Department of Health and Human Services
OFFICE OF 
   
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
INSTITU  TIONAL CONFLICTS OF 
 
I NIH G  
NTEREST AT    RANTEES 
 
 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
January 2011 
OEI-03-09-00480   
   
I N T O R D U C T I O N  
 E X E C U T I V E   S U M M A R Y  
OBJECTIVES
 
1.  To determine whether National Institutes of Health (NIH) 
grantee institutions have written policies and procedures to 
address institutional financial interests and conflicts of interest. 
2.  To determine whether grantee institutions had financial 
interests and financial conflicts of interest related to NIH 
research grants in fiscal year (FY) 2008.  
BACKGROUND 
Grantee institutions consist of universities, medical schools, and other 
research institutions (e.g., private or nonprofit research organizations) 
receiving research grants from NIH.  An institutional conflict may arise 
when an institutions own financial interests (e.g., royalties, equity, 
stockholdings, and gifts) or those of its senior officials pose a risk of 
undue influence on decisions involving the institutions research.   
Pursuant to Federal regulations, each grantee institution receiving NIH 
funds must have a written policy for identifying researchers financial 
conflicts of interest (hereinafter referred to as conflicts) and ensuring 
that conflicts are managed, reduced, or eliminated.  These regulations 
do not apply to institutions conflicts.  The Public Health Service (PHS) 
Act directed the establishment of regulations that would protect PHS-
funded research (i.e., NIH grant research) from bias resulting from 
conflicts of both researchers and entities (i.e., grantee institutions).  
However, there are currently no Federal requirements to define, 
identify, report, and manage actual or potential institutional conflicts.  
Therefore, NIH lacks information on the number of institutional 
conflicts at its grantee institutions and the impact these conflicts may 
have on NIH-sponsored research.   
We surveyed 250 grantee institutions to determine whether they have 
any policies and procedures regarding institutional financial interests 
and conflicts.  We requested information on any institutional financial 
interests related to NIH grants awarded in FY 2008.  A total of 156 
grantee institutions responded, for a response rate of 62 percent.     
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  i   
   
E X E C U T I V E   S U M M A R Y  
FINDINGS 
Although not required for institutional financial interests, 70 of  
156 responding NIH grantee institutions have written policies and 
procedures addressing institutional interests.  Fifty-nine of the 
seventy institutions use a variety of definitions for what constitutes an 
institutional financial interest.  Policies and procedures for some 
institutions relate only to financial interests held by the institutions 
themselves, others consider the interests of both the institutions and 
their employees/officials, and still others relate only to the interests of 
institutional employees/officials.       
The number of definitions used by institutions for institutional financial 
interests ranged from one to eight.  The average number of definitions 
was five.  The three most common definitions are (1) an institutional 
officials individual financial interests, (2) equity held by the institution 
in publicly held entities, and (3) equity held by the institution in 
nonpublicly held entities.   
Although not required for institutional conflicts, 69 of  
156 responding NIH grantee institutions have written policies and 
procedures addressing institutional conflicts.  Fifty-nine of these 
institutions have defined, in writing, what constitutes an institutional 
conflict.  These institutions typically defined institutional conflicts as 
financial interests that could affect the research, decisionmaking, 
loyalty, or objectivity of either the institution or individuals.   
Fifty-three of the sixty-nine institutions have implemented a process to 
determine whether an institutional financial interest creates an 
institutional conflict.  Their processes generally involve notifying an 
institutional official and/or committee regarding the financial interests.  
The official and/or committee then determines whether the financial 
interest is an institutional conflict.  
Eighteen NIH grantee institutions identified 38 institutional conflicts.  
Twenty-one of one-hundred fifty-six institutions identified institutional 
financial interests.  Of those, almost all identified the financial interests 
as institutional conflicts.  Eighteen of the twenty-one institutions 
identified at least 38 institutional conflicts related to NIH research 
grants in FY 2008.  Institutions that have written policies and 
procedures were more likely to identify conflicts (15 of 69 institutions) 
compared to those that do not (3 of 87 institutions).  The most common 
type of institutional conflict was institutions holding equity in 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  i   
   
E X E C U T I V E   S U M M A R Y  
nonpublicly held companies.  For institutions that identified 
institutional conflicts, the strategy most often used to address them was 
disclosure. 
RECOMMENDATION 
NIH is the primary Federal agency responsible for conducting and 
supporting medical research.  It is vital to public health and safety that 
this research be free from bias.  Federal regulations establish standards 
to ensure that the design, conduct, and reporting of federally funded 
research will not be biased by any conflicting financial interest of a 
researcher.  Currently, no Federal regulations require grantee 
institutions to identify and report institutional conflicts to NIH.  
Therefore, NIH lacks information on the number of institutional 
conflicts that exist among its grantee institutions and the impact these 
conflicts may have on NIH-sponsored research.   
We continue to recommend that NIH require grantee institutions to 
identify, report, and address institutional conflicts in a consistent and 
uniform manner to NIH.  It is important that NIH know of the existence 
of institutional conflicts so it can ensure that the related research is free 
from any intended or unintended bias.   
Therefore, we recommend that NIH: 
Promulgate regulations that address institutional financial conflicts 
of interest.  Until regulations are promulgated, NIH should encourage 
grantee institutions to develop policies and procedures regarding 
institutional financial interests and conflicts. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
NIH stated that it is reviewing public comments to finalize regulations 
regarding financial conflicts of interest and, therefore, it neither concurs 
nor nonconcurs with our recommendation.  Instead, NIH stated it will 
take the Office of Inspector Generals (OIG) recommendation into 
consideration as it considers future actions on extramural financial 
conflicts of interest.   
OIG understands that NIH is engaged in the rulemaking process 
regarding financial conflicts of interest.  However, in the  
May 21, 2010, Notice of Proposed Rulemaking regarding financial 
conflicts of interest, NIH proposed regulatory changes that focus only on 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  ii   
   
researchers conflicts.  The proposed regulations do not address 
institutional conflicts.  Therefore, OIG continues to recommend that 
NIH include institutional conflicts in regulations addressing financial 
conflicts of interest.
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  iii   
 T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
 
