Institutional Review Board
Human Research Protection Program
1 Park Avenue | 6th Floor | New York, NY 10016
http://irb.med.nyu.edu
Application for New Protocol Review
When to Use this Form
What type of research are you undertaking, and what type of form should you use? This form should be used
to submit a research study involving human subjects for IRB review and approval when the proposed research
falls under either:


Full Board Review
Expedited Review
Study review categories are explained here: http://irb.med.nyu.edu/forms-guidance-waivers/categories-review
Do not use this form to submit an exempt study. Exempt studies should be submitted to the IRB using the
Application for Exemption form.
If applying for the review of a Humanitarian Use Device, do not use this form. Instead, download the correct
form on from our website: http://irb.med.nyu.edu/
Submission Instructions
Our website provides full instructions on submitting applications to the IRB: http://irb.med.nyu.edu/esubmission
Please contact the IRB office at 212 263-4110 with any questions.
Attachments to Include
Always Submit These
Documents
Submit Only Where Applicable
Application for New Protocol Review
CV/Resume for Principal Investigator and all Co-Investigators
Investigator Financial Disclosure Form: for all staff involved in the design and/or
conduct of this study
Consent/Authorization Form
Protocol
Protocol Summary
Waiver of Authorization/Consent
Your research subjects include vulnerable populations; you have attached the
following appendixes to this form:
Appendix: Children
Appendix: Cognitively Impaired
Appendix: Data Stored for Future Use
Appendix: Deception
Appendix: IND Requirements Exemption
Appendix: International Research
Appendix: Physiological Processes
Appendix: Pregnant Women, Fetuses, and Neonates
Appendix: Prisoners
NIH Grant
RCOIC determination for this protocol (issued w/in last year)
Investigator’s Brochure or Product Information
Questionnaires
Recruitment Materials
any additional institutional approvals: PRMC, Bio-safety, Radiation
any other information that is pertinent to the review of your project
required information for IND or IDE number
HIV-related forms
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Administrative Information
Study#
Study Title
Department
Role*
Date of This Request
Division
Name
Email
Phone
Fax
Principal Investigator
Contact Person
Co-Investigators
* PI and Contact Person are required; list all other study personnel as well, one line per person. Principal Investigators and CoInvestigators must be NYU SoM faculty.
All personnel listed above have completed the CITI Tutorial; copies
Yes
of their current certificate of completion are in our Regulatory Binder
No
http://www.citiprogram.org
An NYU SoM Billing Plan is
Yes**; There are items or services that could generate a charge to a subject,
required for this study
subject’s 3rd party payer, grant, study account or other funding source
If an NYU SoM Billing Plan is
required, it will be generated
No; my study is conducted/sponsored at the NYU College of Dentistry
by the Office of Clinical Trials
No; this study is limited to the following exempt criteria (no potential billable
and emailed to the PI for final
items):
review and approval. The
database
approved Billing Plan will be
educational program
sent to the PI, IRB, and other
questionnaires/surveys or quality of life data
specified administrative offices
non-billable interviews
impacted by this study. No
site acting as coordinating center or core lab for processing samples
other Billing Plan form(s) are
umbrella or site grant (study will have additional studies conducted under this
required of the PI. For more
project with distinct Research #s and protocols that will be evaluated
information, see the OCT
separately)
website:
retrospective image review study
http://www.med.nyu.edu/oct or
call 212.263.4210
chart review
tissue sample/analysis (discarded tissue samples or blood collection by the PI
for internal processing not utilizing a hospital laboratory)
humanitarian use devices (HUD)/humanitarian device exemption (HDE)
Category of Review
For full details on categories of IRB review, visit our website.
Select the category of review
you believe your study falls
under
Full Board Review
Expedited Review
Expedited Review Category #
the research presents no more than minimal risk of harm to subjects; explain:
Exempt Review; STOP; use the Application for Exemption instead (don’t use or
continue filling out this form)
Disclosure of Financial Interest
This application must include a signed and dated Investigator Financial Disclosure Form for all study personnel
involved in the design and/or conduct of this study.
Each staff person must submit a Financial Disclosure Form for each protocol, even if no financial interest
exists. In other words, this application must be accompanied by financial disclosure forms for every research
study personnel involved in the design and/or conduct of this study.

