28688 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Proposed Rules 

1 48 CFR Subpart 9.1, ‘‘Responsible Prospective 

Contractors,’’ and 48 CFR Subpart 9.5, 

‘‘Organizational and Consultant Conflicts of 

Interest,’’ also address conflicts of interest in 

Federally-funded projects. These provisions apply 

only to acquisitions, not to grants or cooperative 

agreements. 

2 ‘‘Institution’’ is currently defined under 42 CFR 

Part 50, Subpart F, as any domestic or foreign, 

public or private, entity or organization (excluding 

a Federal agency), and under 45 CFR Part 94 as any 

public or private entity or organization (excluding 

a Federal agency) (1) that submits a proposal for a 

research contract whether in response to a 

solicitation from the PHS or otherwise, or (2) that 

assumes the legal obligation to carry out the 

research required under the contract. 42 CFR 

50.603; 45 CFR 94.3. 

3 ‘‘Investigator’’ is currently defined under the 

regulations as the principal investigator and any 

other person who is responsible for the design, 

conduct, or reporting of research (or, in the case of 

PHS contracts, a research project) funded by PHS, 

or proposed for such funding. For purposes of the 

regulatory requirements relating to financial 

interests, the term ‘‘Investigator’’ includes the 

Investigator’s spouse and dependent children. 42 

CFR 50.603; 45 CFR 94.3. 

4 ‘‘Significant Financial Interest’’ is currently 

defined under the regulations as anything of 

monetary value, including but not limited to, salary 

or other payments for services (e.g., consulting fees 

or honoraria); equity interests (e.g., stocks, stock 

options or other ownership interests); and 

intellectual property rights (e.g., patents, copyrights 

and royalties from such rights). The term does not 

include: (1) Salary, royalties, or other remuneration 

from the applicant institution; (2) any ownership 

interests in the institution, if the institution is an 

applicant under the SBIR/STTR programs; (3) 

income from seminars, lectures, or teaching 

engagements sponsored by public or nonprofit 

entities; (4) income from service on advisory 

committees or review panels for public or nonprofit 

entities; (5) an equity interest that when aggregated 

for the Investigator and the Investigator’s spouse 

and dependent children meets both of the following 

tests: Does not exceed $10,000 in value as 

determined through reference to public prices or 

other reasonable measures of fair market value, and 

does not represent more than a five percent 

ownership interest in any single entity; or (6) salary, 

royalties, or other payments that when aggregated 

for the investigator and the investigator’s spouse 

and dependent children over the next twelve 

months, are not expected (or, in the case of PHS 

contracts, are not reasonably expected) to exceed 

$10,000. 42 CFR 50.603; 45 CFR 94.3. 

5 ‘‘PHS Awarding Component’’ is currently 

defined as the/an organizational unit of the PHS 

that funds [the] research that is subject to the 

regulations. 42 CFR 50.603, 45 CFR 94.3. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 50 

45 CFR Part 94 

[Docket Number: NIH–2010–0001] 

RIN 0925–AA53 

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: Notice of proposed rulemaking. 

SUMMARY: The Department of Health and 

Human Services (HHS or the 

Department) and the HHS Public Health 

Service (PHS), proposes to amend its 

regulations on the Responsibility of 

Applicants for Promoting Objectivity in 

Research for which PHS Funding is 

Sought and Responsible Prospective 

Contractors. Since the promulgation of 

the regulations in 1995, biomedical and 

behavioral research and the resulting 

interactions among Government, 

research institutions, and the private 

sector have become increasingly 

complex. This complexity, as well as a 

need to strengthen accountability, have 

led to the proposal of amendments that 

would expand and add transparency to 

investigator disclosure of significant 

financial interests, enhance regulatory 

compliance and effective institutional 

oversight and management of 

investigators’ financial conflicts of 

interests, as well as NIH’s compliance 

oversight. 

DATES: Comments must be received on 

or before July 20, 2010 in order to 

ensure we will be able to consider the 

comments when preparing the final 

rule. 

ADDRESSES: Individuals, organizations 

and institutions interested in submitting 

comments identified by RIN 0925–AA53 

and Docket Number [NIH–2010–0001] 

may do so by any of the following 

methods: 

Electronic Submissions 

You may submit electronic comments 

in the following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• To ensure timely processing of 

comments, NIH is no longer accepting 

comments submitted to the agency by 

e-mail. 

Written Submissions 

You may submit written comments in 

the following ways: 

• Fax: 301–402–0169. 

• Mail: Jerry Moore, NIH Regulations 

Officer, Office of Management 

Assessment, National Institutes of 

Health, 6011 Executive Boulevard, Suite 

601, MSC 7669, Rockville, MD 20852– 

7669. 

Instructions: All submissions received 

must include the agency name and 

Regulatory Information Number (RIN) 

[0925–AA53] and docket number [NIH– 

2010–0001] for this rulemaking action. 

All comments may be posted without 

change, including any personal 

information provided. 

Docket: For access to the docket to 

read background documents or 

comments received concerning this 

rulemaking action, go to the 

eRulemaking.gov Portal: http:// 

www.regulations.gov and follow the 

instructions provided for conducting a 

search, using the docket number [NIH– 

2010–0001]. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Moore, NIH Regulations Officer, Office 

of Management Assessment, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 601, MSC 7669, 

Rockville, MD 20852–7669, telephone 

301–496–4607, fax 301–402–0169, 

e-mail jm40z@nih.gov, concerning 

questions about the rulemaking process 

and Dr. Sally Rockey, NIH Deputy 

Director for Extramural Research, 

concerning substantive questions about 

the proposed rule, e-mail FCOINPRM@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: Proper 

stewardship of Federal funds includes 

ensuring objectivity of results by 

protecting Federally-funded research 

from potential bias due to investigator 

financial conflicts of interest (FCOI). 

I. Background 

In 1995, the PHS and the Office of the 

Secretary of HHS published regulations 

at 42 CFR Part 50 Subpart F and 45 CFR 

Part 94 (the regulations), that are 

designed to promote objectivity in PHSfunded research.1 The current 

regulations are applicable to Institutions 

that apply for or seek PHS funding for 

research (except for Small Business 

Innovation Research (SBIR)/Small 

Business Technology Transfer Research 

(STTR) Phase I applications) and, 

through implementation of the 

regulations by these Institutions, to each 

Investigator participating in the 

research. Generally, under the current 

regulations: 

• The Institution 2 is responsible for 

complying with the regulations, 

including maintaining a written and 

enforced policy; managing, reducing, or 

eliminating identified conflicts; and 

reporting identified conflicts to the PHS 

Awarding Component. The reports 

denote the existence of a conflicting 

interest and the Institution must assure 

that it has been managed, reduced, or 

eliminated. 

• Investigators 3 are responsible for 

complying with their Institution’s 

written FCOI policy and for disclosing 

their Significant Financial Interests 4

(SFIs) to the Institution. 

• The PHS Awarding Components 5

are responsible for overseeing 


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6Moses H et al, JAMA; 2005; 294:1333–1342 7Blumenthal D et al, N Engl J Med; 1996; 

335:1734–9 8Zinner DE et al, Health Aff; 2009; 28:1814–25. 

9 In those few cases where an individual, rather 

than an institution, is an applicant for PHS grants 

or cooperative agreements for research, PHS 

Awarding Components will make case-by-case 

determinations on the steps to be taken to ensure 

that the design, conduct, and reporting of the 

research will not be biased by any conflicting 

financial interest of the individual. 10 60 FR 35810, 35814 (July 11, 1995) 

Institutional compliance with the 

regulations. 

Ensuring objectivity in research 

requires a commitment from Institutions 

and their Investigators to: 

• Completely disclose, 

• Appropriately review, and 

• Robustly manage identified 

conflicts. 

The purpose of the existing 

regulations is to ensure that there is no 

reasonable expectation that the design, 

conduct, or reporting of PHS-funded 

research will be biased by any 

Investigator FCOI. 

Since the publication of these 

regulations, the pace by which new 

discoveries are translated from the 

research bench into effective treatment 

of patients has accelerated significantly 

and the biomedical and behavioral 

research enterprise in the United States 

has grown in size and complexity. For 

example, an analysis of financial 

support of biomedical research from 

1994 to 2004 6 showed that funding 

increased from $37.1 billion in 1994 to 

$94.3 billion in 2003. Fifty seven 

percent of the funding in 2003 came 

from industry sources. At the same time, 

relationships between individual 

academic researchers and industry have 

also increased from 28% in a 1996 

survey 7 to 52.8% in a survey conducted 

in 2007.8

Researchers frequently work in 

multidisciplinary teams to develop new 

strategies and approaches for translating 

basic research into clinical application, 

thus hastening discovery and advancing 

human health. In addition, these newer 

translational strategies often involve 

complex collaborations between 

investigators and the private sector. 

The growing complexity of 

biomedical and behavioral research; the 

increased interaction among 

Government, research institutions, and 

the private sector in attaining common 

public health goals while meeting 

public expectations for research 

integrity; as well as increased public 

scrutiny, all have raised questions as to 

whether a more rigorous approach to 

Investigator disclosure, management of 

financial conflicts, and Federal 

oversight is required. Consequently, we 

previously published an Advance 

Notice of Proposed Rulemaking 

(ANPRM) in the Federal Register on 

May 8, 2009 (74 FR 21610–21613), 

inviting public comment on potential 

changes to the regulations. 

The ANPRM invited comment on the 

following major areas of the regulation: 

1. Expanding the scope of the 

regulation and disclosure of interests 

2. Definition of ‘‘significant financial 

interest’’ (including questions regarding 

the appropriate de minimis threshold 

and exemptions to the definition) 

3. Identification and management of 

conflicts by Institutions 

4. Assuring institutional compliance 

5. Requiring Institutions to provide 

additional information to the PHS 

6. Institutional conflict of interest 

After careful consideration of the 

comments received in response to the 

ANPRM and further deliberation within 

the Department, we are proposing 

substantial revisions to the current 

regulations, detailed below. The specific 

comments to the ANPRM are discussed 

in the relevant sections describing the 

proposed changes to the regulations. We 

believe that the proposed revisions 

would expand and add transparency to 

investigator disclosure of SFIs as well as 

enhance regulatory compliance and 

effective FCOI oversight. 

II. Description of Proposed Revisions 

The following provides a more 

detailed discussion of the proposed 

revisions to the current regulations in 

the order that they would appear in 42 

CFR Part 50, Subpart F and 45 CFR Part 

94. 

Purpose (42 CFR 50.601; 45 CFR 94.1) 

We are proposing minor revisions to 

the text of this section. These revisions 

reflect a broader effort to improve 

internal consistency with regard to the 

use of various terms and phrases 

throughout these regulations. As a 

general matter, along with the more 

substantive changes to the regulations 

discussed further below, we are seeking 

to use this rulemaking proceeding as an 

opportunity to refine the current text of 

the regulations to improve clarity and 

readability for users. 

Applicability (42 CFR 50.602, 45 CFR 

94.2) 

The current regulations at 42 CFR Part 

50, Subpart F, are applicable to each 

Institution that applies for PHS grants or 

cooperative agreements for research 

and, through implementation of the 

regulations by each Institution, to each 

Investigator participating in such 

research.9 The current PHS contracting 

regulations at 45 Part 94 similarly apply 

to each Institution that seeks PHS 

funding for research and, through 

implementation of the regulations, to 

each Investigator who participates in 

such research. In neither case do the 

regulations currently apply to SBIR/ 

STTR Phase I applications. 

When the existing regulations were 

published as a final rule in 1995, it was 

acknowledged in the preamble that 

SBIR/STTR Phase I applications ‘‘are for 

limited amounts.’’ 10 Since that time, the 

size of these awards has increased and 

the amounts are not insignificant 

expenditures of public funds. For 

example, the median amount of an NIH 

Phase I award increased from 

approximately $99,000 in 1995 to 

approximately $182,000 in 2009. In 

addition, Phase I awards are often used 

to leverage Phase II funding or 

significant outside financial support, 

and a significant proportion of 

Institutions receiving Phase I funding 

from NIH, in particular, already have 

Phase II awards (approximately 200 

Institutions in 2008 and 2009). As a 

result, it would be reasonable to 

conclude that many Institutions with 

Phase I awards will be required to 

implement these regulations in due 

course. 

In light of these factors, we asked in 

the ANPRM whether the scope of the 

regulations should be expanded to cover 

SBIR/STTR Phase I applications. Many 

of the respondents to the ANPRM 

indicated that any and all applications 

and proposals for PHS funding should 

be subject to the regulations, including 

SBIR/STTR Phase I applications. For the 

reasons stated above and the sentiment 

expressed in public comments on the 

ANPRM, we are proposing to broaden 

the applicability of the regulations by 

eliminating the current exception for 

SBIR/STTR Phase I applications. 

We also propose to add language in 

this section clarifying that the 

regulations continue to apply once the 

PHS-funded research is underway (i.e., 

after the application process). Finally, 

we are proposing to make minor 

revisions to the text of this section as 

part of a broader effort to improve 

internal consistency in the use of 

various terms and phrases throughout 

the regulations and, where feasible, 

consistency between the text of 42 CFR 

Part 50, Subpart F, and 45 CFR Part 94. 

Definitions (42 CFR 50.603, 45 CFR 

94.3) 

We propose to add several new 

definitions in this section of the 

regulations, revise some of the existing 


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28690 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Proposed Rules 

definitions, and remove one definition, 

as follows: 

1. Contractor. We propose a minor 

revision to the current definition of 

‘‘Contractor’’ in 45 CFR 94.3 that would 

clarify that the term applies to an entity 

that provides property or services 

‘‘under contract’’ for the direct benefit or 

use of the Federal Government. 

2. Disclosure of significant financial 

interests. This definition would be new 

and would mean an Investigator’s 

disclosure of significant financial 

interests to an Institution. We propose 

to include this definition—along with 

the definition of ‘‘FCOI report’’ below— 

because of the confusion that can result 

from the seemingly interchangeable use 

of the terms ‘‘disclosure’’ and ‘‘report’’ 

with regard to communications from an 

Investigator to an Institution and, 

correspondingly, from an Institution to 

the PHS. We propose to use the phrase 

‘‘disclosure of significant financial 

interests’’ to describe the 

communication that occurs between an 

Investigator and the Institution 

requesting SFI information from the 

Investigator as part of its compliance 

with these regulations. We intend for 

the term ‘‘FCOI report’’ to describe 

communications from an Institution to 

the PHS regarding FCOI. 

3. FCOI report. This definition would 

be new and would mean an Institution’s 

report of a financial conflict of interest 

to a PHS Awarding Component. We 

propose to add this new definition for 

the reasons described above regarding 

the ‘‘disclosure of significant financial 

interests’’ definition. 

4. Financial conflict of interest. This 

definition would be new and would 

mean a significant financial interest that 

could directly and significantly affect 

the design, conduct, or reporting of 

PHS-funded research. Although this 

definition would be ‘‘new’’ in the sense 

that it is not listed in the current 

definitions sections (42 CFR 50.603 and 

45 CFR 94.3), the definition is 

consistent with language contained 

elsewhere in the current regulations. 

Specifically, subsection (a)(1) of the 

current 42 CFR 50.605 and 45 CFR 94.5 

provides that a ‘‘conflict of interest 

exists when the designated official(s) 

reasonably determines that a Significant 

Financial Interest could directly and 

significantly affect the design, conduct, 

or reporting of the PHS-funded 

research.’’ We propose to incorporate a 

modified version of this text into a 

freestanding financial conflict of interest 

definition in order to improve the 

clarity and readability of the 

regulations. 

5. Financial interest. This definition 

would be new and would mean 

anything of monetary value or potential 

monetary value. We propose adding this 

new definition as a companion to our 

proposed revision of the ‘‘significant 

financial interest’’ definition, described 

below. In the current regulations, the 

‘‘significant financial interest’’ definition 

incorporates the phrase, ‘‘anything of 

monetary value.’’ In the new definition 

of ‘‘financial interest,’’ we propose 

adding the phrase ‘‘or potential 

monetary value’’ to capture financial 

interests that may not have monetary 

value currently, but could become 

valuable in the future. This proposed 

definition could apply, for example, to 

an ownership interest that an 

Investigator may hold in a small startup company. 

6. Institution. We propose to revise 

the current definition of ‘‘Institution’’ in 

42 CFR 50.603 to refer specifically to an 

Institution that is applying for, or that 

receives, PHS research funding. We 

propose this revision to clarify the 

entities and organizations to which the 

requirements in 42 CFR Part 50, Subpart 

F would apply. We propose 

corresponding changes to the current 

definition of ‘‘Institution’’ in 45 CFR 

94.3 to maintain consistency, where 

feasible, between the text of 42 CFR Part 

50, Subpart F, and 45 CFR Part 94. 

7. Institutional responsibilities. This 

definition would be new and would 

mean an Investigator’s professional 

responsibilities on behalf of the 

Institution including, but not limited to, 

activities such as research, research 

consultation, teaching, professional 

practice, institutional committee 

memberships, and service on panels 

such as Institutional Review Boards or 

Data and Safety Monitoring Boards. We 

propose to add this new definition 

because, as described further below, we 

are proposing to modify the ‘‘significant 

financial interests’’ definition and 

Investigator disclosure obligations such 

that the SFIs being disclosed are those 

that reasonably appear to be related to 

the Investigator’s ‘‘institutional 

responsibilities’’ as defined. 

Under the current regulations, an 

Investigator generally is obligated to 

disclose SFIs on a project-specific basis 

(i.e., interests that would reasonably 

appear to be affected by the research for 

which PHS funding is sought, or in 

entities whose financial interests would 

reasonably appear to be affected by the 

research). We believe that the proposed 

shift to a focus on ‘‘institutional 

responsibilities’’ in the regulations 

would provide Institutions with a better 

understanding of the totality of an 

Investigator’s interests and would result 

in more consistent identification, 

evaluation, and management of any 

identified conflicts. We also believe that 

the revised approach would be 

consistent with the current practices at 

many institutions, which require 

investigators to disclose interests 

annually and/or on an ongoing basis, 

regardless of specific research projects 

that are underway. We welcome public 

comment on the specific elements that 

should (or should not) be included in an 

‘‘institutional responsibilities’’ 

definition. 

8. Investigator. We propose to revise 

the definition of ‘‘Investigator’’ to clarify 

that it means the PD/PI as well as any 

other person, regardless of title or 

position, who is responsible for the 

design, conduct, or reporting of research 

funded by the PHS, or proposed for 

such funding, including persons who 

are subgrantees, contractors, 

collaborators, or consultants (or, in the 

case of PHS contracts, subcontractors, 

collaborators, or consultants). We 

propose these revisions based on our 

observations regarding the current 

regulations and the proper application 

of the ‘‘investigator’’ definition. 

Although we have developed regulatory 

guidance on this issue with regard to 

grants and cooperative agreements (see 

NIH ‘‘Frequently Asked Question’’ A.7 at 

http://grants.nih.gov/grants/policy/ 

coifaq.htm), we believe that further 

clarification in the regulations 

themselves is warranted. 

We have also revised this definition to 

eliminate reference to the Investigator’s 

spouse and dependent children. As 

described further below, we propose to 

include reference to an Investigator’s 

spouse and dependent children in the 

revised ‘‘significant financial interest’’ 

definition. 

