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_at_uma
ryland.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. Grassleys
  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 researchers stock holding
  could grow dramatically if the results of Dr.
  Schatzbergs 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 Clinics 1,800 physicians and
researchers will be publicly aired on the
clinics Web site as part of the institutions
conflict-of-interest crackdown, The New York
Times reported. The clinic, one of the nations
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 clinics 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_at_umaryland.edu)

14
Information Resources

• www.umaryland.edu/research_integrity/COI/conflict_
  interest.html
• http//grants.nih.gov/grants/policy/coi/tutorial/f
  coi.htm

15
Project Officer Institute Address Address Date R
e 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
Baltimores 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
Universitys Conflict of Interest Officer at
410-706-1853 or via e-mail (jgiff001_at_umaryland.edu
). Sincerely, James L Hughes Vice President
for Research and Development Cc Investigator P
rincipal Investigator J Giffels
16
October 09, 2008 James HughesVice President for
Research and Development660 West Redwood Street, 
Room 021Baltimore, MD 21201 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   [phone]
51 fax         [phone] e-mail   
gizam_at_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/common
s/ 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
  Pfizers 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
  Pfizers competitors and PI of a Pfizer clinical
  trial of one of its 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 Deans 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_at_uma
ryland.edu
24
42CFR50F(45CFR94)
AUTHORITY

• Responsibility of Applicants for Promoting
  Objectivity in Research for Which PHS Funding Is
  Sought