Transcript Slide 1

Introduction to Research
Administration
March 28, 2011
Joy Jurnack
IRB Education Analyst
http://irb.med.nyu.edu/
Human Research Protections is
a Shared Responsibility
Institutional Review Board (IRB)
Office of Research
Compliance and Conflict of
Interest
Office of Clinical Trials (OCT)
Sponsored Programs
Administration (SPA)
Office of Institutional Liaison (OIL)
Principal Investigator and
Research Team
Our Speakers:
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Tony Carna, Director, SPA
Nicky O’Connor, Associate Director, OCT
Abram M. Goldfinger, Executive Director, OIL
Helen Panageas, Associate Director, IRB
Keisha Lightbourne, Director of Research
Compliance and COI
Introduction to Research
Administration (HRPP)
Tony Carna, Director
Sponsored Programs Administration
Month Day Year
Introduction to Research
Administration (HRPP)
Tony Carna, Director
Sponsored Programs Administration
Month Day Year
Role of SPA in HRPP
1. Assure that agreements with external parties
who fund research at the University, such as
federal agencies, foundations and for-profit
corporations, are consistent with University
requirements related to the ethical conduct of
research.
Role of SPA in HRPP
2. Negotiate agreements with external parties who
fund research at the University that are
consistent with University requirements related
to the protection of research participants.
Role of SPA in HRPP
3. Guarantee that research grant and contract
funds are not expended for human research
prior to approval or determination of exemption
by one of the NYU IRBs
4. Ensure that clinical trial agreement terms do not
conflict with the IRB approved protocols.
Other Sponsored Programs
Compliance Requirements
• Safeguarding all assets
• Spending funds in accordance with the
authorized purpose
• Developing and implementing systems to ensure
proper stewardship of funds
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Financial management systems
Procurement systems
Time & effort reporting systems
Monitoring activities
Adherence to terms & conditions of award
Sponsored Programs Policy
Requirements
Institutional Policies
• Organizational Structure
• Purchasing
• Accounting/Budgetary Controls
• Time and Effort Reporting
• Travel
• Consulting
• Property Management
• Ethics/Conflict of Interest
NYU School of Medicine
Office of Science & Research Administration:
Office of Clinical Trials
Introduction to Research Administration
The Role of the Office of Clinical Trials
March 28, 2011
Nicky O’Connor, BSN, MPH, CCRC
Associate Director
Office of Clinical Trials
Office of Science & Research
Organizational Structure
OSR Administration
Division
Of
Laboratory
Animal Resources
Institutional
Animal
Care & Use
Facilities
Office
Of
Industrial
Liaison
Office
Of
Clinical
Trials
Institutional
Review
Board
Sponsored
Programs
Administration
Office of Science & Research
Affiliates
Funding
Source
Medical
Center
Information
Technology
Office of
Science
&
Research
RESEARCH
PROJECT
Department
Of
Finance
Office of
Legal
Counsel
Office of
Research
Compliance
Definition of a Clinical Trial
Clinical trials are a subset of clinical research and must include the
following factors in order to qualify as a clinical trial:
1. The objective of the study is either:
a. testing of drugs, devices, diagnostics, treatments, interventions,
or preventive measures including testing for an unapproved
indication;
OR
b. data collection to increase knowledge that would lead to
enhanced safety and efficacy of a specified drug or device;
AND
2. The study must involve contact with humans or retrospective review
of medical records, clinical data or specimens obtained from contact
with humans
Office of Clinical Trials – Our Role
Facilitate clinical research by:
– Developing and negotiating clinical trial agreements
– Serving as liaison between investigators, administrative
and service departments and sponsors
– Billing and collecting for industry-sponsored clinical trials
– Financial oversight and management of clinical trials
– Ensuring billing compliance for trial services
Primary OCT Functions
• Review clinical trial proposals
• Negotiate contracts with industry in conjunction with Legal Counsel
• Negotiate trial budgets with Sponsor Organizations
• Complete Medicare Coverage Analyses for both industry-sponsored
and grant- sponsored clinical trials
• Enter Financial and Physical matrix information into InfoEd CTMS
Database
• Route NYUMC research encounter information to ensure
appropriate identification research subjects & procedures, and
appropriate billing by NYU Hospitals Center
• Invoice sponsor for services (initial and ongoing)