 
I N T RO DUC T IO N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 
 
 
F I N D IN G S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 
Although not required for institutional financial interests,                 
70 of 156 responding NIH grantee institutions have written      
policies and procedures addressing institutional interests. . . . . . . 9 
Although not required for institutional conflicts, 69 of                       
156 responding NIH grantee institutions have written policies        
and procedures addressing institutional conflicts. . . . . . . . . . . . . 11 
Eighteen NIH grantee institutions identified 38 institutional   
conflicts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 
 
 
R E C O MMEN D A T ION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 
Agency Comments and Office of Inspector General Response . . . 18 
 
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 
A:  Results by Stratum for Grantee Institutions With Written      
Policies and Procedures Regarding Institutional Financial      
Interests and Institutional Conflicts . . . . . . . . . . . . . . . . . . . . . . . 20 
B:  Number of Grantee Institutions That Reported Incorporating 
Recommended Actions From Departmental Guidance in Written 
Policies and Procedures Regarding Institutional Financial      
Interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 
C:  Methods Employed by Grantee Institutions To Manage,      
Reduce, or Eliminate Institutional Conflicts. . . . . . . . . . . . . . . . . 22 
D:  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 
   
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25   
   
 I N T R O D U C T I O N  
OBJECTIVES 
1.  To determine whether National Institutes of Health (NIH) 
grantee institutions have written policies and procedures to 
address institutional financial interests and conflicts of interest. 
2.  To determine whether grantee institutions had financial 
interests and financial conflicts of interest related to NIH 
research grants in fiscal year (FY) 2008.  
BACKGROUND 
Grantee institutions consist of universities, medical schools, and other 
research institutions (e.g., private or nonprofit research organizations) 
receiving research grants from NIH.  Pursuant to Federal regulations, 
each institution receiving NIH funds must have a written policy for     
(1) identifying investigators (hereinafter referred to as researchers) 
financial conflicts of interest (hereinafter referred to as conflicts) and  
(2) ensuring that conflicts are managed, reduced, or eliminated.1, 2  The 
purpose of these regulations is to promote objectivity in research by 
establishing standards to ensure that there is no reasonable expectation 
that the design, conduct, or reporting of research funded under NIH 
grants will be biased by any conflicting financial interest of a 
researcher. 
Conflicts can also exist for the institutions themselves.  An institutions 
financial interests (e.g., royalties, equity, stockholdings, and gifts) or 
those of its senior officials can become institutional conflicts when the 
financial interests pose a risk of undue influence on decisions involving 
the institutions research.3  There are no Federal regulations for 
defining, identifying, reporting, and managing institutional conflicts.  
Prior research has shown that not all medical schools have policies 
regarding institutional financial interests and conflicts.4  
 
 
1 42 CFR pt. 50, subpart F.  This regulation covers Public Health Service (PHS) grants 
and NIH is the largest agency within PHS.   
2 The term researcher includes the principal researcher or any other person who is 
responsible for the design, conduct, or reporting of research funded by NIH. 
3 Institute of Medicine of the National Academies, Conflict of Interest in Medical 
Research, Education, and Practice, ch. 8, April 21, 2009. 
4 Ehringhaus, S., et al., Responses of Medical Schools to Institutional Conflicts of 
Interest, Journal of the American Medical Association, February 13, 2008. 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  1   
   
I N T R O D U C T I O N  
NIH Grants 
NIH is the primary Federal agency responsible for conducting and 
supporting medical research.  Organized into 27 Institutes and Centers, 
NIH receives billions of dollars annually to support its mission.  In     
FY 2010, NIHs budget totaled over $31.2 billion.  More than 80 percent 
of this amount was distributed through almost 50,000 competitive 
grants to more than 325,000 researchers at over 3,000 institutions 
across the country and around the world.5      
Impact of the Bayh-Dole Act 
In 1980, the Patent and Trademark Act Amendments (P.L. 96-517), 
commonly known as the Bayh-Dole Act, was enacted to facilitate the 
transfer of technology from grantee institutions to private industry.  
The Bayh-Dole Act has encouraged the commercialization of federally 
funded inventions but has also increased financial ties between grantee 
institutions and private industry. 
The Bayh-Dole Act allows grantee institutions to retain title to 
inventions developed through federally funded research.  If institutions 
elect to retain title to inventions, they can license them to private 
businesses or companies.  Companies can then develop these inventions 
into commercial products that benefit the public.  These inventions have 
provided institutions with millions of dollars in royalties and equity.6  
Commercial products developed as a result of NIH-funded research 
include prescription drugs and other health care products. 
Requirements for Grantee Institutions Regarding Researcher Conflicts  
Federal regulation establishes standards to ensure that the design, 
conduct, or reporting of research funded under NIH grants will not be 
biased by researchers conflicts.7  Each institution receiving NIH funds 
must have a written policy for identifying researchers conflicts and 
ensuring that conflicts are identified, managed, reduced, or eliminated.8   
Each grantee institution must collect from each researcher a listing of 
his/her known significant financial interests that would reasonably 
 
