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Phs6349 FORM PHS 6349

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
INSTITUTIONAL ASSURANCE
AND
ANNUAL REPORT ON
POSSIBLE RESEARCH MISCONDUCT
FORM APPROVED: OMB No. 0937-0198; Expires: 05/31/2020
See Statement of Burden on Reverse
Period Covered by this Report
January 1, 2019 to December 31, 2019
Please make any mailing changes in the space to the right:
INSTITUTIONAL OFFICIAL'S NAME
INSTITUTIONAL OFFICIAL'S TITLE
NAME OF INSTITUTION
MAILING ADDRESS OF INSTITUTIONAL OFFICIAL
Place mailing label here.
Section I. Administrative Policy
Each institution which receives or applies for a PHS research, research-training or research-related grant or cooperative agreement must have established
an administrative policy for responding to allegations of research misconduct that complies with the PHS regulation (42 CFR Part 93) and certify that it will
comply with that policy. This regulation does not cover regulated research under the juris
diction of the Food and Drug Administration (FDA).
.
Has your institution established the administrative policy for responding to allegations of research misconduct required by the PHS regulation?
Yes
(
Please attach your institutional policy and procedures with this form.
)
No
Section II. Types of Misconduct Activity Related to PHS Applications and Awards
A.
PLEASE CHECK THE BOX (to the left) if your institution has NOT received any allegations or conducted any inquiries or investigations of
allegations during the reporting period that (1) fall under the PHS definition of research misconduct and (2) involve receipt of or requests
for PHS funding, then complete Section III. Otherwise, please complete Section II.
B.
Please provide the requested information for each incident of alleged misconduct that involved a request for or receipt of PHS funds that fell within
the PHS definition of research misconduct. Please note that, in accordance with section 93.310(b), all investigations are to be reported to the Office
of Research Integrity (ORI) before or immediately upon commencement of the investigation.
PLEASE NOTE: For each incident of alleged research misconduct resulting in an allegation, inquiry, and/or investigation at your institution:
(1) provide the ORI case number, if assigned; (2) check the type of activity (allegation, inquiry, and/or investigation -- may include more than
one activity type for each reported incident); and (3) check the type of misconduct involved with each activity (ma
y include more than one
type of misconduct). Attach a separate sheet if additional space or clarification is required.
Do NOT include any alleged fiscal misconduct, human or animal subject abuses, conflicts of interest, or violations of FDA regulated research.
1. Activity continued into 2019:
Incident
Number
ORI Case Number,
if assigned:
Type of Activity
Type of
Misconduct:
Fabrication
Type of
Misconduct:
Falsification
Type of
Misconduct:
Plagiarism
1.
Inquiry . . . . . . . . . . .
Investigation . . . . . .
2.
Inquiry . . . . . . . . . . .
Investigation . . . . . .
3.
Inquiry . . . . . . . . . . .
Investigation . . . . . .
Continued on back
PHS-6349
Rev. 11/19
(Front)
PSC Publishing Services (301) 443-6740
EF
Section II. (Continued)
B. (Continued)
2.
Activity begun in 2019:
Incident
Number
ORI Case Number,
if assigned:
Type of Activity
Type of
Misconduct:
Fabrication
Type of
Misconduct:
Falsification
Type of
Misconduct:
Plagiarism
1.
Allegation . . . . . . . .
Inquiry . . . . . . . . . . .
Investigation . . . . . .
2.
Allegation . . . . . . . .
Inquiry . . . . . . . . . . .
Investigation . . . . . .
3.
Allegation . . . . . . . .
Inquiry . . . . . . . . . . .
Investigation . . . . . .
Section III: Who at your institution administers the written policies and procedures for addressing allegations of research misconduct that meet the
requirements of this part (42 CFR 93.300)? At some institutions this person is known as the Research Integrity Officer (RIO).
NAME OF RESEARCH INTEGRITY OFFICER (RIO) (Please type):
TELEPHONE NUMBER:
( )
-
FAX NUMBER:
( )
-
E-MAIL ADDRESS OF RIO:
Section IV: Who is responsible for assuring that your institution fosters a research environment that promotes the responsible conduct of research
and discourages research misconduct (93.300 (c))? At some institutions this is the person with overall responsibility for administering the Responsible
Conduct of Research (RCR) program.
NAME OF RCR COORDINATOR (Please type):
TELEPHONE NUMBER:
( )
-
FAX NUMBER:
( )
-
E-MAIL ADDRESS OF RCR COORDINATOR:
Section V. Certification
Official Certifying for Institution:
NAME OF OFFICIAL (Please type) TITLE
SIGNATURE DATE
TELEPHONE NUMBER
( )
-
FAX NUMBER
( )
-
E-MAIL ADDRESS OF OFFICIAL:
STATEMENT OF BURDEN
Public reporting burden for this collection of information is estimated to
average 10 minutes to complete the form, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the
data needed and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this
collection of information, includi
ng suggestions for reducing this burden to:
OS Reports Clearance Officer, Hubert H. Humphrey Building, Room 503-H,
200 Independence Avenue, S.W., Washington,D.C. 20201 (Attn: PRA) and
to: Office of Management and Budget, Paperwork Reduction Project
(0937-0198) Washington, D.C. 20502. Please do not return this form to
either of these addresses.
RETURN THIS FORM TO:
Robin Parker
Assurance Program
Office of Research Integrity
1101 Wootton Parkway, Suite 240
Rockville, MD 20852
Phone: (240) 453-8407
E-Mail:
ORI_Assurance@hhs.gov
PHS-6349
Rev. 11/19
(Back)
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Completed 27 February 2020

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