• Collect revenue and deposit appropriately, including internal fees
Office of Clinical Trials
Areas of Expertise
ADMINISTRATION
PROJECT
MANAGEMENT
CONTRACTS
NEGOTIATION
COMPLIANCE
REVIEW
FINANCIAL
ANALYSIS
DATA BASE
TECHNOLOGY
Clinical Trial Agreements
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180 New Agreements annually
>600 Active Investigators
1500 Active Research Projects
350 Industry Sponsored/Supported
Projects
Total annual revenue from clinical trials:
~$8.3 million in FY 09
~$9.3 million in FY 10
CONTRACT PROVISIONS
reflected in the ICF
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Subject Injury
Compensation
Drug/Device Supply
Confidentiality
Intellectual Property
Inventions
Indemnification
Insurance
Budget Development
INSTITUTIONAL COSTS
EXPENSES
• F&A
• IRB Fees
• Investigational
Pharmacy
• OCT Administration
• Affiliate Fee
Schedules
• Research Team T&E
• Procedures –
Technical &
Professional
• Correlative
• CTSI
Office of Clinical Trials –
Who we are:
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Director: Jean Gatewood
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Associate Director – Operations :
Nicky O’Connor
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Associate Director – Financial
Management : Eric Koomen
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Clinical Research Management
Coordinators:
– Ronnie Landis
– Erica Epstein
– Leah Caropolo
– Lena Geffrard
– Halley Rogers
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Coordinator Clinical Trials:
– Taslima Kamal
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Financial Services:
– Sue Leung
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Contract Specialists:
– Floyd Berry
– Susan Shin Anderson
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Compliance Review:
– Sumathy Sundarababu
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Project Associates:
– Sunita Latchman
– Rachel Joseph
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Administrative Support:
– Linda Verlin
COMMENTS?
THANK YOU
Nicky O’Connor, BSN, MPH, CCRC
Associate Director – Office of Clinical Trials
New York University Medical Center
550 First Avenue – Bldg #VET
10th Floor – West Wing
Room 10029W
New York, NY 10016
Nicky.O’[email protected]
212 263-4210 – main office
http://www.med.nyu.edu/oct/
New York University
Technology Transfer at NYU
Abram M. Goldfinger
Executive Director,
Industrial Liaison/Technology Transfer
New York University
Mission Statement
Promote the commercial development of
NYU technologies into products to benefit
patients and society, while providing a
return to the University to support its
research and education missions.
New York University
Activities
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Commercialization of NYU Technologies
Research Support from Industry
New Business Ventures
Material/Data Transfer Agreements
Education
New York University
Academic Technology Transfer
• 1980 Bayh-Dole Act
• Concerns about U.S. competitiveness.
• Universities allowed to retain rights to inventions
arising from Federally-funded research
• U.S. manufacture, preference for small business
• Government license, march-in rights
• Activity – Approx. 600 new products introduced, 500
new companies formed, $50B in economic activity
each year
New York University
NYU Patent Policy
• Rights assigned to University
• University responsible for patenting and licensing
• Inventor(s) share in licensing income (42.5%)
New York University
Commercialization Process
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Invention Disclosure to Industrial Liaison
Evaluate commercial potential
Secure intellectual property protection
Identify potential commercial partners
Negotiate license and/or research agreement
Manage ongoing relationship
New York University
Patents
• Right to exclude others from making, using, or selling
claimed invention for 20 years from application filing date
• Cover new, useful, non-obvious inventions
• Prior Art - Publications, abstracts, presentations, etc.,
prior to filing of patent application
• First to invent (keep good notebooks)
• Scope of protection (e.g., specific compound vs. class of
compounds)
• Changes in law
New York University
Trends
• Larger companies interested in later stage
technologies
• University licensing to smaller or start-up companies
who develop and later partner with large companies
• Increased need for translational research
New York University
Applied Research Support Fund
• Provides investments of up to $75K each (increased
from $50K in FY09) in projects with commercial
potential.
