Institutional Review Board
Human Research Protection Program
1 Park Avenue | 6th Floor | New York, NY 10016
http://irb.med.nyu.edu
Application for Continuation
When to Use this Form
Use this form when the research activity for an approved study is planned to extend beyond the current
approval period.
The IRB must review ongoing research at intervals that are appropriate to the level of risk for each research
protocol, but not less than once per year. The approval and expiration date are clearly noted on all IRB
notifications sent to the PI and must be strictly adhered to.
For changes to the protocol or consent form at the time of continuation, use the Application for Amendment
form in addition to this application.
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.
Administrative Information
Study#
Study Title
Department
Role*
Date of this request
Division
Name
Email
Phone
Fax
Principal Investigator
Contact Person
Co-Investigator(s)
* PI and Contact Person are required; list all other study personnel as well, one line per person
All personnel listed above
have completed the CITI
Tutorial
http://www.citiprogram.org
Current IRB approval period
Yes
No
Trial Type
to
Single Center Trial
Multi-Center Trial;
PI of Multi-Center Trial
Estimated study completion
date
Disclosure of Financial Interest
This application must include an Investigator Financial Disclosure Form for all study personnel involved in the
design and/or conduct of this study.
Each staff person must submit an Investigator 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 ALL
research study personnel involved in the design and/or conduct of this study.
The Investigator Financial Disclosure Form can be found at: http://cmu.med.nyu.edu/forms.
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Application for Continuation
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. This form can also 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
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If disclosure forms are not received for all personnel on this study, the submission cannot be processed.
This submission requires completed Investigator Financial Disclosure Forms from all personnel involved in the
design and/or conduct of this study
If the Research Conflict of Interest Committee has made a determination regarding a disclosure, attach a copy of
the determination
Category of Review
Select this study’s review
category
refer to IRB website for
detailed description
Risk
give the overall risk
classification for this study
Full Review
Expedited Review; choose all applicable expedited categories:
#1
#2
#3
#4
#5
#6
#7
#8a
#8b
#8c
Minimal Risk
Greater than Minimal Risk
Enrollment Status
Have any subjects been enrolled since the study began?
Is enrollment of subjects anticipated during the next approval period?
The research is permanently closed to the enrollment of new subjects; all subjects have
completed all research-related interventions; and, the research remains active only for longterm follow up of subjects
(If yes, you should select Expedited Category 8a above)
No subjects have been enrolled, at any time, and no additional risks have been identified
(If yes, you should select Expedited Category 8b above)
The remaining research activities are limited to data analysis only of identifiable/coded data
(If yes, you should select Expedited Category 8c above)
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Subjects
For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc.
Definitions
Enrolled Subject
Research Subjects who’s written or verbal consent has been obtained.
Screen Failure
Subjects who were consented and enrolled, but subsequently did not meet your study’s criteria for inclusion.
Long Term Follow -up
Active interventions/treatments have ended and the interaction with these subjects is limited to data collection.
Completed Study
Subjects who have completed the study only after ending the active treatment/intervention and also completed
any long-term follow-up.
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Application for Continuation
NYU School of Medicine IRB HRPP
By Location
Indicate the total number of subjects enrolled to date at each of the following NYU affiliated sites:
Bellevue Hospital*
Charles B Wang
Co-op Care
Coler-Goldwater Specialty
Hospital and Nursing Center
Coney Island Hospital
Faculty Group Practice (FGP)
Faculty Practice Offices (FPO)
NYU Child Study Center
NYU College of Dentistry
NYU College of Nursing
NYU Graduate School of Arts
and Sciences
NYU HJD
NYU School of Medicine
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
Woodhull Medical & Mental
Health Center
Health Center
Metropolitan Hospital
Other (name/number)
NYU Cancer Center
Other (name/number)
* 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
Enrollment Details
Indicate the total number of subjects enrolled to date at each of the following NYU affiliated sites:
Date first subject screened
Total number of subjects currently approved to enroll
Number of subjects enrolled since the last re-approval
Number of additional subjects to be enrolled (or charts/records to
be reviewed)
[If you have more than one cohort (patients, family members,
treating physicians, etc.) provide answers for each cohort)]
Have any subjects been excluded on the basis of race, ethnic
group, understanding of English, socioeconomic status,
education, gender, or pregnancy?
