Get documents about "Slide 1 - University of Maryland
Document Sample
UM Assurances
Compliance: Why Do We Care?
Right thing to do
State and University policy requirements
Sponsor requirements
Right Things to Do
Human Subjects – protect humans, even if they
are only being surveyed
Animal subjects – ensure that animals are not
being mistreated
Biohazards/radioactive materials – protect
workers from contamination/illness; protect public
from potential terroristic acts
Conflict of Interest – guarantee that undue
influence or unfair advantage is not being
provided
State policy requirements
Human Subjects – IV-2.10 University Of Maryland System
Policy On Human Subjects Of Research
Animal Subjects – UMCP Policy on Animal Care and Use
Biohazards/Radioactive Materials –
VI-11.00(B) UMCP Policy On Occupational Exposure To
Bloodborne Pathogens
VI-13.00(A) UMCP Policy on Occupational Exposure to
Hazardous Chemicals in Laboratories
VI-17.00(A) University of Maryland Policy on Biosafety
Conflict of Interest - II-3.10(A) Policy on Conflict of Interest &
Conflict of Commitment
Sponsor requirements
Human Subjects – The Common Rule (Federal
Policy for the Protection of Human Subjects)
Animal subjects – DHHS, Office of Laboratory
Animal Welfare
Biohazards/radioactive materials – All OSHA,
EPA, DOT, NRC regulations. Other local, state
and federal regulations.
Conflict of Interest – NIH requires all conflicts to
be reported; NSF requires unmanaged conflicts to
be reported
Committees
Institutional Review Board (IRB) – reviews
projects involving human subjects
Institutional Animal Care and Use committee
(IACUC) – reviews projects involving animal
subjects
Institutional Biosafety Committee (IBC) – reviews
projects involving biohazardous materials
Conflict of Interest Committee (COI) – reviews
projects that involve a conflict of interest
University of Maryland College Park
Institutional Review Board
7
o Good Clinical Practices
o Historical Background
o Ethical Milestones
o Basic Protections for Human Subjects
o Regulatory Oversight
o Institutional Requirements
8
“International ethical and scientific quality
standards for designing, conducting,
recording, and reporting trials that involve
the participation of human subjects.”
Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the
individual trial subject and society.
o A trial should be initiated and continued only if the anticipated
benefits justify the risks. Several different components which
vary by country and research setting
9
o Freely given informed consent should be obtained from every
subject prior to clinical trial participation.
o All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting,
interpretation, and verification.
o The confidentiality of records that could identify subjects
should be protected, respecting the privacy and
confidentiality rules in accordance with the applicable
regulatory requirement(s).
10
DEFINITION:
o A human subject is a living individual
about who an investigator obtains
either:
o data through interaction or intervention
with the individual
o bodily materials (blood, urine, nail
clippings, hair) even if the investigator did
not collect these
o Private, identifiable information
(Information found in medical record)
11
o The voluntary consent of the human subject is absolutely
essential.
o The experiment should be such as to yield fruitful results
for the good of society…
o The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury
(minimize risk)
o Proper preparations should be made and adequate
facilities provided to protect the experimental subject
against even remote possibilities of injury, disability, or
death.
o The experiment should be conducted only by scientifically
qualified persons.
12
o During the course of the experiment the human subject
should be at liberty to bring the experiment to an end if
he has reached the physical or mental state where
continuation of the experiment seems to him to be
impossible.
o During the course of the experiment the scientist in
charge must be prepared to terminate the experiment at
any stage, if he has probable cause to believe, in the
exercise of the good faith, superior skill and careful
judgment required of him that a continuation of the
experiment is likely to result in injury, disability, or death
to the experimental subject.
o No experiment should be conducted where there is an a
priori reason to believe that death or disabling injury will
occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.
13
o Builds on Nuremburg Code
o Interests of participants must be given
higher priority than those of society
o Every research participant should receive
the best known treatment
14
o Created the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
o Formed in the aftermath of the Tuskegee Syphilis
Experiments
o Belmont Report (1979)
o Identifies the basic ethical principles that should
underlie the conduct of biomedical and
behavioral research involving human subjects
15
Ethical Principle #1 – Respect for Persons
o Treat individuals as autonomous agents
o Protect persons with reduced autonomy
IRB Requirements
o Participants voluntary consent
o Privacy and confidentiality are protected
16
Ethical Principle #2 – Beneficence
o Two general rules have been formulated as
complementary expressions of beneficent actions in this
sense:
o (1) do not harm and
o (2) maximize possible benefits and minimize
possible harms.
