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Conflict of Interest in Research

Conflict of Interest in Research

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Conflict of Interest in Research

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  1. Conflict of Interest in Research NCI Ethics and You A Primer for New Employees

  2. MISSION To stimulate and support scientific discovery and its application to achieve a future when all cancers are uncommon and easily treated

  3. GOALS • To acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability • To sustain the Nation’s medical research capacity • To provide Federal stewardship

  4. GOALS • And do it with the highest possible integrity and responsibility in the conduct of science

  5. The Non-Government to Government Transition • Retool your basic assumptions…

  6. The Non-Government to Government Transition • A Federal job is a public trust

  7. The Non-Government to Government Transition • Federal corporate ethics are laws and regulations • Executive Orders • Federal Laws • Federal Regulations

  8. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  9. Conflicting Financial Interests Business thought says, “Put your money where your mouth is—invest in what you believe in!” Federal thought says, “If the government pays you to work on it, keep your personal finances out of it.”

  10. Conflicting Financial Interests • Federal criminal law says that you cannot take official action in your job on matters that will have an effect on your personal financial interests

  11. Conflicting Financial Interests • They include: • Stocks, stock options, bonds • Mutual funds and sector funds • Salary, fees, honoraria, or other income • Invention rights and royalties • Employment interests--professional position or title

  12. Conflicting Financial Interests Personal financial interests are those of: • Yourself • Spouse • Minor children or legal dependents • Organization in which you are a partner, officer, trustee, board member, employee • Organization with whom you are seeking employment

  13. Conflicting Financial Interests • Federal employees, researchers, medical personnel, administrators, contracting personnel, grants personnel, procurement personnel, and others holding positions of trust…

  14. Conflicting Financial Interests • Should not own >$5,000 in stock in the associated company • Should not have a spouse…working for the company • Should not have an outside activity with the company • Should not be negotiating for employment with the company • Should not accept sponsored travel/gifts from the company

  15. Conflicting Financial Interests • What should you do if you think you have a conflict of interest?

  16. Conflicting Financial Interests • DISQUALIFY • Stop, do not pass go, do not collect $200

  17. Conflicting Financial Interests • DISCLOSE • Contact your Ethics Official

  18. Conflicting Financial Interests • RESOLVE • Work out a Solution

  19. Contacting NCI Ethics Officials • nciethics-r@mail.nih.gov • Bethesda Office 301-496-1148 • Maureen Wilson, Ph.D., DEC, wilsonm@mail.nih.gov • Cheryl Lynn Nelson nelsonc2@mail.nih.gov • Rockville Office 301-496-9950 • Cynthia Morgan morganc@mail.nih.gov • Shari Wahlert wahlerts@mail.nih.gov • Frederick Office 301-846-5286 • Mary Gregg mgregg@mail.nih.gov • Diane Christensen christdi@mail.nih.gov

  20. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  21. Impartiality in Performing Official Duties A Question of Fairness You should not act on a matter if a reasonable person who knew the circumstances of the situation • Could legitimately question your fairness or • Imply bias or favoritism

  22. Impartiality in Performing Official Duties • What may imply bias or favoritism? • Acting in an official duty matter • Involving a relative who is not your spouse, minor child or legal dependent • Involving an organization in which your spouse, minor child, or legal dependent is seeking employment • Involving someone who paid you a salary, fee, honorarium,… within the last 12 months • Involving an individual with whom you have a close personal or professional relationship

  23. Impartiality in Performing Official Duties • What is the test for impartiality? • Would you be comfortable reading about it in the Washington Post? • Would you like your mom to read about it in the newspaper?

  24. Impartiality in Performing Official Duties • What do you do if you think you have a problem? • Contact an NCI Ethics Official • nciethics-r@mail.nih.gov • Bethesda Office 301-496-1148 • Executive Blvd. Office 301-9950 • Frederick Office 301-846-5286

  25. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  26. Misuse of Position You cannot use your position with the Government for your own personal gain or for the benefit of others---this includes: • Family • Friends • Neighbors • Charitable causes • Others

  27. Misuse of Position • Also, you may not use Government resources including: • Property - phones, computers, facilities • Time – yours or others • Non-public information

  28. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  29. Representation A Federal law prohibits employees from representing the interests of any individual or organization before any agency of the Federal Government with the intent to influence. EXCEPT • Self • Spouse, minor children, and legal dependents • Parents