5 NIH budget information.  Accessed at http://www.nih.gov/about/budget.htm on        
April 15, 2010. 
6 NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' 
Interests Are Protected, July 2001.  Accessed at http://www.nih.gov/news/070101wyden.htm 
on April 15, 2010. 
7 42 CFR pt. 50, subpart F. 
8 42 CFR  50.604. 
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I N T R O D U C T I O N  
appear to be affected by the research.  Federal regulation                     
(42 CFR  50.605(a)) provides that a conflict exists when a designated 
official at the institution reasonably determines that a researchers 
significant financial interest could directly and significantly affect the 
design, conduct, or reporting of  NIH-funded research.  If a researcher 
conflict exists, it must be reported to NIH.  The institution must also 
manage, reduce, or eliminate the researcher conflict. 
Lack of Requirements for Grantee Institutions Regarding Institutional 
Conflicts  
For institutional financial interests, there are no Federal regulations for 
defining, identifying, reporting, or managing conflicts.  Grantee 
institutions are not required to have policies that address either 
institutional financial interests or conflicts.  However, section 493A of 
the PHS Act directed the Secretary of Health & Human Services (HHS) 
to establish regulations that would protect PHS-funded research (i.e., 
NIH grant research) from bias resulting from conflicts of both 
researchers and entities (i.e., grantee institutions).9  In the  
July 1995 final rule that promulgated Federal regulations for 
researchers conflicts (42 CFR pt. 50, subpart F), NIH stated that the 
issue of institutional conflicts would be considered separately from 
researchers conflicts.  Currently, no Federal regulation addresses 
institutional conflicts.   
On May 8, 2009, NIH issued an Advance Notice of Proposed 
Rulemaking (ANPRM) to gain public input on whether modifications 
are needed to 42 CFR pt. 50, subpart F.  NIH invited public comments 
on all aspects of potential regulation in this area, including broadening 
the regulations to address institutional conflicts.10  Taking public 
comments regarding the ANPRM into consideration, on May 21, 2010, 
NIH issued a Notice of Proposed Rulemaking (NPRM).  In the NPRM, 
NIH proposed new requirements to strengthen the reporting and 
management of researcher conflicts.  However, the regulations were not 
broadened to include institutional conflicts.  NIH believed that further 
consideration was necessary before regulations could be formulated that 
would address institutional conflicts in the same comprehensive manner 
as the proposed regulations regarding researcher conflicts.11   
 
9 The Secretary of HHS delegated authority to NIH to promulgate Federal regulations. 
10 74 Fed. Reg. 21610, 21612 (May 8, 2009). 
11 75 Fed. Reg. 28688, 28700 (May 21, 2010). 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  3   
   
I N T R O D U C T I O N  
Recommendations From HHS Regarding Financial Interests Related to 
Human Subjects Research 
In a guidance document finalized in May 5, 2004, HHS Office for 
Human Research Protections recommended 12 actions for grantee 
institutions to consider when handling financial interests in research 
involving human subjects.12  Two of the recommended actions included                  
(1) establishing the independence of institutional responsibility for 
research activities from the management of the institutions financial 
interests and (2) establishing policies regarding the types of financial 
relationships that may be held by parties involved in the research and 
circumstances under which those financial relationships and interests 
may or may not be held. 
Recommendations From the Institute of Medicine Regarding Institutional 
Conflicts  
Institutional conflicts have prompted discussion and recommendations 
from industry and the research community.  In an April 2009 report by 
the Institute of Medicine (IOM), the Committee on Conflict of Interest 
in Medical Research, Education, and Practice (Committee) presented 
challenges with managing institutional conflicts and provided 
recommendations to handle such challenges.13   
According to the Committee, institutional conflicts arise when an 
institutions own financial interests pose risks of undue influence on 
decisions involving the institutions primary interests.  For example, 
conflicts may arise when an institution receives gifts or grants from 
companies to develop clinical practice guidelines related to the 
companies products.14  In addition, research conducted at the 
institution could affect the value of the institutions patents or its equity 
positions or options in biotechnology, pharmaceutical, or medical device 
companies.15   
In addition, the IOM report highlighted that in an American Association 
of Medical Colleges survey of its members conducted in 2006, only       
38 percent of the respondents reported having a policy that applied to 
 
12 HHS, Office for Human Research Protections, Financial Relationships and Interests in 
Research Involving Human Subjects:  Guidance for Human Subject Protection.  Accessed at 
http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf on April 15, 2010.   
13 Institute of Medicine of the National Academies, loc. cit. 
14 A clinical practice guideline is a document that provides criteria regarding diagnosis, 
management, and treatment in specific areas of health care. 
15 Institute of Medicine of the National Academies, loc. cit.  
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  4   
   
I N T R O D U C T I O N  
their institutions financial interests, although another 37 percent 
reported that they were developing such a policy.   
The Committee directed recommendations to NIH and grantee 
institutions.  The Committee recommended that NIH extend Federal 
regulations to cover institutional conflicts as well as researchers 
conflicts by developing rules governing institutional conflicts for grantee 
institutions.  The Committee suggested that these rules require 
institutions to report identified institutional conflicts and the steps that 
have been taken to eliminate or manage such conflicts to NIH.  
The Committee recommended to institutions that the assessment of 
institutional conflicts fall to their governing boards (e.g., board of 
trustees).  Specifically, the governing boards should establish standing 
committees on institutional conflicts that are composed of members 
without conflicts relevant to the activities of the institution and at least 
one member who is not a board member, an employee, or an officer of 
the institution.  Such standing committees would be at a greater 
distance from the daily pressures of decisionmaking that senior officials 
face.  They would also have access to comprehensive information about 
the finances of the institutions to better resolve disputes regarding 
conflicts.   
Related Studies by the Office of Inspector General  
In a January 2008 report, the Office of Inspector General (OIG) found 
that NIH relies on grantee institutions to ensure compliance with 
Federal financial conflict-of-interest regulations rather than directly 
overseeing or reviewing their management of researchers conflicts.16   
In a November 2009 report, OIG reviewed 184 financial               
conflict-of-interest reports for researchers that were received by NIH 
from grantee institutions during FY 2006.17  OIG found vulnerabilities 
in institutions identification, management, and oversight of conflicts.  
OIG also found vulnerabilities related to institutional financial 
interests.  The potential for financial gain can pose an institutional 
conflict when an institution licenses technology/intellectual property for 
the purposes of commercialization.  Therefore, one of our 
 
16 HHS, OIG, National Institutes of Health:  Conflicts of Interest in Extramural 
Research, OEI-03-06-00460, January 2008. 
17 HHS, OIG, How Grantees Manage Financial Conflicts of Interest in Research Funded 
by the National Institutes of Health, OEI-03-07-00700, November 2009. 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  5   
   