IRB Requirements
o Risks of research are justified by potential benefits
o Study is designed to minimized risks
o Adequate data and safety monitoring
o Conflicts of Interest are managed appropriately
17
Ethical Principle #3 – Justice
o Distribute the risks and potential benefits of
research equally among those who may benefit
from the research.
IRB Requirements
o Vulnerable subjects are not targeted for convenience
o Vulnerable populations recruited are adequately
protected
o Subject selection is equitable
o Population exclusion is justified
18
o Regulatory Oversight
o Institutional Review Board (IRB)
o Informed Consent
19
o Office of Human Research Protections
o 45 CFR 46
o Subparts A, B, C (Pregnant Women, Prisoners,
Children)
o Food and Drug Administration
o 21 CFR 50, 56
o Office of Good Clinical Practice
o DHHS Agencies (DOD)
o ICH Good Clinical Practices
20
o The IRB is a committee designated by an
institution to help assure the protection of
the rights and welfare of human subjects.
o The IRB approves the initiation of and
conducts periodic reviews of research
involving human subjects.
o Investigators also share the responsibility
for protecting human subjects.
21
o Initial & Continuing Review
o Addendums to Approved Protocol
o Approve
o Disapprove
o Require modifications
o Terminate
22
o Appropriate Informed Consent Process
o Acceptable Risk/Benefit ratio
o Privacy and Confidentiality Protection
o Data and Safety Monitoring
o Scientific Validity
o Equitable Subject Selection
23
o EXEMPT (45CFR46.101) – 6 Categories
o Exempt from requirements of 45CFR46
o IRB makes this determination, not the PI
o PI can suggest an Exempt Category
o EXPEDITED (45CFR46.110) – 9
Categories
o Does not mean “Fast”
o Minimal Risk transactions
o FULL BOARD
o Research presenting greater than minimal risk to
participants 24
Timeline for Review
Initial Protocol Review [Expedited] –
Two to Three weeks
Continuing Review [Expedited] –
Two to Three weeks
Addendums [Expedited] – Two to Three
weeks depending on the type and number
of changes.
Full Board Transactions [All] – One month
Timeline for Review
Quality of Protocol Applications
Turnaround time likely to be shorter when
protocol is written well and requires little to no
modification
Continuing Review
To avoid Protocol Expiration or Administrative
Closure, submit Continuing Reviews at least 45
days in advance of Expiration date.
Administrative Review
Timeline for Closure
All research activity must cease. New protocol
application must be submitted if PI wishes to
continue
Expiration
Research activity must cease until submitted
Continuing Review is IRB Approved
Continuing Review applications submitted after
Expiration will not be considered
Funding Requirements
o Federal Funding
o Grant application must be included with Initial
Protocol Submission
o The information in the Grant must be consistent
with what human subject research activities will
be conducted at UMCP
o New or change in funding source after initial IRB
Approval must be added to the protocol via an
Addendum application
Funding Requirements
Grants Involving Human Subject Research
Must submit a protocol to the IRB
A protocol may have more than one funding source
Grants Not Involving Human Subject Research
Do not require IRB Review
If unsure, contact IRB to discuss
Better to be safe than sorry!
Complete Request for Non-Human Subjects Research
Determination Form
Subcontracts in Human Subject Research?
Is UMB Engaged
An institution becomes “engaged” in human subjects
research when its employees/agents:
(i) intervene or interact with living individuals for research
purposes or,
(ii) obtain individually identifiable private information for
research purposes
Many factors to consider (too many to list here)
Guidance found at:
www.hhs.gov/ohrp/humansubjects/guidance/engaged08.ht
ml
Unsure? Call IRB Office to discuss
Risk/Benefit Ratio
o What are the risks?
o Is the potential knowledge important
enough to justify the risks?
o Is subject selection equitable?
31
Consent Process
o Are mechanisms for obtaining consent
appropriate?
o All risks/benefits documented appropriately?
o Does the protocol state that all participants
will receive a copy of the signed consent
form?
32
Waiver of Consent
o 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
o The research presents no more than minimal risk of harm
to subjects and involve no procedures for which written
consent is normally required outside of the research
context.
o In cases in which the documentation requirement is
waived, the IRB may require the investigator to provide
subjects with a written statement regarding the research.
