Transcript Slide 1

Research Ethics:
Conflicts of Interest
Michael Kalichman
San Diego Research Ethics Consortium
La Jolla Institute for Allergy and Immunology
August 24, 2011
What is a conflict of interest?
Increased risk of bias or poor judgment because of an
obligation or commitment to two or more competing
interests
Financial Conflicts of Interest…
Dennis Selkoe
Harvard Scientist, Massachusetts General Hospital
1998: NIH report endorsing blood test for Alzheimer’s
Selkoe signed the report, but failed to note:
 Test manufactured by Athena
 Selkoe helped found Athena
 When Athena went public in 1993, Selkoe had 225,000 shares worth $3
million
Another Harvard scientist (and a developer of competing test):
“I have conflicts too, but I don’t sit on a committee telling
people to use the test.”
What might be biased?
Choice of research focus
Framing of research questions
Choice of research methods and design
Selection of research participants
Collection and selection of research data
Analysis and interpretation of research data
Deciding how and if to publish
…in all cases, bias might be either intentional or
unintentional
Positive Findings
Stelfox, Chua, O’Rourke, and Detsky,
New England Journal of Medicine, 1998
Reviewed reports on safety of calcium channel
antagonists
Endorsements more likely to come from those receiving
company support
Percent reports with Direct or Any
commercial support
PERCENT
WITH SUPPORT
100
80
60
Direct
Any
40
20
0
Critical
Ne utral
Supportive
REPORTED FINDINGS
Disclosure?
Krimsky et al., 1998
Reviewed 789 scientific papers
• 34% of articles
• authors
• owned stock
• served as consultants
• had a financial stake
62,000 papers
• only 0.5% included disclosure statements
Questions for Discussion: 1 of 2
If a newly published study demonstrates that a new
drug is effective, before making use of that study in
your own research, do you need to know what financial
stake, if any, the authors have in the success of that
drug?
What about other conflicts of interest?
Publishable results
Academic advancement
Fame
Life outside of work?
Pet theories
Questions for Discussion: 2 of 2
If a newly published study reports a genetic basis for
depression, before making use of that study in your
own research, do you need to know whether any of the
authors have a clinical diagnosis of depression?
Regulatory Path
2007 Environmental Science and Technology journalist
(Thacker) joins Senator Grassley
2008 Based on Thacker’s investigation: “Researchers Fail to
Reveal Full Drug Pay” (NY Times, June 2008)
Grassley expressed concerns about COIs in NIH-supported
institutions to NIH Director Zerhouni
2009 Grassley and Senator Kohl urge  transparency at NIH
IG Report: 9 cases of failure to report >$1 million
2010
New proposed rules for COIs
Final Rule on Financial Conflict of Interest Regulations
August 23, 2011
42 CFR Part 50 | 45 CFR Part 94
RIN 0925-AA53
[Docket Number NIH-2010-0001]
Responsibility of Applicants for Promoting Objectivity in
Research for which Public Health Service Funding is Sought and
Responsible Prospective Contractors
AGENCY: Department of Health and Human Services.
ACTION: Final Rule.
http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf
Final Rule on Financial Conflict of Interest Regulations
August 23, 2011
§ 50.601 Purpose.
This subpart promotes objectivity in research by establishing
standards that provide a reasonable expectation that the design,
conduct, and reporting of research funded under Public Health
Service (PHS) grants or cooperative agreements will be free from
bias resulting from Investigator financial conflicts of interest.
Significant financial interest means:
“...investigators are required to disclose to an official(s)
designated by the institution a listing of Significant Financial
Interests ... that would reasonably appear to be affected by the
research proposed for funding by the PHS.”
“...anything of monetary value, including, but not limited to,
salary or other payments for services …; equity interests …; and
intellectual property rights.”