I N T R O D U C T I O N  
recommendations called for NIH to develop regulations that address 
institutional conflicts. 
METHODOLOGY 
Sample Design 
We determined from a data file found on NIHs Web site that           
2,648 grantee institutions received grant money in FY 2008.18  We 
excluded any institutions located outside the United States (we included 
all 50 States and the District of Columbia).  We also excluded 
institutions that received only training grants.19  Finally, we excluded 
any institutions for which NIHs data listed grant award amounts of $1 
or less.20  After the exclusions, we determined that 2,321 grantee 
institutions received research grants in FY 2008. 
We requested from NIH a list of financial conflict-of-interest reports for 
researchers submitted by grantee institutions during FY 2008.  We 
asked for this information to ensure that we were including in our 
sample a representative number of those institutions that submitted 
reports for researchers to NIH.  Based on the information provided by 
NIH, we determined that 64 institutions reported at least 1 researcher 
conflict to NIH in FY 2008 and 2,257 institutions did not report any 
conflicts. 
We selected a stratified random sample of 250 institutions to survey as 
shown in Table 1.  Stratum 1 contains all of the institutions that 
reported at least one researcher conflict in FY 2008.  Stratum 2 contains 
all of the institutions that did not report any researcher conflicts.   
                   
 
 
 
 
18 NIH,  Aggregate Data 2008.  Accessed at 
http://report.nih.gov/award/trends/AggregateData.cfm?Year=2008 on August 5, 2009.   
19 Training grants are designed to support the research training of scientists for careers 
in the biomedical and behavioral sciences, as well as to help professional schools establish, 
expand, or improve programs of continuing professional education. 
20 After the initial exclusions, five institutions were listed in NIHs file as having 
received $1 in grant awards. 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  6   
   
I N T R O D U C T I O N  
                 Table 1:  Sample of Grantee Institutions 
  Number of 
Number of  Number of 
Grantee 
Grantee  Grantee 
Stratum      D escription of Stratum  Institutions That  Response Rate 
Institutions in  Institutions in 
Responded to 
Population  Sample 
Survey 
 
Grantee institutions 
  that submitted a 
researcher financial   
1    64  64  52  81% 
conflict-of-interest 
report to NIH in  
 
FY 2008 
 Grantee institutions 
that did not submit a 
 researcher financial   
2  2,257  186  104  56% 
conflict-of-interest 
 
report to NIH in  
FY 2008 
 
   Total  2,321  250  156  62% 
 
Source:  OIG analysis of NIH data and OIG sample response rate, March 2010. 
We made at least three attempts by email to request responses from 
nonresponding grantee institutions.  A total of 156 institutions 
responded, for an overall response rate of 62 percent.  However, based 
on the overall response rate and the difference in response rates for 
Stratum 1 (81 percent) and Stratum 2 (56 percent), we did not project 
our findings to the population of 2,321 NIH grantee institutions.  
Instead, we have provided simple unweighted frequencies for our 
findings.  Appendix A provides both overall totals and totals by stratum 
for the main findings in this report.   
Data Collection 
We collected our data between November 2009 and January 2010.  We 
surveyed the sampled institutions to determine whether they have 
developed any policies and procedures regarding institutionally held 
financial interests and conflicts.  We asked whether grantee institutions 
included in their policies and procedures any of the recommendations 
from HHS Office for Human Research Protections or IOM regarding 
institutionally held financial interests or conflicts.  
We asked the institutions whether they had institutional financial 
interests related to any NIH grants awarded in FY 2008.  We requested 
information about whether the institutional financial interests were 
determined to be conflicts by institutions.  We also asked for 
information on how these conflicts were addressed. 
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I N T R O D U C T I O N  
Data Analysis 
From the survey data, we determined the frequency of responses to 
closed-ended survey questions.  We also reviewed and categorized 
responses to open-ended survey questions that were related to 
institutions definitions, policies, and procedures regarding 
institutionally held financial interests and institutional conflicts.  For 
these analyses we have provided, when applicable, both the overall 
totals and totals for each stratum. 
Limitations 
Because of the overall 62-percent response rate and the large difference 
in response rates between the two strata, the data in our findings 
represent only the information for responding grantee institutions.  It is 
possible that the data would have changed if the response rate had been 
higher, especially for Stratum 2 (grantee institutions that did not 
submit a researcher financial conflict-of-interest report to NIH in        
FY 2008). 
All of the information in the findings section of this report was          
self-reported by grantee institutions.  We did not collect supporting 
documentation from them.   
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspections approved by the Council of the Inspectors General on 
Integrity and Efficiency. 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  8   
   
FF II NN DD II NN GG SS   
 F I N D I N G S  
Although not required for institutional financial  Grantee institutions can acquire 
interests, 70 of 156 responding NIH grantee  financial interests related to      
NIH-funded research at their 
institutions have written policies and procedures 
institutions.  These financial 
addressing institutional interests 
interests can include royalties, 
equity, stockholdings, and corporate gifts.  Currently, no Federal 
regulations require grantee institutions to have policies and procedures 
that address institutional financial interests.           
Seventy of the one hundred fifty-six grantee institutions that responded 
to our survey have written policies and procedures regarding 
institutional financial interests.  Institutions that reported a researcher 
conflict to NIH in FY 2008 (Stratum 1) were more likely to have written 
policies and procedures.  Table 2 shows the number of institutions with 
such written policies and procedures. 
Table 2:  Number of Grantee Institutions That Have Written Policies and 
Procedures Regarding Institutional Financial Interests  
 
Percentage of Respondents in 
Number of Grantee 
Stratum  Description of Stratum  Stratum With Written Policies 
  Institutions 
and Procedures 
Grantee institutions that 
 
1  submitted a researcher 
37  71% 
(n=52)    financial conflict-of-interest 
report to NIH in FY 2008 
  Grantee institutions that did 
2  not submit a researcher 
  33  32% 
(n=104)  financial conflict-of-interest 
report to NIH in FY 2008 
 
