Subject: (Copy) Re-Transmission of NIH GUIDE
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 18 Sep 89 15:44 EST

Paul,
    Please post to the Listserver as:
    NIHGUIDE.091589
          Thanks a million.
                           Dottie
 ---------------------------- Text of forwarded message -----------------------
Received: (from MAILER@NIHCU for UNCDOT@UNC via NJE)
         (PXDMAIL-8426;     486 LINES); Mon, 18 Sep 89 15:19:18 EST
To:       UNCDOT
cc:       PXD@NIHCU
From:     PXD@NIHCU
Date:     Mon, 18 Sep 89  14:23:26 EDT
Subject:  Re-Transmission of NIH GUIDE

     

     
     
Vol. 18, No. 32, September 15, 1989

REQUEST FOR COMMENT ON PROPOSED GUIDELINES FOR POLICIES ON
CONFLICT OF INTEREST ........................................................ 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

                             REQUEST FOR COMMENT
     
                                      ON
     
                             PROPOSED GUIDELINES
     
                     FOR POLICIES ON CONFLICT OF INTEREST
     
                                 developed by
     
                      THE NATIONAL INSTITUTES OF HEALTH
     
                                     and
     
          THE ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION

Public Health Service, Department of Health and Human Services
     
P.T. 04, 34; K.W. 1014004, 1014006
     
The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) seek comments from the public on the
following draft issuance, intended to protect against conflicts of interest
related to NIH-and ADAMHA-supported research.  The NIH and ADAMHA are
particularly interested in receiving comments on issues presented below from
individual researchers, scientific societies and associations, independent
science advisory bodies, members of Congress, other Federal agencies that
support or conduct research, and institutions that receive funds from NIH or
ADAMHA to conduct or support biomedical or behavioral research.  Interested
individuals and parties are encouraged to submit their comments by December
l5, l989.
     
Please address your comments in writing to:
     
Dr. Katherine L. Bick
Deputy Director for Extramural Research
National Institutes of Health
Shannon Building, Room 144
9000 Rockville Pike
Bethesda, Maryland  20892
     
For further information, please contact Dr. Bick at (301) 496-1096.
     
BACKGROUND:
     
The section of the PHS Grants Policy Statement on Standards of Conduct for
Employees (of Grantee Organizations), page 55, provides that, "Recipient
organizations must establish safeguards to prevent employees, consultants, or
members of governing bodies from using their positions for purposes that are,
or give the appearance of being, motivated by a desire for private financial
gain for themselves or others such as those with whom they have family,
business, or other ties.  Therefore, each institution receiving financial
support must have written policy guidelines on conflict of interest and the
avoidance thereof.  These guidelines should reflect State and local laws and
must cover financial interests, gifts, gratuities and favors, nepotism, and
other areas such as political participation and bribery.  These rules must
also indicate the conditions under which outside activities, relationships, or
financial interests are proper or improper, and provide for notification of
these kinds of activities, relationships, or financial interests to a
responsible and objective institution official."  It also sets forth an
outline of what those rules of conduct must contain, namely "a provision for
prompt notification of violations to a responsible and objective grantee
official, and must specify the type of administrative action that may be taken
against an individual for violations."
     
The purpose of this draft issuance is to provide further guidance for the
extant PHS Grants Policy Statement and to provide greater detail to the stated
policies of the current guidance.  It is formulated to assist institutions who
receive support for biomedical or behavioral research from the NIH or ADAMHA
to establish acceptable criteria for their own conflict-of-interest policies.
Institutions that receive such funds are expected to adopt policies that build
upon this framework and that reflect their specific needs.  Signature of the
responsible institutional official on the application or proposal constitutes
certification that the institution either has formulated, enacted, and is
enforcing such policies, or will do so no later than the date of any award.

     
                 Vol. 18, No. 32, September 15, 1989 - Page 1
NIH- and ADAMHA-supported investigators appear to be involved increasingly in
non-Federally supported activities.  This situation represents some obvious
philosophical and potential practical advantages, including rapid technology
transfer and cooperative research ventures that facilitate efficient exchange
of research results from the research laboratory or clinical trial to
utilization in the private sector.  With the increased involvement of NIH- and
ADAMHA-supported investigators in non-Federally supported activities,
particularly those sponsored by industry, have come some complex questions.
Intense competition for Federal research funds, often resulting in partial
funding for some research projects, also has stimulated or required
investigators to seek additional research funding from non-Federal sources.
In addition, recent research advances in biomedical science have produced
major opportunities for commercialization of research findings.
     