Investigator Financial Disclosure Form can be found at: http://cmu.med.nyu.edu/forms
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
In addition to the protocol-specific forms outlined above, all research staff must also submit the Annual
Disclosure Form. This annual institutional submission is a separate electronic form submitted to the Conflicts
Management Unit.

Annual Disclosure Form can be found at http://cmu.med.nyu.edu/forms
For more specific information on NYU Langone Medical Center’s policy on disclosures for researchers see:
http://cmu.med.nyu.edu
If disclosure forms are not received for all personnel on this study the submission cannot be processed.
Submit When Applicable
this submission requires completed Investigator Financial Disclosure Forms from all
personnel involved in the design and/or conduct of this study
the Research Conflict of Interest Committee has made a determination regarding a
disclosure; attached is a copy of that determination
Study Summary
Summarize your study. The summary should be written in language intelligible to a moderately educated, nonscientific layperson. It should contain a clear statement of the rationale and hypothesis of your study, a concise
description of the methodology, with an emphasis on what will happen to the subjects, and a discussion of the
results.
The length should be at least one half of a page and no more than one page. You should not refer the reader
to the attached protocol.
Summary
Proposed length (time period) of the study
Proposed Phase of study
Number of qualified staff on this project
Adequacy of Resources to Protect Subject
Investigator (including co-investigators) has
sufficient time to conduct and complete the
research
Facilities
Medical or Psychological Resources, if
applicable
State number of years, months, or weeks:
Justify that the proposed period of time is sufficient to conduct and
complete this study:
Number of staff:
Explain how staff is qualified; include any training specific to the conduct
of this study:
Detail processes to inform staff of the protocol and their duties and
functions for this study:
Yes
No
Justify that adequate facilities have been allocated for this study and will
be used in the conduct of the study:
Explain any medical or psychological resources available for subjects if
needed as a consequence of their participation in this study:
Describe psychological, social or medical monitoring, ancillary care,
equipment needed to protect participants:
Describe other resources needed for the protection of subjects in the
conduct of this research (e.g. participant communication needs
language translation services, etc.):
Purpose of the Study
Scientific or scholarly rationale
Research Procedures
Describe the source of the data and the data
collection procedures
Procedures performed in this study that are specific to the research:
Procedures already being performed for non research purposes
[diagnostic or treatment]:
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Application for New Protocol Review
Risks
Vulnerable Subjects
If this study involves vulnerable subjects
describe additional safeguards included in the
protocol to protect the rights and welfare of
these subjects
More than Minimal Risk of Harm
If the research involves more than minimal risk
of harm to subjects, describe the provisions for
monitoring the data to ensure the safety of
subjects
Benefits
Assess the potential benefits to science and/or
society which may accrue as a result of this
research.
If the risk in this study is more than minimal,
explain how the risks are reasonable in
relation to the benefits
NYU School of Medicine IRB HRPP
Minimal; justify why this category is appropriate:
Greater than minimal
What precautions have been taken to minimize these risks and what
is their likely effectiveness:
Describe other alternative and accepted procedures, if any, that
were considered and why they will not be used:
Unknown; describe:
No
Yes; describe:
No
Yes; describe:
Also complete the Data and Safety Monitoring Plan section below.
Study Type
Type of study
Phase of study
Sponsor
Are you the IND or IDE
holder?
Study includes
sake sure to submit the
appropriate
supplemental form(s)
Double-blind
Single-blind
Open-label
N/A (not a clinical trial)
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
(List study sponsor(s))
Yes; Specify
No
Questionnaire/survey
Chart review – retrospective
Chart review – prospective
Interviews
The Internet
Data Stored for Future Use
Deception
CTSI
International Research
Physiological Processes
Registry
EKG
EEG
Pilot
Other:
Phase 4
Unknown
Other:
MRI with contrast
MRI without contrast
Blood draw
Deception-complete supplement entitled
“Deception”
Repository of Specimens to be obtained
in the future; specify:
Biopsy
Surgical Procedure
Specimen removed during surgery
Collection of clinical specimens
Clinical Tests
Chest X-ray
Other (describe):
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Yes; please complete the questions below
No
For research involving Gene Transfer/recombinant DNA, is an
NYU Bio-safety Committee approval attached?
Yes; please specify the type of research below
No –STOP. An application for this type of research must be approved by
the NYU Bio-safety committee prior to IRB approval:
http://www.med.nyu.edu/spa/compliance/biosafety/
If Genetic research; specify:
If Recombinant DNA; specify:
Yes; please complete the questions below
No
For research involving Radioactive material, is an NYU Radiation Safety
Committee Approval attached?