   Total  70  45% 
   
 Source:  OIG analysis of grantee institution survey responses, March 2010. 
Fifty-nine of the seventy grantee institutions with written policies and 
procedures regarding institutional financial interests have defined, in 
writing, what constitutes an institutional financial interest 
The 59 institutions use a variety of specific definitions for what 
constitutes an institutional financial interest.  Policies and procedures 
for some institutions relate only to financial interests held by the 
institutions themselves, others consider the interests of both the 
institutions and their employees/officials, and still others relate only to 
the interests of institutional employees/officials.  
The number of definitions used by institutions for institutional financial 
interests ranged from one to eight.  The average number of definitions 
used by grantee institutions was five.  The three most common 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  9   
   
F I N D I N G S  
definitions were (1) an institutional officials individual financial 
interests, (2) equity held by the institution in publicly held entities, and 
(3) equity held by the institution in nonpublicly held entities.  Table 3 
shows the number of grantee institutions with written policies and 
procedures that use the different definitions of financial interests.  
Table 3:  Number of Grantee Institutions With Written Policies and 
Procedures Using Various Definitions of Institutional Financial Interests  
  Number of Grantee  Number of Grantee 
Institution Defined Financial  Total Number of Grantee 
Interest As:  Institutions in  Institutions in  Institutions1 
  Stratum 1  Stratum 2 
Institutional officials individual 
30  20  50 
financial inte rests 
Equity in publicly held 
29  19  48 
companies  
Equity in nonpublicly held 
  28  19  47 
companies 
Royalties resulting from 
  19  18  37 
federally funded research 
Royalties res ulting from 
20  16  36 
nonfederally funded research 
Gifts from re search sponsors  17  19  36 
Payments from research 
 
sponsors for reaching 
12  18  30 
  designated milestones in a 
course of a study 
Other (e.g.,  intellectual 
5  7  12 
property) 
 
Source:  OIG analysis of grantee institution survey responses, March 2010. 
1 The total number of institutions with a written definition of an institutional financial interest equals 59.  The number of institutions 
  in this column does not equal 59 because some institutions established more than 1 definition. 
Most of the 70 grantee institutions with written policies and procedures 
reported that they had incorporated recommendations from the HHS 
Guidance Document  
Sixty-two of the seventy institutions stated that they have incorporated 
recommendations from the HHS Guidance Document into their policies 
and procedures.  The Guidance Document, issued by HHSs Office of 
Human Research Protections, outlines 12 recommended actions that 
grantee institutions engaged in human subject research should consider 
to help ensure that financial interests do not compromise the rights and 
welfare of human research subjects.   
The most common recommendation that institutions reported including 
was establishing conflict-of-interest committees or identifying other 
bodies or persons and procedures to deal with individuals or 
institutional financial interests in research.  The recommendation 
incorporated least often was to allow independent organizations to hold 
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F I N D I N G S  
or administer the institutions financial interest.  Appendix B contains 
the number of institutions that incorporated each recommendation. 
Institutional conflicts arise when 
Although not required for institutional conflicts, 
a grantee institutions own 
69 of 156 responding NIH grantee institutions 
financial interests or those of its 
have written policies and procedures 
senior officials pose risks of undue 
addressing institutional conflicts   influence on decisions involving 
the institutions research.21  For 
example, an institutional conflict exists if the outcome of research 
conducted at a grantee institution could affect the value of the 
institutions equity in a particular company.  Currently, there are no 
Federal requirements that grantee institutions have policies and 
procedures to address institutional conflicts.      
Beyond policies and procedures to address institutional financial 
interests, grantee institutions also have policies and procedures 
specifying how to handle instances in which those interests pose an 
actual conflict with research activities.  Sixty-nine institutions have 
written policies and procedures regarding institutional financial 
conflicts.  A total of 78 institutions have not developed written policies 
and procedures for either institutional financial interests or conflicts.22  
Again, institutions that reported a researcher conflict to NIH in FY 
2008 (Stratum 1) were more likely to have written policies and 
procedures regarding institutional conflicts.  Table 4 shows the number 
of institutions with written policies and procedures for institutional 
conflicts.   
 
 
 
 
 
 
21 Institute of Medicine of the National Academies, loc. cit. 
22 Sixty-one grantee institutions have written policies and procedures for both 
institutional financial interests and conflicts, nine institutions have policies and procedures 
for only institutional financial interests, and eight institutions have policies and procedures 
for only institutional conflicts. 
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F I N D I N G S  
Table 4:  Number of Grantee Institutions That Have Written Policies and 
Procedures Regarding Institutional Conflicts  
 
Number of Grantee 
Stratum  Description of Stratum  Percentage of Respondents 
Institutions 
 
Grantee institutions that 
1    submitted a researcher 
37  71% 
(n=52)  financial conflict-of-interest 
  report to NIH in FY 2008 
Grantee institutions that did 
 
2  not submit a researcher 
32  31% 
(n=104)    financial conflict-of-interest 
report to NIH in FY 2008 
 