9. Manage. This definition would be 

new and would mean to take action to 

address a financial conflict of interest, 

which includes reducing or eliminating 

the financial conflict of interest, to 

ensure that the design, conduct, or 

reporting of research is free from bias or 

the appearance of bias. We propose 

adding this definition as part of a wider 

reconsideration of the concepts of 

managing, reducing, and eliminating a 

FCOI. In the current regulations, these 

concepts are typically listed separately 

(see, e.g., 42 CFR 50.604(g), 45 CFR 

94.4(g)), suggesting that reducing or 

eliminating a FCOI may not be the same 

as managing a FCOI. We believe that it 

would be more appropriate to consider 

the reduction or elimination of a FCOI 

as alternate means of managing a FCOI, 

depending on the circumstances. Thus, 

in a hypothetical example where an 

Institution has concluded that an 

Investigator’s ownership interest in a 

company is a FCOI, the Institution 


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Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Proposed Rules 28691 

could manage the FCOI by requiring the 

Investigator to reduce his or her 

ownership interest by some appropriate 

amount, or to sell the ownership interest 

in its entirety. 

10. PD/PI. This definition would be 

new and would mean a project director 

or principal investigator of a PHSfunded research project. We propose to 

use ‘‘PD/PI’’ in the regulation in 

circumstances in which we may have 

traditionally used the term ‘‘principal 

investigator’’ (e.g., in the proposed 

‘‘investigator’’ definition, as revised). 

11. PHS. We propose to revise the 

definition of ‘‘PHS’’ to include a specific 

reference to the National Institutes of 

Health. NIH is part of the Public Health 

Service and provides a substantial 

amount of research funding to 

Institutions, however, it is not otherwise 

referenced specifically in these 

regulations. We want to clarify for 

Institutions applying for, or receiving, 

research funding from the NIH that they 

are subject to these PHS regulations. 

12. Research. We propose to revise 

the definition of ‘‘research’’ to include a 

non-exclusive list of examples of 

different types of PHS funding 

mechanisms to which the definition 

applies. As revised, the definition 

would include any activity for which 

research funding is available from a PHS 

Awarding Component through a grant, 

cooperative agreement, or contract 

whether authorized under the PHS Act 

or other statutory authority, such as a 

research grant, career development 

award, center grant, individual 

fellowship award, infrastructure award, 

institutional training grant, program 

project, or research resources award. 

13. Significant Financial Interest. We 

propose to revise substantially the 

definition of ‘‘significant financial 

interest’’ (SFI). Under the current 

regulations, a SFI means anything of 

monetary value, including but not 

limited to, salary or other payments for 

services (e.g., consulting fees or 

honoraria); equity interests (e.g., stocks, 

stock options or other ownership 

interests); and intellectual property 

rights (e.g., patents, copyrights and 

royalties from such rights). The term 

does not include: (1) Salary, royalties, or 

other remuneration from the applicant 

institution; (2) any ownership interests 

in the institution, if the institution is an 

applicant under the SBIR or STTR 

programs; (3) income from seminars, 

lectures, or teaching engagements 

sponsored by public or nonprofit 

entities; (4) income from service on 

advisory committees or review panels 

for public or nonprofit entities; (5) an 

equity interest that when aggregated for 

the Investigator and the Investigator’s 

spouse and dependent children meets 

both of the following tests: does not 

exceed $10,000 in value as determined 

through reference to public prices or 

other reasonable measures of fair market 

value, and does not represent more than 

a five percent ownership interest in any 

single entity; or (6) salary, royalties, or 

other payments that when aggregated for 

the investigator and the investigator’s 

spouse and dependent children over the 

next twelve months, are not expected 

(or, in the case of PHS contracts, are not 

reasonably expected) to exceed $10,000. 

We propose to revise the definition of 

‘‘significant financial interest’’ as 

follows, incorporating the proposed 

definitions of ‘‘financial interest’’ and 

‘‘institutional responsibilities’’ described 

above: 

‘‘Significant financial interest means, 

except as otherwise specified in this 

definition: ‘‘(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. For 

purposes of this definition, 

remuneration includes salary and any 

payment for services not otherwise 

identified as salary (e.g., consulting fees, 

honoraria, paid authorship, travel 

reimbursement); equity interest includes 

any stock, stock option, or other 

ownership interest, as determined 

through reference to public prices or 

other reasonable measures of fair market 

value; 

‘‘(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 the Investigator (or the 

Investigator’s spouse or dependent 

children) holds any equity interest (e.g., 

stock, stock option, or other ownership 

interest); or 

‘‘(iii) Intellectual property rights (e.g., 

patents, copyrights), royalties from such 

rights, and agreements to share in 

royalties related to such rights. 

‘‘(2) The term significant financial 

interest does not include the following 

types of financial interests: salary, 

royalties, or other remuneration paid by 

the Institution to the Investigator if the 

Investigator is currently employed or 

otherwise appointed by the Institution; 

any ownership interest in the Institution 

held by the Investigator, if the 

Institution is a commercial or for-profit 

organization; income from seminars, 

lectures, or teaching engagements 

sponsored by a federal, state, or local 

government agency, or an institution of 

higher education as defined at 20 U.S.C. 

1001(a); or income from service on 

advisory committees or review panels 

for a federal, state, or local government 

agency, or an institution of higher 

education as defined at 20 U.S.C. 

1001(a).’’ 

This revised SFI definition would 

differ from the current SFI definition in 

a number of respects. 

Institutional responsibilities: As 

indicated in the discussion of the 

‘‘institutional responsibilities’’ definition 

above, SFIs subject to disclosure by an 

Investigator to an Institution would be 

those that reasonably appear to be 

related to the Investigator’s 

‘‘institutional responsibilities’’ and 

would not be specific to a particular 

PHS-funded research project. As a 

result, when read in conjunction with 

the revised Investigator disclosure 

requirements under 42 CFR 50.604 and 

45 CFR 94.4 (discussed below), we 

anticipate that the revised SFI definition 

would result in the disclosure by 

Investigators to Institutions of a wider 

array of interests on a more frequent 

basis. This proposed approach is 

consistent with many of the comments 

we received in response to the ANPRM, 

which supported expansion of the SFIs 

that should be disclosed by Investigators 

to Institutions. 

Monetary threshold: The revised SFI 

definition also would lower—and, in 

some circumstances, eliminate—the 

existing monetary thresholds for 

disclosure. Under the current 

regulations, a SFI does not include an 

equity interest that when aggregated for 

the investigator and the investigator’s 

spouse and dependent children, meets 

both of the following tests: Does not 

exceed $10,000 in value, and does not 

represent more than a five percent 

ownership interest in any single entity. 

Similarly, a SFI does not include 

payments (e.g., salary) that when 

aggregated for the Investigator and the 

Investigator’s spouse and dependent 

children over the next twelve months 

are not expected to exceed $10,000. The 

revised definition would differentiate 

between remuneration to the 

Investigator (and the Investigator’s 

spouse and dependent children) from a 

publicly traded entity and remuneration 

from a non-publicly traded entity. With 

regard to a publicly traded entity, a 


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11 Dana Katz, Arthur L. Caplan, and Jon F. Merz, 

‘‘All Gifts Large and Small,’’ Am. J. of Bioethics, 

summer 2003, vol. 3, no. 3, at 39, 39. 

monetary threshold of $5,000 would 

apply to the aggregated value of any 

remuneration received from the entity 

in the twelve months preceding 

disclosure and the value of any equity 

interest as of the date of disclosure. 

With regard to a non-publicly traded 

entity, a monetary threshold of $5,000 

would apply to any remuneration 

received from the entity in the twelve 

months preceding disclosure; in 

addition, however, a SFI would exist 

with regard to any equity interest in the 

entity, regardless of value. 

In a hypothetical example, the 

proposed changes to the monetary 

threshold would operate as follows. 

Assume an Institution has required an 

Investigator, who conducts biomedical 

research at the Institution, to complete 

a form disclosing her SFIs. Among the 

Investigator’s financial interests are the 

following: $3,000 in consulting fees that 

she has received in the past twelve 

months from Pharmaceutical Company 

A; stock in Pharmaceutical Company A 

held by her husband worth $2,500 as of 

the date of disclosure; and stock options 

she holds in Start-Up Company B, a 

private biotechnology firm whose only 

products are in the early research and 

development stage. Assuming that these 

financial interests reasonably appear to 

be related to the Investigator’s 

institutional responsibilities, the 

Investigator would be required to 

disclose them as SFIs. A SFI in 

Pharmaceutical Company A would exist 

because the aggregated value of her 

remuneration for the past twelve 

months and her husband’s equity 

interest in the company exceeds $5,000 

($3,000 + $2,500 = $5,500). A SFI in 

Start-up Company B would exist 

because the Investigator would have an 

obligation to disclose any ownership 

interest in a non-publicly traded entity, 

even if the interest has only potential 

monetary value as of the time of 

disclosure. 

We recognize that lowering the 

monetary threshold, as proposed, is not 

without cost. In particular, while we 

believe that certain elements of the 

revised ‘‘significant financial interest’’ 

definition would make the disclosure 

and review obligations of Investigators 

and Institutions more efficient, we 

recognize that incorporating a lower 

monetary threshold is likely to lead to 

increased administrative burden on 

Investigators and Institutions because 

more financial interests are likely to be 

subject to disclosure and review. For 

this reason, we considered a variety of 

alternatives for the proposed regulations 

including a threshold that would be 

approximate to the current standard 

(i.e., $10,000), a significantly lower 

threshold for all types of financial 

interests (e.g., $100), as well the current 

proposal. 

We declined to propose a threshold 

equivalent to the current standard 

because we do not believe that this 

approach would be consistent with our 

statutory mandate to revise the 

regulations for the purpose of 

‘‘strengthening Federal and institutional 

oversight and identifying 

enhancements, including requirements 

for financial disclosure to institutions 

* * *.’’ Public Law 111–117, Div. D, Tit. 

II, sec. 219, 123 Stat. 3034 (2009). In 

addition, when we raised this question 

in the ANPRM, a majority of 

respondents who addressed this 

question favored lowering the monetary 

disclosure threshold. These responses 

were consistent with our own sense that 

Institutions would welcome greater 

transparency regarding Investigator 

financial interests because additional 

information would help them to better 

manage identified FCOI. Thus, for 

example, even if an Investigator’s 

disclosed SFIs falling below the current 

monetary threshold would not 

themselves result in new FCOI 

determinations, the information could 

provide context for the Institution’s 

management of higher value SFIs that 

the Institution determines are FCOI. 

Given the arguments in favor of 

lowering the monetary threshold, we 

analyzed whether a significantly lower 

threshold (e.g., $100) would be 

appropriate for all types of financial 

interests. Although there has been 

limited study on the effect of the exact 

monetary value of an Investigator’s 

financial interests on the integrity of his 

or her research, the authors of at least 

one journal article note, ‘‘a large body of 

evidence from the social sciences shows 

that behavior can be influenced by gifts 

of negligible value.’’ 11 In addition, 

recent legislative initiatives have 

incorporated low monetary thresholds 

in comparable circumstances. For 

example, the disclosure provisions that 

apply to applicable manufacturers of 

drugs and other covered items with 

regard to transfers of value to physicians 

and teaching hospitals under title VI, 

section 6002, of the recently enacted 

Patient Protection and Affordable Care 

Act, Public Law 111–148, generally 

apply to transfers of value of $10 or 

more. 

Notwithstanding these arguments for 

a significantly lower monetary 

threshold, we are concerned that the 

administrative costs associated with 

disclosure and review of all but 

negligible financial interests would 

outweigh the intended benefit of these 

regulations in promoting objectivity in 

research. For example, given the 

existing (and proposed) obligation on 

Investigators to update SFI disclosures 

during the period of award, we believe 

it would be a challenge for Investigators 

and Institutions alike to comply with 

this provision every time a new, all-butnegligible financial interest was 

obtained by the Investigator. 

We welcome comment on all aspects 

of the proposed ‘‘significant financial 

interest’’ definition, including comments 

regarding the appropriate balance 

between the costs that may be 

associated with expanding the number 

of financial interests subject to 

disclosure as a result of a lower 

monetary threshold versus the potential 

benefits that might be expected to result 

from the lower threshold. 

Timing: As indicated in the example 

above, the revised SFI definition would 

also change the timing for determining 

whether remuneration represents a SFI. 

The current regulations exclude 

aggregated payments (including salary 

and royalties) that are ‘‘not expected to 

exceed’’ (or, in the case of PHS 

contracts, are ‘‘not reasonably expected 

to exceed’’) the monetary threshold 

‘‘over the next twelve months.’’ Under 

the revised definition, at issue is 

remuneration (including salary and any 

payment for services not otherwise 

identified as salary) received from an 

entity ‘‘in the twelve months preceding 

the disclosure.’’ We believe this change 

would help Institutions and 

Investigators to determine more 

accurately whether or not a financial 

interest represents a SFI because the 

payments have already occurred and are 

likely to have been documented. 

Moreover, to the extent an Investigator 

receives additional remuneration from 

an entity after completing an initial SFI 

disclosure, such remuneration would be 

subject to the Investigator’s ongoing 

disclosure obligations assuming the 

relevant monetary threshold were 

exceeded. This issue is addressed 

further in the discussion of 42 CFR 

50.604, 45 CFR 94.4 below. 

Examples of payment for services: 

The current definition references as 

examples of payments for services, 

receipt of consulting fees, or honoraria. 

We propose to add ‘‘paid authorship’’ 

and ‘‘travel reimbursement’’ as 

additional examples in the revised 

definition. With regard to ‘‘paid 

authorship,’’ in particular, although 

there should be little question that 

receipt of payment from an entity in 

exchange for the drafting of a 


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publication constitutes payment for 

services, we believe it is important to 

reference this form of payment 

specifically in the regulations. This 

practice has come under increasing 

scrutiny in recent years and we wish to 

make it clear to Institutions and 

Investigators that such activity may be 

subject to the disclosure and reporting 

requirements depending on the 

circumstances of a given case, such as 

the amount of payment. 

Royalties & Intellectual Property: 

Under the existing regulation, royalties 

are included among the ‘‘payments’’ 

subject to the $10,000 threshold. Under 

the proposed regulations, the $5,000 

threshold would apply to equity 

interests and ‘‘payment for services,’’ 

which would include salary but not 

royalties. Royalties nevertheless would 

be potentially subject to disclosure, as 

would other interests related to 

intellectual property. Specifically, the 

revised definition would potentially 

apply to any of the following: 

Intellectual property rights (e.g., patents, 

copyrights), royalties from such rights, 

and agreements to share in royalties 

related to intellectual property rights. 

As discussed further below, however, 

royalties received by the Investigator 

from the Institution would still be 

excluded from the SFI definition if the 

Investigator is currently employed or 

otherwise appointed by the Institution. 

Exclusions: We propose to modify the 

types of interests that are specifically 

excluded from the SFI definition. For 

example, the revised definition would 

only exclude income from seminars, 

lectures, teaching engagements, if 

sponsored by a federal, state, or local 

government agency, or an institution of 

higher education as defined at 20 U.S.C. 

1001(a). Similarly, income from service 

on advisory committees or review 

panels would only be excluded if from 

a federal, state, or local government 

agency, or an institution of higher 

education as defined at 20 U.S.C. 

1001(a). Thus, income from non-profit 

entities other than institutions of higher 

education for the types of activities 

described above would be subject to the 

SFI definition. We are proposing this 

change due to the growth of non-profit 

entities that sponsor such activities 

since the current regulations were 

promulgated in 1995. Some of these 

non-profit entities receive funding from 

for-profit entities that may have an 

interest in the outcome of the 

Investigators’ research (e.g., foundations 

supported by pharmaceutical companies 

or other industrial sectors). As a result, 

we believe it would promote objectivity 

in biomedical and behavioral research if 

income in excess of the relevant 

monetary threshold received from such 

non-profit entities for teaching and 

advisory committee-related activities 

were included within the SFI definition 

and disclosed by Investigators to 

Institutions for their review. Under the 

current 1995 exclusions to the SFI 

definition, income from such entities for 

the above-described activities would not 

be disclosed. 

In developing the proposed 

exclusions to the SFI definition, we 

considered various alternatives, 

including whether the exclusions 

described above should be limited 

solely to income from federal, state, or 

local government agencies (i.e., income 

from institutions of higher education for 

such activities would be covered by the 

SFI definition). However, given that 

many academic Investigators engage in 

seminars, lectures, teaching 

engagements, as well as service on 

advisory committees or review panels at 

academic Institutions other than those 

at which they are employed, we 

concluded that the burden of requiring 

disclosure of the income from these 

activities outweighed the potential 

benefit to be gained from such 

disclosures. 

With regard to the current exclusion 

for any ownership interests in the 

institution if the institution is an 

applicant under the SBIR or STTR 

programs, we propose to broaden this 

exclusion to include any ownership 

interest in the Institution held by the 

Investigator if the Institution is a 

commercial or for-profit organization 

(whether or not an SBIR/STTR 

applicant). This proposed change is 

based primarily on the recognition that 

ownership in one’s own company not 

only is generally an inherent and 

understood financial interest, but also is 

an interest that the Institution is already 

in a position to know without having to 

request an Investigator to include it in 

a disclosure of SFIs. 

For similar reasons, we do not 

propose to make substantive changes to 

the current exclusion for salary, 

royalties, or other remuneration paid by 

the Institution to the Investigator, other 

than to limit the exception to 

circumstances in which the Investigator 

is currently employed or otherwise 

appointed by the Institution. With 

regard to current employees and 

appointees, we believe not only that 

these financial interests are inherent 

and understood, but also that an 

Institution is in a position to know this 

information without having to request 

Investigators to include it in a 

disclosure of SFIs. However, other 

Investigators (e.g., subrecipient 

Investigators) may be involved with a 

PHS-funded research project who were 

previously affiliated with an Institution 

(e.g., former employees) but who still 

receive remuneration from the 

Institution (e.g., royalty payments). 

Although an Institution presumably 

maintains information regarding 

payments to all third parties, it may not 

be obvious to institutional officials 

reviewing a SFI disclosure from a 

subrecipient Investigator under these 

circumstances that recent payments 

have been made to the subrecipient 

Investigator. By limiting the exclusion 

to Investigators who are currently 

employed or otherwise appointed by the 

Institution, as proposed, an Institution 

could avoid having to investigate, as a 

matter of course, possible Institution 

payments to every subrecipient 

Investigator participating in a PHSfunded research project. 

We welcome comment on the 

proposed exclusions to the SFI 

definition, including, for example, 

whether the proposed exclusion for 

income from teaching and advisory 

committee-related activities should be 

expanded to apply to all public or nonprofit entities (similar to the current 

regulations) or to specific categories of 

public or non-profit entities, or further 

narrowed to apply solely to federal, 

state, or local government agencies. We 

are particularly interested in comments 

about the balance between the 

cumulative burden of the inclusion of 

non-profits (or certain categories of nonprofits) in conjunction with defining 

SFIs to include institutional 

responsibilities and the potential benefit 

to be gained from such disclosures. 

