[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44847-44850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of Research Integrity; Privacy Act of 1974; Report of an 
Altered System of Records

AGENCY: Office of Research Integrity (ORI), Office of Public Health and 
Science (OPHS), Office of the Secretary (OS), Department of Health and 
Human Services (HHS).

ACTION: Notice of revision to the Privacy Act system of records.

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SUMMARY: HHS proposes to revise the Privacy Act exempt system of 
records 09-37-0021, entitled ``Public Health Service Records Related to 
Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.'' 
This system became effective on August 29, 1994 (59 FR 36717, July 19, 
1994). Changes were made in response to comments received, and the 
revised systems notice was published on January 6, 1995 (60 FR 2140). 
The proposed revisions include changing the routine uses and changing 
the title of the system to ``HHS Records Related to Research Misconduct 
Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the 
changes made by the Public Health Service Policies on Research 
Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 
(``Part 93''), and to update the system to reflect current practices 
and procedures under that regulation.

DATES: This notice will be effective without further notice on 
September 30, 2009 unless modified by a subsequent notice making 
changes in response to public comments. Although the Privacy Act 
requires only that changes in the routine uses be published for 
comment, HHS invites comments on all parts of the systems notice. You 
may submit comments by electronic mail to <a href="/cdn-cgi/l/email-protection#2667554d69746f664e4e5508414950"><span class="__cf_email__" data-cfemail="89c8fae2c6dbc0c9e1e1faa7eee6ff">[email protected]</span></a>. Comments must 
be received on or before September 30, 2009.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852. (240) 453-8800. E-mail: <a href="/cdn-cgi/l/email-protection#89c8fae2c6dbc0c9e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="0445776f4b564d446c6c772a636b72">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: After making changes in response to public 
comments, ORI published its current systems notice entitled ``Public 
Health Service Records Related to Inquiries and Investigations of 
Scientific Misconduct, HHS/OASH/ORI'' on January 6, 1995 (60 FR 2140). 
Since that time, the organizational location of ORI has changed from 
the former Office of the Assistant Secretary for Health to OPHS, and a 
new HHS regulation concerning research misconduct was promulgated and 
codified at 42 CFR Part 93. That regulation substantially changed the 
previous regulation on scientific misconduct (42 CFR Part 50, Subpart 
A), including changing the term ``misconduct in science'' to ``research 
misconduct.''
    This revision updates the ORI system notice to be consistent with 
the definitions and procedures promulgated by the PHS Policies on 
Research Misconduct. The description of the categories of individuals 
covered by the records system and categories of records in the system 
have been amended to reflect the changes made by Part 93, specifically, 
the applicability of that part in terms of the individuals, types of 
research, and types of PHS support that are covered. Pertinent 
provisions of Part 93 are referenced to explain the records system 
coverage. The category of individuals covered by the system remains the 
same: individuals who are the subject of allegations of research 
misconduct. Similarly, the categories of records in the system remain 
essentially the same: records related to all stages of the research 
misconduct proceeding.
    The location of the system is now limited to the premises of ORI 
and the Federal Records Centers (for inactive records). PHS officials 
outside of ORI who are involved in extramural and intramural research 
misconduct proceedings have access to this system of records as 
necessary to carry out their duties.
    We have amended the statement of purposes to state more generally 
that ORI will use the system of records to exercise its oversight 
authority relating to research misconduct proceedings, and to document 
these activities.
    The order of the routine uses has been changed, and the terminology 
used has been updated to reflect the terms used in Part 93. The listing 
of routine uses begins with disclosures that may be made in the course 
of a research misconduct proceeding in roughly the order that they 
might occur, and ends with disclosures that may be necessary for more 
general administrative purposes.
    Routine use 1 is an expanded version of routine uses 2 and 5 in the 
current system notice. It now provides for disclosure to a person able 
to ``obtain'' information, as well as provide information or 
assistance, in a research misconduct proceeding or related proceeding, 
ORI oversight of an institutional research misconduct proceeding or ORI 
oversight of the implementation of HHS administrative actions. The 
reference to ORI oversight functions has also been added. We have also 
added a condition for each disclosure under this routine use. Prior to 
disclosure, ORI will determine whether limited disclosures or 
confidentiality agreements are needed to protect the privacy of 
respondent(s), complainant(s), witnesses, research subjects or others 
who may be identified in the records to be disclosed.
    Routine use 2 is new. It is based on 42 CFR 93.401 that, in part, 
authorizes ORI to notify and consult with other Federal, State, or 
local offices, if ORI has reason to believe that a research misconduct 
proceeding may involve that office. The second routine use in the 
current system notice, relating to disclosures to qualified experts, 
has been deleted because that disclosure is now covered by the more 
general disclosure in the new routine uses 1 and 9.
    Except for editorial changes, routine use 3 is the same as use 8 in 
the current system notice and routine use 4 is the same as use 3 in the 
current notice.
    Routine use 5 is new. It permits additional disclosures after a 
final HHS/ORI finding of research misconduct that are aimed at 
conserving public funds,