   Total  69  44% 
 Source:  OIG a nalysis of grantee institution survey responses, March 2010. 
Fifty-nine of the sixty-nine grantee institutions with written policies and 
procedures regarding institutional conflicts have defined, in writing, what 
constitutes an institutional conflict  
The 59 institutions typically defined institutional conflicts as financial 
interests that could affect the research, decisionmaking, loyalty, or 
objectivity of either the institution or individuals.  Some institutions 
determined that institutional conflicts exist when financial interests are 
of a certain type or reach a certain threshold amount (e.g., $100,000 or  
5-percent equity holding).   
Fifty-three of the sixty-nine grantee institutions with written policies and 
procedures have implemented a process to determine whether an 
institutional financial interest creates an institutional conflict 
These 53 institutions processes generally involved notifying an 
institutional official and/or committee regarding the financial interests.  
The official and/or committee then determines whether the financial 
interest is an institutional conflict.  Some of these officials/committees 
also review institutional equity holdings and/or license/royalty 
agreements to determine whether they are institutional conflicts.   
Forty of the sixty-nine grantee institutions with written policies and 
procedures regarding institutional conflicts have a committee that reviews 
institutional conflicts   
All of the committees among these 40 grantee institutions have the 
authority to determine whether institutional financial interests are 
institutional conflicts.  All but two of the committees have the additional 
authority to determine how the conflicts will be addressed.  Nineteen of 
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F I N D I N G S  
these committees are separate entities from the committees responsible 
for reviewing researchers conflicts at the institutions.   
In its April 2009 report, IOM recommended that grantee institutions 
handle challenges in managing institutional conflicts by implementing 
standing committees to assess the conflicts.  As recommended by IOM, 
15 of the 69 institutions have boards of trustees (or an equivalent 
governing body) that have established their own standing committees 
on institutional conflicts.  Seven institutions also have at least one 
outside member of their committees who is not a board member, an 
employee, or an officer of the institutions.  Five of these committees 
submit annual reports to the boards of trustees regarding institutional 
conflicts, which are made public. 
Twenty-one of one hundred 
Eighteen NIH grantee institutions identified     
fifty-six grantee institutions 
38 institutional conflicts 
identified institutional 
financial interests.  Almost all of those 21 identified the financial 
interests as institutional conflicts.   
Eighteen of the twenty-one institutions identified at least  
38 institutional conflicts related to NIH research grants in FY 2008.23  
The remaining three institutions that identified financial interests did 
not determine them to be conflicts.  Of the 18 grantee institutions that 
identified institutional conflicts, 15 had written policies and procedures 
regarding institutional conflicts.  The remaining three institutions did 
not have written policies and procedures.  Therefore, our findings show 
that institutions with written policies and procedures were more likely 
to identify conflicts (15 of 69 institutions) than those without written 
policies and procedures (3 of 87 institutions).  Table 5 shows the number 
of institutions per stratum that identified conflicts.   
 
 
 
 
 
 
23 Three of the eighteen grantee institutions reported that they had at least one 
institutional conflict, but could not provide a specific number. 
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F I N D I N G S  
Table 5:  Number of Grantee Institutions That Reported Identifying 
Institutional Conflicts 
 
Number of Grantee  Number of These Grantee 
Stratum  Description of Stratum  Institutions With  Institutions With Written 
 
Institutional Conflicts  Policies and Procedures 
Grantee institutions that 
 
1  submitted a researcher 
14  13 
    financial conflict-of-interest 
report to NIH in FY 2008 
  Grantee institutions that did 
2  not submit a researcher 
  4  2 
  financial conflict-of-interest 
report to NIH in FY 2008 
 
   Total  18  15 
 
 Source:  OIG analysis of grantee institution survey responses, March 2010. 
Grantee institutions tended to have the same conflicts as their 
researchers.  This is important because, in essence, institutions are 
overseeing researchers conflicts when they themselves have the same 
potential conflict.  At 17 of the 18 institutions, researchers who worked 
on the grant(s) had the same types of conflict(s) as the institutions.  For 
example, at one institution, both the institution and the researcher held 
equity in the same nonpublicly held company.   
The most common type of institutional conflict was grantee institutions 
holding equity in nonpublicly held companies 
The 18 institutions that had institutional conflicts identified different 
types of conflicts.  The two most common types were holding equity in 
nonpublicly held companies and receiving royalties resulting from 
federally funded research.  Table 6 shows the types of institutional 
conflicts per stratum that were reported by institutions in FY 2008 and 
the number of institutions reporting each type.  
 
 
 
 
 
 
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F I N D I N G S  
Table 6:  Number of Grantee Institutions With Different Types of 
Institutional Conflicts Reported Between October 1, 2007, and 
September 30, 2008 
  Number of Grantee  Number of Grantee  Total Number of 
Institutions in Stratum 1  Institutions in Stratum 2  Grantee Institutions 
Type of Ins titutional Conflicts Reporting Type of  Reporting Type of  Reporting Type of 
  Conflict  Conflict  Conflict1 
Equity in nonpublicly held 
9  2  11 
companies  
Royalties resulting from 
  8  2  10 
federally funded research 
Institutional officials individual 
  4  1  5 
financial interests 
Royalties resulting from       
  3  0  3 
nonfederally funded research 
  Equity in publicly held 
2  0  2 
companies 
  Unspecified royalties  1  0  1 
  Not specified/other  1  1  2 
Source:  OIG analysis of grantee institution survey responses, March 2010. 
1 Eighteen instit utions identified thirty-eight institutional conflicts.  The number of institutions in this column does not equal 
18 because some institutions had more than 1 type of conflict.  The number of conflicts in the column does not equal 38 
because, for example, some institutions reported that a conflictinvolved both equity androyalties. 
 
Grantee institutions reported having various strategies available to address 
their institutional conflicts 
Pursuant to Federal regulation, grantee institutions must ensure that 
researchers conflicts will be managed, reduced, or eliminated.  
Although no such requirement exists for addressing institutional 
conflicts, 98 of 156 institutions reported that they had strategies to 
ensure that institutional conflicts do not bias research.  The five most 
commonly reported strategies were (1) ensuring an open exchange of 
research results through publication and/or presentations, (2) disclosing 
the institutional conflict during the informed consent process for human 
subjects, (3) formally recusing the official who has a conflict from the 
chain of authority over the project and communicating the recusal to the 
officials superior and colleagues, (4) notifying the Institutional Review 
Board24 regarding the institutional conflict, and (5) ensuring that 
adequate peer review of research is performed by the institution.  
Appendix C contains the number of institutions per stratum that use 
these and other strategies. 
 
