C onflict of I nterest for Institutional Review Boards

Conflictof Interestfor Institutional Review Boards Jane Gutcher Office of General Counsel Ethics Specialty Team August 14, 2012

Training Topics • Introductory slides • Applying rules to IRB members as Federal employees • Conflict of Interest Statutes • Gifts from Outside Sources • Outside Activities • Applying rules to VA researchers Department of Veterans Affairs

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 the Federal Government, VA and VHA’s research program Department of Veterans Affairs

Why Get Ethics Advice • Take advantage of Safe Harbor - cannot be disciplined if disclose fully and rely on advice in good faith • Criminal prosecution almost certainly will be declined - if you disclose fully and rely on our advice • Ethics advice should always be in writing - to ensure above protections Department of Veterans Affairs

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 Department of Veterans Affairs

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

Conflict of Interest Laws CRIMINAL STATUTES • No bribery • No representing non-Government parties back to the Federal Government after leaving Government service in certain situations – don’t switch sides Department of Veterans Affairs

Conflict of Interest Laws CRIMINAL STATUTES • No supplementation of Government salary by non-Government entity • No representing non-Government parties, with or without compensation, in matters in which Government is a party or has a substantial interest Department of Veterans Affairs

Standards of Ethical Conduct • Promulgated by the Office of Government Ethics (OGE) pursuant to two Executive Orders • Create Government-wide, mandatory standards for all employees of the Executive Branch. Department of Veterans Affairs

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

Applying Rules to IRB Members as Federal Employees ___________________________________________ Department of Veterans Affairs

Hypothetical #1 • A member of an IRB is approached by someone who offers to pay the member $10,000 if he ensures that a particular research study is approved by the IRB. Should he take the money? Department of Veterans Affairs

Conflict of Interest • Not unless he wants to go to jail for bribery. The person paying the bribe is also subject to the law. Hypothetical #2 What if a member of an IRB is offered a $10,000 speaking engagement with Company XYZ, with the unstated understanding, wink, wink, that he will ensure that a particular study is approved by the IRB? Department of Veterans Affairs

Conflict of Interest • Not as straight forward – • looks as if member is entering a legitimate outside employment arrangement except … • for the unstated requirement that the payment is not really for the speaking engagement, but is in fact a payment to get the member to act in a certain way as part of his official duties. • DO NOT DO IT. • Also a 208 criminal violation Department of Veterans Affairs

Hypothetical #3 • An executive of Company XYZ offers to give the son of a member of the Central IRB a $10,000 scholarship to attend any college of the son’s choosing. May the son accept the gift of the scholarship? Department of Veterans Affairs

Gifts • What is a Gift? • “Gift” is any item of monetary value, including any gratuity, favor, service, discount, entertainment, or hospitality 5 C.F.R. § 2635.203 Department of Veterans Affairs

Gifts • What is not a Gift? • Loans or discounts available to the general public • Presentation item of little intrinsic value • Modest food or refreshments • Coffee and donuts – not a meal Department of Veterans Affairs

Gifts From Outside Sources • RULE: You may not directly or indirectly solicit or accept a gift given: • By a prohibited source • Because of your official position • Examples of “prohibited source” – VA contractor Veteran Veteran Service Org. Patient Drug Co. Vendor Department of Veterans Affairs

Gifts From Outside Sources EXCEPTIONS to gift prohibition • $20/$50 rule • Unsolicited gift from prohibited source with value $20 per less per occasion (no cash) • No more than $50 per year from one source • Gifts based on personal relationship • Gifts based on spouse’s employment Department of Veterans Affairs

Gifts From Outside Sources EXCEPTIONSto gift prohibition • Discounts • Offered to all Government employees • Offered to a group unrelated to Government • Mileage points on official travel • Widely Attended Gathering Department of Veterans Affairs

Gifts From Outside Sources • Unsolicited offer of free attendance at conference • Attend in official VA capacity; and • Assigned to speak, present information, or participate in panel; and • Offer made by sponsor of event • Then acceptance of free attendance on day of presentation allowed- not a gift – 5 C.F.R. § 2635.204(g)(1) Department of Veterans Affairs

Gifts From Outside Sources • Unsolicited offer of travel support from non-Federal source for meeting • Away from duty station in official capacity • Approval in advance using VA Form 0893 • Supervisor agrees meeting is in VA’s interest and related to employee’s official duties • Review by Government Ethics official Department of Veterans Affairs

Gifts From Outside Sources • Non-Federal travel support cont. • Travel support includes travel, lodging, meals, and attendance fees • “Meeting” or similar function does NOT include a meeting required to carry out an agency’s statutory function such as investigations, inspections, audits, site visits, negotiations or litigation • Not appropriate to accept gift from non-Federal source to attend IRB meetings (e.g. Central IRB) Department of Veterans Affairs

Gifts From Outside Sources • Offer of scholarship to son of IRB member could be an “indirect” gift to the member • If given by a prohibited source or given to the son because of the member’s official position, it would be a prohibited gift • Seek ethics advice – ethics official will: • Look at facts of particular gift • See if any exceptions apply Department of Veterans Affairs

Hypothetical #4 • IRB member has outside job as a consultant to small biotech company. A second IRB member has a salaried appointment at the University-affiliate. A VA PI, who is also employed at the University-affiliate, is PI for a VA CRADA with that same biotech company. The study comes to the IRB. Can either of the members participate in the review of the study? Department of Veterans Affairs

Outside Activities RULE: An employee shall not engage in outside employment or any other outside activity that conflicts with official duties Department of Veterans Affairs