The establishment and maintenance of a healthy research environment in which
innovation flourishes clearly depend on the integrity and objectivity
demonstrated by individual investigators, other individuals associated with
research projects, and recipient institutions.  This draft issuance was
developed with those goals in mind.  The intention in formulating them is to
ensure that NIH- and ADAMHA-supported research is carried out in a completely
objective manner, and that research results are not influenced by the
possibility of financial gain.
     
These proposed guidelines should not stifle research creativity or technology
transfer from the research laboratory to commercial use but, rather, provide
guidance concerning the safeguards needed to ensure unbiased performance and
reporting of research results.  Such safeguards are particularly important for
situations in which conflicts of interest exist but are not publicly
discernible.  The proposed guidelines do not apply to research supported under
the Small Business Innovation Research Program, established by the Small
Business Innovation Development Act of 1982 (P.L. 97-219).  This Act was
intended to increase the involvement in research and development of small,
innovative firms by making Federal research and development funds more readily
available to them, so that they may participate more fully in technological
innovation and in strengthening the economy.
     
On June 27 and 28, 1989, NIH and ADAMHA sponsored an open meeting to discuss
issues related to the problem of conflict of interest.  Discussion at that
meeting addressed a number of issues that have served as a basis for this
draft issuance.  There was general agreement that institutions that receive
biomedical research funds from the NIH or ADAMHA should develop their own
policies with respect to conflict of interest.  NIH and ADAMHA have developed
the proposed guidelines in this document to serve as a point of departure for
further discussion on procedures for ensuring high integrity in the
performance, reporting, and utilization of research results, and in the
appropriate use of public funds for public purposes.
     
We request comments on the proposed guidelines that are presented below.  We
also request specific comments on the following questions, as well as on any
other issues related to conflict of interest.
     
  o  What policies does your institution already have in place to deal
     with conflicts of interest?  How does this draft issuance compare
     with them?
     
  o  How should information be disseminated regarding
     conflict-of-interest policies?
     
  o  What is your perception of the impact of your institution's
     adoption of policies, based on the framework presented here, on
     your own research or, more broadly, on basic biomedical research,
     clinical trials, technology transfer, product development, and
     commercialization of research results?
     
Proposed Policy
     
Research activities supported by NIH or ADAMHA must be conducted in an
objective manner, free of any potential for undue influence arising from the
private financial interests of those responsible for the conduct of the
research.  Public funds must be expended to advance public purposes, in this
case, the conduct of biomedical and behavioral research.  Private financial
interests can adversely affect the accomplishment of this public purpose by
directly affecting the manner in which the research is conducted, by creating
the appearance that the research has been influenced by those financial
interests, or by inhibiting the dissemination of research results.
     
Recipients of research funds are responsible for ensuring that the funds are
expended for the public purposes for which they were awarded.  As part of this
     
                 Vol. 18, No. 32, September 15, 1989 - Page 2
responsibility, recipients must adopt procedures that will prevent the
research from being influenced or potentially influenced by the private
financial interests of those responsible for the conduct of research.  The
following proposed guidelines establish minimum standards for the procedures
to be adopted by recipients, including identification of those financial
interests which are incompatible with the need to ensure that publicly funded
research is conducted objectively.

I.  PROPOSED RESPONSIBILITIES OF NIH AND ADAMHA, AWARDEE
    INSTITUTIONS, AND INDIVIDUALS:
     
A.  NIH and ADAMHA:
     
The NIH and ADAMHA are responsible for formulating and disseminating
conflict-of-interest guidelines to assist institutions to develop their own
conflict-of-interest policies.  The NIH and ADAMHA also are responsible for:
     
     In specific instances, reviewing institutions' conflict-of-interest
     policies.
     
     Routinely reviewing actions that the institutions have taken with
     respect to waivers and exceptions.
     
     Assuring that the necessary terms and conditions are discharged
     satisfactorily prior to making an award.  In the absence of
     fulfillment of the necessary terms and conditions, funding may be
     affected.
     
