[Federal Register Volume 60, Number 132 (Tuesday, July 11, 1995)]
[Rules and Regulations]
[Pages 35810-35819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16799]
[[Page 35809]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
National Science Foundation
_______________________________________________________________________
42 CFR Part 50
45 CFR Part 64
Objectivity in Research; Investigatory Financial Disclosure Policy;
Final Rule and Notice
Federal Register / Vol. 60, No. 132 / Tuesday, July 11, 1995 / Rules
and Regulations
[[Page 35810]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 50
Office of the Secretary
45 CFR Part 94
RIN 0905-AE01
Objectivity in Research
AGENCY: Public Health Service and Office of the Secretary, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Public Health Service (PHS) and the Office of the
Secretary, HHS, are promulgating regulations establishing standards and
procedures to be followed by institutions that apply for research
funding from the PHS to ensure that the design, conduct, or reporting
of research funded under PHS grants, cooperative agreements or
contracts will not be biased by any conflicting financial interest of
those investigators responsible for the research.
Under the rules, investigators are required to disclose to an
official(s) designated by the institution a listing of Significant
Financial Interests (and those of his/her spouse and dependent
children) that would reasonably appear to be affected by the research
proposed for funding by the PHS. The institutional official(s) will
review those disclosures and determine whether any of the reported
financial interests could directly and significantly affect the design,
conduct, or reporting of the research and, if so, the institution must,
prior to any expenditure of awarded funds, report the existence of such
conflicting interests to the PHS Awarding Component and act to protect
PHS-funded research from bias due to the conflict of interest.
EFFECTIVE DATE: October 1, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. George J. Galasso, Associate
Director for Extramural Affairs, National Institutes of Health,
Building 1, Room 552, 9000 Rockville Pike, MSC 0154, Bethesda, MD
20892-0154. The telephone number is (301) 496-5356 (this is not a toll-
free number).
SUPPLEMENTARY INFORMATION: On June 28, 1994 the Department of Health
and Human Services (HHS) published proposed regulations (59 FR 33242)
to ensure that PHS-funded research would not be compromised by
financial interests of investigators that could be reasonably expected
to bias the design, conduct or reporting of the research. In addition
to setting forth proposed rules requiring institutional procedures for
the disclosure and management, reduction or elimination of Significant
Financial Interests that would reasonably appear to be directly and
significantly affected by the research funded by PHS, or proposed for
funding, the Notice of Proposed Rulemaking (NPRM) raised several
specific questions about alternatives for implementing the pertinent
statutes and for ensuring that PHS-funded research is not compromised
by any financial conflicts of interest.
The NPRM was published in the Federal Register at the same time the
National Science Foundation (NSF) published its Investigator Financial
Disclosure Policy and reflected coordination between the two agencies.
Since that time, we have continued to work closely with the NSF to
ensure that the NSF policy and our regulations do not impose disparate
requirements upon the many institutions that receive funding from both
agencies. Elsewhere in this separate part in this Federal Register, the
NSF is issuing changes in its policy necessary to maintain consistency
with this final rule, and the changes we have made to conform to the
NSF policy are referenced in the discussion that follows. The agencies
intend to continue their cooperation by working together to develop
common guidance, including a set of questions and answers, to help
institutions implement conflict of interest policies that comply with
both HHS and NSF requirements.
During the 60 day comment period that ended on August 28, 1994, the
PHS received 102 comments on the NPRM. Most of the comments were
generally supportive of giving the applicant institutions primary
responsibility for identifying and resolving financial conflicts of
interest that could directly and significantly affect the PHS-funded
research. The comments are summarized below under the headings: Changes
in the NPRM; Comments Not Resulting in Any Changes; and Responses to
Questions on Alternatives.
Changes in the NPRM
A summary of the changes made in the regulations as proposed on
June 28, 1994, follows.
1. In the section titles, Secs. 50.601, 50.602, 50.605 and several
other sections,\1\ references to ``Significant Financial Interests'' or
``Significant Financial Interests of the type described in
Sec. 50.605,'' have been changed to refer to a conflict of interest or
conflicting financial interests. This change has been made in response
to many of the comments. It was pointed out that this change will make
the HHS regulations consistent with the NSF regulations and that the
institutions can only manage the conflict, not the financial interests.
\1\ Only the sections in 42 CFR part 50 are referenced. Similar
changes have been made in the regulations at 45 CFR part 94 which
will apply to contracts.
---------------------------------------------------------------------------
2. In response to several comments, the ``Purpose'' sections in the
grants and the contracts regulations have been rewritten to make them
more concise and parallel.
3. A reference to Sec. 50.604(a) has been added to the
``Applicability'' section. As explained more fully in paragraph 6
below, this change and the change in Sec. 50.604(a) clarify that the
regulations apply to Investigators carrying out the PHS-funded research
for subgrantees or contractors of the awardee institution.
4. In response to several comments, the definition of
``Investigator,'' has been amended to delete the phrase ``at the
Institution.''
5. The definition of ``Significant Financial Interest'' in
Sec. 50.603 has been changed in several respects. Clause (i) has been
split so that ownership interests are now referenced in a new clause
(ii). Some commenters felt that it was not clear whether the
requirement that an institution be an applicant under the SBIR program
modified both ownership interest and salary, royalties or other
remuneration.