Outside Activities • An activity conflicts with an employee’s official duties when: • It is prohibited by statute • It would require the employee’s disqualification from matters so central to the performance of his official duties that the employee’s ability to perform the duties of his position would be materially impaired Department of Veterans Affairs

Conflict of Interest Laws CRIMINAL STATUTES – 18 U.S. Code • Federal employees are prohibited from participating personally and substantially in a particular matter as part of official duties that will have a direct and predictable effect on their financial interest or the financial interest of their spouse, minor child, outside employer, or certain others 18 U.S.C. § 208 Department of Veterans Affairs

Impartiality • RULE: Federal employee may not participate in particular matter in which any “person” with whom he has a “covered relationship” is a party, or represents a party, where a reasonable person with knowledge of all the relevant facts would question the employee’s impartiality • Violates the ethics rules which prohibit favoritism in performance of official duties Department of Veterans Affairs

Impartiality • Which “persons” are in covered relationship with employee? • Personal (members of household, spouse, relatives, friends) • Business (anyone with whom employee has or seeks a business, contractual, or other financial relationship) Department of Veterans Affairs

Impartiality • Covered relationship, cont. • Organizations in which employee is an active participant • Employers, including: • spouse’s • former • any non-Federal • prospective Department of Veterans Affairs

Conflict of Interest Hypo # 4 - Solution So, IRB member who is a consultant at the biotech company is prohibited from participating in the review of the study funded by the biotech company. Why? Department of Veterans Affairs

Conflict of Interest • Possible violation of 18 U.S.C. § 208 • Central IRB member has personal financial interest in study if his participation in study review is determined to affect the ability or willingness of the biotech company to pay his consulting fees • Fact-driven determination Department of Veterans Affairs

Conflict of Interest • Violation of impartiality regulation • The biotech consultant/IRB member has a covered relationship with the biotech company • Prohibited from participating in review of the study if a person with whom the member has a covered relationship is a party to the matter Department of Veterans Affairs

Conflict of Interest Hypo #4 Solution – cont’d IRB member who is an employee at the University may participate in the review provided: • He has no personal financial interest in the study • University has no financial interest in the study that would be imputed to him • Potential for university to have ownership of any IP resulting from the study because PI is DAP is too attenuated No covered relationship exists just because IRB member works at same university as PI Department of Veterans Affairs

Conflict of Interest • Say another IRB member’s spouse works for a large medical device company that is funding a different study at VA, which comes before the IRB. May this IRB member participate in the study review? Department of Veterans Affairs

Conflict of Interest No. IRB member may not participate. • Possible violation of 18 U.S.C. § 208 • Spouse’s relevant financial interests in company imputed to member • Stock ownership • Bonus dependent on company performance • Other relevant financial interests • Salary is not relevant to participation in study review unless the study affects the ability or willingness of company to pay spouse’s salary Department of Veterans Affairs

Conflict of Interest • Possible violation of 208 cont. • Financial interest of spouse’s employer is not imputed to the member (unless spouse has “ownership” interest in company) • Determination of financial interest fact-driven • If spouse has relevant financial interest in study, then member prohibited from participating in study review due to imputed financial interest Department of Veterans Affairs

Conflict of Interest Violation of impartiality regulation • IRB member has covered relationship with spouse’s employer • Even if no imputed financial interest in the company through his wife • Prohibited from participating in the study review where wife’s employer is a party to the CRADA Department of Veterans Affairs

Applying Rules to VA Researchers ___________________________________________ Department of Veterans Affairs

Hypothetical #5 • 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 Clinical Trial CRADA. • Dr. Stocker holds $14,000 worth of BigDrugCo shares and his 12-year-old daughter holds $10,000 – any problems? Department of Veterans Affairs

Conflict of Interest • Researcher is prohibited from participating in a matter that affects his own financial interest unless there is a regulatory exemption. • $15,000 de minimis exemption for publicly-traded stock • Must aggregate all affected stock held by employee, spouse, minor children • $14,000 and $10,000 takes him over allowed amount Department of Veterans Affairs

Conflict of Interest • Dr. Stocker may – • recuse himself, • sell the stock or • seek a waiver of the criminal conflict • If stock not publicly-traded • no de minimis exemption • ownership of any amount would cause a financial conflict Department of Veterans Affairs

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

Conflict of Interest • Yes. A researcher/IRB member under a WOC (or IPA) appointment is considered a VA employee subject to all of the laws and rules of Government Ethics. • May a VA researcher conduct VA research on a licensed invention owned and patented by the VA researcher? Department of Veterans Affairs

Conflict of Interest • Maybe – • prior to royalty flow unclear if financial interest – attenuated, • but prudence dictates - time to get a waiver of the criminal conflict of interest law • Once royalty flowing – • 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 • Must get a 208 waiver Department of Veterans Affairs

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

Conflict of Interest • No. • The VA researcher may not continue to research the invention at VA without a waiver of the criminal conflict (“208 waiver”) • Likelihood of one in this circumstance is very small Department of Veterans Affairs

Conflict of Interest • Can VA researcher consult for a company that is licensing his invention (under a license with the university affiliate) if he holdsno ownership interest in the company and is NOT researching the invention at VA? Department of Veterans Affairs

Conflict of Interest • Yes. The VA researcher may consult for the licensee under these facts – may not use government time, facilities or equipment • However, he may NOT conduct additional research on his invention at VA if he is a consultant for the outside company Department of Veterans Affairs

C onflict of I nterest for Institutional Review Boards