[[Page 44848]]

protecting Federal records, and otherwise protecting the interests of 
the Federal Government.
    Routine use 6 is an amended version of use 10 in the current 
notice. We have moved ``after * * * a final HHS/ORI finding of research 
misconduct'' to the front, deleted the reference to remedial actions, 
and minimally expanded the list of those to whom disclosures may be 
made.
    Routine use 7 is an amended version of use 6 in the current notice. 
We have moved the reference to an HHS/ORI finding of research 
misconduct to the front, added ``final'' to it, deleted the reference 
to the imposition of remedial actions, and added ``other similar 
entity.'' Use 7 in the current notice, disclosures to IRBs, research 
sponsoring institutions, research subjects, and the public has been 
deleted, because these types of disclosures would now normally be made 
by the institutions and, in any case, these types of disclosures would 
be covered by the more general disclosure covered by new routine uses 2 
and 3.
    Routine use 8 is an amended version of routine use 11 in the 
current notice. We have added a reference to suspension actions and a 
reference to the General Services Administration's (GSA's) Excluded 
Parties List System.
    Routine use 9 is essentially the same as routine use 9 in the 
current notice. It permits disclosures to volunteers and contractors 
engaged by ORI in support of its research misconduct oversight 
functions, if they need access to the records to perform their assigned 
tasks for the agency; provided, however, that in each case ORI 
determines whether limited disclosures or confidentiality agreements 
are needed to protect the privacy of respondent(s), complainant(s), 
witnesses, research subjects or others who may be identified in the 
records to be disclosed. Routine use 10 is authorized by 42 CFR 
93.410(a) to permit disclosure in cases that do not result in an ORI 
finding of research misconduct and that ORI decides to close.
    Routine uses 11 and 12 are derived from use 1 in the current 
notice. That previous use addressed both disclosures to the Department 
of Justice (DOJ) and to courts or other tribunals. Routine use 11 
addresses disclosures to the DOJ and routine use 12 addresses 
disclosure to courts or other tribunals. In addition, the language has 
been clarified.
    The description of record source categories has been revised to 
describe more accurately the many sources from which the records are 
received or obtained. Other changes to improve accuracy, update 
information, terms, and citations, and clarify language have been made 
throughout the systems notice.
    This record system remains exempt from certain requirements of the 
Privacy Act in accordance with the Department's determination published 
in the system notice. (59 FR 36717, July 19, 1994).

    Dated: August 14, 2009.
Donald Wright,
Principal Deputy Assistant Secretary for Health.
09-37-0021

SYSTEM NAME:
    HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.

SECURITY CLASSIFICATION:
    None.

SYSTEM LOCATION(S):
    Office of Research Integrity, 1101 Wootton Parkway, Suite 750, 
Rockville, MD 20852, and Federal Records Centers for inactive, 
permanent records.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The individuals covered by this system are referred to as 
``respondents.'' Part 93 defines the term ``respondent'' to mean ``the 
person against whom an allegation of research misconduct is directed or 
who is the subject of a research misconduct proceeding.'' 42 CFR 
93.225.
    Part 93 and this system notice apply to an allegation of research 
misconduct involving: (1) Applications or proposals for PHS support for 
biomedical or behavioral extramural or intramural research, research 
training or activities related to that research or research training, 
such as the operation of tissue and data banks and the dissemination of 
research information; (2) PHS supported biomedical or behavioral 
extramural or intramural research; (3) PHS supported biomedical or 
behavioral extramural or intramural research training programs; (4) PHS 
supported extramural or intramural activities that are related to 
biomedical or behavioral research or research training; and (5) 
plagiarism of research records produced in the course of PHS supported 
research, research training or activities related to that research or 
research training.
    The term ``research misconduct'' is defined to mean ``fabrication, 
falsification, or plagiarism in proposing, performing, or reviewing 
research, or in reporting research results.'' ``Fabrication'' is 
defined to mean ``making up data or results and recording or reporting 
them.'' ``Falsification'' is ``manipulating research materials, 
equipment, or processes, or changing or omitting data or results such 
that the research is not accurately represented in the research 
record.'' ``Plagiarism'' is ``the appropriation of another person's 
ideas, processes, results, or words without giving appropriate 
credit.'' Research misconduct does not include honest error or 
differences of opinion. 42 CFR 93.103.