“…exceed $10,000”
Existing Public Health Service Policy
Significant financial interest means:
(1) A financial interest consisting of one or more of the following
interests of the Investigator (and those of the Investigator’s
spouse and dependent children) that reasonably appears to be
related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial
interest exists if the value of any remuneration received from the
entity in the twelve months preceding the disclosure and the
value of any equity interest in the entity as of the date of
disclosure, when aggregated, exceeds $5,000…;
New Public Health Service Policy
Significant financial interest means:
(1) A financial interest consisting of one or more of the following
interests of the Investigator (and those of the Investigator’s
spouse and dependent children) that reasonably appears to be
related to the Investigator’s institutional responsibilities:
(ii) With regard to any non-publicly traded entity, a significant
financial interest exists if the value of any remuneration received
from the entity in the twelve months preceding the disclosure,
when aggregated, exceeds $5,000, or when the Investigator (or
the Investigator’s spouse or dependent children) holds any
equity interest (e.g., stock, stock option, or other ownership
interest); or
New Public Health Service Policy
Significant financial interest means:
(1) A financial interest consisting of one or more of the following
interests of the Investigator (and those of the Investigator’s
spouse and dependent children) that reasonably appears to be
related to the Investigator’s institutional responsibilities:
(iii) Intellectual property rights and interests (e.g., patents,
copyrights), upon receipt of income related to such rights and
interests.
New Public Health Service Policy
Major Changes
Effective August 25, 2011
1. Threshold decreased from $10,000 to $5,000
2. Disclosure requirements include review of not just PHSfunded research, but any investigator institutional
responsibilities
3. Public disclosure now required of institution of financial
conflicts of interest
New Public Health Service Policy
Guidelines for Conflicts of Interest
Individual
Recognize
• Avoid or
• Minimize
Disclose
• Who needs to know?
• How much detail?
Manage
Journals, Professional, Institutional, Organizational
Conflicts of Interest?
Dr. Mitchell Conrad has received a grant from an industrial source to do basic research
that has long-term implications for commercialization. A new graduate student,
Michelle Lawless has just joined his lab following the completion of one semester of
graduate coursework. Dr. Conrad outlines several projects that can be pursued by
Michelle under this industrially-sponsored research program. Dr. Conrad indicates that
there is a proviso listed in the industrial grant agreement which says that all material to
be submitted for publication first be reviewed by the company. This review must always
be completed within 120 days. Dr. Conrad points out that this presents only a minimal
disruption to the normal publication process as compared to the unrestricted
publication of material gathered under federal research grants. He also mentions that
the positive aspects of working on this proposal include the fact that there is money in
the grant for Michelle to travel to at least two meetings per year. Also the grant
application provides money for a personal computer that will be placed at Michelle's
lab station while she is working on the project. Dr. Conrad emphasizes that working on
the project will likely give Michelle an "inside track" with the company should she want
to pursue job possibilities there following graduation. Michelle agrees to work on the
project.
© ASM Press, 2000, Scientific Integrity by F.L. Macrina, used with permission.
Insider Trading?
Mr. Asset, a graduate student of Dr. Bond, has been conducting physicochemical
studies on the properties of a new polymer. The research is sponsored by Chemical
Industries, Inc. and it is understood by Mr. Asset and Dr. Bond that the results are
proprietary, confidential, and cannot be used in Mr. Asset's thesis. Mr. Cash, the
technical liaison from Chemical Industries, Inc., meets with Mr. Asset and Dr. Bond and
expresses his pleasure with the outcome of the recent studies and observes that the
new results are the last data required to market a new generation of fire-resistant
electrical insulating material. Mr. Cash further comments that this is the product that
Chemical Industries, Inc. needed to regain its market share, and the stock of Chemical
Industries, Inc. would soar once investors knew of the new product. That evening at
dinner with his wife and brother-in-law, an investment banker, Mr. Asset tells them
about Mr. Cash's enthusiasm about their recent research results and Mr. Cash's
expectations that Chemical Industries' stock would greatly increase in value as soon as
the new product was announced. The next day Mr. Asset's brother-in-law advises
several of his clients to purchase Chemical Industries' stock.
© ASM Press, 2000, Scientific Integrity by F.L. Macrina, used with permission.
Research Ethics Resources
NIH Conflicts of Interest Page
http://grants.nih.gov/grants/policy/coi
UC San Diego Research Ethics Program
http://ethics.ucsd.edu/research.html
Responsible Conduct of Research Education Committee
http://rcrec.org
Resources for Research Ethics Education
http://research-ethics.net