Yes; please specify the type of research below
No –STOP. An application for this type of research must be approved by
the NYU Radiation Safety Committee prior to IRB approval
If radioactive material is being used in this study; specify:
Study involves gene
transfer/recombinant
DNA
If your study uses Gene
Transfer/recombinant
DNA material, it must be
approved by the NYU
Bio-safety Committee
before it receives IRB
approval
Study involves
radioactive material
If your study uses
radioactive material, it
must be approved by the
NYU Radiation Safety
committee before it
receives IRB approval
Study Funding Sources
Specify all the funding sources for your study.
Federal grant; specify agency
and specify SPA grant/award#:
Industry contract; specify company(ies):
Investigator-Initiated
Industry-Initiated
Cooperative groups; specify:
Sub-contract; specify:
Foundation grant; specify:
All other sources of funding not listed above; specify:
Departmental; specify:
PI funded; specify:
Other; specify:
All External funding
sources
All NYU funding sources
Funding sources
Identify all study funding
sources listed in order of
support
Primary:
Secondary:
Study Location
Indicate the site(s) to be used in this study.
Study is a
Single center
Multi-center
I am the Lead Investigator of multi-center study; I’m filling out Lead of a Multi
Center Study subsection below
Other; specify:
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Bellevue Hospital Center (BHC)*
NYU Child Study Center
Charles B Wang
NYU College of Dentistry
Co-op Care
NYU College of Nursing
Coler-Goldwater Specialty Hospital and
NYU Graduate School of Arts and
Nursing Center
Sciences
Coney Island Hospital
NYU HJD
Faculty Group Practice (FGP)
NYU School of Medicine
Faculty Practice Offices (FPO)
NYU Steinhardt School of Education
CTSI/ACTG
NYU Wagner School of Public Services
CTSI/Bellevue*
NYUMC (Tisch Hospital)
CTSI/HJD
Nathan Kline Institute (NKI)
CTSI/NYUMC
Radiology – 660 1st Avenue
CTSI/Skirball 8z
Rivergate Building
Gouverneur Hospital
Rusk Institute
Hassenfeld Children’s Center
Smilow
Kings County Medical Center
VA Medical Center
Lincoln Medical & Mental Health Center
Woodhull Medical & Mental Health Center
Metropolitan Hospital
Other; specify:
NYU Cancer Center
* Studies conducted (in part or whole) at Bellevue Hospital must also apply online using the REASON system at:
http://reason.nychhc.org/ Questions? Call Bellevue at 212.562.4176
Study Site(s)
Indicate the building(s)
and room number(s) of
each location where the
study will take place
Lead of Multi-Center Study
Complete this section when the investigator or the Institution is the lead site or lead investigator of a multicenter site
Management of information
Provide an explanation regarding the
management of information that may be
relevant to the protection of subjects
Management of unanticipated problems from
other sites
Explain the management of unanticipated
problems from other sites [Unanticipated
problems that involve risks to subjects or
others must be reported to the IRB]
Interim Results
Explain how interim results will be evaluated
and managed
Protocol Modifications
Explain how protocol modifications will be
managed
External Sites
Complete the following section only if the study will be conducted at sites that are not affiliated with NYU.
Does the site(s) have an
IRB
Has the site/sites agreed
to allow the research to
be conducted there
Provide an answer for
each site
Contact information of
IRB at site(s)
Provide an answer for
each site
Yes
No
Do you have the other
site(s)IRB Approval
Yes
No
Yes
No
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Investigational Devices
For a device study you must submit to the IRB one of the following forms of documentation of the IDE number:



Communication from the FDA
Written Communication from the Sponsor
Sponsor Protocol
Yes, A Significant Risk* device; please complete this section below
Yes, A Non-Significant Risk* device; please complete this section below
No (skip this section)
*“Significant risk” and “non-significant risk” are FDA classifications
Does the study include a
device?
Provide plan for storage,
security and dispensing
of devices
Investigational Drugs
For studies involving investigational new drugs, you must submit to the IRB one of the following forms of
documentation of the IND number:



Communication from the FDA
Written Communication form the Sponsor
Sponsor Protocol
Does this study involve
an investigational new
drug (IND)?