CATEGORIES OF RECORDS IN THE SYSTEM:
    This system contains records related to research misconduct 
proceedings. The term ``research misconduct proceeding'' is defined to 
mean ``any actions related to alleged research misconduct taken under 
this part, [Part 93] including but not limited to allegation 
assessments, inquiries, investigations, ORI oversight reviews, 
hearings, and administrative appeals.'' 42 CFR 93.223.
    The records include all information that must be submitted to ORI 
by institutions under Part 93 in connection with a research misconduct 
proceeding, and all information that ORI receives or generates in 
overseeing or conducting research misconduct proceedings. This 
information includes, but is not necessarily limited to information 
about respondents (this may include social security numbers), 
complainants, and witnesses; the nature of the allegations; the PHS 
funding involved, including grant numbers; the institutions and 
officials responsible for conducting the actions that are part of the 
research misconduct proceeding; the documentation used in the inquiry 
and investigation, including relevant research data and materials, 
applications, proposals and documentation related to review and award 
actions, reports, abstracts, manuscripts and publications by the 
respondent(s) and other relevant reports, abstracts, manuscripts and 
publications, correspondence; memoranda of telephone calls, summaries 
of interviews and transcripts or recordings of interviews; statistical, 
scientific, and forensic analyses; interim and final institutional 
reports, and records of institutional appeal proceedings, if any.
    The system also includes records relating to: (1) ORI oversight of 
institutional assessments, inquiries and investigations, ORI findings 
of research misconduct, and ORI proposals for HHS administrative 
actions or for settlement of the case; (2) final HHS findings of 
research misconduct, final HHS decisions regarding administrative 
actions, and documentation of the implementation of those actions; and 
(3)

[[Page 44849]]

ORI coordination with other Federal, State, and local offices/agencies, 
including the Department of Justice.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The authorities for maintaining the system are: Sections 301 and 
493 of the Public Health Service Act, 42 U.S.C. 241, and 289b; 5 U.S.C. 
552a, 5 U.S.C. 301 and 44 U.S.C. 3101; 42 CFR Part 93; 2 CFR Part 376; 
48 CFR Subpart 309.4.