The exception for financial interests in business enterprises has
been split to clarify that the per annum measurement applies only to
salary, royalties or other payments not reasonably expected to exceed
$10,000 per annum. In addition, the dollar limits have been changed
from $5,000 to $10,000 and the applicability of the alternative
measures of $10,000 in value or five percent ownership interest, has
been clarified. These changes have been made in response to a large
number of comments stating that the $5,000 limit was too low. A
majority of those comments indicated that $10,000 would be an
appropriate figure, particularly since the experience of state
universities in California, and some other universities, is that
interests up to this amount do not raise conflict of interest concerns.
The reference to determining the value of equity interests on the
basis of public prices or other reasonable measures of fair market
value was adapted from a similar provision in the proposed FDA rule on
conflict of interest (59 FR 48708 et seq., September 22, 1994).
6. Section 50.604(a) has been revised to clarify that the
Institution must
[[Page 35811]]
maintain an appropriate written, enforced conflict of interest policy
(this parallels NSF language) and that the Institution must make
reasonable efforts to ensure compliance with the regulations by
Investigators working for subgrantees and contractors, either by
including those Investigators in the Institution's policy or by
receiving appropriate assurances from their employers. This latter
change was recommended in several comments and is consistent with
current regulations and policies on the applicability of grant terms
and conditions to subgrantees and contractors.
7. In response to many comments, paragraph (a)(3) (redesignated as
paragraph (c)) of Sec. 50.604 has been changed from requiring the
institution to ``ensure'' that investigators have disclosed all
Significant Financial Interest to simply ``require'' disclosures by
each investigator. In addition, in response to several comments and for
uniformity with the NSF guidelines, this paragraph has been revised to
require disclosure, by the time an application is submitted to PHS, of
those Significant Financial Interests attributable to the Investigator
that would reasonably appear to be affected by the research, including
interests in entities whose financial interests would reasonably appear
to be affected by the research. This change eliminates the need to
cross-reference the description of a conflict interest in
Sec. 50.605(a). Also, the changes in this section and in
Secs. 50.604(c) and 50.605(a) will result in a slightly broader
disclosure by the Investigator than under the NPRM. The institutional
official(s) will review the disclosures and determine which disclosed
interests could directly and significantly affect the design, conduct
or reporting of the research, necessitating the management, reduction
or elimination of the conflict of interest. In addition, in response to
a significant number of comments, the reference to ``pendency'' of the
award has been changed to ``period'' of the award.
Paragraph (a)(5) of Sec. 50.604 (redesignated as paragraph (e)) has
been changed to delete the requirement that records be identifiable to
each award, and to refer to the applicable retention requirements in
the HHS grants administration regulations. The former change has been
made for conformity with the NSF policy, and the latter change
clarifies that the recordkeeping requirements of these regulations are
intended to be consistent with the HHS grants administration
regulations. The change in paragraph (f) of Sec. 50.604 (formerly
paragraph (a)(6)) has also been made for conformity with the NSF
policy.
8. In response to many comments, Sec. 50.604(a)(7)(ii), now
redesignated as (g)(2), has been revised to reduce the burden on
institutions and ensure that the application does not have to state
whether a conflict of interest has been found. Rather, the provision
now requires the applicant to certify that action will be taken, prior
to the institution's expenditure of any funds under the award, to
report to the PHS awarding component the existence of a conflicting
interest and assure that the interest has been managed, reduced or
eliminated in accordance with the regulations. The commentors felt that
review of an application would be biased if the application indicated
there was a conflict of interest and that, in any case, it would not be
feasible for an institution to review the disclosed financial interests
and determine whether a conflict of interest was present in the limited
time available prior to submission of the application.
In addition, the previous Sec. 50.604(a)(8)(i) has been
incorporated into Sec. 50.604(g)(2) with minor changes. Many commentors
felt that the 60 day period for management of a conflict of interest
found after the award should be doubled. However, the 60 day period
does not seem unreasonable, since we have clarified that it is measured
from the time the institution identifies the conflict of interest and
that only interim action is required by the end of the 60 day period.
As stated in the NPRM, section 493A of the PHS Act imposes a continuing
obligation on awardees to identify conflicts of interest in clinical
research projects and report their management, reduction or
elimination. This and other statutory requirements for clinical
research have been applied to all PHS-funded research in order to avoid
confusion and provide for uniform PHS reporting requirements. We would
not expect this reporting requirement to be burdensome, as only a few
conflicts of interest are likely to be identified after the award.
Section 50.604(a)(8)(ii) has been incorporated into Sec. 50.606(b),
because the review of records referenced in the former section is
directly related to the inquiry into actions regarding conflicts of
interest addressed in the latter section. Section 50.604(a)(8)(iii) has
been deleted as duplicative of the statement in the definition of
``Significant Financial Interest'' (Sec. 50.603), that salary,
royalties or other remuneration from the institution is not considered
a Significant Financial Interest. Under current regulations and
policies governing applications for PHS research grants, if the
applicant receives non-PHS grant support for the same project to be
supported by the PHS award, the grant must be listed in the ``Other
Support'' section of the application for PHS support.