B.  Awardee Institutions:
     
Institutions that receive NIH or ADAMHA funds are responsible for establishing
and implementing policies and procedures in accord with this draft issuance.
Upon request, institutions shall provide copies of their policies and
procedures and information regarding their implementation to the appropriate
NIH or ADAMHA officials.  The institutions also are responsible for:
     
     Maintaining records of disclosures made and actions taken regarding
     persons associated with any NIH or ADAMHA award for a period of at
     least three years beyond the termination of that award.
     
     Promptly notifying the funding agency if they identify any practice
     or situation involving a conflict of interest which could
     potentially affect one or more NIH or ADAMHA-supported projects.
     
     Resolving any failure to comply with these proposed guidelines
     prior to accepting an award.
     
Policies
     
Each institution that applies for assistance to the NIH or ADAMHA for any
project or program that involves the conduct of biomedical or behavioral
research shall certify by the institutional signature on its application or
proposal that it has institutional policies in place that are in accord with
this draft issuance or will have such policies in place no later than the date
that any award would be accepted.
     
Institutions are encouraged to adopt policies that build upon this framework
and that reflect their specific needs and situations.
     
Education
     
Institutions are expected to establish a means of informing all investigators
applying for or receiving funding from the NIH or ADAMHA, as well as all
relevant research employees, consultants, and administrative staff at that
institution who are in a position to make decisions about or to affect the
outcome of the research, of the institutional policies covering conflicts of
interest.  This information should include, at a minimum, identification of
prohibited financial interests, disclosure procedures, and sanctions for
non-compliance.
     
C. Individuals:
     
These proposed guidelines apply to all investigators, key employees,
consultants, and persons with primary management, advisory, or supervisory
responsibilities for NIH- or ADAMHA-funded research, and all persons who are
in a position to have a critical influence on, or substantive control over,
that research.  Those persons are responsible for avoiding circumstances that
     
                 Vol. 18, No. 32, September 15, 1989 - Page 3
would put them in a conflict-of-interest situation with that research.  These
provisions also apply to the spouses, dependent children, and other dependents
of the individuals mentioned above.
     
Full disclosure of all financial interests and outside professional
activities, by all who are in a position to make decisions concerning one or
more NIH- or ADAMHA-supported projects, shall be made to the institution at
the time a research application or proposal is submitted to the NIH or ADAMHA.
This shall include the financial interests of their spouses, dependent
children, and other dependents.  These disclosures shall be updated to the
institution annually.
     
All individuals for whom these proposed guidelines apply shall comply with the
conflict-of-interest policies of the institutions through which the NIH or
ADAMHA funding is provided and shall report immediately any conflicts of
interest to the appropriate institutional officials.

II.  DISCLOSURES:
     
Full disclosure of all funding other than that from the applicant institution
is required of all personnel of awardee institutions as described above who
are currently involved in, or currently applying for, research funds from NIH
or ADAMHA.  This disclosure includes support for laboratory activities,
special instrumentation or other products, services, consultancies, honoraria,
and other benefits.
     
All disclosures and waivers shall be reviewed at the institution in a timely
manner by knowledgeable and objective individuals appointed by institutional
officials.  In order to assure timely and objective evaluations, institutions
may wish to appoint a panel of at least 3 members, one of whom has no
institutional affiliation and one of whom is the institutional official
responsible for signing the grant application or contract proposal.
     
Confidentiality shall be maintained at all times unless that confidentiality
would interfere with the interests of the institution or the Federal
Government.
     
Institutions may grant waivers in unusual situations when it can be
demonstrated that the financial interest is so insignificant that it would not
compromise the objectivity of the research results or the interests of the
Federal government or the public.  The NIH or ADAMHA shall be informed within
thirty days of any such waiver granted to an individual involved in any way
with a NIH- or ADAMHA-funded project related to the waiver.
     
If a conflict-of-interest situation is identified that involves one or more
NIH- or ADAMHA-supported project(s), the NIH or ADAMHA and appropriate
institutional official(s) shall be notified immediately, and the institution
shall take immediate steps to safeguard Federal funds until such time that the
conflict-of-interest situation is eliminated.
     
Disclosure information shall be updated to the institution at least once per
year.  Changes that could reflect possible conflicts of interest should be
reported immediately to the responsible institutional official(s).
     