Total number of subjects enrolled to date:
(This total should equal the total of Fields A+B+C+D+E below)
A) Total number of subjects in long term follow up
B) Total number of subjects who completed study
C) Total number of subjects actively participating in treatment/
intervention
D) Total number of subjects dropped or withdrawn
E) Total number of screen failures
For those subjects dropped/withdrawn in Field D above, what
number dropped due to a reportable event:
Has the IRB approved the enrollment of vulnerable populations
for this study?
Please note that this does not apply to studies that will include a
full range of subjects, some of whom may be elderly or subjects
who might incidentally be employees
; if not yet initiated, state reason:
No
Yes; explain:
Total dropped or withdrew due to reportable
events
Total dropped or withdrew due for reasons other
than reportable events
Yes (If yes, provide below a cumulative accrual by
vulnerable population)
No
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Application for Continuation
NYU School of Medicine IRB HRPP
By Vulnerable Population Type
Indicate all of the population
types you will be including in
this study
aborted fetuses
AIDS/HIV patients
children
cognitively impaired
institutionalized (not prisoners)
fetuses
in-vitro fertilization
men
Employees/Students/ House
Staff/Fellows
minorities
NYU employees or students
elderly
physically disabled
pregnant women
prisoners
women
Persons in a
Sedated/Traumatized/ Crisis
State
Persons with Cognitive, Social,
Economic, or Educational
Disadvantages
Non-English speaking Persons
Other (describe)
Other (describe)
Children
Pregnant Women
Persons over age 65
Persons with Acute/Severe
Mental/Physical Disabilities
By Demographics
List the cumulative count of all subjects ever enrolled in your study to-date.
American
Indian or
Alaskan
Asian or
Pacific
Islander
Black, not of
HispanicAmerican
Origin
HispanicAmerican
White, not of
HispanicAmerican
Origin
Other or
Unknown
Total
Female
Male
Unknown
Total
Informed Consent/Authorization
Written Consent/assent is
required
Based on results/experience
to date, the currently known
risks and benefits are
adequately described in the
Informed Consent
Yes
No, explain:
Yes
No, explain:
An Amendment and
revised Informed
Consent are
attached
Number of different
consent/assent forms used in
this study
A revised version of the
informed consent /assent
form(s) has been approved
since the last subject was
enrolled
Written Authorization is
required
The consent form is being
changed at this time and
requires re-evaluation and
approval
Yes
No, explain:
Yes; an Application for
Amendment form is
attached to this
application
No
List the languages that
consent(s)/assent(s) and
authorization has been
translated into
Yes; list latest version(s):
No
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Application for Continuation
The research involves the use
and/or disclosure of
individually identifiable health
information (PHI) that is
transmitted or maintained
electronically or in any other
form or medium, including on
paper or orally
If YES was answered to the
question above, the PI
believes that continuation of
this study is justified in light of
the above information
NYU School of Medicine IRB HRPP
No
Yes; HIPAA privacy regulations are being met:
Subject “Authorization to Release Protected Health Information for Research
Purposes” reviewed by the IRB (attach a copy of the reviewed stamped HIPAA
authorization form)
The IRB granted a waiver of authorization for the use of protected health
information for this study
The IRB granted a partial waiver of authorization for the use of protected health
information for this study
Not required because a Data Use Agreement is in place
Not required for this study involves the use of deidentified data
Not required because this study does not involve the use of protected health
information
Not required because no new subjects were recruited after April 13, 2003 and
no current subjects will be reconsented
Other:
Yes
No; explain:
Drugs/Devices
One or more investigational
drugs are used in this study
Yes; IND#:
No
One or more investigational
devices are used in this study
Yes; IDE#:
No
Reportable Events/Withdrawal from Study
Provide a summary of all events that have occurred since the commencement of this study. Summaries should
be in aggregate numbers.
Do not submit detailed reports.
Since your last IRB review, has any subject
suffered any event that was reportable?
formerly serious adverse event/unanticipated
event
Summarize all adverse drug reactions in which
a relationship to your study’s drug cannot be
ruled out
Since the last IRB review, all serious or
unanticipated events have been reported as
required
The frequency of serious but expected side
effects were different from what was anticipated
Number of the recruited subjects at NYU sites
who complained about any aspect of the study
since the initiation of this project
Since the last IRB review, have any subjects or
others complained about the research?