• 34 investments to date. $1.6M invested.
• 10 of 34 funded technologies subsequent licensed.
• $15.2M in license income and $9.7M in corporate
research funding generated.
• Record 54 submissions in FY10. 8 projects awarded.
New York University
NYU Patenting Activity (Cumulative)
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538 U.S. Patents Issued
312 U.S. Patents Licensed (58%)
337 U.S. Patent Applications Pending
286 Active License Agreements
24 Products brought to market
13 Products in clinical trials
New York University
Start-Up Activity
• 50 companies formed
• Over $1 billion raised
• 6 companies public, 6 acquired
New York University
Recent Start-Up Companies
Company
Technology
Alveologic
Dental Devices
Alzicon
Alzheimer’s Treatment
Atreaon
Treatment for Inflammatory Diseases
Brainscrope
Brain Monitoring Technology
Cardium
Cardiovascular Gene Therapy
Constellation Pharmaceuticals
Epigenetics Research
CynVec
Cancer Gene Therapy
HealthC’air
CPAP Technology
Lycera
Treatment for Autoimmune Diseases
MET
MRI Technology
NeuroControl
Robotic Control Systems
NeuroInterface
Brain-Machine Interface Systems
Perceptive Pixel
Touch Screen Technology
Spin Transfer
Non-Volatile Memory (MRAM)
New York University
Multi-touch screen developed by NYU spin-off
company Perceptive Pixel used as
“Magic Wall” by CNN
New York University
Invention Disclosures
New York University
Licenses Signed
New York University
License Revenue
(in millions)
New York University
Top 10 Universities in License Income (2004-8)
(Source: Association of University Technology Managers)
1
New York University
$1.3B
2
Northwestern University
$896M
3
Emory University
$653M
4
Columbia University
$640M
5
Stanford University
$611M
6
University of California System
$579M
7
Wake Forest
$305M
8
University of Rochester
$294M
9
Massachusetts Institute of
Technology
$247M
10
University of Washington
$229M
New York University
2009 TT Activity Per $100M
Research Expenditures
US Universities
NYU
% Difference
Inv. Disclosures
37.8
38.5
(+2%)
Patents Issued
6.4
9.4
(+47%)
New Licenses
9.6
12.3
(+28%)
New Start-Ups
1.1
1.6
(+45%)
$3.5M
$36.6M
(+646%)
License Income
New York University
Products on Market
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24 products on market
Remicade (RA, Crohn’s Disease, AS, UC, Psoriasis)
Sutent (Kidney & Stomach Cancer)
Zinecard (to reduce chemotherapy side effects)
Oracea (Rosacea)
HIV Diagnostics
Vascular Stent
MRI Equipment
CPAP device for sleep apnea
Hip Prosthesis
Anesthesia Monitor
Embolism Coil
Dental Implant
New York University
Products in Clinical Trials
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13 Products in Clinical Trials
DNA-Based Drug for Angina
Drugs for Parkinson’s Disease
Alzheimer’s Disease Drugs
Anti-Cancer Compounds
Anti-Addiction Drug
Imaging Device for CNS Diseases
Malaria Vaccine
Wound Healing Compound
New York University
Conclusions
• Activity (invention disclosures, patents, new licenses)
has increased significantly in recent years.
• Robust technology portfolio for future growth.
• NYU research improving patient care.
• Welcome opportunity to meet.
• Contact us – www.med.nyu.edu/oil, (212) 263-8178.