The institution shall maintain records of disclosures, waivers, and of all
actions in response to review of disclosures for personnel associated with
NIH- or ADAMHA-supported projects for a period of three years after the
termination of that project.

III.  PROHIBITED SITUATIONS:
     
Institutions may establish their own policies on prohibited situations.
However, the following are basic standards for all institutions.
     
1.  No investigator, key employee, consultant, or other persons with primary
research, management, advisory, supervisory, or purchase authorization
responsibilities, or their spouses, dependent children, or other dependents,
shall be allowed to have personal equity holdings or options in any company
that would be affected by the outcome of the research or that produces a
product or equipment being evaluated in the research project.  This does not
apply to equipment or products that are commonly found in research
laboratories, such as commercially available centrifuges, pH meters, and
common reagents.  This prohibition does not include blind trusts, diversified
mutual funds, or other financial interests over which the individual investor
has no discretionary control.  The institution may grant a waiver to this
requirement if it determines that such holdings are so insignificant they do
     
                 Vol. 18, No. 32, September 15, 1989 - Page 4
not have the potential of influencing research results or the direction of the
research.
     
2.  Information and/or research products derived from NIH- or ADAMHA-funded
studies shall not be shared with any company with which a conflict exists
unless or until the information or research products are made publicly
available.
     
3.  Specific requirements shall apply if an investigator, key employee,
consultant, or other involved person receives funds from NIH or ADAMHA as well
as commercial funding, for any of their research, as follows:
     
All research funding for all research projects must be disclosed as required
in the appropriate sections of applications and proposals to the NIH or ADAMHA
(under the "Other Support" section), as well as to the institutional
official(s) responsible for conflict-of-interest review.
     
Institutional conflict-of-interest reviews need to be particularly careful to
ensure that private companies are not in a position to influence the research
plan, results, or the reporting or interpretation of results of NIH- or
ADAMHA-supported research.
     
An investigator, key employee, consultant, or other involved person may not
receive honoraria, fees for service, or a management position from a private
source if that individual is involved in an NIH- or ADAMHA-supported project
that is evaluating or testing a product of the source.  Honoraria, fees for
service, or management positions from other sources are allowed provided that
their acceptance does not jeopardize the recipient's objectivity with respect
to the NIH- or ADAMHA-supported project or result in special access to
information that is not publicly available, and that full disclosure is made
to designated institutional officials.  For example, care must be taken to
ensure that the private company has no role in any decisions that would impede
the standard practices for the publication or other dissemination of research
results related to NIH- or ADAMHA-supported research.

IV.  CRITERIA FOR WAIVERS AND EXCEPTIONS:
     
The institution may grant waivers in certain circumstances if it determines
that such holdings do not have the potential for influencing research results,
the reporting of research results, the direction of the research, or putting
the individual in a situation of being able to derive special advantage
because of information he/she has available through the NIH/ADAMHA research
results.
     
All waivers and exceptions shall be reported to the Deputy Director for
Extramural Research, NIH, if they relate to NIH-supported projects, or to the
Associate Administrator for Extramural Programs, ADAMHA, if they relate to
ADAMHA-supported projects, prior to accepting an award or, if disclosure is
made after the award, within thirty days of granting the waiver or exception.
     
The NIH or ADAMHA may allow a conflict-of-interest situation to exist if it
has been reported to NIH or ADAMHA and the agency determines that this is in
the best interests of the public and of NIH or ADAMHA.

V. REMEDIES:
     
If situations involving a conflict of interest related to NIH- or
ADAMHA-supported research are discovered, the awardee institution has the
first responsibility to resolve the problem.  If the institution does not
resolve the problem in a timely manner, then the NIH or ADAMHA will take
action.
     
Awards will be made without prejudice if prohibited conflict-of-interest
situations are rectified prior to the award date.
     
Institutions are required to notify the funding agency immediately if
prohibited conflict-of-interest situations are detected or develop after
awards have been made and the conflict is not resolved promptly.
     
NIH or ADAMHA may include special terms and conditions in an award if (l) an
institution is not complying with these proposed guidelines or (2) to resolve
a conflict-of-interest situation that has not been resolved by the
institution.  Failure on the part of the institution to meet these special
terms and conditions could affect funding.

     
                 Vol. 18, No. 32, September 15, 1989 - Page 5