NIH Regulation of Conflict of Interest In Research

1. NIH Regulation ofConflict of Interest In Research Some Thoughts for Investigators Joe Giffels Research Integrity Office jgiff001@umaryland.edu

2. NIH-Sponsored Investigators(and their Universities)In the News…

3. Researchers Fail to Reveal Full Drug PayNew York TimesJune 8, 2008 A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators. Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees. Some of their research is financed by government grants. Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

4. Stanford Researcher, Accused of Conflicts, Steps Down as NIH Principal InvestigatorChronicle of Higher EducationAugust 1, 2008 Alan F. Schatzberg, a Stanford University researcher under fire for a possible financial conflict of interest, is stepping down temporarily as principal investigator on his grant from a division of the National Institutes of Health. Dr. Schatzberg, a psychiatrist, [has a] financial connection to Corcept Therapeutics, a drug-development company that the psychiatrist had helped create and in which he had several millions of dollars’ worth of stock. Dr. Schatzberg was leading an NIH-financed investigation of the biology of psychotic depression. The project included studies of the effectiveness of mifepristone — a controversial drug that is used to induce abortions — as an antidepressant. Senator Grassley sent two letters of inquiry to Stanford this week. In a letter on Thursday, he pointed out that the researcher’s stock holding “could grow dramatically if the results of Dr. Schatzberg’s government-sponsored research find that mifepristone could be used to treat psychotic major depression.”

5. Emory U. Psychiatrist Failed to Report Income From Drug MakersChronicle of Higher EducationOctober 4, 2008 A prominent psychiatrist at Emory University is the latest researcher to come under fire in Congress for violating federal and university rules against financial conflicts of interest. The New York Times reports that Charles B. Nemeroff, chairman of the psychiatry department at Emory and former editor in chief of the journal Neuropsychopharmacology, earned more than $2.8-million for consulting with drug companies from 2000 to 2007 and hid much of that income from his university. The figures were disclosed in documents provided to Congressional investigators working for Sen. Charles E. Grassley, a Republican of Iowa, as part of his continuing inquiry into scientists’ financial conflicts of interest.

6. December 2, 2008 Cleveland Clinic to Divulge Scientists' Industry Ties The financial ties of the Cleveland Clinic’s 1,800 physicians and researchers will be publicly aired on the clinic’s Web site as part of the institution’s conflict-of-interest crackdown, The New York Times reported. The clinic, one of the nation’s leading academic medical centers, plans to announce this week that it will disclose individual researchers’ financial links to drug and device manufacturers. It may be the first major medical center to do that, the newspaper said. “They are breaking a new path here,” David J. Rothman, president of the Institute on Medicine as a Profession, told the Times. The institute, a nonprofit group based at Columbia University, studies potential conflicts of interest. Nationwide, doctors and hospitals are under pressure to avoid conflicts that could jeopardize patient safety and taint research results. The Cleveland Clinic has been working aggressively to eliminate such conflicts after some of its top doctors were accused several years ago of having potentially compromising financial ties to companies whose products they were researching. The clinic’s move drew praise from Sen. Charles E. Grassley, an Iowa Republican who has urged Congress to scrutinize doctors’ industry relationships, which are often hidden from public view. The senator has investigated possible financial conflicts of interest by several academic researchers this year, including psychiatrists at Emory,Harvard, and Stanford Universities.—Katherine Mangan Chronicle of Higher Education

7. Purpose To ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator

8. Applicability To each Institution that applies for PHS grants or cooperative agreements for research and, through the implementation of this subpart by each Institution, to each Investigator participating in such research Investigator = principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding… includes the Investigator's spouse and dependent children

9. Purpose To ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator

10. Significant Financial Interest • Anything valued over $10,000, including • Salary, payments or fees for services • Royalties from intellectual property OR Equity interests representing more than 5% ownership interest • Does not include • Salary, royalties or other remuneration from institution

11. Institutional Responsibilities • Promulgate policy • Designate an official • NIH notification • Existence of significant financial CoI • Assurance that the CoI has been eliminated, managed or reduced

12. Investigator Responsibilities • Disclose significant financial interests • To the CoI Officer • As soon as they are anticipated or come into existence

