[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17483]


[[Page Unknown]]

[Federal Register: July 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Office of the Assistant Secretary for Health; Privacy Act of 
1974; New System of Records

AGENCY: Public Health Service, HHS.

ACTION: Notification of a new system of records.

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SUMMARY: In accordance with the requirements of the Privacy Act, the 
Public Health Service (PHS) is publishing a notice of a new system of 
records, 09-37-0021. ``Public Health Service Records Related to 
Inquiries and Investigations of Science Misconduct, HHS/OASH/ORI.'' We 
are also proposing twelve routine uses for this new system. As set 
forth in 45 CFR 5b.11(b)(2)(vii), this system is exempted from certain 
provisions of the Privacy Act, 5 U.S.C. 552a, pursuant to subsections 
(k)(2) and (k)(5) of the Privacy Act, which apply to investigatory 
materials compiled for law enforcement purposes and to protection of 
confidential sources of information.

DATES: PHS invites interested parties to submit comments on the 
proposed routine uses on or before August 29, 1994. PHS has sent a 
Report of a New System to the Congress and to the Office of Management 
and Budget (OMB) on June 29, 1994. The routine uses will be effective 
40 days after submission of the Report to OMB unless PHS receives 
comments which would result in a contrary determination. In no event 
shall this system be effective prior to the effective date of the 
amendment to 5 CFR 5b.11 which exempt this system under subsections 
(k)(2) and (k)(5) of the Privacy Act.

ADDRESSES: Please submit comments to: PHS Privacy Act Officer, room 17-
45, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 
(301) 443-2055 (This is not a toll-free number.) Comments received will 
be available for inspection at this same address from 8:30 a.m. to 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:Barbara Bullman, Esq., Division of 
Policy and Education, Office of Research Integrity, Rockwall II, suite 
700, 5515 Security Lane, Rockville, Maryland 20852, (301) 443-5300 
(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: The Office of the Assistant Secretary for 
Health (OASH), Office of Research Integrity (ORI), proposes to 
establish a new system of records: 09-37-0021, ``Public Health Service 
Records Related to Inquiries and Investigations of Scientific 
Misconduct, HHS/OASH/ORI.'' This system will consist of records related 
to current allegations, inquiries or investigations of scientific 
misconduct and/or to actions that PHS has taken in connection with such 
allegations, inquiries, investigations or findings. Records in this 
system will be maintained according to the name of the individual who 
is the subject of the inquiry or investigation with which they are 
associated.
    The records in the system will be maintained in a secure manner 
compatible with the content, sensitivity and use of the data. Access 
will be given only to ORI staff and to other appropriate HHS personnel 
whose official duties require the use of the records. Individually 
identifiable records in the ORI will be kept in locked files in a room 
locked during non-working hours. Access to the room is limited to 
specific personnel, and the room is protected by access and intrusion 
alarms. The records in this system which are maintained in the 
appropriate PHS Agency Research Integrity Liaison Office (ARILO), the 
PHS Agency Intramural Research Integrity Offices, the PHS Agency 
Extramural Research Integrity Office and applicable NIH Misconduct 
Program offices will be kept in locked files in locked offices.
    Computerized records will be maintained in accordance with the HHS 
Automated Information Systems Security Handbook.
    We are proposing twelve routine uses. Any disclosure pursuant to 
these routine uses will be limited to the minimum necessary to 
accomplish the purpose of the disclosure and will be made so as to 
protect the identities of confidential sources of information. The 
first routine use proposed for this system allows disclosure to the 
Department of Justice or the courts or other tribunals (including 
administrative law proceedings) in the event of litigation. The second 
routine use is proposed to allow experts to review the records in order 
to provide the government with an opinion relevant to the inquiry and 
investigation. The third routine use allows disclosures to current 
employers and to responsible officials of the awardee institution in 
connection with an inquiry and or investigation of scientific 
misconduct by an individual sponsored by the institution. The fourth 
routine use allows PHS to disclose information to other Federal 
Agencies which also are providing support or are considering providing 
support to the awardee institution or which have utilized or relied on 
the relevant research. The records only will be disclosed when 
necessary to enable the agencies to effectively perform their 
responsibilities. The fifth routine use allows PHS to disclose 
information to other Federal, State and local agencies and to other 
individuals and entities assisting the PHS in the investigation and to 
person(s) making the allegations who have knowledge concerning the 
factual basis of the allegation(s). The sixth routine use allows 
disclosure to State licensing boards or certifying bodies to aid in 
their review of the individual in order to effectively protect the 
health and welfare of the population within their jurisdictions and the 
integrity of the profession. The seventh routine use allows disclosure 
of information to journal editors, publishers, professional societies 
or others in order to correct inaccurate or misleading research results 
or to notify the public of invalid studies. The eighth routine use 
allows disclosure to appropriate agencies in cases of investigations or 
prosecutions under a statute, rule, regulation or order. The ninth 
routine use allows disclosure to HHS contractors for the purpose of 
collating, aggregating, analyzing or otherwise refining or processing 
records in this system. The contractor is required to maintain the 
Privacy Act safeguards with respect to these records. The tenth routine 
use allows the ORI to disclose information where there has been a 
finding of misconduct or the inquiry or investigation has become a 
public dispute, to communications and news media, scientific journals 
and publications, and to the public. Providing this information to the 
media, journals, publications and public will serve an educational 
purpose and as a deterrent and will assist institutional officials in 
making informed decisions affecting their institutions and 
organizations. The eleventh routine use allows disclosure of necessary 
records that were filed with or generated by the Departmental Appeals 
Board. These records concern a specific case of scientific misconduct 
where a hearing has been requested before the Research Integrity 
Adjudication Panel (RIAP) of the DAB. The RIAP conducts the hearings on 
the ORI findings and proposed administrative actions at the request of 
the respondent. The twelfth routine use allows disclosure of 
information to the General Services Administration (GSA) after there is 
a final agency action to debar. The GSA publishes and makes available 
this information to the scientific community.
    We have obtained an exemption for these records as provided by the 
Privacy Act to maintain the integrity of the investigative process. 
Therefore, at the discretion of the system manager, the system is 
exempt from the notification, access, correction and amendment 
provisions of the Privacy Act.
    This system notice is written in the present rather than the future 
tense in order to avoid the unnecessary expenditure of public funds to 
republish the notice should it become final.

