Government Ethics Laws and Rules for VA Researchers

Government Ethics Laws and Rules for VA Researchers Office of General Counsel Professional Staff Group III MAR 12 Department of Veterans Affairs 1

TRAINING TOPICS • • MAR 12 INTRODUCTION CONFLICT OF INTEREST GIFTS MISUSE OF GOVERNMENT RESOURCES TRAVEL RULES OUTSIDE ACTIVITIES POST GOVERNMENT EMPLOYMENT Department of Veterans Affairs 2

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 MAR 12 Department of Veterans Affairs 3

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 MAR 12 Department of Veterans Affairs 4

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 MAR 12 Department of Veterans Affairs 5

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) MAR 12 Department of Veterans Affairs 6

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 MAR 12 Department of Veterans Affairs 7

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 MAR 12 Department of Veterans Affairs 8

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 MAR 12 Department of Veterans Affairs 9

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

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 MAR 12 Department of Veterans Affairs 11

Financial Conflict of Interest • Your Financial Interest MAR 12 • Your VA Duties Department of Veterans Affairs 12

What to Do When Faced With Conflict 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 MAR 12 Department of Veterans Affairs 13

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) MAR 12 Department of Veterans Affairs 14

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. MAR 12 Department of Veterans Affairs 15

Conflict of Interest 208 (b) – Waiver given by the official responsible for your appointment (VAMC Director). You must: – – MAR 12 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 16

Conflict of Interest 208 (b) – Waiver At VA – Go to Regional Counsel 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. MAR 12 Department of Veterans Affairs 17

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 MAR 12 Department of Veterans Affairs 18

Conflict of Interest • Do the laws and rules of conflict of interest apply to researchers at VA under a Without Compensation (WOC) appointment? MAR 12 Department of Veterans Affairs 19

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? MAR 12 Department of Veterans Affairs 20

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)? MAR 12 Department of Veterans Affairs 21

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) MAR 12 Department of Veterans Affairs 22

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? MAR 12 Department of Veterans Affairs 23

Conflict of Interest • No, once royalty is flowing. VA employee/WOC/DAP will receive inventor’s share of royalty from non. Federal source (i. e. university). • Must seek 208 waiver to conduct further VA research on that invention. MAR 12 Department of Veterans Affairs 24

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? MAR 12 Department of Veterans Affairs 25

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 company and is not researching the invention at VA? MAR 12 Department of Veterans Affairs 26

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 MAR 12 Department of Veterans Affairs 27

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? MAR 12 Department of Veterans Affairs 28

Conflict of Interest • No. • The VA researcher is prohibited from participating in a matter that could affect his financial interest. His financial interest is 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 MAR 12 Department of Veterans Affairs 29

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? MAR 12 Department of Veterans Affairs 30

Conflict of Interest VA DAP will be considered a university “employee” if has university appointment and receives disqualifying “compensation” from university MAR 12 Department of Veterans Affairs 31

Conflict of Interest • Disqualifying “compensation” – benefits of significant monetary value: – Wages – Salary – Other taxable benefits: • • MAR 12 University contributions to life insurance Disability insurance Retirement plans Subsidized tuition benefits for employee/family Department of Veterans Affairs 32

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 MAR 12 Department of Veterans Affairs 33

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 • • MAR 12 Scarce medical specialist services Health care resource sharing Enhanced use lease Intergovernmental Personnel Act Department of Veterans Affairs 34

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 of your employer (i. e. the University) – Rules for these contracts spelled out in VHA Handbook 1660. 03 MAR 12 Department of Veterans Affairs 35

Conflict of Interest • VA physician/clinician DAP shall not: – – – – MAR 12 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 36

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 MAR 12 Department of Veterans Affairs 37

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. MAR 12 Department of Veterans Affairs 38

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? MAR 12 Department of Veterans Affairs 39

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 MAR 12 Department of Veterans Affairs 40

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 • Non-Federal employee who is university employee must sign and advocate grant application MAR 12 Department of Veterans Affairs 41

Conflict of Interest • VA DAPs applying for NIH grant must have MOU between university and VA • MOU in general defines VA DAP’s work distribution between VA and university • 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 MAR 12 Department of Veterans Affairs 42

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 MAR 12 Department of Veterans Affairs 43

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 MAR 12 Department of Veterans Affairs 44

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 MAR 12 Department of Veterans Affairs 45

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? MAR 12 Department of Veterans Affairs 46

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 Patients Pharmaceutical Co. MAR 12 Veterans Vendors Veterans Service Organizations Department of Veterans Affairs 47

Gifts From Outside Sources • Is it a Gift? – “Gift” is an item of monetary value, including any gratuity, favor, service, discount, entertainment, or hospitality 5 C. F. R. § 2635. 203 MAR 12 Department of Veterans Affairs 48