13. The Questions Are Simple… • Do you have any financial interests which may be related to NIH research in which you are involved ? • If so, contact the CoI Officer with questions: Joe Giffels (jgiff001@umaryland.edu)

14. Information Resources • www.umaryland.edu/research_integrity/COI/conflict_interest.html • http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm

15. Project Officer Institute Address Address Date Re: Award # XXX Dear Institute Chief Grants Management Officer Name: In accordance with 42 CFR Part 50, Subpart F, Section 50.604(g)(2), I am writing to report that Investigator Name has a conflicting interest in the research project entitled “Title.” The conflicting interest has been managed under the University of Maryland Baltimore’s policies and procedures on conflicts of interest in research or development, in accordance with the above-referenced regulation. Should you have any questions, please feel free to contact Mr Joe Giffels, the University’s Conflict of Interest Officer at 410-706-1853 or via e-mail (jgiff001@umaryland.edu). Sincerely, James L Hughes Vice President for Research and Development Cc: Investigator Principal Investigator J Giffels

16. October 09, 2008 James HughesVice President for Research and Development660WestRedwoodStreet,Room021Baltimore,MD21201 Re: Grant Number R01 DKXXXXX Dear Mr. Hughes: I am writing to acknowledge receipt of your letter dated 09/03/2008, informing us that University of Maryland Baltimore has identified and managed, reduced or eliminated a financial conflict of interest. As a reminder, please continue to be aware that as required by the PHS regulation, financial conflicts of interests must be managed, reduced, or eliminated prior to expenditure of funds under the above referenced award; and any conflicting financial interest subsequently identified must be reported and be managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification. Should you have any additional questions, or should there be a new development in the status of the conflict, please contact me. Michael P. Giza Senior Grants Management Specialist Grants Management Branch National Institute of Diabetes & Digestive& Kidney Diseases (NIDDK) National Institutes of Health 6707 Democracy Boulevard, Room 733 Bethesda, MD 20892 phone:301.594.8851 fax: 301.594.9523 e-mail:gizam@mail.nih.gov NIDDK is moving towards electronic communication and  files.  In order to help faciliate this, please use e-mail and the NIH eRA Commons https://commons.era.nih.boy/commons/ as much as possible.  Please remember that all e-mail correspondence must be sent directly to us by an authorized business official with a copy sent to the PI.

17. Example • Consultant for Pfizer, earning $50,000 per year to advise on anti-hypertension candidate compounds in clinical trials sponsored by Pfizer’s competitors and PI of NHLBI grant for research on how a particular virus damages heart muscle. No, because there is clearly no relationship between what the individual is doing for Pfizer and the NIH research

18. Example • Consultant for Pfizer, earning $50,000 per year to advise on anti-hypertension candidate compounds in clinical trials sponsored by Pfizer’s competitors and PI of a Pfizer clinical trial of one of it’s own anti-hypertension drugs. No, because no NIH research is involved

19. Example • Consultant for Pfizer, earning $10,000 per year to make presentations to cardiologists on the science behind a Pfizer anti-hypertension drug and PI of an NHLBI-sponsored clinical trial of the same Pfizer drug. No, because the individual is not receiving over $10,000 from Pfizer

20. Example • Inventor of a compound UMB has licensed to Pfizer, receiving $150K per year in royalties and Investigator on NIH grant to develop a similar compound having less unpleasant side effects. No, because although the royalty payments and NIH research are probably related, the royalty payments are coming to the Investigator through UMB and not directly from Pfizer

21. Example • An inventor of technologies licensed to a Company founded and owned 30% by the inventor and the inventor is involved in an NIH-sponsored clinical trial of compounds related to the technologies Yes – see next slide for how the CoI is managed

22. Management of the CoI • Someone else is the PI of the NIH clinical trial • All research and publications are reviewed quarterly by the Dean’s Office and the CoI Officer • The conflicted researcher discloses the financial interests when publishing or discussing the research • Trainees can talk to the CoI Officer • Annual reviews of the CoI

23. NIH Regulation ofConflict of Interest In Research Some Thoughts for Investigators Joe Giffels Research Integrity Office jgiff001@umaryland.edu

24. AUTHORITY 42CFR50F(45CFR94) Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought