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Senior Compliance Panel: Hot Topics in Research Compliance

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Title: Senior Compliance Panel: Hot Topics in Research Compliance


1
Senior Compliance Panel Hot Topics in Research
Compliance
  • NCURA Regional Meeting
  • April 7, 2009
  • AVC Deborah Motton, UC Merced
  • AVC Patrick Schlesinger, UC Berkeley

2
America COMPETES Act
  • America Creating Opportunities to Meaningfully
    Promote Excellence in Technology, Education, and
    Science
  • Focus Increase research investment in U.S.
  • Increase (double) funding to NSF, DOE, NASA, NOAA
  • Promote High Risk Research
  • Expand NSF fellowship and trainee programs
  • Develop math and science baccalaureate programs
  • Increased support for state elementary and
    secondary school programs and science and math
    initiatives
  • Increase scientific innovation

3
COMPETES Act and the Responsible Conduct of
Research
  • Section 7009 requires
  • each institution that applies for financial
    assistance from the National Science Foundation
    for science and engineering research or education
    describe in its grant proposal efforts to provide
    appropriate training and oversight in the
    responsible conduct of research to undergraduate
    students, graduate students, and postdoctoral
    researchers participating in the proposed
    project.

4
NSF Implementation
  • Effective Oct 1, 2009
  • At submission an Authorized Organizational
    Representative certify institution has plan in
    place
  • Modification of standard award conditions to
    allow verification of RCR training

Federal Register Vol 74 No. 37, Feb 26th 2009
5
Considerations/Challenges
  • How will education and training be administered?
  • In person, mandatory class, online ?
  • Should training be tailored to individual/discipli
    nary needs?
  • Resources needed
  • Faculty and/or administrative role

6
Considerations/Challenges
  • Undergraduate vs. graduate vs. postdoctoral
    researchers
  • Verification Tracking systems
  • NSF funded vs non NSF funded personnel
  • Policy Implementation

7
UC Merced Options
  • Collaborative Institutional Training Initiative
    (CITI)
  • Online training
  • Discipline specific RCR training Biomed, Social
    Behav, Phys Eng, Humanities, Admin.
  • Thorough
  • Self-paced

8
UC Merced Options
  • RCR class
  • Graduate level
  • Currently optional
  • Inclusive of all RCR topics
  • Open to post doctoral researchers
  • Taught once/year
  • Office of Research

9
American Recovery and Reinvestment Act of 2009
10
ARRA Basics
  • Signed into law Feb 17th, 2009
  • provide investments needed to increase economic
    efficiency by spurring technological advances in
    science and health
  • Create jobs
  • Modernize health care
  • Modernize infrastructure

11
Research Funding Under ARRA
  • NIH 10.4 Billion
  • NSF 3.0 Billion
  • DOE, Office of Science 1.6 Billion
  • ARPA-E 400 Million
  • NASA 550 Million
  • DOD, Energy-Related RD 200 Million
  • NIST 180 Million
  • PLUS - Additional funds for IGs and GAO

12
OMB Guidance
  • Unprecedented Level of Reporting
  • Agency Implementation Plans - May 1
  • Govt-wide Terms and Conditions
  • Reporting Requirements in TC
  • More Details to Come - 2-3 weeks

13
Reporting Guidance
  • Reporting guidance sent by NIH and NSF
  • OMB Guidance Pages 14-16
  • Due 10 Days after end of Calendar Quarter
  • Obligated vs.Unobligated?
  • Completion Status?
  • Number of jobs created or retained?
  • Sub-recipient reporting

14
ARRA - NIH
  • Breakdown of 10.4 Billion
  • Three Major Funding Priorities
  • R01s - peer-reviewed and meritorious
  • Supplements- competitive and administrative
  • New Challenge Grant Program
  • Limits on funds
  • Quick Start Activities
  • One time funding
  • Wage requirements

15
ARRA - NSF
  • Breakdown of 3 Billion
  • No new individual investigator calls (Oct 8th,
    2008)
  • Will fund already in house applications
  • Reviewed/awarded by Sept 2009
  • No Supplements
  • MRI Funds and Cost Sharing
  • Up to 5 Year Awards
  • High risk/high return research priority

16
ARRA Issues
  • Direct charge for Research Admin Specialists
  • Just in time flexibility on compliance issues
  • Employ Americans provision should not impact
    foreign student work on grants
  • Submission Grants.gov?