Introduction to the
Institutional Review Board
Helen Panageas
Associate Director
Institutional Review Board
March, 2011
IRB Review made Simple
Overview
 What is an IRB
 Review Type Determinations
 Types of IRB Review
 Categories of Review
 Informed Consent and Authorization
Historical Events in Human Research
1944 -1980s
US
Radiation
Studies
1932 - 72
Tuskegee
Syphilis
Study
1930
1935
1940
1945
1939 - 45
German
Doctors
Experiments
Concentration
Camp
Prisoners
1950 - 1960s
CIA
Mind
Trial
1950
1947
The
Nuremberg
Code
1955
1961
The
Milgram
Studies
1960
1956 - 1980s
The
Willowbrook
Study
1966
Henry
Beecher
NEJM
Article
1965
1974
National
Research
Act
1970
1964
Declaration
of
Helsinki
1981 DHEW
Revises
Federal
Regulations
1975
1980
1989
NIH
Training
Required
1985
1979
The
Belmont
Report
Trigger Events
Nazi Experiments
Holocaust 1933 to 1945
Nazi Doctors Performed Experiments on Concentration
Camp Inmates;
 Without consent,
 During course of experiments
 committed the murders, brutalities, cruelties,
tortures, atrocities, and other inhuman acts.
23 German doctors charged with crimes against
humanity.
Ethical Milestones
Nuremberg Code
Directives of Human Experimentation
1947
1. Voluntary Consent
2. Experiments should yield good
3. Good design and prior research in non-humans
4. Avoid risks when possible
5. No experiments where death is known risk
6. Risk should equal benefits
7. Minimize risks
8. Qualified personnel should conduct research
9. Subject must have right to withdraw
10. Scientist must be prepared to end trial when
needed
Trigger Event
Tuskegee Syphilis Study
U.S. Public Health Service 1932 to 1972,
Examined the natural course of untreated syphilis in
black American men.
Impoverished sharecroppers from Alabama,
Unknowing participants in the study;
Not told they had syphilis,
Not offered effective treatment.
Ethical Milestone
The Belmont Report
National Commission for the
Protection of Human Subjects
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The Belmont Report (1979)
• Respect for Persons – Informed Consent
• Beneficence – Do No Harm
• Justice – Equitable Selection of Subjects
•
Common Rule – 45 CFR 46 (1991)
• Risk are minimized
• Risk/Benefit Ratio is favorable
• Subject Selection is equitable
• Informed Consent
• Data is monitored for safety
• Protect Privacy and Maintain Confidentiality
• Protect Vulnerable Subjects
Institutional Review Board
 Group of Scientist, Non-Scientists and
Non Affiliated Individuals
 Protect Human Research Subjects by
Reviewing and Approving Research
 Required by Federal Regulations
What is an IRB
An IRB is a group that reviews research to ensure
the rights and welfare of human subjects involved in
research are adequately protected.
There are four IRBs at NYU SoM
How is Review Type Determined?
Four Basic Questions:
1. Is the Proposed project Research?
2. Does the proposed project involve Human
Subjects?
3. What type of Risk is involved in the
proposed project?
4. Does the proposed project meet the criteria
for the Review Category?
Research is defined as a systematic
investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.
Human subject means a living individual
about whom an investigator (whether
professional or student) conducting
research obtains:
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Data through intervention or interaction
with the individual, or
Identifiable private information.
Does Your Study Involve Human Subjects?
Risk
Minimal Risk is defined as the probability
and magnitude of harm or discomfort
anticipated in the proposed 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.
Types of IRB Review
Exempt
Expedited
Full
Review Category?
 There are Different Categories
within each Review Type.
 The Project must Fall within One of
the Categories
Full Review
 Project is NOT minimal risk.
 Project is Minimal Risk BUT does not meet
EXEMPT or EXPEDITED CATEGORIES
 Informed Consent and Authorization Required
 Reviewed by a Full Convened Board
 Full Board Review Required
 Ongoing Annual Review
Expedited Research
 Minimal Risk
 HHS regulations define - seven categories
 Informed Consent and Authorization – required
or waived
 Reviewed at any time
 Full Board Review - Not necessary
 All criteria required for Full Board review
 Ongoing Annual Review
Exempt Research
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HHS regulations define - six categories
No requirement to obtain informed consent.
