PHS Obj. in Research -- Correction Judy L. Fredenberg 31 Jul 1995 10:46 EST
The following correction was printed in today's Federal Register. /// Judy
[Federal Register: July 31, 1995 (Volume 60, Number 146)]
[Corrections]
[Page 39076-39077]
-----------------------------------------------------------------------
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
_________________________________________________________
Judy Fredenberg
Research Administration, UH116 Internet: xxxxxx@selway.umt.edu
The University of Montana Web: http://www.umt.edu/research
Missoula, MT 59812 FTP: ftphost.umt.edu (cd to user/fred)
406-243-6670 Fax: 406-243-2797
____________________
Money DOES talk -- it says goodbye.
_________________________________________________________
Judy Fredenberg
Research Administration, UH116 Internet: xxxxxx@selway.umt.edu
The University of Montana Web: http://www.umt.edu/research
Missoula, MT 59812 FTP: ftphost.umt.edu (cd to user/fred)
406-243-6670 Fax: 406-243-2797
____________________
Money DOES talk -- it says goodbye.