9. Section 50.605(a) has been revised to clarify that the
institutional official(s) must identify and manage, reduce or eliminate
any conflicts of interest. Consistent with the language in the NSF
guidelines, this provision states 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. As noted
above in the discussion of the changes to Sec. 50.604(c), Investigators
must disclose those Significant Financial Interests that would
reasonably appear to be affected by the research and the institutional
official must decide which of those interests are conflicting under the
standard prescribed in Sec. 50.605(a). This change is intended to more
clearly define and limit the types of financial interests that must be
managed, reduced or eliminated because they are considered to be
conflicting interests.
In response to a few comments, the clause introducing the examples
of methods for managing, reducing or eliminating conflicts has been
clarified by adding after ``include,'' the phrase ``but are not limited
to.''
10. In Sec. 50.606, the first sentence has been deleted because it
essentially duplicated the provision in proposed Sec. 50.604(a)(6). In
the next sentence, the term ``employee'' has been changed to the
defined term ``Investigator'' and, in response to a comment, the phrase
``or to be taken'' has been added at the end of the sentence. In
addition, paragraph (b) has been rewritten to incorporate
Sec. 50.604(b), because the two provisions were somewhat duplicative.
11. Many commentors were concerned about what they considered to be
a significant underestimation of the annual reporting and recordkeeping
burden. In response, burdens have been further reduced by raising the
dollar threshold for financial interests that are considered
Significant Financial Interests subject to the regulations, and by
amending Sec. 50.604(g)(2) to require the reporting of a conflict of
interest and its management, reduction or elimination only after an
award has been made (but before any expenditure of funds). In addition,
the estimated annual reporting and record keeping burden has been
recalculated in light of these changes and the public comments.
12. Many commentors urged uniformity with the NSF guidelines, but
[[Page 35812]]
indicated the pursuit of that end should not interfere with necessary
changes to the NPRM . As noted above, many of the changes result in
greater uniformity between these regulations and the NSF guidelines.
The few remaining differences between these regulations and the NSF
guidelines are based upon requirements in section 493A of the PHS Act,
42 U.S.C. 289b-1, and differences between the grant programs and
experiences under those programs.
The effective date for these regulations, October 1, 1995, is the
same as the effective date for the NSF guidelines. Although some
commentors felt that a longer lead time would be necessary to enable
institutions to prepare for implementation of the regulations, we
believe the time period provided is ample, particularly because
institutions have had since June 28, 1994, to prepare for
implementation of the similar provisions of the NSF guidelines and
because many institutions already have conflict of interest procedures.
Comments Not Resulting in Any Changes
1. Title
Two commentors felt that the title of the regulations should be
changed to focus upon investigator financial disclosure or conflict of
interest. These are not inappropriate titles, but we have chosen to
focus the title upon the desired outcome of the review of investigator
financial disclosures, that is, objectivity in the design, conduct and
reporting of the research.
2. Section 50.602 Applicability
Several commentors recommended that the regulations be limited to
clinical research. As explained in the preamble to the NPRM, experience
indicates that financial conflicts of interest can arise in all types
of research. It is expected that the risk of a conflict of interest
will be higher in clinical research than in other types of research,
but we have concluded that the latter risk is sufficiently likely that
pertinent financial interests should be disclosed and reviewed.
In response to a specific request for comments on the NSF exemption
from its conflict of interest policy for grantees employing fifty
persons or less, it was generally agreed by those responding that PHS-
funded investigators working for small entities may be just as subject
to conflicts of interest as investigators working at large
institutions. This view is consistent with the PHS experience referred
to in the preamble of the NPRM. The NSF experience has differed,
apparently because of the differences between the research funding that
is provided to small entities by HHS and NSF.
3. Section 50.603 Definitions
Investigator. There were diverse comments on the definition of the
term, ``Investigator.'' Although one commentor supported the approach
of the NPRM of leaving it to the institutions to determine who are
persons ``responsible for the design, conduct, or reporting'' of the
PHS funded research, others felt that the definition should offer more
guidance on who would fall within that category. It was recommended
that the term be limited to Principal Investigators, Co-Principal
Investigators, and faculty collaborators and that students and
technical staff be excluded. It was also recommended that
administrators be excluded by limiting the definition to the
``scientific design'' of the research. The definition of Investigator
has not been changed, except for deleting the phrase ``at the
institution,'' as explained above. The degree to which individuals are
responsible for the design, conduct, or reporting of the PHS-funded
research will vary. In some circumstances students, technical personnel
and administrators may not be ``responsible,'' but in other
circumstances, they may be, in that they are given responsibility for a
task that could have a significant effect on the design, conduct or
reporting of the research. Based on their knowledge of the specific
circumstances, we believe the institutions are in the best position to
determine who is responsible for the design, conduct or reporting of
the research to such a degree that his/her financial interests should
be reviewed.
Significant Financial Interest. As noted above, the public comments
led to several changes in this definition. There were a number of other
detailed comments that were not adopted, primarily because they would
have: Complicated the definition and its application (e.g., have
different threshold levels for publicly traded equity interests and
those not so traded, differentiate between large and small companies,
and adopt criteria for determining reasonably anticipated future
value); led to a long, cumbersome list of additional exclusions (e.g.,
exclude copyright that is not licensable, mutual funds, pensions, and
reimbursement for expenses); or were based upon a misunderstanding of
the definition and its effect (some apparently did not understand that
any remuneration an investigator receives from the applicant
institution was excluded). Some commentors questioned the exclusion of
ownership interests in SBIR applicants. No change has been made in
response to that comment because we believe such ownership interests
are apparent to PHS funding agencies based on the application.
Furthermore, the exclusion does not prohibit institutions from adopting
more rigorous standards, if they wish to do so.
The definition of Significant Financial Interest alone does not
delineate what the investigator must disclose or what the institution
must manage, reduce or eliminate. The Investigator must consider all
Significant Financial Interests, but need disclose only those that
would reasonably appear to be affected by the research proposed for
funding by the PHS, including the Investigator's financial interest in
entities whose interests would be affected. Following this disclosure,
the institutional official must determine, on the basis of the
regulatory standard, whether there are conflicting interests that need
to be managed, reduced, or eliminated. We think it is appropriate to
have a relatively broad range of financial interests considered by the
Investigator in making his/her determination of those that must be
disclosed. In this manner, broad consideration of possibly conflicting
interests is assured with minimal burdens, since only a limited number
of interests need to be disclosed and an even smaller number will need
to be managed, reduced or eliminated.
There were a number of comments recommending different thresholds
than those that were adopted, including a threshold adjusted for
inflation. The threshold amounts adopted were recommended in many
comments and seem to represent a reasonable balance between the need to
consider a broad range of financial interests and the burdens imposed
upon the investigators and the institutions.
4. Section 50.604
Many commented that the requirement for updating financial
disclosures (in Sec. 50.604(c) of these regulations) needed to be
clarified. The provision, which has not been changed, except for a
minor word change, states that financial disclosures must be updated
during the period of the award, either on an annual basis or as new
reportable Significant Financial Interests are obtained. We believe
this language is reasonably clear in conveying that the institutions
have the option of adopting either of two methods for investigators to
report changes in financial interests during the
[[Page 35813]]
period of the PHS award: reporting on an annual basis any changes in
the previously reported financial interests; or requiring investigators
to update disclosures as new reportable Significant Financial Interests
are obtained. An annual reporting requirement would serve as a reminder
for investigators to review their prior disclosures, but it might be
burdensome if in fact there are no changes and it could result in
delayed reporting as compared to the alternative. This burden would be
eliminated by the other reporting alternative, but there would be no
annual reminder to investigators to review and update their
disclosures. The weighing of these factors and the decision are left to
the institutions. The reference to ``new reportable Significant
Financial Interests'' is intended to include financial interests that
become reportable due to an increase in value that meets the reporting
threshold, as well as the acquisition of new interests that are
reportable. Of course, both types of interests are subject to
disclosure by the investigator only if they meet the criteria in
Sec. 50.604(c).
It was recommended that the requirement in Sec. 50.604(g)(2) for
the reporting to the PHS Awarding Component of the existence of a
conflicting interest be changed to conform with the NSF approach that
requires such reporting only ``if the institution finds that it is
unable to satisfactorily manage an actual or potential conflict of
interest.'' As stated in the NPRM, section 493A of the Public Health
Service Act requires that institutions report conflicting interests for
clinical research projects. To avoid disparate requirements for
clinical and nonclinical research, the regulations apply this reporting
requirement to all PHS-funded research.
5. Section 50.606
One commentor felt that the notification required in paragraph (a)
should go to HHS, rather than to the PHS Awarding Component. Because
PHS Awarding Components are responsible for the award and have
delegated authority, it is appropriate for those components to receive
notifications and to act on them. On the other hand, paragraph (b)
refers to HHS inquiries into institutional procedures and actions
because such audit type activities may be conducted by HHS components
other than the awarding agencies. As is made clear in the definitions,
the term HHS encompasses all components of the Department, including
the PHS Awarding Components.
A number of commentors objected to the requirement for submission
of records to the HHS, fearing that the confidentiality of such records
could not be assured. 45 CFR 74.53 already gives the HHS a right of
access to all records pertinent to grants, which would include the
records relating to financial conflicts of interest of investigators
carrying out the PHS-funded research. It is expected that the PHS
funding agencies will not often require the submission of records or
retain copies from audits at the institution, but when that occurs the
records will be maintained confidentially. In addition, although a few
commentors objected to the reference to suspension of funding pending
the resolution of a conflicting interest determined by the PHS awarding
agency as biasing the objectivity of the research, that provision has
been retained and a reference to the regulatory authority for the
suspension has been added. Such suspension action would be necessary to
protect Federal funds only in unusual situations, but we believe
awardees subject to the regulations should be notified of the potential
for such action.
Responses to Questions on Alternatives
The NPRM requested specific comments on the following issues: (1)
Whether the regulations should address institutional conflicts of
interest, as well as individual conflicting interests and, if so, how;
(2) what types of financial interests should be disclosed; (3) whether
the disclosed financial interests should include financial interests in
products that would compete with the product or potential product of
the PHS-funded research; (4) whether an employee's equity or other
nonsalary financial interests in an applicant institution should be
excluded from the definition of Significant Financial Interest; and (5)
whether there should be an exemption for all compensation other than
that tied to the outcome of the research. Most of the commentors
addressed at least some of these issues. Those comments are summarized
below.
Institutional Conflicts
Those addressing this issue were nearly unanimous in concluding
that the regulations should not address the institutional conflict of
interest issue because of the need to carefully consider that issue
through a separate process. We agree with that conclusion. The comments
on the alternatives for addressing institutional conflicts of interest
will be considered separately from this rulemaking.
Competing Products
Over 30 commentors opposed any requirement for disclosing financial
interests in entities or products that would compete with the PHS-
funded research. Twelve commentors supported investigator disclosure of
such competing entities or products, but some felt that the disclosure
should be limited to those financial interests in competitors or
competing products known to the investigator. As revised, the
regulation would not specifically require the disclosure of such
interests, but, depending upon the circumstances, those interests might
come within the definition of the financial interests that must be
disclosed. In clinical research, it is probable that a financial
interest in a product that competes with the product being evaluated
could reasonably appear to be affected by the PHS-funded research. Such
a relationship is much less probable where the PHS funding is for basic
research.
Types of Financial Interests Disclosed
Most of the comments on this issue are summarized above in the
discussion of comments on the definition of Significant Financial
Interests and on the financial interest that must be disclosed. The
financial interests to be disclosed must be known to the investigator
and determined by him/her to be a financial interest that would
reasonably appear to be affected by the PHS-funded research or to be a
financial interest in an entity whose financial interest would
reasonably appear to be affected by the research. This criterion would,
in most cases, require that the financial disclosure be relevant to
biomedical research or health care, as was recommended by one
commentor, but the disclosure would not necessarily be limited to those
fields, because other types of financial interests could reasonably
appear to be affected by the PHS-funded research.
Exclusion of Financial Interests
There were few specific comments on the questions relating to the
exclusion from the definition of Significant Financial Interest of
equity interests in, or compensation from, the applicant institution.
The general comments on the definition emphasized the need for limiting
disclosures to financial interests related to the research proposed for
PHS funding. We are retaining the exclusion for all remuneration paid
to an investigator by an applicant institution and the exclusion of any
ownership interest in the applicant institution if it is an
[[Page 35814]]
applicant under the SBIR or STTR program. We have not expanded the
exclusion for ownership interests to encompass all institutions,
because we believe there may be situations in which an ownership
interest in a for-profit applicant could be in conflict with the
investigator's responsibility for the conduct of the PHS-funded
research and that ownership interest should be subject to appropriate
institutional review. Experience under the regulations may prove this
reasoning to be incorrect. If so, we will consider appropriate
amendments to the regulations.
Regulatory Impact
The Department has concluded that this rule is not economically
significant under Executive Order 12866 and that it thus does not
require the development of a comprehensive benefit-cost analysis. While
we agree with comments received that the initial estimate of
implementation costs was low, none of these comments indicated that the
costs would exceed $100 million annually; in addition, changes made in
the final regulations will reduce implementation costs. Commentors did
not provide any evidence that the rule will hamper desirable research
or otherwise have an adverse effect on the conduct of research under
PHS-funded grants or on the consequent technological progress that is
so important to the Nation's economy.
Executive Order 12866 requires that the Office of Management and
Budget (OMB) review all regulations that may create a serious
inconsistency with or otherwise interfere with an action taken or
planned by another Federal agency. This rule was thus reviewed by OMB
and coordinated with the policy of the NSF on this subject (see the
notice of technical changes in NSF policy published elsewhere in this
separate part of this Federal Register.
The Department prepares a regulatory flexibility analysis, in
accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
chapter 6), if a rule is expected to have a significant impact on a
substantial number of small entities. Although we have not followed the
NSF approach of exempting entities with 50 or fewer employees, we have
concluded that the regulation will not have a significant impact on
small entities. Any such effect is mitigated by the provisions of the
regulations and the fact that the regulations impose obligations
primarily on those receiving grants that can be used, in part (amounts
for indirect costs), to offset the costs of compliance with the
regulatory requirements. The regulations do not apply to SBIR and STTR
Phase I applications. These programs are for small businesses and the
Phase I grants are for limited amounts. Phase II grants are for larger
amounts and thus more funds would be available for meeting the costs of
compliance. Furthermore, we have changed the regulations to reduce
burdens and costs of compliance for all entities subject to the
regulations by eliminating more financial interests from consideration
and by reducing burdens upon institutions through changes in the
certification requirements. Institutions do not have to take action to
identify, report and manage conflicting interests until after being
notified by the PHS Awarding Agency of its decision to award funds.
For the same reasons, this rule will not create an unfunded mandate
on State-owned institutions and thus would not trigger the requirements
of Executive Order 12875 on ``Enhancing the Intergovernmental
Partnership.'' The proposed rule has been changed to significantly
reduce burdens on institutions and, as noted above, institutions will
be able to use amounts awarded for indirect costs to meet the costs of
implementing the regulations.
Paperwork Reduction Act
The final rules contain information collection requirements that
are subject to review by OMB under the Paperwork Reduction Act of 1980.