14. Small Business Innovation 

Research (SBIR) Program. We propose 

to remove the current definition for the 

SBIR Program. In light of the proposed 

removal of reference to the SBIR 

program from the ‘‘Applicability’’ 

section and the ‘‘significant financial 

interests’’ definition, discussed above, 

the SBIR definition would no longer be 

necessary in the revised regulations, as 

proposed. 

Responsibilities of Institutions 

Regarding Investigator Financial 

Conflicts of Interest (42 CFR 50.604, 45 

CFR 94.4) 

We propose to revise substantially the 

regulation addressing the 

responsibilities of Institutions regarding 

Investigator FCOI. 

Subsection (a) of the current 

regulation provides, in part, that each 

Institution must maintain an 

appropriate written, enforced policy on 

conflict of interest that complies with 

the regulations. We propose to revise 

this provision to require an Institution 


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not only to maintain an up-to-date, 

written, enforced policy on FCOI that 

complies with the regulations, but also 

to make such policy available via a 

publicly accessible Web site. We believe 

these revisions would foster greater 

transparency and accountability with 

regard to institutional policies. The 

revised provision would also clarify that 

if an Institution’s policy on FCOI 

includes standards that are more 

stringent than the regulations, the 

Institution shall adhere to its policy and 

shall provide FCOI reports regarding 

identified FCOI to the PHS Awarding 

Component in accordance with the 

Institution’s own standards. Although 

we have developed regulatory guidance 

on this issue with regard to grants and 

cooperative agreements (see NIH 

‘‘Frequently Asked Question’’ B.4 at 

http://grants.nih.gov/grants/policy/ 

coifaq.htm), we believe that further 

clarification in the regulation itself is 

warranted. 

The current subsection (a) also 

requires, in part, that each Institution 

must inform each Investigator of its 

policy on conflict of interest, the 

Investigator’s disclosure 

responsibilities, and of these 

regulations. We propose to address this 

requirement as a new subsection (b), 

and to add to this new subsection an 

Investigator training requirement. 

Specifically, we propose that 

Institutions shall require Investigators to 

complete training regarding the 

Institution’s FCOI policy, the 

Investigator’s responsibilities regarding 

disclosure of FCOI, and the regulations, 

prior to engaging in PHS-funded 

research and, thereafter, at least once 

every two years. This proposal is 

consistent with the comments of a 

majority of the respondents to the 

ANPRM, who supported adding an 

Investigator FCOI training requirement. 

The current subsection (a) also states 

that if the Institution carries out the 

PHS-funded research through 

subgrantees, contractors, or 

collaborators (or, in the case of PHS 

contracts, subcontractors or 

collaborators), the Institution must take 

reasonable steps to ensure that 

Investigators working for such entities 

comply with the regulations, either by 

requiring those Investigators to comply 

with the Institution’s policy or by 

requiring the entities to provide 

assurances to the Institution that will 

enable the Institution to comply with 

the regulations. We propose to create a 

new subsection (c) that would provide 

a substantially expanded clarification of 

an Institution’s obligations with regard 

to PHS-funded research carried out 

through a subrecipient (e.g., subgrantee, 

contractor, or collaborator or, in the case 

of a PHS contract, a subcontractor or 

collaborator). In the ANPRM, we 

included a question that asked whether 

specific requirements related to FCOI 

identification, management, and 

reporting should be established for 

subrecipients. This question was based, 

at least in part, on the concern that 

awardee and subrecipient Institutions 

may not fully recognize their 

responsibilities related to the 

regulations. Many ANPRM respondents 

stated that they comply with the current 

version of subsection (a) by requiring a 

subrecipient to certify to the awardee 

Institution that its FCOI policy complies 

with the applicable Federal regulations 

and, in those cases when a subrecipient 

cannot provide a certification, requiring 

the subrecipient to comply with the 

awardee Institution’s policy. We believe 

that this type of approach provides a 

useful means of reinforcing compliance 

with the regulations. 

Therefore, we propose to include as 

part of the new subsection (c) the 

following requirements: An Institution 

that carries out the PHS-funded research 

through a subrecipient must incorporate 

as part of a written agreement with the 

subrecipient legally enforceable terms 

that establish whether the FCOI policy 

of the awardee Institution or that of the 

subrecipient applies to the 

subrecipient’s Investigators. If the 

subrecipient’s FCOI policy applies to 

subrecipient Investigators, the 

subrecipient shall certify as part of the 

agreement that its policy complies with 

the regulations. If the subrecipient 

cannot provide such certification, the 

agreement shall state that subrecipient 

Investigators are subject to the FCOI 

policy of the awardee Institution. If the 

subrecipient’s FCOI policy applies to 

subrecipient Investigators, the 

agreement shall specify time period(s) 

for the subrecipient to report all 

identified FCOI to the awardee 

Institution. Such time period(s) shall be 

sufficient to enable the awardee 

Institution to provide timely FCOI 

reports, as necessary, to the PHS. If 

subrecipient Investigators are subject to 

the awardee Institution’s FCOI policy, 

the agreement shall specify time 

period(s) for the subrecipient to submit 

all Investigator disclosures of SFIs to the 

awardee Institution. Such time period(s) 

shall be sufficient to enable the awardee 

Institution to comply timely with its 

review, management, and reporting 

obligations under the regulations. 

Subsection (c) would also require that 

the Institution must provide FCOI 

reports to the PHS regarding all FCOI of 

all subrecipient Investigators consistent 

with the regulations. We believe that the 

addition of the above text in the new 

subsection (c) would help clarify for 

Institutions and their subrecipients the 

requirements of both parties in these 

relationships and promote greater 

compliance with the regulations. 

Subsection (b) of the current 

regulation requires that an Institution 

must designate an institutional 

official(s) to solicit and review financial 

disclosure statements from each 

Investigator who is planning to 

participate in PHS-funded research. In 

the ANPRM, we asked whether large 

Institutions (defined as greater than 50 

employees) should be required to 

establish an independent committee to 

review financial disclosures, and 

require that committee to report to an 

organizational level within the 

Institution that is not conflicted by the 

short-term financial interests of the 

Investigator or Institution. After 

considering the responses, we weighed 

the complexity of the issues that can 

arise in reviewing financial interests 

and evaluating conflicts, as well as the 

potential practical difficulty in 

determining which Institutions would 

fall within a ‘‘large’’ Institution 

definition and which would not. As a 

result, we do not propose to change the 

redesignated subsection (d). That being 

said, however, we strongly encourage 

each Institution to form a committee of 

adequate size and scope to review 

Investigator SFI disclosures and assess 

comprehensively the potential conflicts 

that may arise in the Institution. In 

addition, since reviewing Investigator 

financial disclosures for potential FCOI 

can involve many complex issues, we 

recommend that Institutions consult 

available resources from the Federal 

government (e.g., NIH materials posted 

at http://grants.nih.gov/grants/policy/ 

coi/) or other public resources (e.g., 

materials prepared by academic and 

professional associations or other 

scientific organizations). 

The current subsection (c) requires 

that by the time an application is 

submitted to the PHS, each Investigator 

who is planning to participate in the 

PHS-funded research has submitted to 

the designated official(s) a listing of his/ 

her known SFIs (and those of his/her 

spouse and dependent children): (i) 

That would reasonably appear to be 

affected by the research for which PHS 

funding is sought; and (ii) in entities 

whose financial interests would 

reasonably appear to be affected by the 

research. All financial disclosures must 

be updated during the period of award, 

either on an annual basis or as new 

reportable SFIs are obtained. In the 

ANPRM, we asked whether this 


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requirement should be expanded to 

require disclosure by Investigators of all 

SFIs that are related to their 

institutional responsibilities. Many 

respondents to the ANPRM were in 

favor of expanding the SFIs that should 

be disclosed by the Investigator. As 

indicated in the above discussion of the 

‘‘significant financial interest’’ 

definition, the proposed revision would 

capture as part of the definition itself 

the concept that a ‘‘significant financial 

interest’’ is one that reasonably appears 

to be related to the Investigator’s 

‘‘institutional responsibilities.’’ 

Accordingly, we propose to revise the 

current subsection (c) language as part 

of a redesignated subsection (e) with the 

understanding that the scope of 

Investigator disclosures would no longer 

be project specific, but would 

(consistent with the revised SFI 

definition) pertain to the Investigator’s 

institutional responsibilities. As part of 

the new subsection (e), we are also 

proposing to revise and clarify an 

Investigator’s annual and ongoing ad 

hoc disclosure obligations. 

Specifically, in addition to requiring 

that each Investigator who is planning 

to participate in the PHS-funded 

research disclose to the Institution’s 

designated officials the Investigator’s 

SFIs (and those of the Investigator’s 

spouse and dependent children), the 

Institution also would have to require 

that each Investigator who is 

participating in the PHS-funded 

research submit an updated SFI 

disclosure: (1) At least annually during 

the period of the award, including 

disclosure of any information that was 

not disclosed initially to the Institution 

or in a subsequent SFI disclosure, and 

disclosure of updated information 

regarding any previously-disclosed SFI 

(e.g., the updated value of a previouslydisclosed equity interest); and (2) within 

thirty days of acquiring a new SFI (e.g., 

through purchase, marriage, or 

inheritance). Although the current 

regulations include a requirement 

regarding the updating of financial 

disclosures (see current subsection 

(c)(2)), we believe that the revisions 

proposed above will provide 

Institutions and Investigators with 

greater specificity as to the timing of 

disclosures that are required after an 

Investigator’s initial SFI disclosure to 

the Institution. 

The existing subsection (d) requires 

an Institution to provide guidelines 

consistent with the regulations for the 

designated official(s) to identify 

conflicting interests and take such 

actions as necessary to ensure that such 

conflicting interests will be managed, 

reduced, or eliminated. We propose to 

reorganize and expand this requirement 

in a redesignated subsection (f) to clarify 

an Institution’s obligations. First, the 

guidelines to be provided by an 

Institution for the designated 

institutional officials would be required 

to address two related tasks, 

specifically, determination of whether 

an Investigator’s SFI is related to PHSfunded research and, if so related, 

whether the SFI is a FCOI. Under the 

current regulations, the Investigator 

bears the responsibility for determining 

the relatedness of a SFI to the PHSfunded research as part of the disclosure 

process (42 CFR 50.604(c), 45 CFR 

94.4(c)). As discussed above, however, 

the proposed regulations would revise 

the definition of ‘‘significant financial 

interest’’ to address ‘‘institutional 

responsibilities’’ and, as a result, SFIs 

subject to disclosure by an Investigator 

to an Institution would not be specific 

to a particular PHS-funded research 

project. Consistent with these proposed 

changes, the responsibility for 

determining whether an Investigator’s 

SFI is related to PHS-funded research 

would shift to the Institution. This 

subsection would provide that an 

Investigator’s SFI is related to PHSfunded research when the Institution, 

through its designated officials, 

reasonably determines that the SFI: (1) 

Appears to be affected by the PHSfunded research; or (2) is in an entity 

whose financial interest appears to be 

affected by the research. 

To provide clarification regarding the 

determination of whether an 

Investigator’s SFI is a FCOI, the 

redesignated subsection (f) would 

incorporate modified language moved 

from subsection (a)(1) of the current 42 

CFR 50.605 and 45 CFR 94.5. 

Specifically, this subsection would 

provide that a FCOI exists when the 

Institution, through its designated 

officials, reasonably determines that the 

SFI could directly and significantly 

affect the design, conduct, or reporting 

of the PHS-funded research. As 

discussed above, the proposed 

regulations would also incorporate a 

definition of ‘‘financial conflict of 

interest’’ that is similarly based on this 

language. 

With regard to the current 

requirement in subsection (d) regarding 

FCOI management responsibilities, we 

propose to include this requirement in 

a separate subsection (g) and clarify that 

the requirement includes management 

of any financial conflicts of a 

subrecipient Investigator pursuant to the 

new subsection (c), described above. We 

also propose to cross-reference the 

Institution’s revised management 

responsibilities that we propose in 42 

CFR 50.605(a), 45 CFR 94.5(a), 

including development and 

implementation of a management plan 

and, if necessary, a mitigation plan. 

Additional discussion of these proposed 

revisions is addressed below. As a 

related matter, we propose to include a 

new subsection (h) that cross-references 

the Institution’s revised and expanded 

reporting requirements in the proposed 

new subsection 42 CFR 50.605(b), 45 

CFR 94.5(b). 

Subsection (e) of 42 CFR 50.604 

currently requires an Institution to 

maintain records of all financial 

disclosures and all actions taken by the 

Institution with respect to each 

conflicting interest for at least three 

years from the date of submission of the 

final expenditures report or, where 

applicable, from other dates specified in 

45 CFR 74.53(b) for different situations. 

Correspondingly, subsection (e) of 45 

CFR 94.4 currently requires an 

Institution to maintain records of all 

financial disclosures and all actions 

taken by the Institution with respect to 

each conflicting interest for three years 

after final payment or, where applicable, 

for the other time periods specified in 

48 CFR part 4, subpart 4.7. We propose 

to revise this requirement in a 

redesignated subsection (i) of both 42 

CFR 50.604 and 45 CFR 94.4 to include 

a responsibility to maintain records 

relating to all Investigator disclosures of 

financial interests and the Institution’s 

review of, or response to, such 

disclosures (whether or not a disclosure 

resulted in the Institution’s 

determination of a FCOI). We believe 

that this proposed revision would help 

clarify for Institutions our intent for the 

record retention obligation to apply not 

only in cases in which the Institution 

has identified a FCOI, but to all 

Investigator SFI disclosures whether or 

not such disclosure generated a 

response by the Institution. 

The existing regulations require at 

subsection (f) that Institutions establish 

adequate enforcement mechanisms and 

provide for sanctions where 

appropriate. We propose to revise this 

obligation in a redesignated subsection 

(j) to require an Institution to establish 

not only adequate enforcement 

mechanisms and provide for employee 

sanctions, but also to provide for other 

administrative actions to ensure 

Investigator compliance as appropriate. 

We propose to revise and, in some 

respects, shorten the certification 

requirement currently set forth in 

subsection (g). In a redesignated 

subsection (k), the revised requirement 

would require an Institution to certify 

that the Institution (1) has in effect at 

that Institution an up-to-date, written, 


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and enforced administrative process to 

identify and manage FCOI with respect 

to all research projects for which 

funding is sought or received from the 

PHS; (2) shall promote and enforce 

Investigator compliance with the 

regulations’ requirements including 

those pertaining to disclosure of SFIs; 

(3) shall manage FCOI and provide 

initial and ongoing FCOI reports to the 

PHS consistent with the regulations; 

(4) agrees to make information available, 

promptly upon request, to the HHS 

relating to any Investigator disclosure of 

financial interests and the Institution’s 

review of, or response to, such 

disclosure, whether or not the 

disclosure resulted in the Institution’s 

determination of a FCOI; and (5) shall 

fully comply with the requirements of 

the regulations. Notably, this revised 

subsection would eliminate much of the 

current certification language regarding 

an Institution’s reporting obligations. In 

the existing regulations, the certification 

requirement in subsection (g) essentially 

provides the primary source of an 

Institution’s reporting responsibilities 

regarding FCOI. As described further 

below, we propose a substantial revision 

and expansion of the reporting 

requirements and, thus, propose to 

move the discussion of such 

requirements to a newly revised 

subsection 42 CFR 50.605(b), 45 CFR 

94.5(b). 

Management and Reporting of Financial 

Conflicts of Interest (42 CFR 50.605, 45 

CFR 94.5) 

We propose to revise and expand 

substantially the current regulation 

regarding management of FCOI to 

address requirements for both 

management and reporting of FCOI. 

The existing regulations require, at 

subsection (a), that an Institution’s 

designated official(s) review all 

financial disclosures and determine 

whether a conflict of interest exists. If 

so, the official(s) must determine what 

actions should be taken by the 

institution to manage, reduce or 

eliminate such conflict of interest. 

Under the existing regulation, a conflict 

of interest exists when the designated 

official(s) reasonably determines that a 

SFI could directly and significantly 

affect the design, conduct, or reporting 

of the PHS-funded research. Subsection 

(a) also provides examples of conditions 

or restrictions that might be imposed to 

manage conflicts of interest, 

specifically, public disclosure of SFIs, 

monitoring of research by independent 

reviewers, modification of the research 

plan, disqualification from participation 

in all or a portion of the research funded 

by the PHS, divestiture of SFIs, or 

severance of relationships that create 

actual or potential conflicts. 

We propose to revise the above 

language as part of a redesignated 

subsection (a)(1) to require that, prior to 

the Institution’s expenditure of any 

funds under a PHS-funded research 

project, the designated officials of an 

Institution shall, consistent with 

subsection (f) of the preceding section 

(42 CFR 50.604 or 45 CFR 94.4): Review 

all Investigator disclosures of SFIs; 

determine whether any SFIs relate to 

PHS-funded research; determine 

whether a FCOI exists; and, if so, 

develop and implement a management 

plan that shall specify the actions that 

have been, and shall be, taken to 

manage such FCOI. The most significant 

change in the above proposed text is the 

introduction of a management plan 

requirement. Although the existing 

regulations require Institutions to 

manage FCOI, the term ‘‘management 

plan’’ is not used. While many 

Institutions currently may develop and 

implement management plans as a 

means of fulfilling their FCOI 

management responsibilities, we believe 

that explicitly incorporating this 

requirement into the regulations would 

further help to prevent the introduction 

of bias into PHS-funded research across 

the research community. We have not 

proposed to specify comprehensively in 

this subsection what elements must be 

included in a management plan, 

however, as indicated in the discussion 

of subsection (b) below, the expanded 

reporting requirements that we propose 

would include an obligation to report a 

description of certain ‘‘key elements’’ of 

the Institution’s management plan in 

certain FCOI reports. Another change in 

this subsection would be the deletion of 

the current sentence that describes 

when a financial conflict of interest 

exists. As discussed above, a modified 

version of this sentence would be 

moved to the redesignated subsection (f) 

of 42 CFR 50.604 and 45 CFR 94.4, as 

well as incorporated into a definition of 

‘‘financial conflict of interest’’ in 42 CFR 

50.603 and 45 CFR 94.3. 

The revised subsection (a)(1) would 

also include the following updated and 

expanded list of examples of conditions 

or restrictions that might be imposed to 

manage a FCOI: Public disclosure of 

FCOI (e.g., when presenting or 

publishing the research); for research 

projects involving human subjects 

research, disclosure of FCOI directly to 

participants; appointment of an 

independent monitor capable of taking 

measures to protect the design, conduct, 

and reporting of the research against 

bias, or the appearance of bias, resulting 

from the FCOI; modification of the 

research plan; change of personnel or 

personnel responsibilities, or 

disqualification of personnel from 

participation in all or a portion of the 

research; reduction or elimination of a 

financial interest (e.g., sale of an equity 

interest); or severance of relationships 

that create actual or potential financial 

conflicts. Among the differences from 

the current text would be the addition 

of a specific example in the human 

subjects research context. The ANPRM 

posed a number of questions related to 

the issue of whether the regulations 

should be amended to require specific 

approaches to management of FCOI 

related to certain types of research or 

alternatively, specific types of financial 

interests or FCOI. After considering the 

comments, we agree with the majority of 

the respondents that this approach 

would not account for the full range of 

research projects as well as the large 

contextual variation in circumstances in 

which FCOI may arise. As a result, the 

proposed revised regulations would 

impose uniform FCOI management 

responsibilities, regardless of the type of 

research, financial interest, or identified 

FCOI at issue. 

