Title: NIH Regulation of Conflict of Interest In Research
1NIH Regulation ofConflict of Interest In Research
- Some Thoughts for
- Investigators
Joe Giffels Research Integrity Office jgiff001_at_uma
ryland.edu
2NIH-Sponsored Investigators(and their
Universities)In the News
3Researchers 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.
4Stanford 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.
5Emory 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.
6December 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
7Purpose
- 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
8Applicability
- 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
9Purpose
- 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
10Significant 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
11Institutional Responsibilities
- Promulgate policy
- Designate an official
- NIH notification
- Existence of significant financial CoI
- Assurance that the CoI has been eliminated,
managed or reduced
12Investigator Responsibilities
- Disclose significant financial interests
- To the CoI Officer
- As soon as they are anticipated or come into
existence
13The 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)
14Information Resources
- www.umaryland.edu/research_integrity/COI/conflict_
interest.html - http//grants.nih.gov/grants/policy/coi/tutorial/f
coi.htm
15Project 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
16October 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 301.594.88
51 fax 301.594.9523 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.
17Example
- 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
18Example
- 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
19Example
- 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
20Example
- 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
21Example
- 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
22Management 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
23NIH Regulation ofConflict of Interest In Research
- Some Thoughts for
- Investigators
Joe Giffels Research Integrity Office jgiff001_at_uma
ryland.edu
2442CFR50F(45CFR94)
AUTHORITY
- Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding Is
Sought