The title, description, and respondent description applicable to the
information collection are shown below with an estimate of the annual
reporting and recordkeeping burden. These estimates have been revised
in light of the comments on the proposed rules and the changes in the
regulations. Consistent with the comments and a thorough consideration
of the potential burdens imposed by the reporting, recordkeeping and
disclosure requirements of the regulations, the statement of the burden
has been reduced from that stated in the NPRM, based upon changes in
the regulations that will significantly reduce the burdens on
institutions and upon more accurate estimates of the burdens imposed by
specific requirements.
The mean hours per response for initial reports of conflicts of
interest have been significantly increased to account for the review by
the institution of all the financial disclosures relating to an award.
Although not more than 200 reports of conflicts of interest are
expected, the institutions will need to review all financial
disclosures associated with PHS funding awards to determine whether or
not any conflicts of interest exist. Thus, the total burden of 16,000
hours is based on estimates that it will take, on the average, four-
fifths of an hour to review each of the 20,000 financial disclosures
associated with PHS funding awards. If the number of disclosures is
reduced because of the increase in the amount of the threshold for
significance, the burden may be an overestimate.
The burden for subsequent reports of conflicts (made during the
twelve month period after the initial report) is significantly less,
because we do not expect many additional reportable conflicts and there
will be only a limited number of disclosures to review.
We have significantly reduced the respondent number for reporting
that failure of an investigator to comply with the institution's
conflict of interest policy has biased the design, conduct or reporting
of the research (Sec. 50.606(a)). We have estimated there will be no
more than five such instances and we think that is a generous estimate.
For recordkeeping, we have listed the number of files expected to
be necessary, rather than the number of institutions, because it will
result in a more accurate estimation. The 20,000 figure is based upon
35,000 awards annually, reduced to account for those investigators who
will not have any disclosures (no files are required to be established)
and those investigators with more than one award. We have estimated it
will take four hours, on the average, for the establishment and
maintenance of each file. Although we believe this to be a very
generous estimate, we note that it will include the time of both
administrative and clerical personnel.
The burden figures for informing each investigator of the
institution's policy are based upon 2,000 recipient institutions and 20
hours for the performance of this function. This time burden could be
reduced even further if institutions choose to inform investigators
through a notice in the grant application procedures. This method of
notification would be acceptable because the regulations do not specify
the method of notification.
The financial disclosures burden estimate (Sec. 50.604(c)) is based
upon an investigator figure of 35,000 with an average response time of
one hour. We believe experience may show that the number of disclosures
will be significantly less because of the increases in the reporting
threshold. Note that we have not attempted to calculate the overall
hours spent by the institution to establish the necessary
administrative mechanisms to comply with the regulations. The estimates
are for burdens imposed by disclosure,
[[Page 35815]]
reporting and recordkeeping requirements, not all activities of an
institution that may result from the regulations.
Title: Responsibility of Applicants for Promoting Objectivity in
Research for which Public Health Service (PHS) Funding is Sought.
Description: The regulations would require each applicant/offeror
Institution to establish procedures to identify and manage, reduce, or
eliminate any conflicting financial interest of an Investigator
involved in the design, conduct or reporting of the research for which
PHS funding is sought.
Description of Respondents: Public and private non-profit
institutions, small business, and other for-profit organizations and
investigators working for such institutions, businesses and
organizations.
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Applicable
Applicable section of section of Total Mean hours Total hours Total hours
regulation 42 CFR regulation 45 number of per 42 CFR 45 CFR Total hours
CFR respondents response
----------------------------------------------------------------------------------------------------------------
Reporting:
50.604(g)(2) (initial 94.4(g)(2) 200 80.0 14,000 2,000 16,000
report of conflict of
interest).
50.604(g)(2) (subsequent 94.4(g)(2) 30 2.0 54 6 60
reports of conflict of
interest).
50.606(a)................. 94.6(a) 5 10.0 40 10 50
----------------------------------------------------------------
Total................... ............... ........... ........... ........... ........... 16,110
Recordkeeping:
50.604(e)................. 94.4(e) 20,000 4 72,000 8,000 80,000
----------------------------------------------------------------
Total................... ............... ........... ........... ........... ........... 80,000
Disclosure:
50.604(a)................. 94.4(a) 2,000 20.0 36,000 4,000 40,000
50.604(c)................. 94.4(c) 35,000 1 31,600 3,400 35,500
----------------------------------------------------------------
Total................... ............... ........... ........... ........... ........... 75,000
Total Burden............ ............... ........... ........... ........... ........... 171,110
----------------------------------------------------------------------------------------------------------------
In accordance with the requirements of the Paperwork Reduction Act
of 1980, the Department of Health and Human Services has submitted the
information collection requirements cited above to OMB for review and
approval. Organizations and individuals desiring to submit comments on
the information collection requirements and the estimated burden should
direct such comments to the information address cited above and to:
NIH/PHS Desk Officer, Office of Information and Regulatory Affairs,
OMB, New Executive Office Building, room 10235, 725 17th Street NW.,
Washington, DC 20503.
Catalogue of Federal Domestic Assistance
The rule will affect all extramural research, research and
development, and research and development support funded by the Public
Health Service. Questions about the rule should be directed to Dr.
George J. Galasso, Associated Director for Extramural Affairs, National
Institutes of Health, Building 1, Room 552, 9000 Rockville Pike, MSC
0154, Bethesda, MD 20892-0154. The telephone number is (301) 496-5356
(this is not a toll-free number).