In addition to revising the current 

regulation as described above, we also 

propose to introduce two new 

subsections that clarify an Institution’s 

obligations in situations in which an 

Institution becomes aware of a SFI after 

the PHS-funded research is already 

underway. Specifically, new subsection 

(a)(2) would require that whenever, in 

the course of an ongoing PHS-funded 

research project, a new Investigator 

participating in the research project 

discloses a SFI or an existing 

Investigator discloses a new SFI to the 

Institution, the designated officials of 

the Institution shall, within sixty days: 

Review the SFI disclosure; determine 

whether it is related to PHS-funded 

research; determine whether a FCOI 

exists; and, if so, implement, on at least 

an interim basis, a management plan 

that shall specify the actions that have 

been, and will be, taken to manage the 

FCOI. This subsection would 

additionally provide that, depending on 

the nature of the SFI, an Institution may 

determine that additional interim 

measures are necessary with regard to 

the Investigator’s participation in the 

PHS-funded research project between 

the date of disclosure and the 

completion of the Institution’s review. 

A new subsection (a)(3) would 

provide that whenever an Institution 

identifies a SFI that was not disclosed 

timely by an Investigator or, for 

whatever reason, was not previously 

reviewed by the Institution during an 

ongoing PHS-funded research project 


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(e.g., was not timely reviewed or 

reported by a subrecipient), the 

designated officials shall, within sixty 

days: Review the SFI; determine 

whether it is related to PHS-funded 

research; determine whether a FCOI 

exists; and, if so: (A) Implement, on at 

least an interim basis, a management 

plan that shall specify the actions that 

have been, and will be, taken to manage 

such FCOI going forward; and (B) 

implement, on at least an interim basis, 

a mitigation plan which shall include 

review and determination as to whether 

any PHS-funded research, or portion 

thereof, conducted prior to the 

identification and management of the 

FCOI was biased in the design, conduct, 

or reporting of such research. This 

subsection would additionally provide 

that, depending on the nature of the SFI, 

an Institution may determine that 

additional interim measures are 

necessary with regard to the 

Investigator’s participation in the PHSfunded research project between the 

date that the SFI is identified and the 

completion of the Institution’s review. 

Our interest in proposing new 

subsections (a)(2) and (a)(3) is based, at 

least in part, on our experience working 

with awardee Institutions and our 

general impression that some 

Institutions may be more diligent about 

addressing potential FCOI at the onset 

of a PHS-funded research project than 

after the work is already underway. We 

also believe it is important to address in 

the regulations circumstances in which 

an Institution, for whatever reason, has 

not timely reviewed a SFI, particularly 

when such SFI is later determined to be 

a FCOI. In such circumstances, it is of 

course important for an Institution to 

manage the FCOI going forward, 

however, there is also a critical need to 

review and determine whether any bias 

was introduced into the research during 

the period of time prior to review and 

management of the FCOI. We have 

proposed to address this need in 

subsection (a)(3) by introduction of a 

‘‘mitigation plan’’ requirement. We have 

not proposed the specific elements of a 

mitigation plan because we believe 

different circumstances may necessitate 

different measures. In some instances, 

for example, it may be sufficient to 

review a matter internally within a 

given research department, while in 

other instances it may be appropriate to 

have individuals outside the department 

or outside the Institution review and 

determine whether the design, conduct, 

or reporting of the research in question 

was biased by a belatedly-identified or 

belatedly-reviewed FCOI. 

New subsection (a)(4) would require 

that whenever an Institution 

implements a management plan 

pursuant to the regulations, the 

Institution must monitor Investigator 

compliance with the management plan 

on an ongoing basis until the 

completion of the PHS-funded research 

project. This subsection would dovetail 

with the new subsections (a)(2) and 

(a)(3), described above, by ensuring that 

the management actions taken by an 

Institution at the time a FCOI is 

identified continue to be followed by 

the Investigator(s) involved going 

forward through the duration of the 

project. 

We propose to introduce at subsection 

(a)(5) an important and significant new 

requirement to help the biomedical and 

behavioral research community monitor 

the integrity and credibility of PHSfunded research and underscore our 

commitment to fostering transparency, 

accountability, and public trust. 

Specifically, we are proposing to amend 

the regulations to require that, prior to 

the Institution’s expenditure of any 

funds under a PHS-funded research 

project, the Institution shall make 

available via a publicly accessible Web 

site information concerning any SFI that 

meets the following three criteria: (A) 

The SFI was disclosed and is still held 

by the PD/PI or any other Investigator 

who has been identified by the 

Institution as senior/key personnel for 

the PHS-funded research project in the 

grant application, contract proposal, 

contract, progress report, or other 

required report submitted to the PHS; 

(B) the Institution determines that the 

SFI is related to the PHS-funded 

research; and (C) the Institution 

determines that the SFI is a FCOI. 

As part of this new subsection, we 

would require that the information 

posted include, at a minimum, the 

following: The Investigator’s name; the 

Investigator’s position with respect to 

the research project; the nature of the 

SFI; and the approximate dollar value of 

the SFI (dollar ranges would be 

permissible; less than $20,000; less than 

$50,000; less than $100,000; less than or 

equal to $250,000; greater than 

$250,000), or a statement that the 

interest is one whose value cannot be 

readily determined through reference to 

public prices or other reasonable 

measures of fair market value. We 

propose to require the Institution to 

update the posted information at least 

annually. We would also require the 

Institution to update the Web site 

within sixty days of the Institution’s 

receipt or identification of information 

concerning any additional SFI that was 

not previously disclosed by the PD/PI or 

senior/key personnel for the PHSfunded research project, or upon the 

disclosure of a SFI by a new PD/PI or 

new senior/key personnel for the PHSfunded research project, if the 

Institution determines that the SFI is 

related to the PHS-funded research and 

is a FCOI. We would also require that 

information concerning the SFIs of an 

individual subject to this subsection 

(a)(5) shall remain available via the 

Institution’s publicly accessible Web 

site for at least five years from the date 

that the information was most recently 

updated. 

We are aware that this proposed 

public disclosure requirement was not 

discussed in the ANPRM. However, 

given the number and scope of public 

disclosure initiatives that have emerged 

since the ANPRM was developed, we 

believe it is appropriate to include such 

a provision in this Notice of Proposed 

Rulemaking. For example, similar 

disclosure initiatives already are 

underway at some Institutions and 

pharmaceutical companies, and some 

states have implemented similar 

disclosure requirements legislatively. In 

addition, at the federal level, the 

recently enacted Patient Protection and 

Affordable Care Act (Affordable Care 

Act), Public Law 111–148, includes 

several public disclosure provisions. Of 

greatest relevance, title VI, section 6002, 

of the Affordable Care Act generally 

requires designated manufacturers of 

covered drugs, devices, biological or 

medical supplies to submit certain 

information to HHS regarding certain 

payments made to designated 

physicians and teaching hospitals 

annually beginning March 31, 2013, and 

generally requires the Secretary of HHS 

to make such information publicly 

available through an Internet Web site 

annually beginning not later than 

September 30, 2013. This section of the 

Affordable Care Act includes similar 

provisions that generally apply to 

information concerning ownership or 

investment interests held by designated 

physicians in designated manufacturers 

and group purchasing organizations. In 

addition to these institutional and 

legislative initiatives, many scientific 

journals require authors to publicly 

disclose information regarding their 

research-related financial relationships, 

and many scientific organizations 

impose similar requirements with 

regard to speakers at scientific meetings 

and conferences. 

We recognize that the proposed 

public disclosure requirement would 

place an additional administrative 

burden on Institutions, and would also 

impact the privacy of Investigators who 

have information related to their 

personal financial interests posted 

publicly to the extent such interests are 


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determined to be FCOI. Consequently, it 

is important to identify the optimal 

balance between these more onerous 

impacts and the imperative to preserve 

the integrity of the public’s investment 

in biomedical and behavioral research. 

Therefore, we considered several 

alternatives to the proposed text of 

subsection (a)(5), including: 

1. No requirement that Institutions 

publicly disclose Investigators’ SFI. 

2. A requirement that an Institution 

shall make available via a publicly 

accessible Web site information 

concerning any SFI disclosed to the 

Institution and still held by the PD/PI or 

any other Investigator who has been 

identified by the Institution as senior/ 

key personnel for the PHS-funded 

research project in the grant application, 

contract proposal, contract, progress 

report, or other required report 

submitted to the PHS. 

The first alternative—i.e., no 

requirement for public disclosure—has 

the advantage of reducing the burden on 

Institutions and the privacy impact on 

Investigators. However, this alternative 

would not promote as much increased 

transparency or accountability and, 

given the increasing number of other 

public sources of at least some of this 

information, we are unconvinced that 

this alternative would be sufficient to 

assist the PHS in strengthening 

oversight and ensuring proper 

management of potential bias from 

FCOI. The second alternative—i.e., 

requiring public disclosure of all SFIs 

held by certain Investigators—has the 

advantage of providing the public with 

more complete information that aligns 

and harmonizes with information other 

sources (e.g., disclosures in journals, at 

meetings, and in accordance with the 

Affordable Care Act). Expanding the 

public disclosure requirement in this 

manner, however, could increase the 

administrative burden on the 

Institutions in some respects (due to an 

increase in volume of posted 

information) and raise privacy concerns 

among impacted Investigators given the 

increased scope of financial interest 

information, not all of which is related 

to PHS-funded research, that would be 

made publicly available. This 

requirement also risks strengthening the 

misperception that all SFI constitute 

FCOI. 

The text proposed in subsection (a)(5) 

is an attempt to balance the concerns 

presented by these and other 

alternatives by including a public 

disclosure requirement, but limiting it 

to public disclosure of SFIs determined 

by the Institution to be related to the 

PHS-funded research and to be FCOI. 

We believe that including a public 

disclosure requirement in these 

regulations would be advantageous 

because, among other reasons, the 

information would derive directly from 

the Investigator and the Institution (as 

opposed to a third party not involved in 

the PHS-funded research) and the 

information can be updated timely. In 

addition, confining the public 

disclosure requirement solely to those 

SFIs determined by the Institution to be 

related to the PHS-funded research and 

to be FCOI limits the amount of 

Investigator financial information that is 

made publicly available. We recognize, 

however, that limiting the requirement 

for public disclosure in this manner 

does risk strengthening the 

misperception that any FCOI necessarily 

causes bias, which should not be the 

case if the FCOI is sufficiently managed 

by the Institution. 

We welcome comment on the 

proposed requirement set forth in the 

new subsection (a)(5) and the 

alternatives described above, as well as 

suggestions for modifying the proposed 

regulation language or suggestions for 

other alternative approaches. 

Subsection (b) of the current 

regulation provides that, in addition to 

the types of conflicting financial 

interests described in this paragraph 

that must be managed, reduced, or 

eliminated, an Institution may require 

the management of other conflicting 

financial interests, as the Institution 

deems appropriate. We propose to 

maintain this requirement using slightly 

modified language in a new 

redesignated subsection (a)(6). 

In place of the existing subsection (b), 

we propose to include a substantial 

revision and expansion of Institutions’ 

existing FCOI reporting requirements. 

As indicated above, the certification 

requirement in the existing 42 CFR 

50.604(g), 45 CFR 94.4(g), essentially 

provides the primary source of an 

Institution’s FCOI reporting 

responsibilities under the current 

regulations. The existing provision 

requires—as part of the Institution’s 

certification in each contract proposal or 

application for funding to which the 

regulations apply—that, prior to the 

Institution’s expenditure of any funds 

under the award, the Institution will 

report to the PHS Awarding Component 

the existence of a conflicting interest 

(but not the nature of the interest or 

other details) found by the Institution 

and assure that the interest has been 

managed, reduced, or eliminated in 

accordance with the regulation; and, for 

any interest that the Institution 

identifies as conflicting subsequent to 

the Institution’s initial report under the 

award, the report will be made and the 

conflicting interest managed, reduced, 

or eliminated, at least on an interim 

basis, within sixty days of that 

identification. 

A new subsection (b)(1), as proposed, 

would continue the existing regulation’s 

requirement with regard to the timing of 

initial FCOI reports and reference the 

proposed management plan 

requirements addressed in the above 

discussion of subsection (a). 

Specifically, an Institution would be 

required, prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, to provide to 

the PHS Awarding Component a FCOI 

report regarding any Investigator SFI 

found by the Institution to be conflicting 

and ensure that the Institution has 

implemented a management plan in 

accordance with the regulations. 

Similarly, a new subsection (b)(2) 

would continue the existing regulation’s 

requirement with regard to timing of 

follow-up FCOI reports with examples 

of when such reports may be required 

as well as reference to the proposed 

management plan and mitigation plan 

requirements addressed above in the 

discussion of subsection (a). 

Specifically, the regulation would 

require that for any SFI that the 

Institution identifies as conflicting 

subsequent to the Institution’s initial 

FCOI report during an ongoing PHSfunded research project (e.g., upon the 

participation of a new Investigator in 

the research project), the Institution 

shall provide to the PHS Awarding 

Component, within sixty days, a FCOI 

report regarding the FCOI and ensure 

that the Institution has implemented a 

management plan in accordance with 

the regulations. Where such FCOI report 

involves a SFI that was not disclosed 

timely by an Investigator or, for 

whatever reason, was not previously 

reviewed by the Institution (e.g., was 

not timely reviewed or reported by a 

subrecipient), the Institution also would 

be required to provide with its FCOI 

report the mitigation plan implemented 

by the Institution to determine whether 

any PHS-funded research, or portion 

thereof, conducted prior to the 

identification and management of the 

FCOI was biased in the design, conduct, 

or reporting of such research. 

In the ANPRM, we requested 

comment on whether Institutions 

should be required to report additional 

information to the PHS Awarding 

Component and if so, what kind of 

information would provide valuable 

data to the PHS Awarding Component 

in evaluating these reports and the 

potential risk of bias in the conduct of 

research. Many respondents supported 

such a requirement and indicated that 


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reporting additional information would 

allow for enhanced oversight by the 

PHS Awarding Component. 

Consistent with these public 

comments, we are proposing a new 

subsection (b)(3) that would identify the 

information that must be included in 

the FCOI reports required under 

subsections (b)(1) and (b)(2), described 

above. Specifically, any FCOI report 

required under these subsections would 

be required to include sufficient 

information to enable the PHS 

Awarding Component to understand the 

nature and extent of the financial 

conflict, and to assess the 

appropriateness of the Institution’s 

management plan. As proposed, 

elements of the FCOI report shall 

include, but are not limited to the 

following: 

• Project/Contract number; 

• PD/PI or Contact PD/PI if multiple 

PD/PI model is used; 

• Name of the Investigator with the 

FCOI; 

• Nature of the financial interest (e.g., 

equity, consulting fee, travel 

reimbursement, honorarium); 

• Value of the financial interest 

(dollar ranges would be permissible: $0– 

$4,999; $5,000–$9,999; $10,000– 

$19,999; amounts between $20,000– 

X$100,000 by increments of $20,000; 

amounts above $100,000 by increments 

of $50,000), or a statement that the 

interest is one whose value cannot be 

readily determined through reference to 

public prices or other reasonable 

measures of fair market value; 

• A description of how the financial 

interest relates to the PHS-funded 

research and the basis for the 

Institution’s determination that the 

financial interest conflicts with such 

research; 

• A description of the key elements of 

the Institution’s management plan, 

including: 

Æ The role and function of the 

conflicted Investigator in the research 

project; 

Æ The rationale for including the 

conflicted Investigator in the research 

project; 

Æ The conditions of the management 

plan; 

Æ How the management plan will 

safeguard objectivity in the research 

project; 

Æ Confirmation of the Investigator’s 

agreement to the management plan; 

Æ How the management plan will be 

monitored to ensure Investigator 

compliance; 

Æ Other information as needed. 

We welcome public comment on the 

FCOI report elements that we propose to 

include in the new subsection (b)(3). 

We propose to introduce in a new 

subsection (b)(4) a new requirement to 

provide follow-up reports in cases in 

which an FCOI has been previously 

identified and reported. Specifically, the 

regulation would require that for any 

FCOI previously reported by the 

Institution with regard to an ongoing 

PHS-funded research project, the 

Institution shall provide an annual FCOI 

report that addresses the status of the 

FCOI and any changes to the 

management plan to the PHS Awarding 

Component for the duration of the PHSfunded research project. The annual 

FCOI report would be required to 

specify whether the financial conflict is 

still being managed or explain why the 

FCOI no longer exists. The regulations 

would require the Institution to provide 

annual FCOI reports to the PHS 

Awarding Component for the duration 

of the project period (including 

extensions with or without funds) in the 

time and manner specified by the PHS 

Awarding Component. If this provision 

were to be implemented as part of a 

Final Rule, we anticipate that PHS 

Awarding Components would provide 

guidance to Institutions regarding the 

specific mechanics for filing annual 

FCOI reports. 

Finally, we propose in a new 

subsection (b)(5) language with regard to 

FCOI reporting that is similar to the 

language for FCOI management 

proposed in the redesignated subsection 

(a)(5), described above. Namely, we 

propose that in addition to the types of 

financial conflicts of interest as defined 

in the regulations that must be reported 

pursuant to this section, an Institution 

may require the reporting of other FCOI, 

as the Institution deems appropriate. 

Remedies (42 CFR 50.606, 45 CFR 94.6) 

We propose limited revisions to the 

existing regulation regarding remedies. 

Subsection (a) currently provides that if 

the failure of an Investigator to comply 

with the conflict of interest policy of the 

Institution has biased the design, 

conduct, or reporting of the PHS-funded 

research, the Institution must promptly 

notify the PHS Awarding Component of 

the corrective action taken or to be 

taken. We propose to revise this 

requirement such that it applies if an 

Investigator’s failure to comply with an 

Institution’s FCOI policy or a FCOI 

management plan appears to have 

biased the design, conduct, or reporting 

of the PHS-funded research. 

In subsection (b), we propose to 

incorporate language regarding the 

Department’s right of inquiry and access 

to records that is consistent with the 

proposed certification provision in 42 

CFR 50.604(k)(4), 45 CFR 94.4(k)(4), 

discussed above. Specifically, 

subsection (b) would provide that the 

HHS may inquire at any time (i.e., 

before, during, or after award) into any 

Investigator disclosure of financial 

interests and the Institution’s review of, 

or response to, such disclosure, whether 

or not the disclosure resulted in the 

Institution’s determination of a FCOI. 

Similar to the existing regulations, an 

Institution would be required to submit, 

or permit on site review of, all records 

pertinent to compliance with the 

regulations. 

Subsection (b) would also be revised 

to clarify the types of actions that may 

be taken if a PHS Awarding Component 

decides that a particular FCOI will bias 

the objectivity of the PHS-funded 

research to such an extent that further 

corrective action is needed or that the 

Institution has not managed the FCOI in 

accordance with the regulations. With 

regard to grants and cooperative 

agreements, in particular, subsection 

50.606(b) would specify that the PHS 

Awarding Component may determine 

that imposition of special award 

conditions under 45 CFR 74.14 or 

suspension of funding or other 

enforcement action under 45 CFR 74.62 

is necessary until the matter is resolved. 