17
Research Data Integrity and Management
18
Objectives
  • What is research data?
  • Integrity/Misconduct
  • Data sharing
  • Data Storage
  • Ownership
  • Access
  • Retention

19
What is Data?
  • products of research that are intended as a
    basis for reporting of research findings.
    Michael Kalichman
  • Technical data
  • Computer software
  • Laboratory notebooks
  • Field notes
  • Memoranda
  • Unique university resources

20
Reason for Scrutiny
  • ORI Definition of Research Misconduct
  • Fabrication making up data or results and
    recording or reporting them.
  • Falsification manipulating research materials,
    equipment, or processes, or changing or omitting
    data or results such that the research is not
    accurately represented in the research record.
  • Plagiarism the appropriation of another persons
    ideas, processes, results, or words without
    giving appropriate credit.

21
Reason for Scrutiny
  • As a result, the integrity of the data must be
    maintained, and issues of ownership, access,
    retention should be put into institution policy
    as these data records will be the main source of
    materials investigation during an
    allegation/investigation of research misconduct.

22
Data Sharing
  • Deciding to share
  • Proprietary (IP, patents, etc.)
  • Technical obstacles
  • Confidentiality
  • Concerns about qualifications of data requesters
  • Costs associated with sharing

23
Data Sharing
  • NIH and NSF require data sharing if the work
    done/published was funded by these agencies
  • Other funding agencies may have same requirements
  • Part of terms and conditions

24
Data Storage
  • Issues to consider
  • Space
  • Electronic
  • Physical
  • Retention times
  • Will depend on source/type of data
  • Monitoring
  • Security
  • Responsibility Investigator or Institution

25
Ownership of Research Data
  • UC Reg 4 States . . . Notebooks and other
    original records of research are the property of
    the University

26
Ownership Policy
  • Policy should address
  • Definition of Research Data
  • Ownership/Stewardship
  • Acquisition and Use
  • Retention
  • Access
  • Transfer
  • Storage

27
Ownership vs. Stewardship
  • University owns the data
  • Investigator has stewardship over data
  • University maintains rights to access data at any
    time
  • Directs Investigator as to retention times of
    specific types of data

28
Summary
  • Institutions should address issues of data
    integrity and management in policy, developed by
    University administrators, that take into account
    historical university position, as well as the
    context of todays global, technological
    environment.

29
International Research Collaborations
30
Conducting Research Overseas
  • Scope of the Project
  • Is it really research?
  • Clinical care
  • Education
  • Water quality and agricultural projects
  • Field research

31
Conducting Research Overseas Structure of
Operations
  • Existing NGO (services agreement)
  • Local partner (subaward)
  • Monitoring overseas work
  • Local incorporated entities
  • Umbrella US entity for all overseas research
  • Nonprofit Corp. or LLC

32
Conducting Research Overseas MOU Issues
  • Registration
  • MOU legal status
  • Symbolic agreement? Operational agreement?
  • Binding legal obligations?
  • Most major NGOs have MOUs
  • Quasi-diplomatic status granted?
    Indemnification?
  • Duties and taxes

33
Conducting Research Overseas Managing Foreign
Operations
  • Federal agency requirements still apply to
    overseas research conducted by U.S. institutions
    or on their behalf
  • Procurement
  • Subrecipient monitoring
  • Effort reporting
  • Human subjects review

34
Conducting Research Overseas Federal
Requirements
  • OFAC economic sanctions
  • Commerce and State Dept. export control laws
  • Anti-boycott laws
  • Foreign Corrupt Practices Act

35
Conducting Research Overseas Best Practices?
  • NAS International Working Group
  • Campus Efforts
  • Risk Management Efforts
  • Template MOUs, subawards, subcontractor invoices
  • Internal risk assessment of subawardees

36
Effort Reporting Best Practices and Recent
Enforcement Actions
  • OMB A-21
  • Recognizes that, in academic setting, teaching,
    research, service and administration are often
    inextricably intermingled.
  • Precise assessment of factors that contribute to
    costs is not always feasible
  • Reliance is placed on estimates in which a degree
    of tolerance is appropriate.