(Information Sheet) 33
Vulnerable Populations
o Prisoners
o Children
o Pregnant woman and Fetus
o Cognitively impaired
o Students
Are there appropriate protections in place for the
group or groups you are recruiting?
34
Privacy and Confidentiality
o HIPAA – Health Insurance Portability and
Accountability Act (1996)
o Is PHI involved?
o Plans to protect PHI
o Authorization to collect PHI? (HIPAA
Authorization)
o Who will have access to identifiers?
o Will the data be coded?
o Where will the data be stored?
35
o The regulations require Continuing Review of IRB
Approved research at least once per year.
o If Continuing Review is not approved by the
expiration date of the protocol, the protocol will
expire.
o All research activity must cease until approval is
obtained.
o If Continuing Review is not submitted prior to
Expiration, a New application must be submitted.
36
1) Determine if the study is currently actively
enrolling, treating, or following subject
o Review summary of study progress
2) Participant Accrual
o Equitable selection of participants?
o Over enrollment?
o Slow enrollment?
37
3) Review any currently requested protocol
revisions and any revisions that have been
approved since last continuing review.
o How have these impacted the progress of the
protocol?
4) Determine if the study is progressing as
planned.
o Will the study objectives be met?
o Does the Risk/Benefit ratio remain favorable?
38
5) Determine if unexpected events have
occurred that may indicate a need for a
change in the protocol or consent
document.
o Review participant complaints
o Is there an unexpected rate of withdrawals?
39
o Federal Regulations require that all
revisions be approved by the IRB prior to
their implementation.
o Addendums that increase the risk of
research participation must be approved by
the full IRB committee.
40
1) Identify the part of the research proposal
being revised.
2) Determine of the revision increases risk
for currently enrolled and future subjects.
3) Determine if currently enrolled subjects
should be re-consented.
4) Determine if the consent form should be
modified or if the proposed changes to the
consent form are appropriate
41
5) If the revision increases risk to current or
future subjects, determine if the protocol
still meets the criteria that are used to
evaluate new studies.
6) If revisions heavily modify the protocol,
the IRB may request that a New protocol
be submitted.
42
o Scientific validity
o Research design
o Uphold ethical principles
o Quality of study conduct
o Compliant with federal, state, institutional
requirements
43
Know your responsibilities
o Educate others
o Be Accountable (PI, Student Investigator, Research
Staff)
o Utilize your resources
o Contact the IRB Office with any questions
44
Resources
o Website: www.umresearch.umd.edu/IRB
o Policies and Forms are in the process of being updated. Check
back often for changes. Call or email with any questions!
o Joseph M. Smith – IRB Manager
o 301-405-0678
o jsmith@umresearch.umd.edu
o Tykisha Bell – Assistant IRB Manager
o 301-405-7326
o tbell@umresearch.umd.edu
o Main Office/Graduate Assistants
o 301-405-4212(Office)/301-314-1475(Fax)
o Email: irbdeans@umd.edu
o Benjamin Newton/Benjamin West
o Neil Shah – PAS Questions
Animal Subjects in
Research and the
Role of the IACUC
Amanda Underwood
IACUC Manager
graebel@umd.edu
#2100 Lee Building
Purpose of this Presentation
To give a general overview of the IACUC
approval process
Protecting animal subjects
Federal Regulations
Animal Welfare Act - USDA
PHS Policy - OLAW
What is an IACUC?
Institutional Animal Care & Use Committee
Review and approve protocols
Inspect animal program and facilities
Responsible for compliance with federal regulations
Types of Research that require IACUC
approval
On-campus research
Off-campus research
Field research
In general, any research that involves the use
of any living animal. Some tissue use is
also regulated.
Why having IACUC approval is a
requirement.
Protects the animals
Compliance with federal
regulations
Ensures that research is
conducted in a humane and
responsible manner
Ensures that work has scientific
merit
Does this work need IACUC
approval?
General guidelines
Handling live animals
Manipulation of animals or their environment
Collecting tissue from live animal
Using primate tissue
What to know about protocol
submissions?
PI responsibility
Deadlines
Pre-review
Justifications
Resources
Attending Veterinarian
How to submit a protocol?
IACUC website
www.umresearch.umd.edu/IACUC
Fill out Animal Study Protocol
Submit copy to IACUC Manager
Its also recommended to submit a copy to the Attending
Veterinarian for pre-review.