Correspondingly, subsection 94.6(b) 

would specify for PHS contracts that the 

PHS Awarding Component may 

determine that issuance of a Stop Work 

Order by the Contracting Officer or 

other enforcement action is necessary 

until the matter is resolved. 

We propose to revise subsection (c) to 

add that in any case in which the HHS 

determines that a PHS-funded project of 

clinical research whose purpose is to 

evaluate the safety or effectiveness of a 

drug, medical device, or treatment has 

been designed, conducted, or reported 

by an Investigator with a FCOI that was 

not managed or reported by the 

Institution as required by the 

regulations, the Institution must not 

only require the Investigator involved to 

disclose the FCOI in each public 

presentation of the results of the 

research, but also to request an 

addendum to previously published 

presentations. 

We propose additional minor 

revisions to this section as part of a 

broader effort to improve internal 

consistency with regard to the use of 

various terms and phrases throughout 

these regulations and, where feasible, 

consistency between the text of 42 CFR 

Part 50, Subpart F, and 45 CFR Part 94. 

Other HHS Regulations That Apply (42 

CFR 50.607) 

We propose minor revisions to the list 

of other HHS regulations that apply to 


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28700 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Proposed Rules 

12All applicant Institution numbers are based on 

the number of Institutions that applied for NIH 

funding in FY2008. 

13All awardee Institution numbers are based on 

the number of Institutions that were awarded NIH 

funding in FY2008. 14Bureau of Labor Statistics inflation calculator. 

update changes that have been made in 

the CFR location or title of the existing 

references in this section. In the course 

of our review, we considered whether 

this section was necessary, or whether 

it should be deleted as potentially 

confusing to readers with regard to the 

scope of additional regulations that may 

apply to a given Institution or 

Investigator. We welcome comment on 

whether the regulations should be 

further revised to delete this section. 

III. Institutional Conflict of Interest 

Institutional conflict of interest is a 

subject that is not specifically addressed 

in the current regulations. Because this 

is a topic of increasing interest to the 

Department as well as in the research 

community, we invited public comment 

in the ANPRM on the possible revision 

of the regulations to address 

institutional conflict of interest. In 

particular, we asked (a) how 

‘‘institutional conflict of interest’’ would 

be defined, and (b) what an institutional 

conflict of interest policy would address 

in order to assure the PHS of objectivity 

in research. 

The comments that we received in 

response to these questions 

demonstrated a variety of viewpoints on 

this complex issue and, in particular, 

the extensive differences in 

administrative structure among 

Institutions that receive PHS funding. 

As a result, we believe that further 

careful consideration is necessary before 

PHS regulations could be formulated 

that would address the subject of 

institutional conflict of interest in the 

same comprehensive manner as the 

proposed regulations regarding 

Investigator FCOI. Because we believe it 

is important to revise the existing 

regulations regarding Investigator FCOI 

in a timely manner, our proposed 

revisions to the text of the regulations 

are limited to the subject of Investigator 

FCOI. 

Notwithstanding this limitation, we 

welcome comment on whether the 

regulations should be further revised to 

require Institutions, at a minimum, to 

adopt some type of policy on 

institutional conflict of interest, even if 

the scope and elements of the policy 

remain undefined in the regulations. For 

example, in addition to the changes we 

have proposed herein to subsection (a) 

of 42 CFR 50.604 and 45 CFR 94.4, 

discussed above, this subsection could 

be further revised to require that each 

Institution shall maintain up-to-date, 

written, enforced policies on 

Investigator financial conflicts of 

interest and institutional conflict of 

interest that comply with this subpart, 

and make such policies available via a 

publicly accessible Web site. If this 

additional revision to subsection (a) 

were to be incorporated, further 

corresponding revisions to the 

regulations would be made as necessary, 

e.g., to the Purpose section (42 CFR 

50.601, 45 CFR 94.1). 

Whether or not final regulations 

includes further revisions to address 

institutional conflict of interest, the 

Department will continue to consider 

the issue carefully and may propose in 

the future more comprehensive 

revisions to the regulations to address 

this subject. 

IV. Regulatory Impact Analyses (RIA) 

The following is provided as public 

information. 

Analysis of Impacts 

We have examined the impacts of the 

proposed amendments to 42 CFR Part 

50 Subpart F and 45 CFR Part 94 under 

Executive Order 12866, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Order 

12866, Regulatory Planning and Review, 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The Executive 

Order defines an economically 

significant regulatory action as one that 

would have an annual effect on the 

economy of $100 million or more. Based 

on our analyses, we believe that the 

proposed amendments to the 

regulations do not constitute an 

economically significant regulatory 

action under this definition. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of the rule on small 

entities. For the purposes of this 

analysis, small entities include small 

business concerns as defined by the 

SBA, usually businesses with fewer 

than 500 employees. Approximately 

2800 12 such organizations apply for 

research funding annually, of which 

approximately 1300 13 are awarded 

funds. The only proposed change to the 

current regulations that pertains to 

applicant organizations is the proposed 

removal of the exemption for SBIR/ 

STTR Program Phase I applications in 

sections 50.602 and 94.4, respectively. 

This would affect approximately 2000 

small business concerns that apply for 

SBIR/STTR Program Phase I funding. 

All other proposed changes to the 

regulations apply only to the 

approximately 1200 small business 

concerns that receive PHS funding 

(under both the SBIR/STTR Program 

Phase I and Phase II programs). The cost 

of implementing the amended 

regulations is an allowable cost eligible 

for reimbursement as a Facilities and 

Administrative cost on PHS-supported 

grants, cooperative agreements and 

contracts. This generally offsets the cost 

burdens of implementation. Therefore, 

we do not believe that the proposed 

changes to the regulations would have 

a significant economic impact on a 

substantial number of small entities. 

Our analysis is further supported by the 

small number of FCOI reports submitted 

to NIH by small business concerns— 

four reports were submitted in FY2008 

and ten in FY2009. Finally, we 

considered the impact of the proposed 

requirement for Investigator training 

every two years on small entities. For 

the current regulation, NIH developed 

training materials that Institutions, 

including those that small businesses, 

can use which are available on the NIH 

Web site at http://grants.nih.gov/grants/ 

policy/coi/index.htm. NIH will continue 

to update the training materials when 

the Final Rule is published to 

ameliorate the burden on Institutions, 

including small businesses. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation 

with base year of 1995) in any one year.’’ 

The current inflation-adjusted statutory 

threshold is approximately $142 

million.14 The agency does not expect 

that the proposed amendments to the 

regulations will result in any 1-year 

expenditure that would meet or exceed 

this amount. 

Though the proposed amendments 

will not result in the expenditures listed 

above, we do discuss the effects of the 

amendments elsewhere in this 

preamble. 


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Benefits 

The proposed amendments to the 

regulations on the Responsibility of 

Applicants for Promoting Objectivity in 

Research for which PHS Funding is 

Sought (42 CFR Part 50, Subpart F) and 

Responsible Prospective Contractors (45 

CFR Part 94) would expand and add 

transparency to investigator disclosure 

of Significant Financial Interests as well 

as enhance regulatory compliance and 

effective oversight of financial conflicts 

of interest. 

Costs 

Approximately 5000 Institutions that 

apply for PHS funding annually would 

be subject to the amended regulations. 

The only proposed change to the current 

regulations that pertains to applicant 

organizations, however, pertains to a 

subset of applicant organizations and 

that is the proposed removal of the 

exemption for SBIR/STTR Program 

Phase I applications in sections 50.602 

and 94.4, respectively, which would 

affect approximately 2000 small 

business concerns. The remaining 

proposed amendments would affect the 

approximately 2800 organizations (of all 

types, including small businesses) that 

are awarded PHS funding annually and, 

through the implementation of the 

regulations by the Institutions, to the 

estimated 40,500 Investigators 

participating in PHS-funded research 

that have Significant Financial Interests. 

The cost of implementing the amended 

regulations is an allowable cost eligible 

for reimbursement as a Facilities and 

Administrative cost on PHS supported 

grants, cooperative agreements and 

contracts. This generally offsets the cost 

burdens of implementation for the 

affected Institutions and through their 

implementation of the regulations, to 

the Investigators. That said, we are 

including a description of the projected 

costs of the proposed amendments to 

the regulations for general information. 

42 CFR Part 50 

Subpart F/45 CFR 

Part 94 

New proposed 

requirement? 

Number of 

respondents 

Frequency of response (annual) Estimated cost per 

response 15

Estimated annual 

cost 16

50.602/94.2 ................ Only for SBIR/STTR 

Phase I applicants.

Total: ∼5,000 applicant Institutions 

and 2,800 awardee 

institutions 17 and 

an estimated 

40,500 investigators.

NA ............................. NA ............................. Total estimated annual cost 

$$12,047,525.19

New: Approximately 

2,000 applicant Institutions and 700 

awardee Institutions.18

50.604/94.4 

(a) ........................ Only making the policy public.2,800 20 ..................... 1 ................................ $665 .......................... $1,862,000. 

(b) ........................ Only the training 

component is new.

Institutions: 2,800 21 ..

Investigators: 

40,500.22

Institutions: 1 .............

Investigators: 0.5 ......

Institutions: $105 .......

Investigators: $17.5 ..

Total: $122.5 .............

Institutions: $294,000. 

Investigators: 

$708,750. 

Total: $1,002,750. 

(c)(1) .................... n—clarification of current requirements.700 23 ........................ 1 ................................ $35.00 ....................... $24,500. 

(d) ........................ y ................................ 2,800 24 ..................... 1 ................................ $35 ............................ $98,000. 

(e)(1) ................... n but scope has 

changed.

40,500 25 ................... 1 ................................ $70 ............................ $2,835,000. 

(e)(2) ................... n ................................ 40,500 ....................... 1 ................................ $17.50 26 ................... $708,750. 

(e)(3) ................... n ................................ 1,000 27 ..................... 1 ................................ $17.50 ....................... $17,500. 

(f) ......................... n but scope has 

changed.

2,800 awardee Institutions.1 ................................ $35.00 ....................... $98,000. 

(i) ......................... n ................................ 2,800 awardee Institutions.1 ................................ $140 .......................... $392,000. 

50.605/94.5 

(a)(1) ................... Requirement to develop a management plan.2,800 awardee institutions.281 ................................ $35 for review of 

40,500 disclosures 

and $2,800 for developing management plan for 1,000 

identified FCOI.

$4,217,500.29

(a)(2) ................... n ................................ 1,000 30 ..................... NA31 ......................... NA ............................. NA. 

(a)(3) ................... y ................................ 500 32 ........................ 1 ................................ $105 .......................... $52,200. 

(a)(3)(i) ................ n ................................ 50 33 .......................... 1 ................................ $2,800 34 ................... $140,000. 

(a)(3)(ii) ................ y ................................ 50 35 .......................... 1 ................................ $280 36 ...................... $14,000. 

(a)(4) ................... y ................................ 1,000 37 ..................... 12 .............................. $35 ............................ $420,000. 

(a)(5) ................... y ................................ 2,800 ......................... 1 ................................ $35 38 ........................ $98,000. 

(b)(1) ................... n but amount of information reported 

has changed.

Included in 

50.605(b)(3)/94.5 

(b)(3) below.

NA ............................. NA ............................. NA. 

(b)(2) ................... y ................................ 100 39 ........................ 1 ................................ $70 ............................ $7,000. 

(b)(3) ................... y ................................ 1,000 ......................... 1 ................................ $35 ............................ $35,000.40

(b)(4) ................... n but scope has been 

clarified.

1,000 ......................... 1 ................................ $17.50 41 ................... $17,500. 

50.606/94.6 


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15Average burden hours × $35/hour based on 

recent NIH cost analyses. 16Number of respondents × estimated cost per 

response. 17Based on FY2008 numbers. 18Will be newly covered by the regulations under 

the proposed expansion to include the SBIR/STTR 

phase I program. 

19Sum of all the columns below. 

20Assumes 2,800 awardee Institutions and 19 

hours per institution for formulating and 

maintaining the policy. Also assumes that all 

awardee Institutions already maintain a public Web 

site. Therefore, posting the policy to the Web site 

is an incremental cost. 

21Assumes that 2,800 awardee institutions: 1. 

Inform investigators about the policy on an annual 

basis by sending a notification to all investigators 

= 1 hour and 2. Annually adapt NIH-provided 

training materials to Institutional needs = 2 hours. 

22Assumes 40,500 Investigators undergo 1 hour 

of training every two years. This refers to FCOI 

training only and is based on the use of training 

materials developed by the NIH and adapted to the 

Institution’s needs. 

23An estimated maximum 25% of Institutions 

may have sub-recipients in any one year—assuming 

1 hour per Institution to incorporate the 

requirement of the regulations into an already 

existing written agreement. 

24Assumes that 2,800 awardee institutions solicit 

disclosures on an annual basis by sending a 

notification to all investigators. 

25The financial disclosure burden estimate is 

based upon an investigator figure of 40,500 with an 

average response time of 2 hours. 

26Assumes that updating a disclosure takes less 

time/effort and therefore costs less than creating a 

new one. 

27Assumes that only a small number of the 

40,500 investigators will have a new SFI in any 

year. 

28Although not more than 1,000 reports of 

Conflict of Interest are expected annually, the 2,800 

responding institutions must review all financial 

disclosures associated with PHS-funded awards to 

determine whether any conflicts of interest exist. 

Thus, the review cost of $1,417,500 is based upon 

estimates that it will take on the average 1 hour to 

review each of 40,500 financial disclosures 

associated with PHS-funded awards. The cost for 

developing a management plan for identified FCOI 

is estimated at 80 hours × 1,000 cases × $35/hour 

= $2,800,000. 

29 $4,252,500 for review plus $2,800,000 for 

developing management plans = $7,052,500. 

30Based on 50.604/94.4 (e)(3) above. 

31The cost is included in 50.605/94.5 (b)(2) 

below. 

32Assumes that this is a rare occurrence, based 

on prior experience. 

33Assumes only a fraction of the newly identified 

SFIs will constitute FCOI. 

34 Development of management plan. 

35Assumes only a fraction of the newly identified 

SFIs will constitute FCOI. 36Assumes the mitigation plan will be adapted 

from the management plan developed in 50.605/ 

94.5 (a)(3)(i) above and therefore will cost less than 

developing an entirely new plan. 37Based on previous assumption of 1,000 FCOI 

reports annually. 38Assumes that all awardee Institutions already 

maintain a public Web site. Adding the required 

information is an incremental cost. However, 

updating annually does have a cost. 39The cost of subsequent reports of conflicts is 

significantly less, because we do not expect many 

additional reportable conflicts and there will be 

only a limited number of disclosures to review. 40Assumes 1,000 FCOI reports annually × 1 hour 

× $35/hour to prepare the report/complete an NIHprovided web form. 

41Assumes it takes less time to update a report 

than to create a new one. 

42This was originally estimated in the 1995 Final 

Rule to be no more than 5 instances that the failure 

of an investigator to comply with the institution’s 

conflict of interest policy has biased the design, 

conduct or reporting of the research. ‘‘Objectivity in 

Research, Final Rule’’ 60 FR 132 (July 11, 1995) pps. 

35810–35819. This estimate, and others were 

increased in 2002 ‘‘due to increased numbers of 

institutions and investigators.’’ 

43Number based on 50.605/94.5 (a)(3)(i)—of 

those only a fraction will relate to a project of 

clinical research whose purpose is to evaluate the 

safety or effectiveness of a drug, medical device, or 

treatment, but we are calculating the maximum 

assumed cost. 

44Assumes an average of 3 publications annually. 

42 CFR Part 50 

Subpart F/45 CFR 

Part 94 

New proposed 

requirement? 

Number of 

respondents 

Frequency of response (annual) Estimated cost per 

response 15

Estimated annual 

cost 16

(a) ........................ n—but scope has 

been clarified.

20 42 .......................... 1 ................................ $350 .......................... $7,000. 

(c) ........................ n—only the addendum to previously 

published presentations is new.

50 43 .......................... 3 44 ............................ $10.50 ....................... $525. 

Alternatives 

The key alternative to the proposed 

amendment of these regulations would 

be to continue to operate under the 

current regulations. In the intervening 

years since the regulation was 

promulgated, Investigator collaborations 

have become more complex and public 

scrutiny has increased significantly 

creating an environment that would 

benefit from a regulation with more 

effective means for management and 

oversight. If we continue to operate 

under the current regulations, we would 

then lose the opportunity to implement 

enhanced institutional management of 

Investigator financial conflicts of 

interests related to PHS-funded 

research, increased oversight by the PHS 

funding component, and enhanced 

transparency. We believe that the 

incremental increase in the cost of 

implementing the proposed regulation 

is outweighed by the benefits of these 

changes and that the proposed 

regulation will strengthen public trust 

in PHS-funded research. With regard to 

alternative approaches to particular 

requirements in the regulations, we 

have indicated in various provisions of 

the preamble to this Notice of Proposed 

Rulemaking the basis for the 

Department’s proposed approach versus 

alternatives. (See, e.g., section III 

regarding institutional conflicts of 

interest.) 

Paperwork Reduction Act 

This proposed rule contains 

requirements that are subject to OMB 

approval under the Paperwork 

Reduction Act of 1995, as amended (44 

U.S.C. chapter 35). Sections 50.604(a), 

50.604(b), 50.604(c)(1), 50.604(d), 

50.604(e)(1), 50.604(e)(2), 50.604(e)(3), 

50.604(f), 50.605(a)(1), 50.605(a)(3), 

50.605(a)(3)(i), 50.605(a)(3)(ii), 

50.605(a)(4), 50.605(a)(5), 50.605(b)(1), 

50.605(b)(2), 50.605(b)(3), 50.605(b)(4), 

50.606(a), 50.606(c); 94.4(a), 94.4(b), 

94.4(c)(1), 94.4(d), 94.4(e)(1), 94.4(e)(2), 

94.4(e)(3), 94.4(f), 94.5(a)(1), 94.5 (a)(3), 

94.5(a)(3)(i), 94.5(a)(3)(ii), 94.5(a)(4), 

94.5(a)(5), 94.5(b)(1), 94.5(b)(2), 

94.5(b)(3), 94.5(b)(4), 94.6(a), and 94.6(c) 

contain reporting and information 

collection requirements that are subject 

to OMB approval under the Paperwork 

Reduction Act. 

Sections 50.604(i), and 94.4(i), 

contain recordkeeping requirements that 

are subject to OMB review under the 

Paperwork Reduction Act. The title, 

description, and respondent description 

of the information collection and 

recordkeeping requirements contained 

in this proposed rule have been 

submitted to OMB for review. Other 

organizations and individuals desiring 

to submit comments on the information 

collection and recordkeeping 

requirements should send their 

comments to: (1) Mikia Currie, Project 

Clearance Officer, National Institutes of 

Health, Rockledge Center 1, 6705 

Rockledge Drive, Room 3509, Bethesda, 

MD 20817, telephone 301–594–7949 

(not a toll-free number); and (2) the 

Office of Information and Regulatory 

Affairs, OMB, 

OIRA_submission@omb.eop or by fax to 

202–395–6974, and mark ‘‘Attention: 

Desk Officer for the National Institutes 

of Health, Department of Health and 

Human Services.’’ After we obtain OMB 


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45Number of respondents × average burden hours 

× frequency of response. 

