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Government Ethics Laws and Rules for VA Researchers

Government Ethics Laws and Rules for VA Researchers. Office of General Counsel Professional Staff Group III. TRAINING TOPICS. INTRODUCTION CONFLICT OF INTEREST GIFTS MISUSE OF GOVERNMENT RESOURCES TRAVEL RULES OUTSIDE ACTIVITIES POST GOVERNMENT EMPLOYMENT. Why Attend Training?.

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Government Ethics Laws and Rules for VA Researchers

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  1. Government Ethics Laws and Rules for VA Researchers Office of General Counsel Professional Staff Group III Department of Veterans Affairs

  2. TRAINING TOPICS • INTRODUCTION • CONFLICT OF INTEREST • GIFTS • MISUSE OF GOVERNMENT RESOURCES • TRAVEL RULES • OUTSIDE ACTIVITIES • POST GOVERNMENT EMPLOYMENT Department of Veterans Affairs

  3. Why Attend Training? • Memorandum from Under Secretary for Health dated 30 January 2006 • Requires annual Government ethics training for: • All part-time and full-time physicians • All part-time and full-time pharmacists • All researchers – including scientists, nurses and other allied health personnel whose research could result in new pharmaceuticals and/or medical devices • All part-time and full-time physicians in training • VHA will work with OGC to fulfill this requirement Department of Veterans Affairs

  4. Why Follow the Rules? • Public service is a public trust • Employees must place loyalty to the Constitution, the laws and ethical principles above private gain • Maintain public’s confidence in VA and the Federal Government Department of Veterans Affairs

  5. Why Get Ethics Advice? • Avoid penalties – Safe Harbor • Imprisonment • Civil fines • Removal from Federal employment • Other administrative punishment • Be able to explain your actions • Supervisor or IG • Congress or media • Caveats: • Get advice in writing • Tell the whole story truthfully Department of Veterans Affairs

  6. The Rules • Conflict of interest laws 18 U.S.C. §§ 201-209 • Standards of Ethical Conduct for Employees of the Executive Branch 5 C.F.R. Part 2635 • 14 General Principles 5 C.F.R. § 2635.101(b) Department of Veterans Affairs

  7. Conflict of Interest Laws • Criminal statutes – create prohibitions • No official participation in certain matters that affect employees’ outside financial interests • No bribery • No representing non-Government parties in matters in which Government is a party or has a substantial interest • No supplementation of Government salary by non-Government entity Department of Veterans Affairs

  8. Standards of Ethical Conduct • Promulgated by Office of Government Ethics pursuant to two Executive Orders • Provide Government-wide guidance for standards of ethical conduct • Ensure that every citizen can have complete confidence in the integrity of Federal Government Department of Veterans Affairs

  9. The 14 General Principles • Apply to every employee of the Executive Branch • Foundation principles • Two predominant concepts: • Do Not Use Your Public Office for Private Gain • Do Not Give Unauthorized Preferential Treatment to Any Private Organization or Individual Department of Veterans Affairs

  10. Hypothetical #1 • Dr. Rich Stocker, VA researcher and clinician, has an idea for a new use of a drug manufactured by BigDrugCo. He wants BigDrugCo to fund a VA study under a Basic Science CRADA. • Dr. Stocker holds $14,000 worth of BigDrugCo shares and his 12-year old daughter holds $10,000– any problem? Department of Veterans Affairs

  11. Financial Conflict of Interest Federal Government employees are prohibited from participating personally and substantially as part of official duties in a particular matter that has a direct and predictable effect on their financial interests or the financial interest of their spouse, minor child, outside employer, or certain others. 18 U.S.C. § 208 Department of Veterans Affairs

  12. Financial Conflict of Interest Department of Veterans Affairs

  13. What to Do When Faced WithConflict of Interest • Seek advice from a VA Government Ethics official who will determine if conflict exists and help to resolve • Resolve conflict: • Recusal – do not participate • Exemption or exception might apply • Reassignment • Divestiture • Waiver Department of Veterans Affairs

  14. Conflict Exemptions • Exemption for employee’s financial interest in a particular matter where interest is: • $15,000 or less in a publicly traded company • $25,000 or less in a nonparty or matter of general applicability • $50,000 or less for sector fund (aggregating similar funds) Department of Veterans Affairs

  15. Conflict of Interest 208 (b) – Waiver 18 U.S.C. § 208(a) – It is a crime to have a conflict of interest in your official duties 18 U.S.C. § 208(b) – It is not a crime to have a COI in your official duties, if you get a waiver first. Department of Veterans Affairs