No
Yes; specify the number of events and describe briefly their nature
and significance:
(you may submit this information as an attachment)
these events were reported to the IRB, to a sponsor, to the FDA or
to anyone else
Yes
No; explain:
Yes
No; explain:
Yes; explain:
No
No
Yes; attach summary describing the number and nature of
complaints
If yes, were these complaints reported to the IRB?
Yes
No; explain:
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Application for Continuation
Did you remove any subject from the study due
to adverse reactions, noncompliance or other
reasons?
Since the last IRB review, have there been any
multi-center trial reports?
Did any subject voluntarily withdraw for the
study for medical or non-medical reasons?
NYU School of Medicine IRB HRPP
Yes; provide a description of the medical problem or other
circumstances for each subject who was terminated involuntarily:
No
No
Yes; attach a summary of all multi-center trial reports and attach a
summary of those reports.
If yes, were these reports reviewed by the IRB?
Yes
No; explain:
Yes; provide a description of known reasons for each subject who
withdrew:
No
Data Safety Monitoring
Provide a DSM Report for the
last year
Pasted here:
or
Attached as a separate document
Protocol Modifications
Before implementation of the change, the IRB must approve any changes in a research protocol, such as
changes in subject population, recruitment plans, advertising materials, research procedures, study sites, study
instruments, or to investigators who are instrumental to the design or execution of the study.
Investigators must submit requests for such changes listed above in an Application for Amendment.
Since the last IRB review, there have been problems with or
changes in the research, including the following: subject
recruiting; advertising; subject compensation; inclusion of
exclusion criteria; costs to subjects; investigator inducements;
informed consent; documentation of informed consent; privacy or
confidentiality protections; safety monitoring; vulnerable subject
protections
This study’s protocol has been modified
Protocol changes are proposed at this time and require reevaluation
Yes; explain:
No
Yes; the IRB approved the modification:
No
Yes; on date
No
Yes; an Application for Amendment form is attached
No
Study Results
Summarize any results (preliminary or final) obtained in the
study. State whether the results to date have been consistent
with what you expected
Since the last IRB review, have there been any publications in
the literature relevant to the research?
Since the last IRB review, have subjects experienced any
benefits?
In the opinion of the PI, have the risks or potential benefits of this
research changed?
Yes; attach a copy of all publications and attach a
summary of the new findings.
No
Yes; attach summary of subject benefits.
No
Yes; attach summary of the description of those
changes.
No
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Application for Continuation
NYU School of Medicine IRB HRPP
Summarize anything that has occurred since the last IRB review
which may have altered the risk/benefit relationship. Please
specify any reports of studies done elsewhere which might have
implications for this study. Attach copies of relevant publications.
PI’s Statement of Assurance
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and
welfare of human subjects, conduct of the study and the ethical performance of the project. I agree to accept
responsibility for the conduct and supervision of this research and the protection of human subjects as required
by: (a) state and federal law and regulations, and (b) NYU IRB human research protection program policies
and the Federal-wide Assurance (FWA), such that:
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The protocol will be performed by qualified personnel according to the IRB approved protocol
All changes in the protocol and consent form will be approved by the IRB before they are initiated, except when
necessary to eliminate immediate hazard(s) to the subject(s)
Legally effective informed consent will be obtained from human subjects as required
Unanticipated problems involving risk to subjects or others will be reported to the IRB in a timely manner
If I leave NYU SoM/MC, I will assure that all appropriate documents, constituting a final report, are submitted to
the IRB for review
I will complete the required research education requirements in a timely manner and ensure that all study staff
involved in this study have completed the research requirements in a timely manner.
Date
Print Name
Signature
I ATTEST THAT THE INFORMATION CONTAINED HEREIN IS A TRUE AND ACCURATE
REPRESENTATION OF MY ONGOING 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 NYU SCHOOL OF
MEDICINE AND THE IRB, FEDERAL AND NEW YORK STATE LAWS AND REGULATIONS, AND
ANY AGREEMENT WITH THE SPONSOR IN THE CONDUCT OF THIS RESEARCH STUDY’S
PROTOCOL.
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