PURPOSE(S):
    The purposes of this system are to:
    (1) Enable HHS, ORI, and the Federal Government to protect the 
health and safety of the public, to promote the integrity of PHS 
supported research, and to conserve public funds;
    (2) Enable ORI to implement its authority relating to research 
misconduct proceedings as set forth in 42 U.S.C. 289b and 42 CFR Part 
93, and to document HHS and ORI activities in implementing that 
authority;
    (3) Ensure that research misconduct proceedings, including 
institutional implementation of HHS administrative actions, are carried 
out in accordance with 42 CFR Part 93 and other applicable Federal 
statutes and regulations;
    (4) Enable ORI to inform PHS agency officials who have a need for 
the records in the performance of their duties, of the status and 
results of research misconduct proceedings; and
    (5) Enable ORI to notify, consult with, and provide assistance to 
other Federal, State, or local governmental agencies to permit them to 
take action to protect the health and safety of the public, to promote 
the integrity of PHS supported research, to conserve public funds, or 
to pursue potential violations of civil and criminal statutes.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM INCLUDING THE PURPOSES 
OF SUCH USES AND CATEGORIES OF USERS:
    The HHS Privacy Act regulation lists, at 45 CFR 5b.9(b), 
disclosures of records that may be made without the consent of the 
individual who is the subject of the records. Among the permitted 
disclosures are disclosures to those officers and employees of the 
Department who have a need for the record in the performance of their 
duties and routine uses that are listed in the notice of the system of 
records. A ``routine use'' is defined in 45 CFR 5.1(j) to mean ``the 
disclosure of a record outside the Department, without the consent of 
the subject individual, for a purpose which is compatible with the 
purpose for which the record was collected.'' The routine uses for this 
system of records are listed below.
    1. Disclosure may be made to any person able to obtain information 
or provide information or assistance in a research misconduct 
proceeding or related proceeding, ORI oversight of an institutional 
research misconduct proceeding, or ORI oversight of the implementation 
of HHS administrative actions. Recipients of disclosures under this 
routine use may include experts asked to perform statistical, forensic 
or other analyses, the relevant PHS supported institution(s), 
institutions with which the respondent(s) was previously or is 
currently affiliated, Federal, State and local agencies, the 
respondent(s), the complainant(s), witnesses, and organizations or 
individuals acting on behalf of those agencies, institutions and 
individuals; provided, however, that in each case ORI determines 
whether limited disclosures or confidentiality agreements are needed to 
protect the privacy of respondent(s), complainant(s), witnesses, 
research subjects or others who may be identified in the records to be 
disclosed.
    2. Disclosure may be made to other Federal, State, or local 
agencies and offices, if ORI has reason to believe that a research 
misconduct proceeding may involve that agency or office.
    3. When a record on its face, or in conjunction with other records, 
indicates a violation or potential violation of law, whether civil, 
criminal or regulatory in nature, disclosure may be made to the 
appropriate agency, whether Federal, foreign, State, local or Tribal, 
or other public authority responsible for enforcing, investigating or 
prosecuting such violation, if the information disclosed is relevant to 
the responsibilities of the agency or public authority.
    4. Disclosure may be made to responsible officials of PHS-supported 
institutions or organizations, when in connection with a research 
misconduct proceeding concerning an individual previously or currently 
employed by, or affiliated with the institution or organization, or 
when ORI or HHS makes a finding or takes an action potentially 
affecting the institution or organization or its PHS support for 
research, research training, or related activities.
    5. After there is a final HHS/ORI finding of research misconduct, 
disclosure may be made to a Federal, State, local or Tribal agency in 
connection with the hiring or retention of an employee, the issuance of 
a security clearance, the reporting of an investigation of an employee, 
or the issuance of a license or other benefit by the agency, to the 
extent that the record is relevant to the agency's decision on the 
matter.
    6. After there is a final HHS/ORI finding of research misconduct, 
disclosure may be made to professional journals, other publications, 
news media, other individuals and entities, and the public concerning 
research misconduct findings and the need to correct or retract 
research results or reports that have been affected by research 
misconduct. No information will be released that would reveal a 
confidential source.
    7. After there is a final HHS/ORI finding of research misconduct, 
disclosure may be made to a State licensing board, certifying body, or 
other similar entity conducting a review of the respondent, to aid the 
entity in meeting its responsibility to protect the health of the 
population in its jurisdiction or the integrity of the profession.
    8. After there is an HHS decision to suspend, or a final HHS 
decision to debar the respondent from Federal procurement and 
nonprocurement programs, disclosure may be made to GSA for the purpose 
of adding the respondent to GSA's Excluded Parties List System.
    9. Disclosure may be made to volunteers and contractors engaged to 
perform a service in support of an ORI research misconduct oversight 
function, if such persons need access to the records to perform their 
assigned task; provided, however, in each case ORI determines whether 
limited disclosures or confidentiality agreements are needed to protect 
the privacy of respondent(s), complainant(s), witnesses, research 
subjects or others who may be identified in the records to be 
disclosed; and ORI determines that the disclosure is for a purpose 
compatible with the purpose for which the agency collected the records.
    10. When ORI closes a case without a settlement or finding of 
research misconduct, disclosure may be made to the respondent, relevant 
institution, and complainant(s); provided, however, that in each case 
ORI determines whether limited disclosures or confidentiality 
agreements are needed to protect the privacy of respondent(s), 
complainant(s), witnesses, research subjects or others who may be 
identified in the records to be disclosed.
    11. Disclosure may be made to DOJ when: (a) The agency or any 
component thereof; or (b) any employee of the agency in his or her 
official capacity where the DOJ has agreed to represent the employee; 
or (c) the United States Government, is a party to litigation or has an 
interest in such litigation and,

[[Page 44850]]

prior to disclosure, the agency determines that the records are both 
relevant and necessary to the litigation and the use of such records by 
the DOJ is therefore deemed by the agency to be for a purpose that is 
compatible with the purpose for which the agency collected the records.
    12. Disclosure may be made to a court or other tribunal, when: (a) 
The agency or any component thereof; or (b) any employee of the agency 
in his or her official capacity where the DOJ has agreed to represent 
the employee; or (c) the United States Government is a party to the 
proceeding or has an interest in such proceeding and, prior to 
disclosure, the agency determines that the records are both relevant 
and necessary to the proceeding and the use of such records is 
therefore deemed by the agency to be for a purpose that is compatible 
with the purpose for which the agency collected the records.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records are stored in file folders, electronic and magnetic media 
and other types of data storage devices.

