Conflict of Interest for Institutional Review Boards Jane

Conflict of Interest for 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 � AUG 12 Applying rules to VA researchers Department of Veterans Affairs 2

Why Follow the Rules? � � � AUG 12 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 3

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 AUG 12 Department of Veterans Affairs 4

The Rules � � � AUG 12 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 5

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 AUG 12 Department of Veterans Affairs 6

Conflict of Interest Laws CRIMINAL STATUTES � � AUG 12 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 7

Conflict of Interest Laws CRIMINAL STATUTES � � AUG 12 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 8

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. AUG 12 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 AUG 12 Department of Veterans Affairs 10

Applying Rules to IRB Members as Federal Employees ______________________ AUG 12 Department of Veterans Affairs 11

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? AUG 12 Department of Veterans Affairs 12

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, that he will ensure that a particular study is approved by the IRB? AUG 12 Department of Veterans Affairs 13

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 AUG 12 Department of Veterans Affairs 14

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? AUG 12 Department of Veterans Affairs 15

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 AUG 12 Department of Veterans Affairs 16

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 AUG 12 Department of Veterans Affairs 17

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 Service Org. Patient Vendor AUG 12 Drug Co. Department of Veterans Affairs 18

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 � AUG 12 Department of Veterans Affairs 19

Gifts From Outside Sources EXCEPTIONS � to gift prohibition Discounts �Offered to all Government employees �Offered to a group unrelated to Government �Mileage points on official travel � AUG 12 Widely Attended Gathering Department of Veterans Affairs 20

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) AUG 12 Department of Veterans Affairs 21

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 AUG 12 Department of Veterans Affairs 22

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) AUG 12 Department of Veterans Affairs 23

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 AUG 12 Department of Veterans Affairs 24

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? AUG 12 Department of Veterans Affairs 25

Outside Activities RULE: An employee shall not engage in outside employment or any other outside activity that conflicts with official duties AUG 12 Department of Veterans Affairs 26

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 AUG 12 Department of Veterans Affairs 27

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 AUG 12 Department of Veterans Affairs 28

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 � AUG 12 Violates the ethics rules which prohibit favoritism in performance of official duties Department of Veterans Affairs 29

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) AUG 12 Department of Veterans Affairs 30

Impartiality � Covered relationship, cont. �Organizations in which employee is an active participant �Employers, including: AUG 12 spouse’s former any non-Federal prospective Department of Veterans Affairs 31

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? AUG 12 Department of Veterans Affairs 32

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 AUG 12 determination Department of Veterans Affairs 33

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 AUG 12 Department of Veterans Affairs 34

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 AUG 12 Department of Veterans Affairs 35

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? AUG 12 Department of Veterans Affairs 36

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 AUG 12 Department of Veterans Affairs 37

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 AUG 12 Department of Veterans Affairs 38

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 AUG 12 Department of Veterans Affairs 39

Applying Rules to VA Researchers ______________________ AUG 12 Department of Veterans Affairs 40

Hypothetical #5 � 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 Clinical Trial CRADA. �Dr. Stocker holds $14, 000 worth of Big. Drug. Co shares and his 12 -year-old daughter holds $10, 000 – any problems? AUG 12 Department of Veterans Affairs 41

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 AUG 12 Department of Veterans Affairs 42

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 AUG 12 Department of Veterans Affairs 43

Conflict of Interest � AUG 12 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 44

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? AUG 12 Department of Veterans Affairs 45

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 AUG 12 Department of Veterans Affairs 46

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? AUG 12 Department of Veterans Affairs 47

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 AUG 12 Department of Veterans Affairs 48

Conflict of Interest � AUG 12 Can VA researcher 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 49

Conflict of Interest � � AUG 12 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 50

Conflict of Interest � � AUG 12 Must maintain a clear delineation between VA job and consulting job – cannot be paid by another to do his Government job (209 violation) Researcher should legal seek advice – each factual situation is different Department of Veterans Affairs 51

Conflict of Interest � AUG 12 May a VA employee who is a consultant for, or in a speaker’s bureau for, a company conduct VA research that benefits that company? Department of Veterans Affairs 52

Conflict of Interest � No. VA researcher is prohibited from participating in matter that could affect his financial interest. � Here, financial interest is the ability or willingness of the company to continue to hire him as a consultant or speaker by conducting the research. � AUG 12 Department of Veterans Affairs 53

Conflict of Interest � Even without a criminal prohibition, the researcher has a covered relationship with the company �Absent an authorization, he would be prohibited from participating in research study where the company is a party if a reasonable person with knowledge of the facts would question his impartiality AUG 12 Department of Veterans Affairs 54

Conflict of Interest � May 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? AUG 12 Department of Veterans Affairs 55

Conflict of Interest � Absent a 208 waiver, the researcher is prohibited by the conflict of interest law from participating in a matter that affects his own financial interest or the financial interest of certain others such as his outside employer, the university � VA researcher may request contracting officer procure certain service not available within VA � Request must not be for a specific entity or researcher � Needs a 208 waiver to put specifics into grant proposals AUG 12 Department of Veterans Affairs 56

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 AUG 12 Department of Veterans Affairs 57

Conflict of Interest � VA researchers 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 �Need to segregate VA research from non-VA research �Data issues – authority to give VA data to others AUG 12 Department of Veterans Affairs 58

Advice and Guidance � When in doubt, seek advice before taking any action! � Contact the Designated Agency Ethics Official (DAEO), Alternate DAEO, or Deputy Ethics Officials in the Office of General Counsel or Regional Counsel and their Staff ethics officials AUG 12 Department of Veterans Affairs 59

Contact Information VA Ethics Officials � � � Walter A Hall, Assistant General Counsel and Designated Agency Ethics Official Renée L. Szybala, Associate General Counsel and Alternate DAEO VACO Deputy Ethics Officials: Jane Gutcher, Jonathan Gurland, Chris Britt Office of General Counsel (023) 810 Vermont Avenue, NW Washington, DC 20420 (202) 461 -7694 or (202) 461 -1600 or at Government. Ethics@va. gov AUG 12 Department of Veterans Affairs 60

Contact Information Other VA Ethics Officials: � OGCNorth. East. Ethics@va. gov for ME, NH, VT, MA, RI, CT, NY, NJ, DE, PA, OH, WV, MI, WI � OGCSouth. East. Ethics@va. gov for VA, NC, SC, GA, FL, MS, AL, LA, southern TX, Puerto Rico � OGCMidwest. Ethics@va. gov for DC, MD, IN, KY, TN, AR, MO, IL, IA, MN, ND, SD, NE, KA, � OGCWest. Ethics@va. gov for northern TX, OK, NM, AZ, CO, UT, WY, MT, ID, NV, CA, OR, WA, HI, AK, Guam, Philippines AUG 12 Department of Veterans Affairs 61