Select all applicable
categories
Yes; complete this section
No
An FDA approved drug for indication and population
A drug for off-label purpose
An investigational drug-population
An investigational drug
A placebo
Provide plan for storage,
security and dispensing
of drugs
Data Safety Monitoring
Studies involving any amount of risk are required to have a Data Safety Monitoring Plan (Board, Committee,
etc.; DSMP). The plan must be appropriate to the level of risk to subjects, study design, objectives and
procedures. A Data and Safety Monitoring Report (DSMR) based on the DSMP will be due (at a minimum) with
annual renewal.
Risk Level Guide
This is a guide to help you understand how risk levels are determined and how the risk level affects the type of
oversight or monitoring that is appropriate for your study.
Level I
Low
Minimal Risk
Explanation
Examples
Suggested Guidance
Study poses no more risk than
expected in daily life or in routine
physical or psychological
examination.
Venipuncture, IV, EKG,
questionnaire, MRI, glucose
tolerance testing, study eligible for
exemption from IRB review or
expedited review, Phase IV
studies
A formal plan is required; oversight
of the trial by PI and their
designees is required. Independent
reviewer may be considered if
potential or actual conflict of
interest exists.
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Application for New Protocol Review
Level II
Moderate
Greater than
Minimal Risk
Level III
High Risk
Low risk intervention in a
population at risk for serious
clinical events based on
underlying disease; interventions
of undefined risk or with low
frequency risk for Reportable
Events.
Interventions associated with risk
of serious Reportable events at
high or uncertain frequency;
studies in populations associated
with very high risk of serious
adverse clinical events based on
underlying disease or in whom
assessment of treatmentassociated adverse events may
be difficult; vulnerable populations
requiring special protection
NYU School of Medicine IRB HRPP
Study drug, vaccine, x-ray or CT
with contrast, phase I or II study
with safety data in humans,
population at risk for serious
clinical events based on
underlying disease, investigator
initiated single center randomized
trials
Phase III studies, complex multicenter studies, high risk
procedures, gene transfer studies,
interventional studies involving
vulnerable populations (ex.
children, pregnant women, elderly,
normal volunteers, cognitively
impaired) require additional
protections, interventions
associated with very high risk of
serious clinical events based on
underlying disease
Full Data Safety Monitoring Plan is
required. The plan may outline
either a Independent reviewer or a
DSMB.
DSMB required.
Data Safety Monitor Details
Who will do the data and
safety monitoring for this
study
Check whichever apply.
(This role is distinct from
the study monitor.)
Principal investigator
Principal investigator’s designee:
In–house or PI initiated; describe:
NYU Cancer Institute: The NYU CI will conduct ongoing interim safety monitoring and
the PI will send a copy of their reports to the IRB
Industry Sponsor, does the sponsor have a DSMB in place for this study?
No; explain how data safety will be monitored (provide attachment detailing this
process)
Yes; a copy of its membership and charter including a description of the planned
meeting frequency and how information will be distributed to investigators is provided
Cooperative Group, Name _________does the sponsor have a DSMB in place for this
study?
No
Yes; a copy of its membership and charter including a description of the planned
meeting frequency and how information will be distributed to investigators is provided
Other, describe:
Explain how data safety
will be monitored
Write in here or provide
attachment detailing this
process
Primary Data and Safety
Monitor Contact
Information
Provide name, phone,
email and qualifications
Describe in detail any
potential conflict of
interest the DSM Contact
may have
Data Safety Monitor Details
A DSMP must be attached detailing the information stated above and below, and providing a clear description
of the DSMP for this study. The description must detail: Types of data or events that will be captured under the
DSMP, responsibilities and roles for gathering, evaluating and monitoring data, Information about the
monitoring entity, reportable events that will be reported to the monitoring entity and when the events will be
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
reported, assessments for the frequency of monitoring, stopping rules and criteria for safe withdrawal of
subjects, communication and dissemination of information.
The screened/enrolled
subjects will be
monitored
Dropouts will be
monitored
Primary and secondary
efficacy endpoints will be
monitored
Reportable Events will be
monitored using an
accepted scale
Describe the frequency
of monitoring
Yes
No; explain:
Yes
No; explain:
Yes
No; explain:
Yes
No; explain:
Every 12 mos
Every 6 mos
Every 3 mos
Other:
Yes; describe:
No; explain:
Interim analysis will take
place
Reportable Events
A plan for reporting unanticipated events that cause risk of harm to subjects or others must be reported to the
IRB in accordance with IRB policy.