24 Institutional review boards ensure the rights and safety of people participating in 
clinical trials. 
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F I N D I N G S  
Grantee institutions that identified institutional conflicts most often used 
disclosure to address them 
For the 18 institutions that identified institutional conflicts, the             
2 methods most often used to address conflicts were (1) disclosing them 
during the informed consent process for research involving human 
subjects and (2) notifying the Institutional Review Board regarding the 
conflicts.  The next two strategies most commonly used were disclosing 
the institutional conflicts in public presentations and publications and 
ensuring that adequate peer review of research was performed by the 
institution. 
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I N T O R D U C T I O N  
 R E C O M M E N D A T I O N  
 
 
NIH is the primary Federal agency responsible for conducting and 
supporting medical research.  It is vital to public health and safety that 
this research be free from bias.  Federal regulations establish standards 
to ensure that the design, conduct, and reporting of federally funded 
research will not be biased by a researchers conflict.  The PHS Act 
directed the establishment of regulations that would protect            
PHS-funded research (i.e., NIH grant research) from bias resulting from 
conflicts of both researchers and entities (i.e., grantee institutions).  
However, there are currently no Federal requirements to identify and 
report institutional conflicts to NIH.  Therefore, NIH lacks information 
on the number of institutional conflicts that exist among its grantee 
institutions and the impact these conflicts may have on NIH-sponsored 
research.   
Our review shows that institutional conflicts do exist at grantee 
institutions.  Eighteen of the one hundred fifty-six institutions that 
responded to our survey identified institutional conflicts related to their 
NIH grants in FY 2008.  We found that the institutions with written 
policies and procedures regarding institutional conflicts were more 
likely to identify conflicts.  However, because half of the responding 
institutions have no written policies and procedures, it is impossible to 
know how many additional institutions would have identified 
institutional conflicts if they had policies and procedures.   
Even institutions with polices and procedures differed in how they 
defined and addressed institutional financial interests and conflicts 
related to research.  Therefore, we continue to recommend that NIH 
require institutions to identify, report, and address institutional 
conflicts in a consistent and uniform manner.  It is important that NIH 
know of the existence of institutional conflicts so it can ensure that 
research is free from any intended or unintended bias. 
Therefore, as in our previous report, we recommend that NIH: 
Promulgate regulations that address institutional financial conflicts of 
interest 
We recommend that the regulations include the following:  
  the definition of an institutional financial conflict of interest;  
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R E C O M M E N D A T I O N  
  a requirement that grantee institutions have written policies 
regarding the identification and oversight of institutional 
financial conflicts of interest; 
  the elements required in an institutions policy regarding 
institutional financial conflicts of interest (such as the 
identification and management of conflicts); 
  a requirement that institutions report institutional conflicts to 
NIH, including reporting the details regarding the nature and 
management of such conflicts; these details should include the 
value of the financial interest, a description of how the financial 
interest relates to the research, a description of how the 
institutional conflict will be managed, and a description of how 
the management of the institutional conflict will ensure 
objectivity in the research; and 
  guidance on how institutional conflicts should be identified, 
managed, reduced, or eliminated. 
Until regulations are promulgated, NIH should encourage grantee 
institutions to develop policies and procedures regarding institutional 
financial interests and conflicts. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
NIH agreed that institutional conflict of interest is a significant and 
timely topic worthy of serious consideration.  NIH stated that it is 
reviewing public comments to finalize regulations regarding financial 
conflicts of interest and, therefore, it neither concurs nor nonconcurs 
with our recommendation.  Instead, NIH stated it will take OIGs 
recommendation into consideration as it considers future actions on 
extramural financial conflicts of interest.  NIH also made several 
technical comments on the report, and OIG has made changes to the 
report based on these comments where appropriate.     
OIG understands that NIH is engaged in the rulemaking process 
regarding financial conflicts of interest.  However, in the  
May 21, 2010, Notice of Proposed Rulemaking regarding financial 
conflicts of interest, NIH proposed regulatory changes that focus only on 
researchers conflicts.  The proposed regulations do not address 
institutional conflicts.  Therefore, OIG continues to recommend that  
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R E C O M M E N D A T I O N  
NIH include institutional conflicts in regulations addressing financial 
conflicts of interest.  The full text of NIHs comments is provided in 
Appendix D.   
 
 
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 A P P E N D I X ~ A  
Table A-1:  Results by Stratum for Grantee Institutions With Written Policies and 
Procedures Regarding Institutional Financial Interests and Institutional Conflicts  
Number of Grantee  Number of Grantee  Total Number of Grantee 
  Institutions in Stratum 1  Institutions in Stratum 2   Institutions 
Number of grantee institutions that have written policies 
37  33  70 
and procedures regarding institutional financial interests  
Number of institutions that have defined, in 
  writing, what constitutes an institutional financial  32  27  59 
interest 
Number of grantee institutions that have written policies 
37  32  69 
and procedures regarding institutional conflicts 
Number of institutions that have defined, in 
  35  24  59 
writing, what constitutes an institutional conflict 
Number of institutions that have implemented a 
  process to determine whether an institutional  31  22  53 
financial interest creates an institutional conflict 
Number of institutions that have a committee that 
  26  14  40 
reviews institutional conflicts 
Number of institutions whose committees have 
  the authority to determine whether institutional  26  14  40 
financial interests are institutional conflicts 
Number of institutions whose committees have 
  the authority to determine how institutional  24  14  38 
conflicts will be addressed 
Number of institutions whose committees are   
  separate entities from the committees responsible  12  7  19 
for reviewing researchers conflicts 
Number of institutions whose boards of trustees 
(or equivalent governing bodies) have also 
  established their own standing committees on  9  6  15 
institutional conflicts as recommended by the 
Institute of Medicine 
 Sou rce:  Office of Inspector General analysis of grantee institution survey responses, March 2010. 
 