    Dated: July 1, 1994.
Wilford J. Forbush,
Director, Office of Management.
09-37-0021
    Public Health Service Records Related to Inquiries and 
Investigations of Scientific Misconduct, HHS/OASH/ORI.
    None.
    For Intramural and Extramural Research Programs: Office of Research 
Integrity, Rockwall II, suite 700, 5515 Security Lane, Rockville, 
Maryland 20852; and at offices for (1) each of the Agency Extramural 
Research Integrity Officers (AERIOs), (2) each of the Agency Research 
Integrity Liaison Officers (ARILOs), (3) each of the Agency Intramural 
Research Integrity Officers for those agencies covered by this notice; 
and (4) each of the NIH Misconduct Program Offices and (5) the Federal 
Records Centers for inactive records.
    Individuals who are the subject of allegation(s) of scientific 
misconduct or related matters. These categories include: (1) 
Researchers currently or formerly employed by the Federal Government, 
(2) guest researchers, (3) Advisory Committee members, and (4) 
investigators or applicants for research grants, research training 
grants, fellowships, cooperative agreements or contracts. Investigators 
may include principal investigators, co-investigators, program 
directors, trainees, recipients of career awards or fellowships, or 
other individuals who conduct or are responsible for research or 
research training funded by the PHS or who are the subject of 
applications for PHS funding.
    This system contains records related to allegations, inquiries, 
investigations or findings of misconduct in science and/or to actions 
that PHS has taken in connection with such allegations, inquiries, 
investigations or findings. Scientific misconduct 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 
interpretation or judgment of data.
    This system consists of records concerning or collateral to 
pending, ongoing or completed inquiries and investigations of alleged 
scientific misconduct. It includes information about the individuals 
under investigation or under an inquiry; the other PHS agencies or 
other federal agencies involved; the organization responsible for 
conducting the inquiry or investigation; the funding mechanism 
identification number(s) involved; names of individual involved; names 
of witnesses; general nature of the allegation; and the documentation 
used in the inquiry or investigation, including relevant research data 
and reagents, proposals, publications, copies of relevant publications 
by persons under investigation, qualification statements and curriculum 
vitae of expert consultants, correspondence, memoranda of telephone 
calls, summaries of interviews, social security numbers, interim and 
final reports prepared by the institution, Office of Research Integrity 
(ORI), Department Appeals Board (DAB) and other related data.
    The authorities for maintaining the system are Sections 215(b), 301 
and 493 of the Public Health Service Act; 42 U.S.C. 216(b), 241, and 
289b; 5 U.S.C. 301, and 44 U.S.C. 3101, 42 CFR Part 50, subpart A; 45 
CFR part 76.
    The purposes of this system are (1) to enable PHS agencies to 
discharge effectively their responsibilities in managing PHS intramural 
and extramural research programs and in the application, award, and 
administration of research and training awards, cooperative agreements 
and contracts while protecting the rights and privacy of the 
individuals under investigation as well as confidential sources of 
information; (2) to determine whether there has been scientific 
misconduct in research relevant to funding; (3) to assure the 
institutions applying for or receiving PHS funds have appropriate 
mechanisms for detailing with allegations of scientific misconduct and 
the protection of whistleblowers; (4) to determine whether results of 
PHS-related research may be inaccurate so that PHS can notify the 
scientific community or others who may rely on the results; (5) to 
serve as a working file and enable the ORI to inform PHS agency 
officials of the status and results of inquiries and investigations so 
that they may take actions appropriate to each case; (6) to investigate 
allegations of misconduct and take appropriate remedial and corrective 
actions with respect to individuals who are found to have committed 
misconduct; and (7) to ensure that inquiries and investigations are 