However, only submission to IACUC office places your
protocol in the IACUC agenda.
What to be prepared for.
It may not be approved at the meeting
Most delays are for clarifications and
modifications of the protocol
Timely response from the PI is necessary
Submission to the IACUC is not approval –
PIs cannot begin work
Maintaining a protocol
Protocols receive 3 year approval
Cannot be renewed
Must undergo de novo review at end of 3rd year
Annual reviews required once a year
Changes must be submitted to the IACUC for
review
PIs should notify IACUC Office that they are
closing a protocol
QUESTIONS?
Amanda Underwood
Ext. 55037
graebel@umd.edu
HAZARDOUS
PROCEDURES
ENVIRONMENTAL
SAFETY
3115 CHESAPEAKE BUILDING
(301) 405-3960
Chris Benas Tom O’Brien
Chemical Hygiene Radiation Safety
Officer Officer
cbenas@umd.edu tobrien2@umd.edu
February 25, 2009
59
Acronyms
• PI: Principal Investigator
• rDNA: recombinant DNA
• NIH Guidelines: Guidelines for Research Involving
Recombinant DNA Molecules
• IBC: Institutional Biosafety Committee
• ORAA: Office of Research Administration and
Advancement
• DES: Department of Environmental Safety
• BSO: Biological Safety Officer
• RSO: Radiation Safety Officer
• DSO: Diving Safety Officer
• DCB: Diving Control Board
60
Hazardous Procedures
may include:
• Biological materials (rDNA,
infectious agents, human or non-
human primate blood)
• Select agents and toxins
• Radioactivity
• Scientific diving/Boats
• Hazardous chemicals
• Highly toxic/Reactive gases
Why do assurances?
61
• Federal and State agencies
have specific requirements for
conducting hazardous
operations or using hazardous
materials
– National Institutes of Health (NIH)
– Nuclear Regulatory Commission
(NRC)
– Centers for Disease Control and
Prevention
– Occupational Safety & Health
Regulations/Guidelin
62
es
• “NIH Guidelines for
Research Involving
Recombinant DNA
Molecules” (NIH
Guidelines), April 2002
• COMAR – Code of
Maryland Regulations
26.12.01.01 “Regulations
for the Control of Ionizing
Radiation”
Who is responsible for
63
assurances?
• The Vice President for Research is
responsible for “reviewing matters
involving human subjects, DNA
research, hazardous substances,
and the experimental use of
animals”
Who provides the assurances?
64
• Biological, Radioactive,
Chemicals/Gases, Diving/Boats,
Environmental Protection
– Dept. of Environmental Safety via various
faculty committees (e.g., IBC, RSC)
• Animals
– Institutional Animal Care and Use
Committee
• Human subjects
– Institutional Review Board
65
What does DES do?
Environmental Safety helps PIs comply with
•requirements: Officer
Radiation Safety
– Radioisotopes
– Ionizing radiation producing devices
– Non-ionizing radiation producing devices
• Biological Safety Officer
– Recombinant DNA
– Infectious agents
– Human or non-human primate blood / tissue / primary
cell culture
• Diving Safety Officer
– Scientific diving/Boats
Chemical Hygiene Officer
– Hazardous chemicals/gases
Environmental Compliance Manager
– Environmental Impact
66
Forms
• All forms available on ORAA’s web
page:
www.umresearch.umd.edu
/oraa
• and on DES’ web page:
www.des.umd.edu
Question #23
68
Environmental Impact
• Protocols are not forwarded to DES for
approval unless funding agency requires
specific environmental assurances that
must be provided by institution (e.g.,
Certificate of Environmental Compliance –
USAMRMC)
– DES typically notified by PI of documentation
need
Question #26
Radiation Safety
Regulations
NRC, MDE, EPA, DOT
NRC and MDE
Regulations
License Conditions
Radiation Safety
ProceduresRadioactive Material
Authorizations
Radioactive Material &
Radiation Producing Devices
• Only personnel who are Authorized by the
Radiation Safety Committee can use
radioactive material and radiation
producing devices
• The University has 4 licenses from the
Maryland Department of the Environment
and the Nuclear Regulatory Commission
X-Ray Radiation Producing Devic
Radioactive Material
LASERS Lasers
73
Sequence of Events
• VP for Research routes “yes”
applications to DES
• Grant application reviewed by the
Radiation Safety Office
– If researcher is authorized for possession and use
of radioactivity (isotopes), the protocol will be
approved by RSO, otherwise, PI must receive RSO
approval prior to ordering the radioactive material
Question #28
75
rDNA Guidelines
• “As a condition for NIH
funding of recombinant DNA
research, institutions shall
ensure that such research
conducted at or sponsored
by the institution,
irrespective of the source of
funding, shall comply with
the NIH Guidelines”
76
Question 28
• Biological materials
– rDNA (approval #:________)
• Not needed to submit grant
– Infectious agents
– Toxins
– Blood, unfixed tissue, primary cell
culture from humans or non-
human primates
77
Changes
• “Intent to perform recombinant DNA
experiments” form no longer used
• “Assurance on Hazardous Procedures”
form no longer used
• rDNA and infectious agents registration
is now online
• Researcher only needs to register new
rDNA experiments that are described in
grant application
• Grant application may be submitted
78
Sequence of Events
• VP for Research routes “yes” applications to
DES.