Reviewed at any time
Full Board Review - Not necessary
Ongoing Annual Review - Not required
(unless the research is changed so that it no
longer meets the exemption criteria)
Informed Consent on
the Review Continuum
Risk:
Low
Minimal
Higher
Review:
Informed
Consent:
Exempt
Expedited
Full
None
May be Waived Required
Criteria for IRB Approval
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Risks are Minimized
Risks are Reasonable in Relation to Benefits
Selection of Subjects is Equitable
Informed Consent will be Sought
Informed Consent will Be Documented
Monitoring the Data Collected to Ensure
Safety
 Protection of Privacy and Confidentiality is
Maintained
 Protection of Vulnerable Subjects
Consent Form Elements
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Statement that the study involves research
Research is described
Description of Risks
Description of Benefits
Disclosure of Alternatives
Confidentiality
If more than minimal risk, compensation and/or
medical treatment
 Participation is voluntary
 Whom to Contact
Waiver of Consent
• Are waivers allowed?
– Waiver of Informed Consent
Minimal Risk Research,
Waiver will not adverse effect rights,
It is impracticable to obtain IC,
When appropriate info will be shared
– Waiver of Documentation of Consent
Minimal Risk
Procedure involved does not require written ICF OR
Written ICF is only link to subject
Other IRB Reviews
 Continuing Review
 Amendments
 Reportable Events
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Unanticipated Problems involving risk
Safety Reports that indicate potential risk
Noncompliance
Incarceration of Subject
 Study Closure
Q&A
QUESTIONS?
Contact Us
IRB Main Office Location:
423 East 23rd Street, VA Building, 10th floor, West Wing
Office Hours: Monday - Friday, 8:00 am - 5:00 pm
General Information: [email protected]
Phone: 212-263-4110
Fax: 212-263-4147
Exploring Research Compliance Issues
Human Subjects Research at NYU Langone Medical Center
Presented by:
Keisha A. Lightbourne, JD, MHA, CHC
Director, Office of Research Compliance
Director, Conflict of Interest Management Unit
Objectives
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Getting to Know ORC
Understanding what ORC does at NYULMC
Understanding Research Compliance
Concepts for Human Subjects Research
Agenda
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General Principles for Performing Research
at NYU
Managing Research Data
Responsible Conduct of Research
Conflicts of Interest
Board of Trustees
Dean/CEO
Annette Johnson
General Counsel
Nancy Dean
VP Of Audit & Compliance
Director of Research Compliance
Conflicts Management Unit
Office of Research Compliance
Responsibilities
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Oversight of all offices that deal with Research
Programs at NYULMC
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IRB
SPA
Post Award Finance
Research Misconduct
Environmental Health & Safety
Radiation Safety
IACUC
DLAR
IBC
ESCRO
Operational administration of the CMU
Performing Research At
NYU Langone Medical Center
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Research performed by NYU School of
Medicine (not NYU Hospitals Center)
NYU School of Medicine is separate
from New York University for
sponsored research purposes
Research administered by Office of
Science & Research via SPA
Principal Investigator responsible
for the compliant conduct of
research.
General Principles of Performing Research
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Research is intended to
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impart knowledge
enlarge humanity’s store of knowledge.
Results of research must be made available to the
general public on a nondiscriminatory basis.
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NYU does not conduct secret or classified research.
Investigators must be able to publish research results
without prior approval of sponsor.
**Failure to adhere to these rules could put non-profit
status at risk and/or put tax-exempt status of NYU’s
bonds at risk**
Managing Data
Retention & Access to Research Data
Under Medical Center’s Policy on Retention of and
Access to Research Data:
• Research data means
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any recorded, retrievable information, necessary for the
reconstruction and evaluation of reported results of
Research
Some examples include:
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laboratory notebooks
case history records
filed specimens
computer files or other electronic data
software programs and databases
cell lines
Managing Data
Retention & Access to Research Data
Under Medical Center’s Policy on Retention of and
Access to Research Data:
• Principal Investigator is responsible for collecting and
maintaining research data
• Research Data must be retained for AT LEAST from:
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three years after the final project close-out or
five years after the final reporting or publication or
may be longer per policy
• Data owned by NYU
• Transfer of data from NYU requires approval
Managing Data
Freedom of Information Act (FOIA)
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FOIA defines federal agency records subject to
disclosure upon public request, outlines mandatory
disclosure procedures and grants nine exemptions.
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FOIA applies for records related to federal
sponsored research.