37
Effort Reporting Lessons from NSF Audits
  • Late effort reports and timeliness
  • A-21 provides no guidance
  • Institutional policies used
  • Dept. chair should play role in monitoring late
    reports
  • Suitable means of verification
  • If PI doesnt certify, person who does must have
    active engagement
  • Independent internal evaluations
  • NSF has not accepted A-133 audit

38
Effort Reporting Lessons from NSF Audits
  • Education and training programs
  • 5 Variance Threshold
  • NSF appears to endorse COGR recommendation that
    payroll adjustment occur when actual effort
    differs by 5 or more
  • Key personnel zero salaries charged
  • Definition of voluntary commitments in grant
    application
  • NSF may look at narrative even when not proposed
    in budget

39
Export Control Issues
40
J. Reece Roth
  • Professor Emeritus of U. of Tennessee, Knoxville
  • 18-count indictment for technology transfer to
    foreign nationals

41
UT Not Indicted
  • UT was victimized by the conspirators and
    cooperated throughout with the FBI
  • UTs Code of Conduct specifically prohibited
    employee activities that violated federal
    securities laws
  • UT policies required employees to report
    violations of state or federal laws.
  • UT policies required employees to
  • Understand any export control requirements that
    related to employees work
  • Ensure that no exports were made contrary to
    requirements

42
Conspiracy Charge
  • AGT subcontracted to Roth
  • Roth employed foreign grad students, including
    China and Iran
  • Roth and AGT falsely stated to AFRL that no
    foreign nationals would be used
  • Roth directed foreign nationals to work on the
    project
  • AGT assigned PRC national to work on project in
    task order to Roth
  • Roth sent letter to PRC national asking him to
    work on project

43
Export Violations
  • AGT exported restricted technical data to foreign
    national
  • Final report
  • Progress reports
  • Roth exported restricted technical data in travel
    to PRC and delivery of 30-pp DARPA proposal
    containing plasma actuator technology for
    specific USAF aviation munitions project
  • Roth directed PRC student to transmit data to PRC
    contact
  • Roth allowed access to restricted equipment and
    data to Iranian student

44
Trial
  • Roth
  • Didnt believe he had broken the law
  • Research hadnt produced anything tangible
  • Received only 6,000 from contract
  • US
  • Roth knew information was restricted
  • Initially kept restricted information with U.S.
    student but eventually shared with foreign
    nationals

45
Conviction
  • Guilty on all 18 counts
  • Jurors deliberated 6 hours
  • Roth faces 160 years and 1.5M in fines
  • Verdict should serve as a warning to anyone who
    knowingly discloses restricted U.S. military data
    to foreign nationals. Patrick Rowan, Acting
    Asst. AG for National Security

46
Export Control Issues
  • Export control information provided under NDAs
  • ITAR defense services vs. fundamental
    research
  • EAR working with semiconductor design kits
  • DDTC 2/27/09 Guidance Licensing of Foreign
    Persons
  • License required for foreign persons who require
    access to ITAR-controlled defense articles

47
Protecting Animal Research Programs
48
Protecting Animal Research Programs
49
What Effect Is This Having On Researchers?
You Win- UCLA Vivisector Quits Animal
Experimentation Los Angeles - In an email
received by the Press Office today, a UCLA
vivisector stated he will no longer experiment on
non-human primates. Although no reason was
expressly stated, the correspondence asked that
his name be removed from websites exposing his
atrocities, and asked that his family be left
alone. There was no mention of regrets or plans
for atonement.
50
Public Records Requests
  • California Public Records Act
  • Freedom of Information Act

51
FOIA Requests for Animal Records
  • Exemption 4 trade secrets and confidential
    commercial or financial information
  • Exemption 6 clearly unwarranted invasions of
    personal privacy
  • NIH balances foreseeable harm of invading privacy
    against public benefit of release

52
NIH FOIA Rules
  • NIH not inclined to release information for a
    purely commercial venture.
  • More inclined to release information about a
    research project that provides valuable
    information to a wide audience.