• Compliance with NIH rDNA Guidelines is not
optional – it is a condition for NIH funding. But
grant may be submitted prior to receiving IBC
approval.
• Grant application reviewed by DES and
compared with PI’s previous registrations
– IBC reviews, approves, and sets containment for
experiments involving rDNA and infectious agents.
– If the same type of biological experiments have been
79
Sequence of Events
• Submit online registration
form for rDNA and
infectious agents only if
similar experiments have
not been registered
previously.
80
IBC Sequence of Events
• If grant contains research that is not
already registered, BSO contacts PI.
• If needed, PI submits registration for
new experiments.
• Institutional Biosafety Committee
(IBC) reviews registration
• IBC approves/disapproves registration
and sets level of containment.
• BSO reports to ORAA that grant
application has been approved.
Question #29
82
Sequence of Events
• VP for Research routes “yes”
applications to DES
• DES contacts PI to determine
which toxins are used and the
quantity in possession
• DES notifies ORAA of approval
status
• ORAA releases funds only after
Question #30
Toxic & Reactive
84
Gases
• Building Code Control Requirements
– Exhaust Ventilation
– Gas Detection
– Alarm/Control
• UM Chemical Hygiene Program – Prior
Approval
Toxic & Reactive
85
Gases
86
Sequence of Events
• VP for Research routes “yes”
applications to DES
• DES contacts PI to determine if
gas monitoring & control
equipment is necessary
• DES notifies ORAA of approval
status
• ORAA releases funds only after
Question #31 &
32
Summary of Requirements
88
• Individuals conducting
scientific diving under the
auspices of UM must be
registered with the Diving
Safety Program through the
DSO.
• Prior to operating any UM
vessel, prospective
operators must be checked
out by the SBO and
www.des.umd.edu/risk_comm/diving/i
demonstrate skills in the
89
Sequence of Events
• VP for Research routes “yes”
applications to DES
• DSO reviews and approves scientific
diving
• SBO ensures prospective boat operators
can demonstrate skills in the operation of
any size boat. Checking “yes” for “Boats
Used in Research” implies the researcher
is familiar with the requirements stated in
Question #33
Summary of Requirements
91
• All labs with hazardous chemicals must
develop a Chemical Hygiene Plan:
– Standard Operating Procedures
– Designated Areas
– Personal Protective Equipment
– Prior Approval Criteria
– Chemical Safety Data
– Copy to DES
• Protocols are not forwarded to DES (at this
time)
ANY QUESTIONS?
