[Federal Register Volume 60, Number 146 (Monday, July 31, 1995)]
[Corrections]
[Pages 39076-39077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X95-40731]



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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

Correction

    In rule document 95-16799 beginning on page 35810, in the issue of 
Tuesday, July 11, 1995, make the following corrections:
    1. On pages 35818 through 35819, Secs. 50.604, 50.605, and 50.606 
should be removed.
    2. The following sections were inadvertently omitted and should 
read as set forth below:


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.

[[Page 39077]]



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.
    (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.


BILLING CODE 1505-01-D