Gifts From Outside Sources • Not a “gift” – Loans or discounts available to the general public – Greeting cards and plaques of little intrinsic value – Modest food or refreshments • Coffee and donuts – not a meal MAR 12 Department of Veterans Affairs 49

Gifts From Outside Sources • Exceptions to Prohibited Gifts – Unsolicited gift from prohibited source with value of less than $20 • No more than $50 per year from one source – Gifts based on personal relationship – Gifts based on spouse employment • Always acceptable to refuse a gift! MAR 12 Department of Veterans Affairs 50

Gifts from Outside Source • Offered dinner to Dr. Tide is a gift • Pharmaceutical company is prohibited source • Dr. Tide may attend dinner if value is under $20 – pizza anyone? • Dr. Tide may pay her own way – Okay to refuse a gift – Appearances might indicate refusal as safer option • Drug samples are gifts MAR 12 Department of Veterans Affairs 51

Hypothetical #3 • While discussing possible research with Dr. Tide, the pharmaceutical company invites Dr. Tide to attend (for free) a local conference that it is sponsoring and would like Dr. Tide to then stick around and talk to company executives about marketing strategies. MAR 12 Department of Veterans Affairs 52

Non-Federal Travel Support • As a VA employee, you may not solicit or accept reimbursement for official travel and related expenses from any source other than the Government except… MAR 12 Department of Veterans Affairs 53

Non-Federal Travel Support • EXCEPTION: an unsolicited offer of travel support from a non-Government entity for attendance at a meeting or similar function that has been appropriately approved by your Supervisor and Ethics Counsel. 31 U. S. C. § 1353 MAR 12 Department of Veterans Affairs 54

Non-Federal Travel Support • Your Supervisor must agree: – it is in VA’s interest that you attend – Travel relates to your official duties • Non-Federal source must not be disqualified by conflict of interest • Approval must include review by an appropriate ethics official • Use VA Form 0893 MAR 12 Department of Veterans Affairs 55

May Dr. Tide Attend Conference? • Gift to VA of cost of conference if she attends in official capacity • Authority to accept gift under 31 U. S. C. § 1353 only if employee is in travel status – Facts indicate Dr. Tide not in travel status • Authority to accept gift under 5 U. S. C. § 4111 only if donor is tax-exempt 501(c)(3) organization • General gift acceptance authority – difficult to use MAR 12 Department of Veterans Affairs 56

May Dr. Tide Attend the Conference? • May Dr. Tide attend off-duty? – Only Agency Officials with delegated authority may approve acceptance of non. Federal entity offers of free attendance at a conference, seminar, etc. that you are attending in your personal capacity. – If: • The offer was unsolicited • Your Supervisor articulates how attendance is in VA’s interest because it will further VA’s programs and operations 5 C. F. R. § 2635. 204(g)(2) MAR 12 Department of Veterans Affairs 57

Gifts from Outside Sources • Supervisor must agree that Dr. Tide is attending in personal capacity, but attendance is in VA’s interest because it furthers VA’s programs and operations – policy decision. • Supervisor may choose to allow Dr. Tide to attend on excused absence • Supervisor may determine that “sticking around to discuss marketing strategies” is not part of conference, is not in VA’s interest and will not be allowed on excused absence – Permissible on own time MAR 12 Department of Veterans Affairs 58

Hypothetical #4 • Dr. Rogers, VA clinician and researcher has a little side internet business selling diet supplements. On his website, he uses ads that endorse his product by quoting himself and ascribing the quote to “Dr. Rogers, Chief of Internal Medicine, VAMC Smallville. ” He also likes to photocopy his business pamphlets and order forms at VA. • Problems? MAR 12 Department of Veterans Affairs 59

Misuse of Position • You must avoid improper use of your official title to state or imply official endorsement or sanction of any non. Federal entity, its products, services, or activities. • Outside the performance of your official duties, your official title may be used only in limited purposes such as providing biographical information. MAR 12 Department of Veterans Affairs 60

Use of Government Resources • Employees shall protect and conserve Federal property and shall not use it for other than authorized purposes. 5 C. F. R. § 2635. 101(b)(9) – Supervisor may authorize use of copier, email, telephone and the like if of little additional expense to VA • Never allowed to use Government resources for personal commercial activity MAR 12 Department of Veterans Affairs 61

Hypothetical #5 • Dr. Rogers, when performing certain procedures, takes an “extra” tissue sample for “his” research. He stores the tissue in his VA lab. He keeps a log, including personally identifiable information of patients. • Any problems? MAR 12 Department of Veterans Affairs 62

Hypothetical #5, cont’d. • Non-ethics issues raised – Only VA approved research may be performed at VA – Creation of illegal database under the Privacy Act, 5 U. S. C. § 552 a – Storage of VA data must be in accordance with VA Handbook 6500 – VA rules on tissue banking – Proper Informed Consent and HIPAA authorization – Might be violating terms of CRADA – research outside scope of Protocol MAR 12 Department of Veterans Affairs 63

