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					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

				
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