53
Protect Information in the First Place
  • PHS Policy on Humane Care and Use
  • Code IACUC member names (except Chair and AV)
  • OLAW Guidance on Prompt Reporting
  • Name category (e.g. PI) not individual

54
Is the Information Already Publicly Available?
  • CRISP Database
  • CRISPER database
  • Availability vs. connecting the dots

55
On-campus Protests
56
Response by Research Community Society for
Neuroscience
  • Leadership Administration
  • Public affirmation of academic freedom
  • Pursue legal measures
  • Security
  • Coordinate with local law enforcement
  • Deploy campus resources
  • No gaps in jurisdiction
  • Public Affairs and Communication

57
On-Campus Security Strategies
  • Adoption of time, place, and manner regulations
  • Content neutral
  • Non-affiliates
  • Without regulations, DA may not act

58
UC Non-affiliate Regulations
  • Prior approval required for any tent, platform,
    booth, bench, table, building, sound system or
    other structure.

59
UC Non-affiliate Regulations
  • Regulated items
  • Flammable, explosive, or otherwise dangerous
    materials
  • Firearms
  • Tasers
  • Knife with a blade gt2½ in length
  • Any dirk or dagger

60
UC Non-affiliate Regulations
  • Prohibited conduct wearing a mask, personal
    disguise, or otherwise concealing ones identity
    with the intent of intimidating any person or
    group

61
UCLA Litigation
  • Civil Harassment
  • Trespass
  • Intentional Infliction of Emotional Distress
  • Violation of the Right of Privacy
  • Intentional Interference with Prospective
    Business Advantage or Contractual Relations

62
Funding Sources for Physical Security
  • Self-insurance program
  • Former policy UC not liable for loss to
    property not owned or in authorized custody of UC
  • New policy self-insurance program act as gap
    insurance between staff members personal
    insurance and UC insurance
  • Other coverage?

63
Legislation
  • Federal Animal Enterprise Terrorism Act of 2006
  • California Research Protection Act of 2008

64
Animal Enterprise Terrorism Act of 2006
  • New prosecutorial tools
  • New prohibitions
  • Against damaging or interfering with the
    operations of an animal enterprise
  • Against third-party entities that have a
    connection to the animal enterprise

65
History of Violence Against UC Researchers
  • 1987 Arson fire at UC Davis
  • 1999 UC Davis, letters rigged with razor blades
  • 2001-2005 Attacks on UCSF researchers
  • 2006-2007 Attacks on UCLA researchers

66
Researcher Protection Act of 2008
  • Sponsored by UC
  • Based on federal Freedom of Access to Clinic and
    Church Entrances Act of 1994

67
Researcher Protection Act of 2008 Original
Proposal
  • New crimes against animal enterprises
  • Enhanced criminal penalties
  • Allowed actions brought on behalf of employees
  • Prohibition on Internet posting of personal
    information
  • New exemption under PRA where reasonable basis to
    conclude disclosure would result in harassment of
    researchers

68
Legislative Process
  • Opposition by California Newspapers Assn., HSUS
  • Bill cut back to intent language
  • While individuals are entitled to express views
    and mount protests under 1st Amendment
  • Use of physical threats, violence, or destruction
    of property should not be tolerated

69
Protecting Animal Research Programs
  • Animal Law
  • is a relatively new but quickly growing area
  • any type of legal action, whether transactional
    or litigation that affects the rights, standing
    and/or welfare of an animal
  • encompasses companion animals, wildlife, animals
    used in entertainment and animals raised for food
    and used in research
  • permeates and affects most traditional areas of
    the law including tort, contract, criminal and
    constitutional law

70
Protecting Animal Research Programs Animal Law
  • Law schools
  • training new generation of animal lawyer
    advocates and future judges
  • 107 U.S. Animal law courses
  • 119 Student Animal Legal Defense Groups
  • Donations by Bob Barker helped establish animal
    law programs at prominent law schools
  • Bar Associations
  • 14 State Bar Associations have animal law
    sections or committees
  • ABA Animal Law Committee of the Tort Trial
    Insurance Practice Section (TIPS)

71
Conflict of Interest and Human Subjects Research
72
COI and Human Subject Research
73
COI and Human Subject Research
  • Sen. Charles Grassley inquiries
  • Under-reporting of drug company payments to
    researchers
  • Pharma response
  • Physician Payments Sunshine Act (bill)
  • Endorsed by AAMC
  • NIH ANPR on COI
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