46Based on FY2008 numbers. 

47Will be newly covered by the regulations under 

the proposed expansion to include the SBIR/STTR 

phase I program. 

48Sum of all the columns below. 

49Assumes 2,800 awardee Institutions and 19 

hours per institution for formulating and 

maintaining the policy. Also assumes that all 

awardee Institutions already maintain a public Web 

site. Therefore, posting the policy to the Web site 

is an incremental burden. 

50Assumes that 2,800 awardee institutions: 1. 

Inform investigators about the policy on an annual 

basis by sending a notification to all investigators 

Continued 

approval, we will publish the OMB 

control number in the Federal Register. 

Following are details of the estimated 

burden of implementing the proposed 

regulations. 

42 CFR Part 50 Subpart F/45 CFR Part 94 New proposed 

requirement? 

Number of 

respondents 

Frequency of 

response 

(annual) 

Average burden 

hours 

Annual burden 

hours 45

50.602/94.2 ................ Only for SBIR/STTR 

Phase I applicants.

Total: ∼5,000 applicant Institutions 

and 2,800 awardee 

institutions 46 and 

an estimated 

40,500 investigators.

NA ............................. NA ............................. Total estimated burden hours: 

344,215.48

New: Approximately 

2,000 applicant Institutions and 700 

awardee Institutions.47

50.604/94.4 

(a) ........................ Only making the policy public.2,800 49 ..................... 1 ................................ 19 .............................. 53,200. 

(b) ........................ Only the training 

component.

Institutions: 2,800 50 ..

Investigators: 

40,500.51

Institutions: 1 .............

Investigators: 0.5 ......

Institutions: 3 .............

Investigators: 1 .........

Institutions: 8,400. 

Investigators: 20,250. 

(c)(1) .................... n-clarification of current requirements.700 52 ........................ 1 ................................ 1 ................................ 700. 

(d) ........................ y ................................ 2,800 53 ..................... 1 ................................ 1 ................................ 2,800. 

(e)(1) ................... n but scope has 

changed.

40,500 54 ................... 1 ................................ 2 ................................ 81,000. 

(e)(2) ................... n ................................ 40,500 ....................... 1 ................................ 0.5 55 ......................... 20,250. 

(e)(3) ................... n ................................ 1,000 56 ..................... 1 ................................ 0.5 ............................. 500. 

(f) ......................... n but scope has 

changed.

2,800 awardee Institutions.1 ................................ 1 ................................ 2,800. 

(i) ......................... n ................................ 2,800 awardee Institutions.1 ................................ 4 ................................ 11,200. 

50.605/94.5 

(a)(1) ................... Requirement to develop a management plan.2,800 awardee institutions.571 ................................ 1 hour per disclosure 

to review plus 80 

hours per identified 

FCOI to develop 

management plan.

120,500.58

(a)(2) ................... n ................................ 1,000 59 ..................... NA60 ......................... NA ............................. NA. 

(a)(3) ................... y ................................ 500 61 ........................ 1 ................................ 3 ................................ 1500. 

(a)(3)(i) ................ n ................................ 50 62 .......................... 1 ................................ 80 63 .......................... 4,000. 

(a)(3)(ii) ................ y ................................ 50 64 .......................... 1 ................................ 8 65 ............................ 400. 

(a)(4) ................... y ................................ 1,000 66 ..................... 12 .............................. 1 ................................ 12,000. 

(a)(5) ................... y ................................ 2,800 ......................... 1 67 ............................ 1 ................................ 2,800. 

(b)(1) ................... n but amount of information reported 

has changed.

Included in 

50.605(b)(3)/94.5 

(b)(3) below.

NA ............................. NA ............................. NA. 

(b)(2) ................... y ................................ 100 68 ........................ 1 ................................ 2 ................................ 200. 

(b)(3) ................... y ................................ 1,000 ......................... 1 ................................ 1 ................................ 1,000.69

(b)(4) ................... n-scope has been 

clarified.

1,000 ......................... 1 ................................ 0.5 70 ......................... 500. 

50.606/94.6 

(a) ........................ n-scope has been 

clarified.

20 71 .......................... 1 ................................ 10 .............................. 200. 

(c) ........................ n-only the addendum 

to previously published presentations.

50 72 .......................... 3 73 ............................ 0.3 ............................. 15. 

Environmental Impact 

We have determined that this action 

is of a type that does not individually 

or cumulatively have a significant effect 

on the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
28704 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Proposed Rules 

= 1 hour, and 2. Annually adapt NIH-provided 

training materials to Institutional needs = 2 hours. 

51Assumes 40,500 Investigators undergo 1 hour 

of training every two years. This refers to FCOI 

training only and is based on the use of training 

materials developed by the NIH and adapted to the 

Institution’s needs. 

52An estimated maximum 25% of Institutions 

may have sub-recipients in any one year—assuming 

1 hour per Institution to incorporate the 

requirement of the regulations into an already 

existing written agreement. 

53Assumes that 2,800 awardee institutions solicit 

disclosures on an annual basis by sending a 

notification to all investigators. 

54The financial disclosure burden estimate is 

based upon an investigator figure of 40,500 with an 

average response time of 2 hours. 

55Assumes that updating a disclosure takes less 

time/effort than creating a new one. 

56Assumes that only a small number of the 

40,500 investigators will have a new SFI in any 

year. 

57Although not more than 1,000 reports of 

Conflict of Interest are expected annually, the 2,800 

responding institutions must review all financial 

disclosures associated with PHS-funded awards to 

determine whether any conflicts of interest exist. 

Thus, the review burden of 40,500 hours is based 

upon estimates that it will take on the average 1 

hour for an institutional official to review each of 

40,500 financial disclosures associated with PHS 

funded awards.. The burden for developing a 

management plan for identified FCOI is estimated 

at 80 hours × 1,000 cases = 80,000 hours. 

58 40,500 for reviewing disclosures from 40,500 

Investigators plus 80,000 for developing 

management plans for 1,000 identified FCOI. 

59Based on 50.604/94.4 (e)(3) above. 

60The burden is included in 50.605/94.5 (b)(2) 

below. 

61Assumes that this is a rare occurrence, based 

on prior experience. 

62Assumes only a fraction of the newly identified 

SFIs will constitute FCOI. 

63 Development of management plan. 

64Assumes only a fraction of the newly identified 

SFIs will constitute FCOI. 

65Assumes the mitigation plan will be adapted 

from the management plan developed in 50.605/ 

94.5(a)(3)(i) above and therefore will take less time/ 

effort than developing an entirely new plan. 

66Based on previous assumption of 1,000 FCOI 

reports annually. 

67Assumes that all awardee Institutions already 

maintain a public Web site. Adding the required 

information is an incremental burden. However, 

updating annually does have a burden. 

68The burden for subsequent reports of conflicts 

is significantly less, because we do not expect many 

additional reportable conflicts and there will be 

only a limited number of disclosures to review. 

69Assumes 1,000 FCOI reports annually × 1 hour 

to prepare the report/complete an NIH-provided 

Web form. 

70Assumes it takes less time to update a report 

than to create a new one. 

71This burden was originally estimated in the 

1995 Final Rule to be no more than 5 instances that 

the failure of an investigator to comply with the 

institution’s conflict of interest policy has biased 

the design, conduct or reporting of the research. 

‘‘Objectivity in Research, Final Rule’’ 60 FR 132 

(July 11, 1995) pps. 35810–35819. This burden 

estimate and others was increased in 2002 ‘‘due to 

increased numbers of institutions and 

investigators.’’ 

72Number based on 50.605/94.5(a)(3)(i)—of those 

only a fraction will relate to a project of clinical 

research whose purpose is to evaluate the safety or 

effectiveness of a drug, medical device, or 

treatment, but we are calculating the maximum 

assumed burden/cost. 

73Assumes an average of 3 publications annually. 

Catalogue of Federal Domestic 

Assistance 

The Catalogue of Federal Domestic 

Assistance numbered programs 

applicable to this proposed rule are: 

93.113—Environmental Health 

93.121—Oral Diseases and Disorders 

Research 

93.142—NIEHS Hazardous Waste Worker 

Health and Safety Training 

93.143—NIEHS Superfund Hazardous 

Substances—Basic Research and 

Education 

93.172—Human Genome Research 

93.173—Research Related to Deafness and 

Communication Disorders 

93.187—Undergraduate Scholarship Program 

for Individuals from Disadvantaged 

Backgrounds 

93.209—Contraception and Infertility 

Research Loan Repayment Program 

93.213—Research and Training in 

Complementary and Alternative 

Medicine 

93.220—Clinical Research Loan Repayment 

Program for Individuals from 

Disadvantaged Backgrounds 

93.233—National Center on Sleep Disorders 

Research 

93.242—Mental Health Research Grants 

93.271—Alcohol Research Career 

Development Awards for Scientists and 

Clinicians 

93.272—Alcohol National Research Service 

Awards for Research Training 

93.273—Alcohol Research Programs 

93.279—Drug Abuse and Addiction Research 

Programs 

93.280—National Institutes of Health Loan 

Repayment Program for Clinical 

Researchers 

93.281—Mental Health Research Career/ 

Scientist Development Awards 

93.282—Mental Health National Research 

Service Awards for Research Training 

93.285—National Institutes of Health 

Pediatric Research Loan Repayment 

Program 

93.286—Discovery and Applied Research for 

Technological Innovations to Improve 

Human Health 

93.307—Minority Health and Health 

Disparities Research 

93.310—Trans-NIH Research Support 

93.361—Nursing Research 

93.389—National Center for Research 

Resources 

93.393—Cancer Cause and Prevention 

Research 

93.394—Cancer Detection and Diagnosis 

Research 

93.395—Cancer Treatment Research 

93.396—Cancer Biology Research 

93.397—Cancer Centers Support Grants 

93.398—Cancer Research Manpower 

93.399—Cancer Control 

93.701—Trans-NIH Recovery Act Research 

Support RECOVERY 

93.702—National Center for Research 

Resources, Recovery Act Construction 

Support Recovery 

93.837—Cardiovascular Diseases Research 

93.838—Lung Diseases Research 

93.839—Blood Diseases and Resources 

Research 

93.846—Arthritis, Musculoskeletal and Skin 

Diseases Research 

93.847—Diabetes, Digestive, and Kidney 

Diseases Extramural Research 

93.853—Extramural Research Programs in 

the Neurosciences and Neurological 

Disorders 

93.855—Allergy, Immunology and 

Transplantation Research 

93.856—Microbiology and Infectious 

Diseases Research 

93.859—Biomedical Research and Research 

Training 

93.865—Child Health and Human 

Development Extramural Research 

93.866—Aging Research 

93.867—Vision Research 

93.879—Medical Library Assistance 

93.891—Alcohol Research Center Grants 

93.989—International Research and Research 

Training 

List of Subjects 

42 CFR Part 50 

45 CFR Part 94 

Colleges and universities, Conflict of 

interests, Contracts, Financial 

disclosure, Grants-health, Grants 

programs, Non-profit organizations, 

Research, Scientists, Small businesses. 

For the reasons set forth in the 

preamble, the Department proposes to 

amend 42 CFR chapter I, subchapter D, 

part 50, subpart F and 45 CFR subtitle 

A, subchapter A, part 94 as follows: 

TITLE 42—GRANTS AND 

AGREEMENTS 

PART 50—POLICIES OF GENERAL 

APPLICABILITY 

1. Revise Subpart F to read as follows: 

Subpart F—Promoting Objectivity in 

Research 

Sec. 

50.601 Purpose. 

50.602 Applicability. 

50.603 Definitions. 

50.604 Responsibilities of Institutions 

regarding Investigator financial conflicts 

of interest. 

50.605 Management and reporting of 

financial conflicts of interest. 

50.606 Remedies. 

50.607 Other HHS regulations that apply. 

Subpart F—Promoting Objectivity in 

Research 

Authority: 42 U.S.C. 216, 289b–1, 299c– 

4; Sec. 219, Tit. II, Div. D, Pub. L. 111–117, 

123 Stat. 3034. 

§ 50.601 Purpose. 

This subpart promotes objectivity in 

research by establishing standards that 

provide a reasonable expectation that 


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the design, conduct, and reporting of 

research funded under PHS grants or 

cooperative agreements is free from bias 

resulting from Investigator financial 

conflicts of interest. 

§ 50.602 Applicability. 

This subpart is applicable to each 

Institution that is applying for, or that 

receives, PHS research funding by 

means of a grant or cooperative 

agreement and, through the 

implementation of this subpart by the 

Institution, to each Investigator 

participating in such research. In those 

few cases where an individual, rather 

than an Institution, is applying for, or 

receives, PHS research funding, PHS 

Awarding Components will make caseby-case determinations on the steps to 

be taken, consistent with this subpart, to 

provide a reasonable expectation that 

the design, conduct, and reporting of the 

research will be free from bias resulting 

from a financial conflict of interest of 

the individual. 

§ 50.603 Definitions. 

As used in this subpart: 

Disclosure of significant financial 

interests means an Investigator’s 

disclosure of significant financial 

interests to an Institution. 

FCOI report means an Institution’s 

report of a financial conflict of interest 

to a PHS Awarding Component. 

Financial conflict of interest means a 

significant financial interest that could 

directly and significantly affect the 

design, conduct, or reporting of PHSfunded research. 

Financial interest means anything of 

monetary value or potential monetary 

value. 

HHS means the United States 

Department of Health and Human 

Services, and any components of the 

Department to which the authority 

involved may be delegated. 

Institution means any domestic or 

foreign, public or private, entity or 

organization (excluding a Federal 

agency) that is applying for, or that 

receives, PHS research funding. 

Institutional responsibilities means an 

Investigator’s professional 

responsibilities on behalf of the 

Institution including, but not limited to, 

activities such as research, research 

consultation, teaching, professional 

practice, institutional committee 

memberships, and service on panels 

such as Institutional Review Boards or 

Data and Safety Monitoring Boards. 

Investigator means the PD/PI and any 

other person, regardless of title or 

position, who is responsible for the 

design, conduct, or reporting of research 

funded by the PHS, or proposed for 

such funding, including persons who 

are subgrantees, contractors, 

collaborators, or consultants. 

Manage means to take action to 

address a financial conflict of interest, 

which includes reducing or eliminating 

the financial conflict of interest, to 

ensure that the design, conduct, or 

reporting of research is free from bias or 

the appearance of bias. 

PD/PI means a project director or 

principal investigator of a PHS-funded 

research project. 

PHS means the Public Health Service, 

an operating division of the U.S. 

Department of Health and Human 

Services, and any components of the 

PHS to which the authority involved 

may be delegated, including the 

National Institutes of Health. 

PHS Awarding Component means the 

organizational unit of the PHS that 

funds the research that is subject to this 

subpart. 

Public Health Service Act or PHS Act 

means the statute codified at 42 U.S.C. 

201 et seq. 

Research means a systematic 

investigation designed to develop or 

contribute to generalizable knowledge 

relating broadly to public health, 

including behavioral and social-sciences 

research. The term encompasses basic 

and applied research and product 

development. As used in this subpart, 

the term includes any such activity for 

which research funding is available 

from a PHS Awarding Component 

through a grant, cooperative agreement, 

or contract, whether authorized under 

the PHS Act or other statutory authority, 

such as a research grant, career 

development award, center grant, 

individual fellowship award, 

infrastructure award, institutional 

training grant, program project, or 

research resources award. 

Significant financial interest means, 

except as otherwise specified in 

paragraph (1) of this definition: 

(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. For 

purposes of this definition, 

remuneration includes salary and any 

payment for services not otherwise 

identified as salary (e.g., consulting fees, 

honoraria, paid authorship, travel 

reimbursement); equity interest includes 

any stock, stock option, or other 

ownership interest, as determined 

through reference to public prices or 

other reasonable measures of fair market 

value; 

(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 the Investigator (or the 

Investigator’s spouse or dependent 

children) holds any equity interest (e.g., 

stock, stock option, or other ownership 

interest); or 

(iii) Intellectual property rights (e.g., 

patents, copyrights), royalties from such 

rights, and agreements to share in 

royalties related to such rights. 

(2) The term significant financial 

interest does not include the following 

types of financial interests: Salary, 

royalties, or other remuneration paid by 

the Institution to the Investigator if the 

Investigator is currently employed or 

otherwise appointed by the Institution; 

any ownership interest in the Institution 

held by the Investigator, if the 

Institution is a commercial or for-profit 

organization; income from seminars, 

lectures, or teaching engagements 

sponsored by a federal, state, or local 

government agency, or an institution of 

higher education as defined at 20 U.S.C. 

1001(a); or income from service on 

advisory committees or review panels 

for a federal, state, or local government 

agency, or an institution of higher 

education as defined at 20 U.S.C. 

1001(a). 

§ 50.604 Responsibilities of Institutions 

regarding Investigator financial conflicts of 

interest. 

Each Institution shall: 

(a) Maintain an up-to-date, written, 

enforced policy on financial conflicts of 

interest that complies with this subpart, 

and make such policy available via a 

publicly accessible Web site. If an 

Institution maintains a policy on 

financial conflicts of interest that 

includes standards that are more 

stringent than this subpart (e.g., that 

require a more extensive disclosure of 

financial interests), the Institution shall 

adhere to its policy and shall provide 

FCOI reports regarding identified 

financial conflicts of interest to the PHS 

Awarding Component in accordance 

with the Institution’s own standards. 

(b) Inform each Investigator of the 

Institution’s policy on financial 

conflicts of interest, the Investigator’s 

responsibilities regarding disclosure of 

significant financial interests, and of 


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these regulations, and require each 

Investigator to complete training 

regarding same prior to engaging in 

PHS-funded research and, thereafter, at 

least once every two years. 

(c) If the Institution carries out the 

PHS-funded research through a 

subrecipient (e.g., subgrantee, 

contractor, or collaborator): 

(1) Incorporate as part of a written 

agreement with the subrecipient legally 

enforceable terms that establish whether 

the financial conflicts of interest policy 

of the awardee Institution or that of the 

subrecipient applies to the 

subrecipient’s Investigators. 

(i) If the subrecipient’s financial 

conflicts of interest policy applies to 

subrecipient Investigators, the 

subrecipient shall certify as part of the 

agreement that its policy complies with 

this subpart. If the subrecipient cannot 

provide such certification, the 

agreement shall state that subrecipient 

Investigators are subject to the financial 

conflicts of interest policy of the 

awardee Institution; 

(ii) If the subrecipient’s financial 

conflicts of interest policy applies to 

subrecipient Investigators, the 

agreement shall specify time period(s) 

for the subrecipient to report all 

identified financial conflicts of interest 

to the awardee Institution. Such time 

period(s) shall be sufficient to enable 

the awardee Institution to provide 

timely FCOI reports, as necessary, to the 

PHS; 

(iii) If subrecipient Investigators are 

subject to the awardee Institution’s 

financial conflicts of interest policy, the 

agreement shall specify time period(s) 

for the subrecipient to submit all 

Investigator disclosures of significant 

financial interests to the awardee 

Institution. Such time period(s) shall be 

sufficient to enable the awardee 

Institution to comply timely with its 

review, management, and reporting 

obligations under this subpart. 