List of Subjects
42 CFR Part 50
Grant programs--health; Conflict of interest; Medical research;
Behavioral, biological, biochemical, psychological and psychiatric
research.
45 CFR Part 94
Government procurement.
Dated: March 13, 1995.
Philip R. Lee,
Assistant Secretary for Health.
Approved: May 17, 1995.
Donna E. Shalala,
Secretary.
Accordingly, 42 CFR part 50 and 45 CFR subtitle A are amended as
set forth below:
1. Subpart F is added to 42 CFR part 50 to read as follows:
Subpart F--Responsibility of Applicants for Promoting Objectivity in
Research for Which PHS Funding Is Sought
Sec.
50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Institutional responsibility regarding conflicting interests
of investigators.
50.605 Management of conflicting interests.
50.606 Remedies.
50.607 Other HHS regulations that apply.
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Subpart F--Responsibility of Applicants for Promoting Objectivity
in Research for Which PHS Funding Is Sought
Sec. 50.601 Purpose.
This subpart promotes objectivity in research by establishing
standards to ensure there is no reasonable expectation that the design,
conduct, or reporting of research funded under PHS grants or
cooperative agreements will be biased by any conflicting financial
interest of an Investigator.
Sec. 50.602 Applicability.
This subpart is applicable to each Institution that applies for PHS
grants or cooperative agreements for research and, through the
implementation of this subpart by each Institution, to each
Investigator participating in such research (see Sec. 50.604(a));
provided, that this subpart does not apply to SBIR Program Phase I
applications. 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.
[[Page 35816]]
Sec. 50.603 Definitions.
As used in this subpart:
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).
Investigator means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of research
funded by PHS, or proposed for such funding. For purposes of the
requirements of this subpart relating to financial interests,
``Investigator'' includes the Investigator's spouse and dependent
children.
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.
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 or
cooperative agreement, whether authorized under the PHS Act or other
statutory authority.
Significant Financial Interest 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 Program;
(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 to exceed $10,000.
Small Business Innovation Research (SBIR) Program means the
extramural research program for small business that is established by
the Awarding Components of the Public Health Service and certain other
Federal agencies under Pub. L. 97-219, the Small Business Innovation
Development Act, as amended. For purposes of this subpart, the term
SBIR Program includes the Small Business Technology Transfer (STTR)
Program, which was established by Pub. L. 102-564.
Sec. 50.604 Institutional responsibility regarding conflicting
interests of investigators.
Each Institution must:
(a) Maintain an appropriate written, enforced policy on conflict of
interest that complies with this subpart and inform each Investigator
of that policy, the Investigator's reporting responsibilities, and of
these regulations. If the Institution carries out the PHS-funded
research through subgrantees, contractors, or collaborators, the
Institution must take reasonable steps to ensure that Investigators
working for such entities comply with this subpart, 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 this subpart.
(b) Designate an institutional official(s) to solicit and review
financial disclosure statements from each Investigator who is planning
to participate in PHS-funded research.
(c)(1) Require that by the time an application is submitted to 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 Significant Financial Interests (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.
(2) All financial disclosures must be updated during the period of
the award, either on an annual basis or as new reportable Significant
Financial Interests are obtained.
(d) Provide guidelines consistent with this subpart 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.
(e) 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.
(f) Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.
(g) Certify, in each application for the funding to which this
subpart applies, that:
(1) There is an effect at that Institution a written and enforced
administrative process to identify and manage, reduce or eliminate
conflicting interests with respect to all research projects for which
funding is sought from the PHS,
(2) 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 this
subpart; 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;
(3) The Institution agrees to make information available, upon
request, to the HHS regarding all conflicting interests identified by
the Institution and how those interests have been managed, reduced, or
eliminated to protect the research from bias; and
(4) The Institution will otherwise comply with this subpart.
[[Page 35817]]
Sec. 50.605 Management of conflicting interests.
(a) The designated official(s) must: Review all financial
disclosures; and determine whether a conflict of interest exists and,
if so, determine what actions should be taken by the institution to
manage, reduce or eliminate such conflict of interest. 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.
Examples of conditions or restrictions that might be imposed to manage
conflicts of interest include, but are not limited to:
(1) Public disclosure of significant financial interests;
(2) Monitoring of research by independent reviewers;
(3) Modification of the research plan;
(4) Disqualification from participation in all or a portion of the
research funded by the PHS;
(5) Divestiture of significant financial interests; or
(6) Severance of relationships that create actual or potential
conflicts.
(b) 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.
Sec. 50.606 Remedies.
(a) 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. 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 at any time inquire into the Institutional
procedures and actions regarding conflicting financial interests in
PHS-funded research, including a requirement for submission of, or
review on site, 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 and/or other information that may be available, the PHS
Awarding Component may decide that a particular 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, reduced, or eliminated the conflict of interest in
accordance with this subpart. The PHS Awarding Component may determine
that suspension of funding 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 conflicting
interest that was not disclosed or managed as required by this subpart,
the Institution must require the Investigator(s) involved to disclose
the conflicting interest in each public presentation of the results of
the research.
Sec. 50.607 Other HHS regulations that apply.
Several other regulations and policies apply to this subpart.
