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Senior Compliance Panel: Hot Topics in Research Compliance

Senior Compliance Panel: Hot Topics in Research Compliance

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Senior Compliance Panel: Hot Topics in Research Compliance

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  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/disciplinary 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 R&D: $200 Million NIST: $180 Million PLUS - Additional funds for IGs and GAO

  12. OMB Guidance Unprecedented Level of Reporting Agency Implementation Plans - May 1 Gov’t-wide Terms and Conditions Reporting Requirements in T&C 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 –

  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 person’s 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 today’s 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 doesn’t 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 • UT’s 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 employee’s 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: • Didn’t believe he had broken the law • Research hadn’t 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 VivisectorQuits 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