RETRIEVABILITY:
    Records are retrieved by manual or computer search of the case-
tracking system using the name of the respondent(s) (i.e., the 
individual or individuals who are the subject of an allegation of 
research misconduct or of a research misconduct proceeding).

SAFEGUARDS:
    1. Authorized users: Records are available to the system manager, 
to the Director, ORI, and to other appropriate ORI staff when they have 
a need for the records in the performance of their duties. Records are 
also available to the head of intramural research for the PHS agency 
involved, and to other appropriate HHS officials, including attorneys 
in the Office of the General Counsel, the Agency Research Integrity 
Liaison Officer (ARILOs), the Agency Intramural Research Integrity 
Officer (AIRIOs), the Agency Extramural Research Integrity Officer 
(AERIOs), and the Research Integrity Officers (RIOs) located in the 
Institutes and Centers of the National Institutes of Health (NIH) that 
are involved in the research misconduct proceeding, when there is a 
need to know in the performance of their duties. All authorized users 
are informed that the records are confidential and are not to be 
further disclosed.
    2. Procedural safeguards: Access is strictly controlled by the 
system manager and the Director, ORI, in compliance with the Privacy 
Act and this system notice. Access to the records is limited to ensure 
confidentiality. All questions and inquiries from any party should be 
addressed to the system manager.
    3. Physical safeguards: ORI records are kept in locked file 
cabinets in a room that is locked during non-working hours. Access to 
this room is restricted to specific personnel. The ORI office suite is 
protected by access and intrusion alarms at the front and emergency 
entrances. Access to computer files is strictly limited through 
passwords and user-invisible encryption. Special measures commensurate 
with the sensitivity of the record are taken to prevent unauthorized 
copying or disclosure of the records.

RETENTION AND DISPOSAL:
    The files are retained and disposed of in accordance with the 
General Records Schedule (accessions) and a disposition schedule 
approved by the National Archives and Records Administration (cases).

SYSTEM MANAGER AND ADDRESS:
    Director, Division of Investigative Oversight, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852.

NOTIFICATION PROCEDURES:
    This system is exempt from access; however, consideration will be 
given to requests addressed to the system manager. The requester must 
verify his or her identity by providing either a notarization of the 
request or a written certification that the requester is who he or she 
claims to be and understands that the knowing and willful request for 
acquisition of a record pertaining to an individual under false 
pretenses is a criminal offense under the Privacy Act, subject to a 
five thousand dollar fine. The request should include: (a) Full name, 
(b) address, and (c) year of records in question.

RECORD ACCESS PROCEDURES:
    Same as notification procedures. Requesters should reasonably 
specify the record contents being sought. Although the system is 
exempt, respondents may, upon request, receive records from this system 
and an accounting of disclosure of their records, if the system manager 
determines the disclosure would not compromise the activities of ORI or 
the confidentiality of information.

CONTESTING RECORD PROCEDURES:
    Exempt. However, consideration may be given to requests addressed 
to the system manager. Requests for corrections should reasonably 
identify the record and specify the information to be contested, the 
corrective action sought and the reasons for the corrections with 
supporting justification. The right to contest records is limited to 
information that is incomplete, irrelevant, incorrect, or obsolete.

RECORD SOURCE CATEGORIES:
    Information in this system is received or obtained from many 
sources, including: (1) Directly from the respondent or complainant or 
his/her representative; (2) derived from materials supplied by the 
respondent or complainant or his/her representative; (3) from 
information supplied by the institutions, witnesses, scientific 
publications and other nongovernmental sources; (4) from observation 
and analysis made by ORI staff and scientific experts; (5) departmental 
and other Federal, State, and local government records; (6) from 
hearings and other administrative proceedings; and (7) from any other 
relevant source.

SYSTEM EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    This system is exempted pursuant to 5 U.S.C. 552a(k)(2) and (k)(5) 
of the Privacy Act from access, notification, correction, and amendment 
provisions of the Act (5 U.S.C. 552a(c)(3), (d)(1)-(4), (e)(4)(G)-(H), 
and (f)).

[FR Doc. E9-20893 Filed 8-28-09; 8:45 am]
BILLING CODE P


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