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 A P P E N D I X ~ B  
Table B-1:  Number of Grantee Institutions That Reported Incorporating 
Recommended Actions From Departmental Guidance in Written Policies and 
Procedures Regarding Institutional Financial Interests 
Number of Grantee  Number of Grantee  Total Number of Grantee 
Recommendation  Institutions in Stratum 1  Institutions in Stratum 2   Institutions1  
Establish conflict-of-interest committees or identify other 
bodies or persons and procedures to deal with individual 
or institutional financial interests in research or verify the  35  20  55 
absence of such interests and address institutional 
financial interests in research 
Establish criteria to determine what constitutes an 
institutional financial conflict, including identifying 
leadership positions for which the individuals financial  32  20  52 
interests are such that they may need to be treated as 
institutional financial interests 
Determine whether particular individuals should report 
financial interests to the conflict-of-interest committee 
(individuals could include Institutional Review Board  34  17  51 
members and staff, appropriate officials of the 
institutions, and researchers) 
Establish policies on providing information, 
recommendations, or findings from conflict-of-interest  29  16  45 
committee deliberations to Institutional Review Boards 
Establish the independence of institutional responsibility 
for research activities from the management of the  26  17  43 
institutions financial interests 
Establish policies regarding the types of financial 
relationships that may be held by parties involved in the 
25  18  43 
research and circumstances under which those 
relationships and interests may or may not be held 
Establish clear channels of communication between 
conflict-of-interest committees and Institutional Review  29  13  42 
Boards 
Establish measures to foster the independence of 
Institutional Review Boards and conflict-of-interest  28  14  42 
committees 
Establish procedures for disclosures of institutional 
25  16  41 
financial relationships to conflict-of-interest committees 
Provide training to appropriate individuals regarding 
27  11  38 
financial interest requirements 
Include individuals from outside the institution in the 
23  10  33 
review and oversight of financial interests in research 
Use independent organizations to hold or administer the 
12  4  16 
institutions financial interest 
 Source:  Office of Inspector General anal ysis of grantee institution survey responses, March 2010. 
 1 The total number of institutions that reported incorporating recommendations equals 62.  The number of institutions in this column does not equal 62 because some 
institutions incorporated more than 1 recommendation. 
 
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 A P P E N D I X ~ C  
Table C-1:  Methods Employed by Grantee Institutions To Manage, Reduce, or 
Eliminate Institutional Conflicts 
Number of Grantee  Number of Grantee  Number of Grantee 
Methods  Institutions In Stratum 1  Institutions in Stratum 2  Institutions 1 
Ensuring open exchange of research results through 
30  40  70 
publications and/or presentations 
Disclosure of institutional conflicts during the informed 
31  24  55 
consent process for research subjects 
Where the institutional conflict involves senior officials, 
formal recusal of the conflicted officials from the chain of 
authority over the research and communication of the  37  17  54 
recusal arrangement to the officials superiors and 
colleagues 
Notification of the Institutional Review Boards regarding 
31  22  53 
institutional conflicts 
Ensuring that adequate peer review of research is 
18  34  52 
performed by the institution 
Disclosure of the institutional conflicts in public 
25  25  50 
presentations and publications 
Where the institutional conflict involves a senior official, 
designation of a safe haven (e.g., a nonconflicted senior 
32  15  47 
individual) with whom researchers can address  
institutional-conflict-related concerns 
Monitoring the use of institution facilities or prohibiting the 
use of institution facilities/resources to further the interests  24  19  43 
of companies connected to institutional conflicts 
Ensuring that no technology/intellectual property is 
inappropriately shared with companies connected to  19  23  42 
institutional conflicts 
External monitoring of research studies  20  19  39 
Prohibiting outside companies related to institutional 
conflicts from sponsoring research associated with the 
17  17  34 
conflicts or requiring approval for outside companies to 
sponsor research 
Preapproving/overseeing purchases of goods/services from 
17  16  33 
companies connected to institutional conflicts 
Elimination of the institutional conflict  18  15  33 
Disclosure of the institutional conflicts to other researchers 
11  10  21 
and/or centers in a multicenter trial 
Additional internal monitoring of research studies  3  0  3 
Prohibiting clinical research at the grantee institutions   2  0  2 
   
 Sou rce:  Office of Inspector General analysis of grantee institution survey responses, March 2010. 
 1 The total number of institutions equals 156.  The number of institutions in this column does not equal 156 because some institutions use more than 1 method for 
managing, reducing, and/or eliminating institutional conflicts.  
 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  22  x  o 
A  P  PEN  0 
Agency Comments 
DEPARTMENT OF HEALTH &. HUMAN SERVICES 	 Public Health Servic.e 
National Institutes of Health 
Bethesda. Mar,y land 20892 
NOV  2 201D 
TO: 	 Stuart Wright 
Deputy Inspector General for Inspection and Evaluations, HHS 
FROM: 	 Director, NIH 
SUBJECT: 	 National Institutes of Health Comments on the Draft Office oflnspector 
General Report: Institutional Conflicts ofInterest at NIH Grantees 
(OEI-03-09-0048'O)  .  . 
Attached are our general and technical comments on the draft Office ofInspector General 
report, entitled Institutional Conflicts ofInterest at NIH Grantees (OEI-03-09-00480). 
We appreciate the opportunity to review and comment on this important topic. Should you 
have questions or concerns regarding our comments, please contact Mary Anne Mazzarino 
in the Office of Management Assessment at 3014962461. 
Francis S. Collins, M.D., Ph.D. 
Attachments 
OEI030900480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  23   
   
AA PP PP EE NN DD II XX    ~~    DD   
 
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 A C K N O W L E D G M E N T S  
This report was prepared under the direction of Robert A. Vito, Regional 
Inspector General for Evaluation and Inspections in the Philadelphia 
regional office, and Linda M. Ragone, Deputy Regional Inspector 
General.   
Tanaz Dutia served as the team leader for this study.  Other principal 
Office of Evaluation and Inspections staff from the Philadelphia 
regional office who contributed to the report include Emily Multari; 
central office staff who contributed include Heather Barton.  
 
  OEI-03-09-00480  INSTITUTIONAL CONFLICTS OF INTEREST AT NIH GRANTEES  25   
Office of Inspector General 
http://oig.hhs.gov 
 
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amended, is to protect the integrity of the Department of Health and Human Services 
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