[Federal Register Volume 65, Number 93 (Friday, May 12, 2000)]
[Notices]
[Pages 30600-30601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary; Office of Public Health and Science
Statement of Organization, Functions, and Delegations of
Authority
Part A, (Office of the Secretary) of the Statement of Organization,
Functions, and Delegations of Authority for the Department of Health
and Human Services, Chapter AC, Office of Public Health and Science
(OPHS), paragraph ACA, Immediate Office, as last amended at 62 FR 5009-
10, 2/3/97; and paragraph ACF, Office of Research Integrity (ORI), as
last amended at 60 FR 56606-06,
[[Page 30601]]
dated November 9, 1995, are being amended to make policy changes
approved by the Secretary. Specifically, the Notice is to reflect that
the Assistant Secretary for Health (ASH) will make proposed findings of
research misconduct and administrative actions in response to
allegations of research misconduct involving research conducted or
supported by components of the Public Health Service (PHS); that direct
investigations, previously conducted by ORI, will be conducted by
components of the PHS for intramural research and by the Office of
Inspector General for extramural research; and that role and structure
of ORI will be changed to focus more on preventing misconduct and
promoting research integrity through expanded education programs. The
changes are as follows:
I. Amend Chapter AC.20 Functions, paragraph A. ``Office of Public
Health and Science,'' paragraph titled, ``The Immediate Office (ACA)''
by adding the following new clause:
(1) Proposes findings of research misconduct and administrative
actions in response to allegations of research misconduct involving
research conducted or supported by the Public Health Service (PHS)
OPDIVs, including reversal of an institution's no misconduct finding or
opening of a new investigation.
II. Under Section AC.20 Function, delete, paragraph E. ``Office of
Research Integrity (ACF)'' in its entirety, and replace with the
following:
E. Office of Research Integrity (ACF)--The Director reports to the
Secretary and will: (1) Oversee and direct Public Health Service (PHs)
research integrity activities on behalf of the Secretary with the
exception of the regulatory research integrity activities of the Food
and Drug Administration; (2) recommend to the Assistant Secretary for
Health for decision, findings of research misconduct and administrative
actions in connection with research conducted or supported by the PHS;
(3) coordinate the development of research integrity policies designed
to ensure that subjects of investigations and whistleblowers are
treated fairly, including clear specification of what constitutes
misconduct, a fair hearing process, appropriate time limits on pursuing
allegations, and specific whistleblower protections; (4) manage the
financial resources and provide overall administrative guidance in
carrying out the activities; and (5) oversee and direct the research
misconduct and integrity activities of the office, including the
oversight of research misconduct inquiries and investigations,
education and training in the responsible conduct of research,
activities designed to promote research integrity and prevent
misconduct, and research and evaluation programs.
1. Division of Education and Integrity (ACF2)--The Director and
staff: (1) develop and implement, in consultation with the PHS OPDIVs,
activities and programs for PHS intramural and extramural research to
teach the responsible conduct of research, promote research integrity,
prevent research misconduct, and to enable the extramural institutions
and PHS OPDIVs to respond effectively to allegations of research
misconduct; (2) coordinate the dissemination of research integrity
policies, procedures, and regulations; (3) conduct policy analyses,
evaluations, and research to improve DHHS research integrity policies
and procedures and build the knowledge base in research misconduct,
research integrity, and prevention; (4) develop (in consultation with
the PHS OPDIVs) policies, procedures, and regulations for review by the
Director, Office of Research Integrity, and recommendations to the
Secretary; (5) administer programs for: approval of institutional
assurances; response to Freedom of Information Act and Privacy Act
requests; review and approval of intramural and extramural policies and
procedures; and response to allegations of whistleblower retaliation.
2. Division of Investigative Oversight (ACF3)--The Director and
staff: (1) review and monitor investigations conducted by applicant and
awardee institutions and intramural research programs; (2) evaluate
investigations and investigatory findings of awardee and applicant
institutions, intramural research programs, and the Office of Inspector
General and develop and recommend to the ORI Director, findings of
research misconduct and proposal administrative actions against those
who committed misconduct; (3) assist the Office of the General Counsel
(OGC) in preparing and presenting cases in hearings before the Research
Integrity Adjudications Panel of the DHHS Department Appeals Board; (4)
provide information on DHHS policies and procedures, as requested, to
individuals who have made an allegation or have been accused of
research misconduct; and (5) establish and implement a program of
advice and technical assistance to entities that conduct inquiries and
investigations, or otherwise respond to allegations of research
misconduct.
III. Under Chapter AC, Section ACF-30, Delegations of Authority--
All delegations and redelegations of authority to the Assistant
Secretary for Health and officials of the Office of Research Integrity
that were in effect prior to the effective date of this reorganization
shall continue in effect pending further redelegation.
Dated: April 14, 2000.
Betsy D'Jamos,
Acting Assistant Secretary for Management and Budget.
[FR Doc. 00-11958 Filed 5-11-00; 8:45 am]
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