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Nine categories of records exempt from mandatory
disclosure; some of which apply to research.
Managing Data
HIPAA Privacy
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Protected Health Information (PHI) is not accessible for
RESEARCH without the patient’s written authorization
Unless PHI access is “preparatory to research”
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Use or disclosure is solely to view PHI necessary to prepare a
research protocol or similar purposes to prep for research
The PHI cannot be removed from the premises in the course of
the review
The PHI for which use or access is requested is necessary for the
research
Options –
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De-Identified data ≠ PHI
Limited Data Set & Data Use Agreement
Research on Decedents (not Human Subjects’ Research)
Managing Data
HIPAA Security
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Make Passwords Strong & NO sharing
Walking Away? Remember to Log Out…Each
Time!
Save PHI data on shared drives (not local ones)
Do not email PHI outside of NYULMC (without
secure messaging)
Do not leave paper records containing PHI out and
accessible
Double check fax # before faxing PHI
Use NYU OnsiteHealth to access PHI when away
Encrypt USBs, Laptops & SmartPhones
For potential violations call 1-800-PHI-LOSS
Responsible Conduct of Research
Research must be conducted and results published
with the highest standards of ethical conduct, truth,
and accuracy, and must be free of appearance of
impropriety or conflict of interest.
 Public Health Service Policies on Research
Misconduct at 42 C.F.R. 93
• NYU policy, research misconduct means fabrication,
falsification, or plagiarism in proposing, performing,
or reviewing research, or in reporting research
results.
• Purpose: Protect the accuracy, reliability, and
integrity of the research
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Responsible Conduct of Research
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A finding of research misconduct requires
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Significant departure from accepted practices
Committed intentionally, or knowingly, or recklessly
Proven by a preponderance of evidence
• Four phase process for Review
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Assessment
Inquiry
Investigation
Adjudication which may lead to sanctions up to and
including disbarment
Responsible Conduct of Research
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The responsible conduct of research requires
careful consideration of the following:
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Responsible Authorship
The Mentor-Trainee Relationship
Responsible Data Management
Responsible Collaboration
Conflicts of Interest
For more information, see the Office of
Research Integrity’s Guide:
http://ori.dhhs.gov/documents/rcrintro.pdf
Conflicts of Interest
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Research at the Medical Center must be free of the appearance
of conflict
Under Medical Center’s Policy on Conflicts of Interest in
Sponsored Research and Sponsored Programs:
 A conflict of interest in research may occur whenever an
investigator has a personal financial interest in a party affected by
the research.
 All investigators in all studies must complete disclosure form.
 All disclosed interests will be reviewed for all studies.
 When the financial interest is significant, review will be made by a
faculty Research Conflicts of Interest Committee (RCOIC).
 The RCOIC will permit the conflicted investigator to participate in
the research only if compelling circumstances are present and
the research is subject to a plan which effectively manages the
conflict.
Conflicts of Interest – The Mechanics
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Annual Disclosure using
http://eresearchadmin.nyumc.org
At submission of a grant application/IRB
using the Investigator Financial Disclosure
Form and the Supplemental Form if “yes”
checked on the Investigator Form
Both can be found at
http://cimu.med.nyu.edu
Conflicts of Interest
Institutional
Under Medical Center’s Policy on Institutional
Conflicts of Interest in Human Subjects Research:
• an institutional conflict of interest (ICOIC) occurs if
NYU or the Medical Center has an equity interest in
a research sponsor of, or an IP interest in an
investigational product being used in, a human
subjects’ research project.
• If an ICOI exists, the research will not be permitted
to proceed without a compelling circumstances
finding by the RCOIC.
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Institutional Conflicts of Interest- The
Mechanics
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Proactive review is the best way to avoid
ICOI
Creating a protocol that uses NYU IP?
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To find out request access to the master list at
http://cimu.med.nyu.edu/policies/conflicts-interestresearch-/institutional-conflicts-interest-list
Questions?

Keisha Lightbourne, JD, MHA, CHC
212-404-4070
REPORT COMPLIANCE VIOLATIONS TO
1-866-NYU-1212