They include, but are not necessarily limited to:
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 Non-
Profit Organizations, and Commercial Organizations; and Certain
Grants and Agreements with States, Local Governments and Indian
Tribal Governments
45 CFR Part 76--Government-wide debarment and suspension (non-
procurement)
45 CFR Part 79--Program Fraud Civil Remedies
45 CFR Part 92--Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments
2. A new part 94 is added to 45 CFR, subtitle A, to read as
follows:
PART 94--RESPONSIBLE PROSPECTIVE CONTRACTORS
Sec.
94.1 Purpose.
94.2 Applicability.
94.3 Definitions.
94.4 Institutional Responsibility Regarding Conflicting Interests
of Investigators.
94.5 Management of Conflicting Interests.
94.6 Remedies.
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Sec. 94.1 Purpose.
This part promotes objectivity in research by establishing
standards to ensure there is no reasonable expectation that the design,
conduct, or reporting of research to be performed under PHS contracts
will be biased by any conflicting financial interest of an
Investigator.
Sec. 94.2 Applicability.
This part is applicable to each Institution that seeks PHS funding
for research and, through the implementation of this part, to each
Investigator who participates in such research (see Sec. 94.4(a));
provided that this part does not apply to SBIR Program Phase I
applications.
Sec. 94.3 Definitions.
As used in this part:
Contractor means an entity that provides property or services for
the direct benefit or use of the Federal Government.
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 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.
Investigator means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of a research
project funded by PHS, or proposed for such funding. For purposes of
the requirements of this part relating to financial interests,
``Investigator'' includes the Investigator's spouse and dependent
children.
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.
Public Health Service Act or PHS Act mean the statute codified at
42 U.S.C. 201 et seq.
PHS Awarding Component means an organizational unit of the PHS that
funds research that is subject to this part.
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 funding is
available from a PHS Awarding Component, whether
[[Page 35818]]
authorized under the PHS Act or other statutory authority.
Significant Financial Interest 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 program;
(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 reasonably expected to exceed
$10,000.
Small Business Innovation Research (SBIR) Program means the
extramural research program for small business that is established by
the awarding components of the Public Health Service and certain other
Federal agencies under Public Law 97-219, the Small Business Innovation
Development Act, as amended. For purposes of this part, the term SBIR
Program includes the Small Business Technology Transfer (STTR) Program,
which was established by Public Law 102-564.
Sec. 94.4 Institutional responsibility regarding conflicting interests
of investigators.
Each Institution must:
(a) Maintain an appropriate written, enforced policy on conflict of
interest that complies with this part and inform each Investigator of
that policy, the Investigator's reporting responsibilities, and of
these regulations. If the Institution carries out the PHS-funded
research through subcontractors, or collaborators, the Institution must
take reasonable steps to ensure that Investigators working for such
entities comply with this part, 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 this part.
(b) Designate an institutional official(s) to solicit and review
financial disclosure statements from each Investigator who is planning
to participate in PHS-funded research.
(c)(1) Require that by the time an application is submitted to 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 Significant Financial Interests (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.
(2) All financial disclosures must be updated during the period of
the award, either on an annual basis or as new reportable Significant
Financial Interests are obtained.
(d) Provide guidelines consistent with this part 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.
(e) 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.
(f) Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.
(g) Certify, in each contract proposal, that:
(1) there is in effect at that Institution a written and enforced
administrative process to identify and manage, reduce or eliminate
conflicting interests with respect to all research projects for which
funding is sought from the PHS;
(2) prior to the Institution's expenditure of any funds under the
award, the Institution will report to the PHS Awarding Component the
existence of any 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
this part; 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.
(3) the Institution agrees to make information available, upon
request, to the HHS regarding all conflicting interests identified by
the Institution and how those interests have been managed, reduced, or
eliminated to protect the research from bias; and
(4) the Institution will otherwise comply with this part.
Sec. 94.5 Management of conflicting interests.
(a) The designated official(s) must: Review all financial
disclosures; and determine whether a conflict of interest exists, and
is so, what actions should be taken by the institution to manage,
reduce, or eliminate such conflict of interest. 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. Examples
of conditions or restrictions that might be imposed to manage conflicts
of interest include, but are not limited to:
(1) Public disclosure of significant financial interests;
(2) Monitoring of the research by independent reviewers;
(3) Modification of the research plan;
(4) Disqualification from participation in all or a portion of the
research funded by the PHS;
(5) Divestiture of significant financial interests, or;
(6) Severance of relationships that create actual or potential
conflicts.
(b) 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.
Sec. 94.6 Remedies.
(a) 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. 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.
[[Page 35819]]
(b) The HHS may at any time inquire into the Institutional
procedures and actions regarding conflicting financial interests in
PHS-funded research, including a review of all records pertinent to
compliance with this part. HHS may require submission of the records or
review them on site. 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 and/or other information that may be
available, the PHS Awarding Component may decide that a particular
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, reduced, or eliminated the
conflict of interest in accordance with this part. The issuance of a
Stop Work Order by the Contracting Officer may be 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 conflicting
interest that was not disclosed or managed as required by this part,
the Institution must require disclosure of the conflicting interest in
each public presentation of the results of the research.
[FR Doc. 95-16799 Filed 7-10-95; 8:45 am]
BILLING CODE 4140-01-M
