Title: Senior Compliance Panel: Hot Topics in Research Compliance
1Senior Compliance Panel Hot Topics in Research
Compliance
- NCURA Regional Meeting
- April 7, 2009
- AVC Deborah Motton, UC Merced
- AVC Patrick Schlesinger, UC Berkeley
2America 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
3COMPETES 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.
4NSF 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
5Considerations/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
6Considerations/Challenges
- Undergraduate vs. graduate vs. postdoctoral
researchers - Verification Tracking systems
- NSF funded vs non NSF funded personnel
- Policy Implementation
7UC Merced Options
- Collaborative Institutional Training Initiative
(CITI) - Online training
- Discipline specific RCR training Biomed, Social
Behav, Phys Eng, Humanities, Admin. - Thorough
- Self-paced
8UC Merced Options
- RCR class
- Graduate level
- Currently optional
- Inclusive of all RCR topics
- Open to post doctoral researchers
- Taught once/year
- Office of Research
9American Recovery and Reinvestment Act of 2009
10ARRA 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
11Research 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
12OMB 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
13Reporting 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
14ARRA - 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
15ARRA - 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
16ARRA 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?
17Research Data Integrity and Management
18Objectives
- What is research data?
- Integrity/Misconduct
- Data sharing
- Data Storage
- Ownership
- Access
- Retention
19What 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
20Reason 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.
21Reason 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.
22Data Sharing
- Deciding to share
- Proprietary (IP, patents, etc.)
- Technical obstacles
- Confidentiality
- Concerns about qualifications of data requesters
- Costs associated with sharing
23Data 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
24Data Storage
- Issues to consider
- Space
- Electronic
- Physical
- Retention times
- Will depend on source/type of data
- Monitoring
- Security
- Responsibility Investigator or Institution
25Ownership of Research Data
- UC Reg 4 States . . . Notebooks and other
original records of research are the property of
the University
26Ownership Policy
- Policy should address
- Definition of Research Data
- Ownership/Stewardship
- Acquisition and Use
- Retention
- Access
- Transfer
- Storage
27Ownership 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
28Summary
- 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.
29International Research Collaborations
30Conducting Research Overseas
- Scope of the Project
- Is it really research?
- Clinical care
- Education
- Water quality and agricultural projects
- Field research
31Conducting 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
32Conducting 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
33Conducting 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
34Conducting Research Overseas Federal
Requirements
- OFAC economic sanctions
- Commerce and State Dept. export control laws
- Anti-boycott laws
- Foreign Corrupt Practices Act
35Conducting Research Overseas Best Practices?
- NAS International Working Group
- Campus Efforts
- Risk Management Efforts
- Template MOUs, subawards, subcontractor invoices
- Internal risk assessment of subawardees
36Effort 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.
37Effort 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
38Effort 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
39Export Control Issues
40J. Reece Roth
- Professor Emeritus of U. of Tennessee, Knoxville
- 18-count indictment for technology transfer to
foreign nationals
41UT 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
42Conspiracy 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
43Export 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
44Trial
- 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
45Conviction
- 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
46Export 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
47Protecting Animal Research Programs
48Protecting Animal Research Programs
49What 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.
50Public Records Requests
- California Public Records Act
- Freedom of Information Act
51FOIA 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
52NIH 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.
53Protect 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
54Is the Information Already Publicly Available?
- CRISP Database
- CRISPER database
- Availability vs. connecting the dots
55On-campus Protests
56Response 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
57On-Campus Security Strategies
- Adoption of time, place, and manner regulations
- Content neutral
- Non-affiliates
- Without regulations, DA may not act
58UC Non-affiliate Regulations
- Prior approval required for any tent, platform,
booth, bench, table, building, sound system or
other structure.
59UC Non-affiliate Regulations
- Regulated items
- Flammable, explosive, or otherwise dangerous
materials - Firearms
- Tasers
- Knife with a blade gt2½ in length
- Any dirk or dagger
60UC Non-affiliate Regulations
- Prohibited conduct wearing a mask, personal
disguise, or otherwise concealing ones identity
with the intent of intimidating any person or
group
61UCLA Litigation
- Civil Harassment
- Trespass
- Intentional Infliction of Emotional Distress
- Violation of the Right of Privacy
- Intentional Interference with Prospective
Business Advantage or Contractual Relations
62Funding 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?
63Legislation
- Federal Animal Enterprise Terrorism Act of 2006
- California Research Protection Act of 2008
64Animal 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
65History 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
66Researcher Protection Act of 2008
- Sponsored by UC
- Based on federal Freedom of Access to Clinic and
Church Entrances Act of 1994
67Researcher 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
68Legislative 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
69Protecting 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
70Protecting 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)
71Conflict of Interest and Human Subjects Research
72COI and Human Subject Research
73COI 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