RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLECONDUCT OF RESEARCH



NIH GUIDE, Volume 23, Number 42, December 2, 1994



P.T. 34



Keywords:

  Grants Administration/Policy+ 

  Ethics/Values in Science & Technol 



National Institutes of Health



The responsible conduct of research is an important public policy

issue.  Cases of misconduct in science present a serious threat to

continued public confidence in the integrity of the scientific

process and the stewardship of Federal funds.  The Public Health

Service (PHS) has set forth regulations and policies (42 CFR Part 50,

Subpart A) for handling misconduct in science.  The purpose of this

notice is to provide guidance on the responsibilities of awardee

institutions under current regulations when misconduct in science

affects the design, conduct, or reporting of research funded by the

NIH.



DEFINITION



Misconduct in science is defined as fabrication, falsification,

plagiarism, or other practices that seriously deviate from those that

are commonly accepted within the scientific community for proposing,

conducting, or reporting research.  It does not include honest error

or honest differences in interpretations or judgements of data. (42

CFR Part 50.102) Copies of the regulation pertaining to misconduct in

science are available from the Office of Research Integrity (ORI) at

the address listed below.



POLICY



1.  It is the policy of PHS to maintain high ethical standards in

research and investigate and resolve promptly and fairly all

instances of alleged or apparent misconduct.  The NIH places

responsibility on awardee institutions to assure that each NIH funded

program, function, or activity is progressing toward its respective

goals (45 CFR Part 74.81) and that awarded funds are expended solely

for the purpose of the award in accordance with the approved

application and budget, applicable regulations, the terms and

conditions of the award, and the applicable cost principles.  These

responsibilities must be carried out with extra care where misconduct

in science has been found or where a misconduct in science

investigation has been initiated.



2.  Where a misconduct in science investigation has been initiated

that involves alleged misconduct affecting an ongoing project, the

awardee institution, consistent with its responsibilities under

applicable regulations, is responsible for taking whatever steps are

necessary to protect the scientific integrity of the project; protect

human or animal subjects; provide reports to ORI; ensure that awarded

funds are properly expended; and ensure the continuation of the

project, to the extent such continuation is consistent with the

foregoing objectives and the need to ensure a prompt, fair

investigation.  Affirmative obligations are imposed in each of these

areas by 42 CFR 50.103 and 50.104.  The institution should consult

with the ORI and the funding agency as necessary to accomplish these

objectives.  Appointment of a qualified institutional official not

previously connected with the research project to oversee the

scientific and/or financial aspects of the project is an example of

an action that may be necessary, depending upon the circumstances.



3.  When a finding of misconduct in science has been made against an

individual or individuals working on the funded project by the ORI,

the awardee institution must assess the effect of that finding upon

the qualifications of the Principal Investigator (PI) or other staff

named in the application.  Proposed changes must be reported promptly

to the awarding agency.  In accord with 42 CFR Parts 52.2 and

52.5(a), the awarding agency may withdraw its approval of the PI or

other staff named in the application against whom a finding of

misconduct has been made, and require the appointment of acceptable

substitutes before the project may continue. If PHS or HHS has

imposed administrative actions based on an ORI finding of misconduct,

such as debarment of an investigator from Federal funding, the

awardee institution is expected to make any changes necessary on the

funded project to comply with such actions.



4.  A finding of misconduct in science that has a significant effect

upon the conduct of a funded project may constitute grounds for the

withholding of additional awards and the suspension and/or

termination of current funding under 45 CFR Parts 74.114 and 74.115.



5.  Under 45 CFR 74.170, et seq., and the cost principles referenced

therein, expenditures of awarded funds for research that is invalid

or unreliable because of misconduct in science may be considered

unallowable costs for which the awardee institution is liable for

repayment to the awarding agency.  This is decided on a case-by-case

basis.  This and any other determination of unallowable costs is

appealable under 42 CFR Part 50, Subpart D and 45 CFR Part 16.



6.  Where the validity or reliability of data has been affected by

misconduct in science, the awardee institution and its employee

authors are responsible for submitting a correction or retraction of

data to a journal, as appropriate, and/or for republishing the

corrected data.  Such corrections or retractions may be required as a

PHS administrative action.  If the institution does not meet its

responsibilities, the awarding agency may invoke its rights to access

the data (45 CFR Part 74.211) and to use copyrightable material

developed under the award (45 CFR Part 74.145), have the data

reviewed, and submit the correction.



COOPERATION AND TECHNICAL ASSISTANCE



Staff of the ORI are available to assist awardee institutions in

responding to misconduct in science.  Staff of the NIH awarding

agencies are available to provide technical assistance to protect

funded projects from the adverse effects of misconduct in science.

The joint responsibilities of the awarding agencies and the awardee

institutions are the protection of human and animal subjects, proper

stewardship of public funds, and ensuring the integrity of the

scientific data from the project.



INQUIRIES



Written, telephone, and email requests for additional information or

clarification of the issues addressed in this notice are welcome.



Questions concerning technical assistance to protect funded projects

should be directed to:



NIH Agency Extramural Research Integrity Officer

National Institutes of Health

Building 1, Room 152

Bethesda, MD  20892

Telephone:  (301) 496-5356

Email:  [email protected]



Questions concerning the conduct of institutional or ORI inquiries or

investigations should be directed to:



Division of Research Investigations

Office of Research Integrity



5515 Security Lane, Suite 700

Rockville, MD  20852

Telephone:  (310) 443-5330

FAX:  (301) 594-0039

Email:  [email protected]



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