This proposal will adhere
to NYU SoM IRB policy
for Reportable Event
reporting
All other entities to which
reportable events will be
reported
Yes; the protocol or Investigator’s Brochure outlines the type of events and the
reporting schedule
No; explain:
No other entities
Sponsor; specify:
NIH; specify institute:
FDA (if working under 1572 or IDE)
NYU Cancer Institute
CTSI
ACTG
PACTG
Other; explain:
Study Subjects
For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc.
Estimated number of Subjects
The estimated number of subjects to be
enrolled (signed consent, including screen
failures)
Subjects age range
Local enrollment
Subject Participation
Describe how participants will be involved
in the study, including the total time
involved for subjects and how often the
subjects will participate
Literature search has been conducted
Yes
No
Yes
No
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Application for New Protocol Review
Proposed compensation/ reimbursement
to subjects
Indicate pro-rated amounts and frequency
Describe the nature of the compensation.
Indicate amounts and schedule of
payments as well as conditions for subject
receiving compensation for participating in
the research
Proposed payments are reasonable and
commensurate with the expected
contributions of the participant
Proposed payments are fair and
appropriate
Proposed payments do not constitute (or
appear to constitute) undue pressure or
influence on the perspective research
participants to volunteer for, or to continue
to participate in, the research study
Proposed payments do not constitute (or
appear to constitute) coercion to
participate in, or continue to participate in,
the research study
Feasible enrollment plan
Justify that the study will be able to
access a population that will allow
recruitment of the necessary subjects
proposed in this section, within the
proposed timeframe
Some or all of the subjects in this study
will be vulnerable
Provide a rational for use of special
groups or subjects whose ability to give
voluntary informed consent may be in
question (e.g., cognitively impaired).
Groups or categories of subjects will be
excluded from this research
Explain how the subject selection process
in this research is fair and equitable,
taking into account eligibility criteria,
vulnerability and recruitment process
Inclusion and Exclusion criteria
Recruitment procedures
All recruitment materials (including all
advertisements, radio scripts, print ads
etc.) are attached along with this form
NYU School of Medicine IRB HRPP
Yes
No
Yes
No
Yes
No
Yes
No
Yes; check all:
Children
Cognitively Impaired
Pregnant Women, Fetuses, and Neonates
Prisoners
Employees
Students
You may need to submit a supplemental form(s) as well
No
n/a
explain:
no
yes; explain:
Yes; describe:
No
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Methods of Recruitment
Subjects will be recruited by searching
records (e.g., school records, medical
records
Databases will be utilized
Fliers and/or brochures be posted, mailed
or otherwise distributed
There will be any web postings
An advertising company will be employed
for recruitment purposes
Letters will be sent to potential
participants
Physician referral will be utilized for
recruitment
Other methods not covered above will be
employed to recruit subjects
Describe provisions to protect the privacy
interest of subjects
Privacy means: having control over the
extent, timing, and circumstances of
sharing oneself (physically, behaviorally,
or intellectually) with others. Your answer
should explain how you plan to recruit
subjects (e.g from your practice and a
letter will be sent to each potential
subject) and when and where consent
processes will take place with subjects to
maximize privacy.
YOUR ANSWER SHOULD NOT
INDICATE HOW YOU ARE MAINTAING
THE CONFIDENTIALITY OF THE DATA
Describe provisions to maintain the
confidentiality of data
Confidentiality means: Methods used to
ensure that information obtained by
researchers about their subjects is not
improperly divulged.
Your answer should indicate where
information collected in this study will be
stored, how it will stored, who has access
to the data and how is access controlled
No
Yes; describe:
1) If YES, are any of these records paper files
No
Yes; describe:
If YES, describe where these paper files are located:
2) If YES, are any of these records electronic
No
Yes; describe:
If YES, describe where these electronic files are located and who
maintains them:
No
Yes;
No
Yes;
No
Yes;
No
Yes;
describe where DB is and who maintains it:
describe:
give URL(s):
give full contact information and list services they will be providing:
No
Yes; samples attached
No
Yes; I understand that HIPAA regulations prohibit physician-to-physician
referral; patients must first be informed of a trial and agree to be
contacted before any physician referral can be initiated
No
Yes; describe in detail:
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
No
Yes; describe data and justify collection:
If YES, could any of this data, if disclosed, have adverse consequences
for subjects or damage their financial standing, employability,
insurability, or reputation
No
Yes; describe:
If YES, will a Certificate of Confidentiality be obtained
No; explain:
Yes; attached
No
Yes; describe in detail:
details of this disclosure is incorporated in the attached consent form
The data collected in the course of the
study contains sensitive data, e.g. mental
health, HIV status, SS#, etc.