  30. Representation Examples: • Testifying in a Federal Court other than for the US Government • Appearing before Congress on behalf of an outside organization • Lobbying • Political Activities • Advocating for award of grant or contract • Representing a friend or neighbor before a branch of the US Government • Social Security • Peer Review

  31. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  32. Gifts You may not ask for or accept a gift from persons or organizations who: • Do business with or seek to do business with your agency • Seek official action by your agency • Are regulated by your agency • Have interests that may be significantly affected by you when you are doing your job • Are giving you a gift because of your official positions • Gifts can be viewed as bribes under the law

  33. Gifts What is a Gift? • Gratuity • Favor • Discount • Entertainment • Hospitality • Loan or Forbearance • Other item having monetary value

  34. Gifts What is not a Gift? • Modest food and refreshments at a meeting • Loans generally available from commercial lenders • Benefits, rates, discounts generally available to the public or all Government employees • Plaques, certificates or trophies • Rewards or prizes given as part of public events • Pensions or other benefits from participation in an employee benefit plan • Anything bought or secured by the Government • A Gift accepted by the Government under law

  35. Gifts What are exceptions to the gift provisions? • Gifts valued at $20 or less and no more than $50/source/yearNO CASH or SECURITIES! • Waiver of registration for a meeting at which you are speaking • Authorizedattendance at a widely attended event of interest to your agency

  36. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  37. Activities with Outside Organizations What you can do Depends on what you do for the Government ~Need prior clearance~

  38. Activities with Outside Organizations Generally • Activities involving professional competence with organizations outside the Department of Health and Human Services

  39. Activities with Outside Organizations • Teaching and Speaking • Writing and Editing • Consulting/Advising • Legal Consulting/Advice • Outside Clinical Practice • Legal Advice • Serving on Boards and Committees

  40. Activities with Outside Organizations Official - You represent the NCI • Related to professional and official competence • Use Government title and affiliation • Use Government resources • Use Government time • Use Government travel –sometimes reimburseable • May talk about current projects*** • May serve on boards and committees*** • May provide advice, but generally not consult*** ***with limitations

  41. Activities with Outside Organizations Personal - You represent yourself • Related to professional competence • May be compensated or uncompensated • May not use your Government title and affiliation • May not use Government resources if compensated • May not use Government time if compensated • May not use Government travel – may be reimbursed in certain circumstances • May not use non-public information or discuss your current projects within the last 12 months

  42. Activities with Outside Organizations • What if you can’t decide whether it is official business or personal activity? • Contact an NCI Ethics Official • nciethics-r@mail.nih.gov • Bethesda Office 301-496-1148 • Frederick Office 301-846-5286

  43. Activities with Outside Organizations • How do you obtain clearance?

  44. Activities with Outside Organizations BEFORE YOU ACCEPT….. • Talk to your SUPERVISOR • Contact the Ethics Office nciethics-r@mail.nih.gov

  45. Activities with Outside Organizations Before You Begin…. • Clear through your ARC • Obtain Approval by submitting paperwork to the NCI ETHICS OFFICE Office nearest you. • Bethesda Office 31/4A48 • Frederick Office 372/12 • Executive Blvd 6116/Suite 600 • Forms may be found athttp://ethics.od.nih.gov/forms.htm

  46. Conflict of Interest in Research • Conflicting Financial Interests • Impartiality in Performing Official Duties • Misuse of Position • Representation • Gifts • Activities with Outside Organizations • Seeking Other Employment

  47. Seeking Other Employment • Federal criminal law says that you cannot take official action in your job on matters that will have an effect on your personal financial interests • The relationship developed in seeking employment is a financial interest

  48. Seeking Other Employment What do you do if you wish to seek outside employment? • DISQUALIFY – if needed • DISCLOSE – as necessary • RESOLVE – if required

  49. Conflict of Interest Commandments • Avoid Conflicting Financial Interests • Maintain Impartiality in Performing Official Duties • Don’t Misuse Government Position • Don’t Represent Outside Organizations to the Federal Government • Be Careful of Non-Feds Bearing Gifts • Get Prior Authorization for Activities with Outside Organizations • Avoid Conflict of Interest in Seeking Outside Employment

  50. Media Inquiries Contact the Press Office when: • Your study is accepted for publication • A journalist calls you for an interview • You need background material for reporters • A development in your field is likely to generate media attention General Contact Information: 301-496-6641. email: mcneilc@mail.nih.gov