(2) Provide FCOI reports to the PHS 

regarding all financial conflicts of 

interest of all subrecipient Investigators 

consistent with this subpart. 

(d) Designate an institutional 

official(s), to solicit and review 

disclosures of significant financial 

interests from each Investigator who is 

planning to participate in the PHSfunded research. 

(e)(1) Require that each Investigator 

who is planning to participate in the 

PHS-funded research disclose to the 

Institution’s designated official(s) the 

Investigator’s significant financial 

interests (and those of the Investigator’s 

spouse and dependent children). 

(2) Require that each Investigator who 

is participating in the PHS-funded 

research submit an updated disclosure 

of significant financial interests at least 

annually during the period of the award. 

Such disclosure shall include any 

information that was not disclosed 

initially to the Institution pursuant to 

paragraph (e)(1) of this section, or in a 

subsequent disclosure of significant 

financial interests, and shall include 

updated information regarding any 

previously-disclosed significant 

financial interest (e.g., the updated 

value of a previously-disclosed equity 

interest). 

(3) Require that each Investigator who 

is participating in the PHS-funded 

research submit an updated disclosure 

of significant financial interests within 

thirty days of acquiring a new 

significant financial interest (e.g., 

through purchase, marriage, or 

inheritance). 

(f) Provide guidelines consistent with 

this subpart for the designated 

institutional officials to determine 

whether an Investigator’s significant 

financial interest is related to PHSfunded research and, if so related, 

whether the significant financial interest 

is a financial conflict of interest. An 

Investigator’s significant financial 

interest is related to PHS-funded 

research when the Institution, through 

its designated officials, reasonably 

determines that the significant financial 

interest: Appears to be affected by the 

PHS-funded research; or is in an entity 

whose financial interest appears to be 

affected by the research. A financial 

conflict of interest exists when the 

Institution, through its designated 

officials, reasonably determines that the 

significant financial interest could 

directly and significantly affect the 

design, conduct, or reporting of the 

PHS-funded research. 

(g) Take such actions as necessary to 

manage financial conflicts of interest, 

including any financial conflicts of a 

subrecipient Investigator pursuant to 

paragraph (c) of this section. 

Management of an identified financial 

conflict of interest requires development 

and implementation of a management 

plan and, if necessary, a mitigation plan 

pursuant to § 50.605(a). 

(h) Provide initial and ongoing FCOI 

reports to the PHS as required pursuant 

to § 50.605(b). 

(i) Maintain records relating to all 

Investigator disclosures of financial 

interests and the Institution’s review of, 

or response to, such disclosures 

(whether or not a disclosure resulted in 

the Institution’s determination of a 

financial conflict of interest), for at least 

three years from the date of submission 

of the final expenditures report or, 

where applicable, from other dates 

specified in 45 CFR 74.53(b) for 

different situations. 

(j) Establish adequate enforcement 

mechanisms and provide for employee 

sanctions or other administrative 

actions to ensure Investigator 

compliance as appropriate. 

(k) Certify, in each application for 

funding to which this subpart applies, 

that the Institution: 

(1) Has in effect at that Institution an 

up-to-date, written, and enforced 

administrative process to identify and 

manage financial conflicts of interest 

with respect to all research projects for 

which funding is sought or received 

from the PHS; 

(2) Shall promote and enforce 

Investigator compliance with this 

subpart’s requirements including those 

pertaining to disclosure of significant 

financial interests; 

(3) Shall manage financial conflicts of 

interest and provide initial and ongoing 

FCOI reports to the PHS consistent with 

this subpart; 

(4) Agrees to make information 

available, promptly upon request, to the 

HHS relating to any Investigator 

disclosure of financial interests and the 

Institution’s review of, or response to, 

such disclosure, whether or not the 

disclosure resulted in the Institution’s 

determination of a financial conflict of 

interest; and 

(5) Shall fully comply with the 

requirements of this subpart. 

§ 50.605 Management and reporting of 

financial conflicts of interest. 

(a) Management of financial conflicts 

of interest. 

(1) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the designated 

officials of an Institution shall, 

consistent with § 50.604(f): Review all 

Investigator disclosures of significant 

financial interests; determine whether 

any significant financial interests relate 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so, develop and 

implement a management plan that 

shall specify the actions that have been, 

and shall be, taken to manage such 

financial conflict of interest. Examples 

of conditions or restrictions that might 

be imposed to manage a financial 

conflict of interest include, but are not 

limited to: 

(i) Public disclosure of financial 

conflicts of interest (e.g., when 

presenting or publishing the research); 

(ii) For research projects involving 

human subjects research, disclosure of 

financial conflicts of interest directly to 

participants; 

(iii) Appointment of an independent 

monitor capable of taking measures to 


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protect the design, conduct, and 

reporting of the research against bias, or 

the appearance of bias, resulting from 

the financial conflict of interest; 

(iv) Modification of the research plan; 

(v) Change of personnel or personnel 

responsibilities, or disqualification of 

personnel from participation in all or a 

portion of the research; 

(vi) Reduction or elimination of the 

financial interest (e.g., sale of an equity 

interest); or 

(vii) Severance of relationships that 

create actual or potential financial 

conflicts. 

(2) Whenever, in the course of an 

ongoing PHS-funded research project, a 

new Investigator participating in the 

research project discloses a significant 

financial interest or an existing 

Investigator discloses a new significant 

financial interest to the Institution, the 

designated officials of the Institution 

shall, within sixty days: Review the 

disclosure of significant financial 

interests; determine whether it is related 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so, implement, on at least 

an interim basis, a management plan 

that shall specify the actions that have 

been, and will be, taken to manage such 

financial conflict of interest. Depending 

on the nature of the significant financial 

interest, an Institution may determine 

that additional interim measures are 

necessary with regard to the 

Investigator’s participation in the PHSfunded research project between the 

date of disclosure and the completion of 

the Institution’s review. 

(3) Whenever an Institution identifies 

a significant financial interest that was 

not disclosed timely by an Investigator 

or, for whatever reason, was not 

previously reviewed by the Institution 

during an ongoing PHS-funded research 

project (e.g., was not timely reviewed or 

reported by a subrecipient), the 

designated officials shall, within sixty 

days: Review the significant financial 

interest; determine whether it is related 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so: 

(i) Implement, on at least an interim 

basis, a management plan that shall 

specify the actions that have been, and 

will be, taken to manage such financial 

conflict of interest going forward; 

(ii) Implement, on at least an interim 

basis, a mitigation plan which shall 

include review and determination as to 

whether any PHS-funded research, or 

portion thereof, conducted prior to the 

identification and management of the 

financial conflict of interest was biased 

in the design, conduct, or reporting of 

such research. Depending on the nature 

of the significant financial interest, an 

Institution may determine that 

additional interim measures are 

necessary with regard to the 

Investigator’s participation in the PHSfunded research project between the 

date that the significant financial 

interest is identified and the completion 

of the Institution’s review. 

(4) Whenever an Institution 

implements a management plan 

pursuant to this subpart, the Institution 

shall monitor Investigator compliance 

with the management plan on an 

ongoing basis until the completion of 

the PHS-funded research project. 

(5)(i) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the Institution 

shall make available via a publicly 

accessible Web site information 

concerning any significant financial 

interest disclosed to the Institution that 

meets the following three criteria: 

(A) The significant financial interest 

was disclosed and is still held by the 

PD/PI or any other Investigator who has 

been identified by the Institution as 

senior/key personnel for the PHSfunded research project in the grant 

application, contract proposal, contract, 

progress report, or other required report 

submitted to the PHS; 

(B) The Institution determines that the 

significant financial interest is related to 

the PHS-funded research; and 

(C) The Institution determines that the 

significant financial interest is a 

financial conflict of interest. 

(ii) The information that the 

Institution makes available via a 

publicly accessible Web site shall 

include, at a minimum, the following: 

The Investigator’s name; the 

Investigator’s position with respect to 

the research project; the nature of the 

significant financial interest; and the 

approximate dollar value of the 

significant financial interest (dollar 

ranges are permissible: Less than 

$20,000; less than $50,000; less than 

$100,000; less than or equal to $250,000; 

greater than $250,000), or a statement 

that the interest is one whose value 

cannot be readily determined through 

reference to public prices or other 

reasonable measures of fair market 

value. 

(iii) The information that the 

Institution makes available via a 

publicly accessible Web site shall be 

updated at least annually. In addition, 

the Institution shall update the Web site 

within sixty days of the Institution’s 

receipt or identification of information 

concerning any additional significant 

financial interest that was not 

previously disclosed by the PD/PI or 

senior/key personnel for the PHSfunded research project, or upon the 

disclosure of a significant financial 

interest by a new PD/PI or new senior/ 

key personnel for the PHS-funded 

research project, if the Institution 

determines that the significant financial 

interest is related to the PHS-funded 

research and is a financial conflict of 

interest. 

(iv) Information concerning the 

significant financial interests of an 

individual subject to this paragraph 

(a)(5) shall remain available via the 

Institution’s publicly accessible Web 

site for at least five years from the date 

that the information was most recently 

updated. 

(6) In addition to the types of 

financial conflicts of interest as defined 

in this subpart that must be managed 

pursuant to this section, an Institution 

may require the management of other 

financial conflicts of interest, as the 

Institution deems appropriate. 

(b) Reporting of financial conflicts of 

interest. 

(1) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the Institution 

shall provide to the PHS Awarding 

Component a FCOI report regarding any 

Investigator significant financial interest 

found by the Institution to be conflicting 

and ensure that the Institution has 

implemented a management plan in 

accordance with this subpart. 

(2) For any significant financial 

interest that the Institution identifies as 

conflicting subsequent to the 

Institution’s initial FCOI report during 

an ongoing PHS-funded research project 

(e.g., upon the participation of a new 

Investigator in the research project), the 

Institution shall provide to the PHS 

Awarding Component, within sixty 

days, a FCOI report regarding the 

financial conflict of interest and ensure 

that the Institution has implemented a 

management plan in accordance with 

this subpart. Where such FCOI report 

involves a significant financial interest 

that was not disclosed timely by an 

Investigator or, for whatever reason, was 

not previously reviewed by the 

Institution (e.g., was not timely 

reviewed or reported by a subrecipient), 

the Institution shall also provide with 

its FCOI report the mitigation plan 

implemented by the Institution to 

determine whether any PHS-funded 

research, or portion thereof, conducted 

prior to the identification and 

management of the financial conflict of 

interest was biased in the design, 

conduct, or reporting of such research. 

(3) Any FCOI report required under 

paragraphs (b)(1) or (b)(2) of this section 

shall include sufficient information to 

enable the PHS Awarding Component to 


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understand the nature and extent of the 

financial conflict, and to assess the 

appropriateness of the Institution’s 

management plan. Elements of the FCOI 

report shall include, but are not limited 

to the following: 

(i) Project/Contract number; 

(ii) PD/PI or Contact PD/PI if a 

multiple PD/PI model is used; 

(iii) Name of the Investigator with the 

financial conflict of interest; 

(iv) Nature of the financial interest 

(e.g., equity, consulting fee, travel 

reimbursement, honorarium); 

(v) Value of the financial interest 

(dollar ranges are permissible: $0– 

$4,999; $5,000–$9,999; $10,000– 

$19,999; amounts between $20,000– 

$100,000 by increments of $20,000; 

amounts above $100,000 by increments 

of $50,000), or a statement that the 

interest is one whose value cannot be 

readily determined through reference to 

public prices or other reasonable 

measures of fair market value; 

(vi) A description of how the financial 

interest relates to the PHS-funded 

research and the basis for the 

Institution’s determination that the 

financial interest conflicts with such 

research; 

(vii) A description of the key elements 

of the Institution’s management plan, 

including: 

(A) The role and function of the 

conflicted Investigator in the research 

project; 

(B) The rationale for including the 

conflicted Investigator in the research 

project; 

(C) The conditions of the management 

plan; 

(D) How the management plan will 

safeguard objectivity in the research 

project; 

(E) Confirmation of the Investigator’s 

agreement to the management plan; 

(F) How the management plan will be 

monitored to ensure Investigator 

compliance; 

(G) Other information as needed. 

(4) For any financial conflict of 

interest previously reported by the 

Institution with regard to an ongoing 

PHS-funded research project, the 

Institution shall provide an annual FCOI 

report that addresses the status of the 

financial conflict of interest and any 

changes to the management plan to the 

PHS Awarding Component for the 

duration of the PHS-funded research 

project. The annual FCOI report shall 

specify whether the financial conflict is 

still being managed or explain why the 

financial conflict of interest no longer 

exists. The Institution shall provide 

annual FCOI reports to the PHS 

Awarding Component for the duration 

of the project period (including 

extensions with or without funds) in the 

time and manner specified by the PHS 

Awarding Component. 

(5) In addition to the types of 

financial conflicts of interest as defined 

in this subpart that must be reported 

pursuant to this section, an Institution 

may require the reporting of other 

financial conflicts of interest, as the 

Institution deems appropriate. 

§ 50.606 Remedies. 

(a) If the failure of an Investigator to 

comply with an Institution’s financial 

conflicts of interest policy or a financial 

conflict of interest management plan 

appears to have biased the design, 

conduct, or reporting of the PHS-funded 

research, the Institution shall promptly 

notify the PHS Awarding Component of 

the corrective action taken or to be 

taken. The PHS Awarding Component 

will consider the situation and, as 

necessary, take appropriate action, or 

refer the matter to the Institution for 

further action, which may include 

directions to the Institution on how to 

maintain appropriate objectivity in the 

funded project. 

(b) The HHS may inquire at any time 

(i.e., before, during, or after award) into 

any Investigator disclosure of financial 

interests and the Institution’s review of, 

or response to, such disclosure, whether 

or not the disclosure resulted in the 

Institution’s determination of a financial 

conflict of interest. An Institution is 

required to submit, or permit on site 

review of, all records pertinent to 

compliance with this subpart. To the 

extent permitted by law, HHS will 

maintain the confidentiality of all 

records of financial interests. On the 

basis of its review of records or other 

information that may be available, the 

PHS Awarding Component may decide 

that a particular financial conflict of 

interest will bias the objectivity of the 

PHS-funded research to such an extent 

that further corrective action is needed 

or that the Institution has not managed 

the financial conflict of interest in 

accordance with this subpart. The PHS 

Awarding Component may determine 

that imposition of special award 

conditions under 45 CFR 74.14 or 

suspension of funding or other 

enforcement action under 45 CFR 74.62 

is necessary until the matter is resolved. 

(c) In any case in which the HHS 

determines that a PHS-funded project of 

clinical research whose purpose is to 

evaluate the safety or effectiveness of a 

drug, medical device, or treatment has 

been designed, conducted, or reported 

by an Investigator with a financial 

conflict of interest that was not managed 

or reported by the Institution as 

required by this subpart, the Institution 

shall require the Investigator involved to 

disclose the financial conflict of interest 

in each public presentation of the 

results of the research and to request an 

addendum to previously published 

presentations. 

§ 50.607 Other HHS regulations that apply. 

Several other regulations and policies 

apply to this subpart. They include, but 

are not necessarily limited to: 

2 CFR Part 376—Nonprocurement 

Debarment and Suspension (HHS) 

42 CFR Part 50, Subpart D—Public Health 

Service Grant Appeals Procedure 

45 CFR Part 16—Procedures of the 

Departmental Grant Appeals Board 

45 CFR Part 74—Uniform Administrative 

Requirements for Awards and Subawards to 

Institutions of Higher Education, Hospitals, 

Other Nonprofit Organizations, and 

Commercial Organizations 

45 CFR Part 79—Program Fraud Civil 

Remedies 

45 CFR Part 92—Uniform Administrative 

Requirements for Grants and Cooperative 

Agreements to State, Local, and Tribal 

Governments 

TITLE 45—PUBLIC WELFARE 

2. Revise Part 94 to read as follows: 

PART 94—RESPONSIBLE 

PROSPECTIVE CONTRACTORS 

Sec. 

94.1 Purpose. 

94.2 Applicability. 

94.3 Definitions. 

94.4 Responsibilities of Institutions 

regarding Investigator financial conflicts 

of interest. 

94.5 Management and reporting of financial 

conflicts of interest. 

94.6 Remedies. 

Authority: 42 U.S.C. 216, 289b–1, 299c– 

4. 

§ 94.1 Purpose. 

This part promotes objectivity in 

research by establishing standards that 

provide a reasonable expectation that 

the design, conduct, and reporting of 

research performed under PHS contracts 

is free from bias resulting from 

Investigator financial conflicts of 

interest. 

§ 94.2 Applicability. 

This part is applicable to each 

Institution that solicits, or that receives, 

PHS research funding by means of a 

contract and, through the 

implementation of this part by the 

Institution, to each Investigator 

participating in such research. 


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§ 94.3 Definitions. 

As used in this part: 

Contractor means an entity that 

provides property or services under 

contract for the direct benefit or use of 

the Federal Government. 

Disclosure of significant financial 

interests means an Investigator’s 

disclosure of significant financial 

interests to an Institution. 

FCOI report means an Institution’s 

report of a financial conflict of interest 

to a PHS Awarding Component. 

Financial conflict of interest means a 

significant financial interest that could 

directly and significantly affect the 

design, conduct, or reporting of PHSfunded research. 

Financial interest means anything of 

monetary value or potential monetary 

value. 

HHS means the United States 

Department of Health and Human 

Services, and any components of the 

Department to which the authority 

involved may be delegated. 

Institution means any domestic or 

foreign, public or private, entity or 

organization (excluding a Federal 

agency) that solicits, or that receives, 

PHS research funding. 

Institutional responsibilities means an 

Investigator’s professional 

responsibilities on behalf of the 

Institution including, but not limited to, 

activities such as research, research 

consultation, teaching, professional 

practice, institutional committee 

memberships, and service on panels 

such as Institutional Review Boards or 

Data and Safety Monitoring Boards. 

Investigator means the PD/PI and any 

other person, regardless of title or 

position, who is responsible for the 

design, conduct, or reporting of research 

funded by the PHS, or proposed for 

such funding, including persons who 

are subcontractors, collaborators, or 

consultants. 

Manage means to take action to 

address a financial conflict of interest, 

which includes reducing or eliminating 

the financial conflict of interest, to 

ensure that the design, conduct, or 

reporting of research is free from bias or 

the appearance of bias. 

PD/PI means a project director or 

principal investigator of a PHS-funded 

research project. 

PHS means the Public Health Service, 

an operating division of the U.S. 

Department of Health and Human 

Services, and any components of the 

PHS to which the authority involved 

may be delegated, including the 

National Institutes of Health. 

PHS Awarding Component means the 

organizational unit of the PHS that 

funds the research that is subject to this 

subpart. 

Public Health Service Act or PHS Act 

means the statute codified at 42 U.S.C. 

201 et seq. 