Data that identifies individual subjects is to
be published or otherwise disclosed to
third parties other than project personnel
Inpatients
This study includes inpatient
subjects
The protocol extends the
hospital stay of study’s subjects
Yes
No
Yes, by
days per
patient (est.)
No
Outpatients
This study includes outpatient
subjects
Yes
No
Populations
Indicate all of the population types you will be including in this study and submit the applicable
Supplement(s)
Indicate all of the population
types you will be including in
this study
aborted fetuses
patients with HIV
children
children who are wards of the state
cognitively impaired
institutionalized (not prisoners)
fetuses
neonates
in-vitro fertilization
men
Indicate the number of
subjects per category
Male
healthy volunteer
residents – fellows
non-English speakers
minorities
NYU employees or students
elderly
physically disabled
pregnant women
prisoners
women
Female
total
Adults
Children
total
Women or minorities are
excluded in this nongender/racial/ethnic-specific
protocol
Yes;
justification is provided in the protocol
justification is:
No
Yes; Consent to Release HIV Information form and Informed Consent to Perform an
HIV Test are both attached*
No
* These forms are available on the IRB web site: http://irb.med.nyu.edu/
AIDS/HIV patients are
involved
Yes; PRMC approval is attached to this form*
No
* If your study is cancer related, PRMC approval must be obtained prior to IRB review. Contact the PRMC for information on
submissions to the PRMC.
This study is cancer-related
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Informed Consent Process
Describe how the required
information is being presented
to subjects (consent form, oral
consent, information sheet,
etc.)
attach a copy of what is being
presented to subjects
Describe the circumstances
under which consent will be
obtained, including where the
process will take place
Who will obtain consent?
Describe their experience in
obtaining consent from
subjects
How will it be determined that
the subjects or the subjects’
authorized representatives
understand the information
presented?
If English is not the subjects’
native language, how will
translation be provided?
Will any subjects be
cognitively impaired so that
they may not have the
capacity to give consent
Yes; describe:
No
Informed Consent Forms
Unless waived by the IRB, informed consent is necessary for all research involving human subjects and
must be documented in some manner. The investigator may determine which method would best serve the
interest of the subject population, but the IRB reserves the right to require alternative or more stringent
means of securing consent.
This study includes the
following types of consent
This study’s consent
procedure will require these
waivers.
Complete the Request for
Waiver of Informed Consent
and Authorization form
This study’s subject
population will require foreign
language consent forms
If YES, the IRB must receive a
copy of each translated
consent form and a Certificate
of Accuracy and/or Attestation
after your English version is
approved. This can be done
via an Amendment once IRB
approval is received
Comprehensive written Informed Consent/Authorization Forms
Assent of Children
Informed consent will be obtained from all subjects and documented with a signed,
written consent form.
If checked, answer Informed Consent and Documentation of Consent (below)
Informed consent will be obtained from subjects, but no signed consent form will be
used. This includes oral consent and implied consent (e.g., completing a survey).
If checked, answer the questions in Informed Consent (below)
Fully informed consent will not be obtained from all subjects. This includes
deception, withholding information, etc.
Waiver of one or more elements of informed consent
Waiver of documentation of informed consent
Waiver of authorization
Yes; list language(s):
No
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Application for New Protocol Review
More than one consent form
will be used for this study (not
including language
translations)
This study involves
audio/videotape or other
electronic recording
If YES, attach separate
authorization for
audio/video/digital recording
consent
NYU School of Medicine IRB HRPP
Yes; list each consent subject heading:
No
Yes; specify:
No
Documentation of Informed Consent Form
Note: signed, written consent forms are required unless waived by the IRB, but are not the only—or most
effective—forms of documentation. You must provide copies of all written consent forms.
Note: the Consent Form Writer is available to assist in preparing consent forms. Contact the IRB for details.
