for which written consent is normally required outside of the research context.Subject
must be informed of applicable basic elements of consent. No signed document is necessary on the part of the
subject, but(1) a sample oral consent script that includes information to be imparted to the subject must be
submitted and approved by the Board; and (2)Documentation confirming that informed consent was obtained
from each subject must still be maintained in your research records. Please note that this method of obtaining
consent is approved ONLY for no more than minimal risk studies.
Sample documentation is attached: Yes No

4. Will you use a standard hospital consent form? Yes No

Revised3-2012 Page 33 of 36
NOTE: Special written research consent form is not required for use of unidentified surgical waste tissues, or
autopsy specimens including specimens from Special Subject Populations (i.e. fetuses, minors, pregnant women,
prisoners or the mentally disabled), provided that the Tissue Submission policy has been followed and
completed satisfactorily and appropriate approval from the Department of Pathology has been obtained. The
standard hospital form, which clearly permits use of the tissue or fluid for research MUST BE ATTACHED
(Form #45350 for surgery, or Form #41160 for autopsy specimens).

Revised3-2012 Page 34 of 36
PRINT:
PI Name
Protocol Title

SECTION N. SIGNATURES

1. I certify that the above information concerning procedures to be taken for protection of human subjects is
correct. I will seek and obtain prior approval for any amendment of this protocol and will report promptly to
the Institutional Review Board any unexpected or otherwise significant adverse effects encountered during the
course of the study.

Investigator’s Name Signature Date

This proposal has been reviewed and approved for submission to the Institutional Review Board

Department Chairperson’s Signature Date
Name

2 Are subjects covered under this research protocol administratively the responsibility of another
. department?
No Yes, approval is required, please obtain signature below.

Department
a) Name:

Department Chairperson Signature Date
Name

b) Department
Name:

Department Chairperson Signature Date
Name

3. Will your research involve the use of human tissue(s)?
No Yes, approval is necessary by the Chairperson of the Department of Pathology

Human Tissue IRB Compliance Signature Date
Leader

Revised3-2012 Page 35 of 36
The International Committee of Medical Journal Editors (ICMJE) has established a requirement
that all clinical trials be entered in a public registry before the onset of patient enrollment as a
condition of consideration for publication. Additional information may be found at:
http://clinicaltrials.gov/ and at http://www.icmje.org/clin_trialup.htm

Please contact the Protocol Registration System ("PRS") administrator by e-mail at:
ICR@med.cornell.edu to set up a PRS user account to register new and ongoing clinical trials.
The e-mail should contain the PI’s full name, department, phone number and e-mail address.

Attachments

Please attach the following for the IRB to review your research:

 IRB Protocol Application
 Consent/Assent Form(s)
 Recruitment notices or advertisement materials
(see guidelines here: http://www.med.cornell.edu/research/rea_com/Human_Subject_Rec.html)
 HIPAA (applicable form)
 Study Specific report for each investigator
 Human Research Billing Analysis Form (HRBAF)
 Data collection sheets, survey instruments, questionnaires, psychological tests, interview forms, scripts,
etc.
 Communication from the FDA regarding IND, IDE, or Humanitarian Use applications related to this
submission
 Sponsor’s protocol
 Investigator’s brochure
 Grant application (NIH or other)

Note: Items in bold are required, others should be submitted as they apply to your study.

Revised3-2012 Page 36 of 36