Conflict of Interest
News Items Related to UM
Faculty
• UM-Based Startup Wins Global Security Challenge (TERP) -
TRX Systems (Dr. Gil Blankenship, founder)
• “University of Maryland Faculty are the Source News Media
Turn to for Expertise – From Politics and Public Policy to
Society and Culture to Science and Technology” (TERP)
– Larry Shinagawa (Asian American Studies) quoted
in LA Times
– John Robinson (Sociology) and Roger Lewis
(Architecture) quoted in Washington Post
– Peter Morici (Business) appeared on ABC World
News with Charles Gibson
News Items Related to UM
Faculty
“Five Maryland faculty researchers are among the 486
new fellows named by the American Association for
the Advancement of Science”
• Avis Cohen (Biology): has focused on spinal
regeneration and the development of the fields of
computational neuroscience and neuromorphic
engineering
• Nathan Fox (Human Development): has worked on
elucidating the basis of early temperament and social
behavior in young children
News Items Related to UM
Faculty
• Nicholas Hadley (Physics) has taken a leadership role in the
discovery of the top quark and searched for phenomena
beyond the standard model of particle physics
• K.J. Ray Liu (Electrical and Computer Engineering): has
contributed to discoveries in signal processing for wireless
communications, multimedia, information forensics, and
security
• Venkatramana Subrahmanian (Director of the Institute for
Advanced Computer Studies): has contributed to advances
in computer science and multidisciplinary computing,
especially as it relates to forecasting group behaviors
(Research at Maryland Newsletter)
Conflict of Interest
• Official Policies and Procedures Manual
– Maintained in Office of Legal Affairs, Maryland
Room in McKeldin Library
• University Web Sites
– http://www.inform.umd.edu/CampusInfo/Departments/PRES
– http://www.umresearch.umd.edu/oraa
• click on Memos and Policies
• click on Policies Regarding Research
Conflict of Interest Policies
• BOR III-1.11 Conflict of Interest in Research
or Development
• UMCP II-3.10 (A) Policy and Procedures on
Conflict of Interest
• State Ethics Law, Sections 15-501 et seq. of
the State Government Article of the Annotated
Code of Maryland
General Policy Overview
• UM employees have an obligation to report actual
or potential ethical, legal, financial, or other
conflicts of interest and commitment
• Working with supervisors and institutional
management, UM employees must either find
means to resolve or to manage any conflicts, or
they must not participate in the activities that give
rise to them
Conflicts of Interest: UM
• May arise when a UM employee is in a
position to gain financial advantage or
personal benefit (broadly construed) from
his/her position, either through:
– outside professional activities or
– actions or decisions at the University
Conflicts of Interest:
State Ethics Law
• UM employees are State employees
• COI may also arise in context of State Ethics
Law
– Restricts the relationships (employment,
consulting and other) and financial interests that
UM employees may have with outsiders
• Under UM authority or
• That do or seek to do business with UM or the State
Conflicts of Interest:
State Ethics Law
• COI may also arise in context of State
Ethics Law
– Prohibits other things like:
• Participating in certain matters
• Using prestige of office or confidential information
for private gain
• Asking for or accepting certain gifts
• Representing parties in State matters for
contingent compensation
Key Items:
Full and Prompt Disclosure
• What to Disclose
– Significant professional activities outside UM or
the unit
• “significant” to be determined by Unit Head, in
consultation with unit faculty and approval by Dean or
other appropriate administrator
– Other situations where a conflict or perception of
conflict may occur
Key Items:
Full and Prompt Disclosure
• When to Disclose
– As situations arise, inform Unit Head (defined
as the chair or director in an academic
department, or a similar official in a non-
academic unit, unless a different individual is
designated by proper authority)
– In context of formal UM reporting process
Form and Procedures
• COI Form
– Obtain
• from COI administrator
• ORAA web page
– When to file
• initial approval
• annual confirmation, as requested
• change in circumstances
• when relationship ends
Form and Procedures
• COI Form (cont.)
– Contents
• full description
• supporting documentation
• additional information as requested
– Submit
• to Unit Head
– Attach proposed management plan, as appropriate to manage, reduce
or eliminate real or potential COI
• through Dean or other official, to COI administrator
• may become part of the public record
Review
• COI committee reviews and makes
recommendation to President (through the
AVP and VP for Research)
• Restrictions may be imposed to manage,
reduce, or eliminate, any actual, or potential
COI
Requirements for Approval
• Relationship may not
– Give improper advantage
– Lead to misuse of students or employees
– Interfere with employees’ responsibilities
More Requirements
• Relationship may not (cont.)
– Constitute a harmful interest (an interest found to
be so influential as to impair impartiality in the
conduct of research, the interpretation of results
and/or the determination of research, professional
or employment priorities)
– Present an unacceptable COI
– Otherwise violate policies, procedures or best
interest of UMCP
Approval
• President’s decision is final
• Approval may be withdrawn
– Misrepresentation
– Change in circumstances
• Approval is filed with Chancellor and State
Ethics Commission
Continuing Obligations After
Approval
• Ensure improper advantage is not given to
outside entity
• Do not disclose unauthorized data to outside
entity