  16. Conflict of Interest 208 (b) – Waiver Waiver given by the official responsible for your appointment (VAMC Director). You must: • Request a waiver in writing; • Fully disclose the financial interest; • Receive written determination; • That the interest is not so substantial as to be likely to affect the integrity of the service the Government may expect. Department of Veterans Affairs

  17. Conflict of Interest 208 (b) – Waiver At VA – ask Regional Counsel for referral to ethics attorney/Deputy Ethics Official You will work with Ethics official to: • Draft the request for waiver • Ensure waiver determination is factually accurate Ethics official will: • Draft the determination with your input • Consult with Office of Government Ethics • Provide concurrence New and expedited process is in place. Department of Veterans Affairs

  18. Conflict of Interest • Dr. Stocker (hypothetical #1) is facing a conflict of interest • Particular matter (study agreement) • Personal and substantial participation • Direct and predictable effect on his financial interest. • Falls outside exemption • Aggregate value of stock held by him and his minor daughter exceeds $15,000 • Recuse, choose to sell, or seek waiver Department of Veterans Affairs

  19. Conflict of Interest • Do the laws and rules of conflict of interest apply to researchers at VA under a Without Compensation (WOC) appointment? Department of Veterans Affairs

  20. Conflict of Interest • Yes – a researcher under a WOC appointment is considered a VA employee subject to all of the laws and rules of Government Ethics. • May a VA researcher conduct further VA research on a licensed invention owned solely, and patented by, VA? Department of Veterans Affairs

  21. Conflict of Interest • Yes. • May a VA researcher conduct VA research on a licensed invention owned and patented by the VA researcher (i.e. royalty flowing from non-Federal entity)? Department of Veterans Affairs

  22. Conflict of Interest • No • The Government-employee researcher may not participate (conduct research) in a particular matter (licensed invention) that will have a direct and predictable effect on his own financial interest • A waiver of the criminal conflict of interest should be sought under 208(b) Department of Veterans Affairs

  23. Conflict of Interest • May a VA researcher conduct further VA research on his invention owned jointly by VA and the university-affiliate and licensed by the university if VA researcher • is solely VA employee or VA WOC? • holds in-name-only appointment at Univ? • is salaried employee of university? Department of Veterans Affairs

  24. Conflict of Interest • VA employee-inventor entitled to future inventor’s royalties has a disqualifying financial interest in the invention. • Gray area – point at which the disqualifying financial interest arises • At time of invention? • At time of patent? • At time of license? • At time of royalty flow? Department of Veterans Affairs

  25. Conflict of Interest • Prudent course – if want to conduct further research into your invention or into area that could affect your invention, first obtain 208 waiver • If royalty is already flowing, MUST obtain 208 prior to further research Department of Veterans Affairs

  26. Conflict of Interest • What if a VA researcher starts his own company to license an invention owned by VA? • May he continue to research the invention at VA? Department of Veterans Affairs

  27. Conflict of Interest • No • The VA researcher may not continue to research the invention without a 208 waiver • Likelihood of one in this circumstance is very small. • Can he consult for a company that is licensing his invention (under a license with the university affiliate) if he holds no ownership interest in the company and is not researching the invention at VA? Department of Veterans Affairs

  28. Conflict of Interest • Yes. The VA researcher may consult for the licensee under the facts – may not use government time, facilities or equipment • Must maintain clear delineation between VA job and consulting job – cannot be paid by another to do his government job (18 U.S.C. §209) • Seek advice – each factual situation is different Department of Veterans Affairs

  29. Conflict of Interest • May a VA employee who is a consultant or in a speaker’s bureau for a pharmaceutical company conduct VA research that benefits that pharmaceutical company? Department of Veterans Affairs

  30. Conflict of Interest • No. • The VA researcher is prohibited from participating in a matter that could affect his financial interest. His financial interest is consulting fees. He affects the ability or willingness of the pharmaceutical company to continue to hire him as a consultant or speaker by conducting the research. 18 U.S.C. § 208 Department of Veterans Affairs

  31. Conflict of Interest • Can the VA researcher who is also a University-affiliate employee, request that part of his VA research be contracted to: • himself at the University? • his spouse at the University? • another University employee? Department of Veterans Affairs

  32. Conflict of Interest VA DAP will be considered a university “employee” if has university appointment and receives disqualifying “compensation” from university Department of Veterans Affairs

  33. Conflict of Interest • Disqualifying “compensation” – benefits of significant monetary value: • Wages • Salary • Other taxable benefits: • University contributions to life insurance • Disability insurance • Retirement plans • Subsidized tuition benefits for employee/family Department of Veterans Affairs