Research means a systematic 

investigation designed to develop or 

contribute to generalizable knowledge 

relating broadly to public health, 

including behavioral and social-sciences 

research. The term encompasses basic 

and applied research and product 

development. As used in this part, the 

term includes any such activity for 

which research funding is available 

from a PHS Awarding Component 

through a grant, cooperative agreement, 

or contract, whether authorized under 

the PHS Act or other statutory authority, 

such as a research grant, career 

development award, center grant, 

individual fellowship award, 

infrastructure award, institutional 

training grant, program project, or 

research resources award. 

Significant financial interest means, 

except as otherwise specified in this 

definition: 

(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. For 

purposes of this definition, 

remuneration includes salary and any 

payment for services not otherwise 

identified as salary (e.g., consulting fees, 

honoraria, paid authorship, travel 

reimbursement); equity interest includes 

any stock, stock option, or other 

ownership interest, as determined 

through reference to public prices or 

other reasonable measures of fair market 

value; 

(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 the Investigator (or the 

Investigator’s spouse or dependent 

children) holds any equity interest (e.g., 

stock, stock option, or other ownership 

interest); or 

(iii) Intellectual property rights (e.g., 

patents, copyrights), royalties from such 

rights, and agreements to share in 

royalties related to such rights. 

(2) The term significant financial 

interest does not include the following 

types of financial interests: Salary, 

royalties, or other remuneration paid by 

the Institution to the Investigator if the 

Investigator is currently employed or 

otherwise appointed by the Institution; 

any ownership interest in the Institution 

held by the Investigator, if the 

Institution is a commercial or for-profit 

organization; income from seminars, 

lectures, or teaching engagements 

sponsored by a federal, state, or local 

government agency, or an institution of 

higher education as defined at 20 U.S.C. 

1001(a); or income from service on 

advisory committees or review panels 

for a federal, state, or local government 

agency, or an institution of higher 

education as defined at 20 U.S.C. 

1001(a). 

§ 94.4 Responsibilities of Institutions 

regarding Investigator financial conflicts of 

interest. 

Each Institution shall: 

(a) Maintain an up-to-date, written, 

enforced policy on financial conflicts of 

interest that complies with this part, 

and make such policy available via a 

publicly accessible Web site. If an 

Institution maintains a policy on 

financial conflicts of interest that 

includes standards that are more 

stringent than this part (e.g., that require 

a more extensive disclosure of financial 

interests), the Institution shall adhere to 

its policy and shall provide FCOI 

reports regarding identified financial 

conflicts of interest to the PHS 

Awarding Component in accordance 

with the Institution’s own standards. 

(b) Inform each Investigator of the 

Institution’s policy on financial 

conflicts of interest, the Investigator’s 

responsibilities regarding disclosure of 

significant financial interests, and of 

these regulations, and require each 

Investigator to complete training 

regarding same prior to engaging in 

PHS-funded research and, thereafter, at 

least once every two years. 

(c) If the Institution carries out the 

PHS-funded research through a 

subrecipient (e.g., subcontractor or 

collaborator): 

(1) Incorporate as part of a written 

agreement with the subrecipient legally 

enforceable terms that establish whether 

the financial conflicts of interest policy 

of the awardee Institution or that of the 

subrecipient applies to the 

subrecipient’s Investigators. 

(i) If the subrecipient’s financial 

conflicts of interest policy applies to 

subrecipient Investigators, the 

subrecipient shall certify as part of the 

agreement that its policy complies with 

this part. If the subrecipient cannot 


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provide such certification, the 

agreement shall state that subrecipient 

Investigators are subject to the financial 

conflicts of interest policy of the 

awardee Institution; 

(ii) If the subrecipient’s financial 

conflicts of interest policy applies to 

subrecipient Investigators, the 

agreement shall specify time period(s) 

for the subrecipient to report all 

identified financial conflicts of interest 

to the awardee Institution. Such time 

period(s) shall be sufficient to enable 

the awardee Institution to provide 

timely FCOI reports, as necessary, to the 

PHS; 

(iii) If subrecipient Investigators are 

subject to the awardee Institution’s 

financial conflicts of interest policy, the 

agreement shall specify time period(s) 

for the subrecipient to submit all 

Investigator disclosures of significant 

financial interests to the awardee 

Institution. Such time period(s) shall be 

sufficient to enable the awardee 

Institution to comply timely with its 

review, management, and reporting 

obligations under this part. 

(2) Provide FCOI reports to the PHS 

regarding all financial conflicts of 

interest of all subrecipient Investigators 

consistent with this part. 

(d) Designate an institutional 

official(s) to solicit and review 

disclosures of significant financial 

interests from each Investigator who is 

planning to participate in the PHSfunded research. 

(e)(1) Require that each Investigator 

who is planning to participate in the 

PHS-funded research disclose to the 

Institution’s designated official(s) the 

Investigator’s significant financial 

interests (and those of the Investigator’s 

spouse and dependent children). 

(2) Require that each Investigator who 

is participating in the PHS-funded 

research submit an updated disclosure 

of significant financial interests at least 

annually during the period of the award. 

Such disclosure shall include any 

information that was not disclosed 

initially to the Institution pursuant to 

paragraph (e)(1) of this section, or in a 

subsequent disclosure of significant 

financial interests, and shall include 

updated information regarding any 

previously-disclosed significant 

financial interest (e.g., the updated 

value of a previously-disclosed equity 

interest). 

(3) Require that each Investigator who 

is participating in the PHS-funded 

research submit an updated disclosure 

of significant financial interests within 

thirty days of acquiring a new 

significant financial interest (e.g., 

through purchase, marriage, or 

inheritance). 

(f) Provide guidelines consistent with 

this part for the designated institutional 

officials to determine whether an 

Investigator’s significant financial 

interest is related to PHS-funded 

research and, if so related, whether the 

significant financial interest is a 

financial conflict of interest. An 

Investigator’s significant financial 

interest is related to PHS-funded 

research when the Institution, through 

its designated officials, reasonably 

determines that the significant financial 

interest: Appears to be affected by the 

PHS-funded research; or is in an entity 

whose financial interest appears to be 

affected by the research. A financial 

conflict of interest exists when the 

Institution, through its designated 

officials, reasonably determines that the 

significant financial interest could 

directly and significantly affect the 

design, conduct, or reporting of the 

PHS-funded research. 

(g) Take such actions as necessary to 

manage financial conflicts of interest, 

including any financial conflicts of a 

subrecipient Investigator pursuant to 

paragraph (c) of this section. 

Management of an identified financial 

conflict of interest requires development 

and implementation of a management 

plan and, if necessary, a mitigation plan 

pursuant to § 94.5(a). 

(h) Provide initial and ongoing FCOI 

reports to the PHS as required pursuant 

to § 94.5(b). 

(i) Maintain records relating to all 

Investigator disclosures of financial 

interests and the Institution’s review of, 

or response to, such disclosures 

(whether or not a disclosure resulted in 

the Institution’s determination of a 

financial conflict of interest), for at least 

three years from the date of final 

payment or, where applicable, for the 

time periods specified in 48 CFR part 4, 

subpart 4.7. 

(j) Establish adequate enforcement 

mechanisms and provide for employee 

sanctions or other administrative 

actions to ensure Investigator 

compliance as appropriate. 

(k) Certify, in each contract proposal 

to which this part applies, that the 

Institution: 

(1) Has in effect at that Institution an 

up-to-date, written, and enforced 

administrative process to identify and 

manage financial conflicts of interest 

with respect to all research projects for 

which funding is sought or received 

from the PHS; 

(2) Shall promote and enforce 

Investigator compliance with this part’s 

requirements including those pertaining 

to disclosure of significant financial 

interests; 

(3) Shall manage financial conflicts of 

interest and provide initial and ongoing 

FCOI reports to the PHS consistent with 

this part; 

(4) Agrees to make information 

available, promptly upon request, to the 

HHS relating to any Investigator 

disclosure of financial interests and the 

Institution’s review of, or response to, 

such disclosure, whether or not the 

disclosure resulted in the Institution’s 

determination of a financial conflict of 

interest; and 

(5) Shall fully comply with the 

requirements of this part. 

§ 94.5 Management and reporting of 

financial conflicts of interest. 

(a) Management of financial conflicts 

of interest. 

(1) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the designated 

officials of an Institution shall, 

consistent with § 94.4(f): Review all 

Investigator disclosures of significant 

financial interests; determine whether 

any significant financial interests relate 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so, develop and 

implement a management plan that 

shall specify the actions that have been, 

and shall be, taken to manage such 

financial conflict of interest. Examples 

of conditions or restrictions that might 

be imposed to manage a financial 

conflict of interest include, but are not 

limited to: 

(i) Public disclosure of financial 

conflicts of interest (e.g., when 

presenting or publishing the research); 

(ii) For research projects involving 

human subjects research, disclosure of 

financial conflicts of interest directly to 

participants; 

(iii) Appointment of an independent 

monitor capable of taking measures to 

protect the design, conduct, and 

reporting of the research against bias, or 

the appearance of bias, resulting from 

the financial conflict of interest; 

(iv) Modification of the research plan; 

(v) Change of personnel or personnel 

responsibilities, or disqualification of 

personnel from participation in all or a 

portion of the research; 

(vi) Reduction or elimination of the 

financial interest (e.g., sale of an equity 

interest); or 

(vii) Severance of relationships that 

create actual or potential financial 

conflicts. 

(2) Whenever, in the course of an 

ongoing PHS-funded research project, a 

new Investigator participating in the 

research project discloses a significant 

financial interest or an existing 

Investigator discloses a new significant 


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financial interest to the Institution, the 

designated officials of the Institution 

shall, within sixty days: Review the 

disclosure of significant financial 

interests; determine whether it is related 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so, implement, on at least 

an interim basis, a management plan 

that shall specify the actions that have 

been, and will be, taken to manage such 

financial conflict of interest. Depending 

on the nature of the significant financial 

interest, an Institution may determine 

that additional interim measures are 

necessary with regard to the 

Investigator’s participation in the PHSfunded research project between the 

date of disclosure and the completion of 

the Institution’s review. 

(3) Whenever an Institution identifies 

a significant financial interest that was 

not disclosed timely by an Investigator 

or, for whatever reason, was not 

previously reviewed by the Institution 

during an ongoing PHS-funded research 

project (e.g., was not timely reviewed or 

reported by a subrecipient), the 

designated officials shall, within sixty 

days: Review the significant financial 

interest; determine whether it is related 

to PHS-funded research; determine 

whether a financial conflict of interest 

exists; and, if so: 

(i) Implement, on at least an interim 

basis, a management plan that shall 

specify the actions that have been, and 

will be, taken to manage such financial 

conflict of interest going forward; 

(ii) Implement, on at least an interim 

basis, a mitigation plan which shall 

include review and determination as to 

whether any PHS-funded research, or 

portion thereof, conducted prior to the 

identification and management of the 

financial conflict of interest was biased 

in the design, conduct, or reporting of 

such research. Depending on the nature 

of the significant financial interest, an 

Institution may determine that 

additional interim measures are 

necessary with regard to the 

Investigator’s participation in the PHSfunded research project between the 

date that the significant financial 

interest is identified and the completion 

of the Institution’s review. 

(4) Whenever an Institution 

implements a management plan 

pursuant to this part, the Institution 

shall monitor Investigator compliance 

with the management plan on an 

ongoing basis until the completion of 

the PHS-funded research project. 

(5)(i) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the Institution 

shall make available via a publicly 

accessible Web site information 

concerning any significant financial 

interest disclosed to the Institution that 

meets the following three criteria: 

(A) The significant financial interest 

was disclosed and is still held by the 

PD/PI or any other Investigator who has 

been identified by the Institution as 

senior/key personnel for the PHSfunded research project in the grant 

application, contract proposal, contract, 

progress report, or other required report 

submitted to the PHS; 

(B) The Institution determines that the 

significant financial interest is related to 

the PHS-funded research; and 

(C) The Institution determines that the 

significant financial interest is a 

financial conflict of interest. 

(ii) The information that the 

Institution makes available via a 

publicly accessible Web site shall 

include, at a minimum, the following: 

The Investigator’s name; the 

Investigator’s position with respect to 

the research project; the nature of the 

significant financial interest; and the 

approximate dollar value of the 

significant financial interest (dollar 

ranges are permissible: Less than 

$20,000; less than $50,000; less than 

$100,000; less than or equal to $250,000; 

greater than $250,000), or a statement 

that the interest is one whose value 

cannot be readily determined through 

reference to public prices or other 

reasonable measures of fair market 

value. 

(iii) The information that the 

Institution makes available via a 

publicly accessible Web site shall be 

updated at least annually. In addition, 

the Institution shall update the Web site 

within sixty days of the Institution’s 

receipt or identification of information 

concerning any additional significant 

financial interest that was not 

previously disclosed by the PD/PI or 

senior/key personnel for the PHSfunded research project, or upon the 

disclosure of a significant financial 

interest by a new PD/PI or new senior/ 

key personnel for the PHS-funded 

research project, if the Institution 

determines that the significant financial 

interest is related to the PHS-funded 

research and is a financial conflict of 

interest. 

(iv) Information concerning the 

significant financial interests of an 

individual subject to this paragraph 

(a)(5) of this section shall remain 

available via the Institution’s publicly 

accessible Web site for at least five years 

from the date that the information was 

most recently updated. 

(6) In addition to the types of 

financial conflicts of interest as defined 

in this part that must be managed 

pursuant to this section, an Institution 

may require the management of other 

financial conflicts of interest, as the 

Institution deems appropriate. 

(b) Reporting of financial conflicts of 

interest. 

(1) Prior to the Institution’s 

expenditure of any funds under a PHSfunded research project, the Institution 

shall provide to the PHS Awarding 

Component a FCOI report regarding any 

Investigator significant financial interest 

found by the Institution to be conflicting 

and ensure that the Institution has 

implemented a management plan in 

accordance with this part. 

(2) For any significant financial 

interest that the Institution identifies as 

conflicting subsequent to the 

Institution’s initial FCOI report during 

an ongoing PHS-funded research project 

(e.g., upon the participation of a new 

Investigator in the research project), the 

Institution shall provide to the PHS 

Awarding Component, within sixty 

days, a FCOI report regarding the 

financial conflict of interest and ensure 

that the Institution has implemented a 

management plan in accordance with 

this part. Where such FCOI report 

involves a significant financial interest 

that was not disclosed timely by an 

Investigator or, for whatever reason, was 

not previously reviewed by the 

Institution (e.g., was not timely 

reviewed or reported by a subrecipient), 

the Institution shall also provide with 

its FCOI report the mitigation plan 

implemented by the Institution to 

determine whether any PHS-funded 

research, or portion thereof, conducted 

prior to the identification and 

management of the financial conflict of 

interest was biased in the design, 

conduct, or reporting of such research. 

(3) Any FCOI report required under 

paragraphs (b)(1) or (b)(2) of this section 

shall include sufficient information to 

enable the PHS Awarding Component to 

understand the nature and extent of the 

financial conflict, and to assess the 

appropriateness of the Institution’s 

management plan. Elements of the FCOI 

report shall include, but are not limited 

to the following: 

(i) Project/Contract number; 

(ii) PD/PI or Contact PD/PI if a 

multiple PD/PI model is used; 

(iii) Name of the Investigator with the 

financial conflict of interest; 

(iv) Nature of the financial interest 

(e.g., equity, consulting fee, travel 

reimbursement, honorarium); 

(v) Value of the financial interest 

(dollar ranges are permissible: $0– 

$4,999; $5,000–$9,999; $10,000– 

$19,999; amounts between $20,000– 

$100,000 by increments of $20,000; 

amounts above $100,000 by increments 

of $50,000), or a statement that the 


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interest is one whose value cannot be 

readily determined through reference to 

public prices or other reasonable 

measures of fair market value; 

(vi) A description of how the financial 

interest relates to the PHS-funded 

research and the basis for the 

Institution’s determination that the 

financial interest conflicts with such 

research; 

(vii) A description of the key elements 

of the Institution’s management plan, 

including: 

(A) The role and function of the 

conflicted Investigator in the research 

project; 

(B) The rationale for including the 

conflicted Investigator in the research 

project; 

(C) The conditions of the management 

plan; 

(D) How the management plan will 

safeguard objectivity in the research 

project; 

(E) Confirmation of the Investigator’s 

agreement to the management plan; 

(F) How the management plan will be 

monitored to ensure Investigator 

compliance; 

(G) Other information as needed. 

(4) For any financial conflict of 

interest previously reported by the 

Institution with regard to an ongoing 

PHS-funded research project, the 

Institution shall provide an annual FCOI 

report that addresses the status of the 

financial conflict of interest and any 

changes to the management plan to the 

PHS Awarding Component for the 

duration of the PHS-funded research 

project. The annual FCOI report shall 

specify whether the financial conflict is 

still being managed or explain why the 

financial conflict of interest no longer 

exists. The Institution shall provide 

annual FCOI reports to the PHS 

Awarding Component for the duration 

of the project period (including 

extensions with or without funds) in the 

time and manner specified by the PHS 

Awarding Component. 

(5) In addition to the types of 

financial conflicts of interest as defined 

in this part that must be reported 

pursuant to this section, an Institution 

may require the reporting of other 

financial conflicts of interest, as the 

Institution deems appropriate. 

§ 94.6 Remedies. 

(a) If the failure of an Investigator to 

comply with an Institution’s financial 

conflicts of interest policy or a financial 

conflict of interest management plan 

appears to have biased the design, 

conduct, or reporting of the PHS-funded 

research, the Institution shall promptly 

notify the PHS Awarding Component of 

the corrective action taken or to be 

taken. The PHS Awarding Component 

will consider the situation and, as 

necessary, take appropriate action, or 

refer the matter to the Institution for 

further action, which may include 

directions to the Institution on how to 

maintain appropriate objectivity in the 

funded project. 

(b) The HHS may inquire at any time 

(i.e., before, during, or after award) into 

any Investigator disclosure of financial 

interests and the Institution’s review of, 

or response to, such disclosure, whether 

or not the disclosure resulted in the 

Institution’s determination of a financial 

conflict of interest. An Institution is 

required to submit, or permit on site 

review of, all records pertinent to 

compliance with this part. To the extent 

permitted by law, HHS will maintain 

the confidentiality of all records of 

financial interests. On the basis of its 

review of records or other information 

that may be available, the PHS 

Awarding Component may decide that a 

particular financial conflict of interest 

will bias the objectivity of the PHSfunded research to such an extent that 

further corrective action is needed or 

that the Institution has not managed the 

financial conflict of interest in 

accordance with this part. The PHS 

Awarding Component may determine 

that issuance of a Stop Work Order by 

the Contracting Officer or other 

enforcement action is necessary until 

the matter is resolved. 

(c) In any case in which the HHS 

determines that a PHS-funded project of 

clinical research whose purpose is to 

evaluate the safety or effectiveness of a 

drug, medical device, or treatment has 

been designed, conducted, or reported 

by an Investigator with a financial 

conflict of interest that was not managed 

or reported by the Institution as 

required by this part, the Institution 

shall require the Investigator involved to 

disclose the financial conflict of interest 

in each public presentation of the 

results of the research and to request an 

addendum to previously published 

presentations. 

Dated: March 26, 2010. 

Francis S. Collins, 

Director, National Institutes of Health. 

Approved: April 14, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–11885 Filed 5–20–10; 8:45 am] 

BILLING CODE 4140–01–P 


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