Hypothetical #5, cont’d. • Ethics Issues – Misuse of Government resources • Must protect non-public information • Cannot use non-public information for personal business, teaching, speaking or writing – Possible use of public office for private gain – Possible violation of conflict of interest MAR 12 Department of Veterans Affairs 64

Outside Activities • RULE: You shall not engage in outside employment or any other outside activity that conflicts with your official duties: – If the activity is prohibited by law or regulation, or – You would have to recuse yourself from performing official duties to the degree of materially impairing your performance MAR 12 Department of Veterans Affairs 65

Hypothetical #6 • Dr. Luna, VA clinician and researcher, wants the VA nonprofit to hire him to work under a WOC appointment back at VA doing the same research he does during his official duty hours. MAR 12 Department of Veterans Affairs 66

Outside Activities • Because one cannot distinguish Dr. Luna’s official duties from his NPC duties, Dr. Luna would run afoul of 18 U. S. C § 209 that prohibits a government employee from being paid by another for performing his official government duties. MAR 12 Department of Veterans Affairs 67

Hypothetical #7 • Dr. Mello, VA clinician and researcher is invited to speak at a university conference on diabetes. Dr. Mello has been asked to discuss his VA clinical and VA research experiences in a particular area of diabetes. • May Dr. Mello receive an honorarium for this talk? MAR 12 Department of Veterans Affairs 68

Outside Activities Teaching, Speaking and Writing • RULE: You may not accept compensation, including honoraria, from a non-Federal source for teaching, speaking or writing that relates to your official duties. 5 C. F. R. § 2635. 807 MAR 12 Department of Veterans Affairs 69

Outside Activities Teaching, Speaking and Writing Teaching, speaking or writing relates to official duties when: • Activity is undertaken as part of employee’s official duties. • Invitation is extended because of: • position rather than expertise on the subject matter or • by person whose interests may be affected by your official duties. MAR 12 Department of Veterans Affairs 70

Outside Activities Teaching, Speaking and Writing Teaching, speaking or writing relates to official duties when the content: • Includes non-public information • Deals in significant part with • matter to which you were assigned during the past one-year period or • with ongoing policy, program or operation MAR 12 Department of Veterans Affairs 71

Outside Activities Teaching, Speaking and Writing • Dr. Mello may not receive honorarium for speaking related to his official VA duties. • May Dr. Mello receive compensation for speaking as a guest lecturer at a non. VA affiliated community college class on the medical profession as a career? The presentation will be made during non-duty hours. MAR 12 Department of Veterans Affairs 72

Outside Activities Teaching, Speaking and Writing • Yes. This presentation does not relate to Dr. Mello’s official duties so he may receive compensation. • May Dr. Mello, on his own time, be compensated for writing or updating a textbook on the treatment of diabetes? MAR 12 Department of Veterans Affairs 73

Outside Activities Teaching, Speaking and Writing • Yes, provided the book does not focus on VA research, programs, or specific VA patients, but rather conveys scientific knowledge gleaned from the scientific community as a whole. The book may include treatments or research of diabetes that although occurring at VA, are known to the public. MAR 12 Department of Veterans Affairs 74

Post-Government Employment • Former Federal employee is prohibited from representing another before Government agencies or courts with intent to influence: – On a specific party matter in which employee participated personally and substantially as part of his official duties – On a specific party matter under employee’s official responsibility during last year of Government service – Other matters spelled out in 5 C. F. R. Part 2641 MAR 12 Department of Veterans Affairs 75

Post-Government Employment • Representational prohibitions • Not prohibited by post-Government rules from working for a particular company • Very fact driven • SEEK ADVICE from an Ethics Official before you start looking for employment outside the Government MAR 12 Department of Veterans Affairs 76

Advice and Guidance WHAT TO KNOW: When in doubt, ask for advice before taking any action! WHERE TO GO FOR ADVICE: Contact the Designated Agency Ethics Official (DAEO), Alternate DAEO, in the Office of General Counsel, Regional Counsel, and/or their staff ethics officials with questions. MAR 12 Department of Veterans Affairs 77

USEFUL CONTACT INFORMATION VA Ethics Officials: • Walter A. Hall, Assistant General Counsel Designated Agency Ethics Official (DAEO) • Renée L. Szybala, Associate General Counsel Alternate DAEO • Regional Counsel: To locate your Regional Counsel go to the Office of General Counsel – Regional Counsel Index at http: //vaww. client. gc. va. gov/offices/rc/ • VACO Deputy Ethics Officials: Jane Gutcher, Jonathan Gurland, Chris Britt Office of General Counsel (023) Tel: (202) 461 -7694 Fax: (202) 273 -6403 MAR 12 Department of Veterans Affairs 78