  34. Conflict of Interest • Faculty perks of minimal value not considered “compensation”: • Parking permits • Library access • Admissions to artistic and athletic events • Access to online university resources • Office space • Royalty payments Department of Veterans Affairs

  35. Conflict of Interest • VHA Handbook 1660.03 • Conflict of Interest issues raised by contracting with University-affiliate under certain situations • Certain contracts authorized by statute • Scarce medical specialist services • Health care resource sharing • Enhanced use lease • Intergovernmental Personnel Act Department of Veterans Affairs

  36. Conflict of Interest • Conflict of Interest issues raised • Sole source allowed – no need to bid • Physician and manager DAPs have financial interest in the University • Conflict of interest law prohibits participation in matters that will affect your financial interest or financial interest of your employer (i.e. the University) • Rules for these contracts spelled out in VHA Handbook 1660.03 Department of Veterans Affairs

  37. Conflict of Interest • VA physician/clinician DAP shall not: • Draft specifications or solicitations • Act as COTR • Negotiate any part of the contract • Evaluate bids or proposal • Select or recommend the contractor • Review, certify or approve the contract itself • Evaluate contractor performance • Review time and attendance for contract administration purposes Department of Veterans Affairs

  38. Conflict of Interest • VA physician/clinician DAP may: • Supervise professional service to ensure quality of care • Develop workload projections • Develop specific research task • Provide direct patient care within VA responsibilities • Perform oversight of professional service • Participate in a matter where neither University nor employee has financial interest Department of Veterans Affairs

  39. Conflict of Interest • VA researcher DAP who is university employee may not recommend that his research be contracted to himself, his spouse or any other University employee • VA researcher may request contracting officer procure certain service not available within VA • Request must not be for a specific entity or researcher, etc. Department of Veterans Affairs

  40. Conflict of Interest • May VA researcher seek an NIH or other Federal grant for himself as a university researcher on behalf of his university research? Department of Veterans Affairs

  41. Conflict of Interest • Federal employees are prohibited from representing another, with or without compensation, before a Federal Executive branch agency or Federal court in matters where the U.S. is a party or has a substantial interest 18 U.S.C. §§ 203 and 205 Department of Veterans Affairs

  42. Conflict of Interest • VA employees may not represent university before Federal agencies including VA • Grant application may indicate VA employee is PI • VA PI may sign grant application indicating undertakes responsibilities as PI Department of Veterans Affairs

  43. Conflict of Interest • Non-Federal employee who is university employee must sign and advocate grant application • ALTERNATIVELY VA employee could seek grant through NPC instead of through University • Depends on capability of NPC Department of Veterans Affairs

  44. Conflict of Interest • VA DAPs applying for NIH grant through university must have MOU between university and VA • MOU in general defines VA DAP’s work distribution between VA and university Department of Veterans Affairs

  45. Conflict of Interest • VA signatory of MOU: • may not earn disqualifying “compensation” from university • may not plan to earn university salary under NIH grant that will fall under MOU • Research conducted at university and research conducted at VA under the grant must be distinguishable Department of Veterans Affairs

  46. Conflict of Interest • Federal employees are prohibited from receiving any salary or contribution to or supplementation of salary from any source other than the United States as compensation for services as a Government employee. 18 U.S.C. § 209 Department of Veterans Affairs

  47. Conflict of Interest • You may work for both the University and VA, but NOT at the same moment in time • Need strict accounting of time • Need to use VA computer systems and email when on VA time • Be aware of need to segregate VA research from non-VA research • Data issues – authority to give VA data to others Department of Veterans Affairs

  48. Conflict of Interest • Seeking employment • Once you have started seeking employment with a prospective employer, you may not take any official action that could affect the financial interest of that prospective employer. 18 U.S.C. § 208 5 C.F.R. § 2635.604 Department of Veterans Affairs

  49. Hypothetical #2 • Dr. Pepper Tide has an idea for a VA basic research study involving a drug already on the market. She contacts the pharmaceutical company to discuss the possibility of it funding her research. The company suggests that they continue discussions over dinner at an upscale restaurant – at the company’s expense. Can she dine? Department of Veterans Affairs

  50. Gifts From Outside Source • RULE: You may not directly or indirectly solicit or accept a gift given: • by a prohibited source; or • because of your official position. 5 C.F.R. 2635.202(a) Examples of prohibited sources: VA contractors Veterans Patients Vendors Pharmaceutical Co. Veterans Service Organizations Department of Veterans Affairs

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