Describe every allowable ways in which
consent can be documented for your
study
If non-English speaking subjects will be
included, describe how translation of
consent forms will be provided
all translated consent forms must be
submitted to the IRB along with back
translations
If subjects cannot read the consent form,
due to literacy or language problems, how
will consent be documented?
see the instructions on the “short form” for
guidance
http://www.med.nyu.edu/irb/consent_temp
lates/short_forms.html
Equipment
Machines, equipment, and/or instruments
will be used
If YES, list and describe their use
No
Yes; describe in detail:
Investigator’s Responsibilities Checklist
The following are the minimum responsibilities of Principal Investigators as stated in the formal agreement
between New York University School of Medicine and the Federal Office of Human Research Protection (the
“Assurance”).
Investigators conducting research subject to FDA jurisdiction and who are also the sponsors of the research
(“Sponsor-investigators”) have additional responsibilities and should consult the Investigator Guide at
http://irb.med.nyu.edu for a more detailed discussion of their responsibilities. Sponsor-investigators must
comply with these additional requirements.
Check off each item to indicate that you have carefully read and understand your responsibilities.
I, the Principal Investigator, acknowledge and accept my responsibility for protecting the rights and welfare of human
research subjects and for complying with all applicable provisions of the Assurance.
If I intend to involve human research subjects in my research, I will be responsible for obtaining IRB review and
approval prior to the initiation of that research.
I am responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at
the time of consent, unless the IRB has specifically waived this requirement or the study is determined by the IRB to be
exempt.
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
All signed consent documents will be retained in a manner approved by the IRB.
Unless otherwise authorized by the IRB, I am responsible for obtaining and documenting informed consent in accord
with applicable federal regulations at 45 CFR §46.116 and 45 CFR §46.117.
I shall be responsible for promptly reporting proposed changes in previously approved human subject research
activities to the IRB. My proposed changes may not be initiated without IRB review and approval, except where
necessary to eliminate apparent immediate hazards to my subjects. See Request Form for Approval of Amendment
I will report to the IRB any problems that require prompt reporting to the IRB within 5 calendar days of my first
discovering it. See Reportable Events form and guidelines
I will submit a progress report (Request for Continuation or Final Study Closure) at least four weeks prior to the date
at which the IRB has determined continuing review is required. If the progress report is not received by the due date, I
understand that it cannot be guaranteed that my study will be reviewed before the expiration of the IRB approval date. If
my study is not reviewed prior to the expiration date, all enrollment is suspended and I may not continue with the study
for previously enrolled subjects except as approved by the IRB.
I have completed and will require my research team to complete an educational program on the protection of human
subject research participants.
PI’s Signature
Date
Print Name
Signature
I ATTEST THAT THE INFORMATION CONTAINED HEREIN IS A TRUE AND ACCURATE
REPRESENTATION OF MY PROPOSED STUDY. I ATTEST THAT I HAVE NOT BEEN
DISBARRED, SUSPENDED OR RESTRICTED BY ANY FEDERAL OR STATE AGENCY FROM
CONDUCTING THIS RESEARCH STUDY. I WILL ABIDE BY THE REQUIREMENTS OF NEW
YORK UNIVERSITY AND THE IRB AS PER THE ABOVE INVESTIGATOR’S RESPONSIBILITIES
CHECKLIST, FEDERAL AND NEW YORK STATE LAWS AND REGULATIONS, AND THE
AGREEMENT WITH THE SPONSOR IN THE CONDUCT OF THIS RESEARCH STUDY’S
PROTOCOL.
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Application for New Protocol Review
NYU School of Medicine IRB HRPP
Department Chair’s Signature
Date
Department
Print Name
Signature
I CERTIFY THAT THE ABOVE-INDICATED INVESTIGATOR IS A MEMBER OF MY DEPARTMENT
IN GOOD STANDING, THE DEPARTMENT OR NEW YORK UNIVERSITY SCHOOL OF
MEDICINE HAS THE RESOURCES NECESSARY TO CARRY OUT THIS RESEARCH, AND THE
INVESTIGATOR IS QUALIFIED TO BE THE PRINCIPAL INVESTIGATOR ON THE RESEARCH
STUDY.
Service Chief’s Signature
Required for studies being conducted at BHC
Date
Print Name
Signature
Subject’s Department Chair’s Signature
If subjects covered under this research protocol are under the administrative responsibility of a different
department of departments, approval is required.
Date
Department
Print Name
Signature
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