timely, thorough, complete and objective in accordance with applicable 
federal regulations.
    Disclosure may be made for the routine uses as indicated below: 1. 
To the Department of Justice, or to a court or other tribunal, when (a) 
the Department of Health and Human Services (HHS), or any component 
thereof; or (b) any HHS employee in his or her official capacity; or 
(c) any HHS employee in his or her individual capacity where the 
Department of Justice (or HHS, where it is authorized to do so) has 
agreed to represent the employee; or (d) the United States or any 
agency thereof where HHS determines that the litigation is likely to 
affect HHS or any of its components, is a party to litigation or has an 
interest in such litigation, and HHS determines that the use of such 
records by the Department of Justice, court or other tirbunal is 
relevant and necessary to the litigation and would help in the 
effective representation of the government party, provided, however, 
that in each case HHS determines that such disclosure is compatible 
with the purpose for which the records were collected.
    2. To qualified expert(s) for the purpose of obtaining the expert's 
assistance on matters pertinent to the inquiry, investigation, or 
related legal proceeding.
    3. To responsible officials of the awardee institutions or 
organizations, when in connection with an inquiry, investigation or 
finding of misconduct by an individual previously or currently employed 
by or affiliated with the institution or organization, a PHS agency 
makes a finding or takes an action potentially affecting research and 
research training awards to the institution or organization.
    4. To other Federal Agencies who have supported, are supporting or 
are considering support of a research grant, fellowship, cooperative 
agreement or contract with an affected individual or institution or 
which have utilized or relied on the relevant research to the extent 
that the record is relevant and necessary to the Agency's decision on 
the matter.
    5. To the relevant PHS-supported or other institution(s), Federal, 
State and local agencies, the persons(s) making the allegations and 
other entities or individuals who may have knowledge concerning the 
factual basis of the allegation or otherwise be able to assist in an 
inquiry, investigation or related proceeding, provided however, that in 
each case HHS determines that such disclosure is desirable or necessary 
in order to conduct a thorough and fair investigation into allegations 
of scientific misconduct.
    6. To a State licensing board or certifying body conducting a 
review of the individual to aid the board or body in meeting its 
responsibility to protect the health of the population in its 
jurisdiction or the integrity of the profession.
    7. To journal editors, publishers, professional societies or others 
in order to correct inaccurate or misleading research results or to 
notify the public of invalid studies.
    8. To the appropriate agency, whether Federal, State or local, 
charged with the responsibility of investigation or enforcing a 
statute, or rule, regulation, or order issued pursuant thereto where 
such responsibility rests outside of HHS when there exists a violation 
or potential violation of law whether civil, criminal or regulatory in 
nature and whether arising by general statute or particular program 
statute or by regulation, rule or order.
    9. To HHS contractors for the purpose of collating, analyzing, 
aggregating or otherwise refining or processing records in this system. 
The contractor shall be required to maintain Privacy Act safeguards 
with respect to the records.
    10. To professional journals, news media, other publications and to 
the public after there is a final agency finding of scientific 
misconduct or where the inquiry or investigation has become a public 
dispute.
    11. To persons who request records filed with or generated by the 
Departmental Appeals Board regarding a specific case of alleged 
scientific misconduct where a hearing was requested.
    12. To the General Services Administration (GSA), after there is a 
final agency action to debar, for the purpose of distributing and 
publishing that decision to debar.
    Records are stored in file folders and on computer discs.
    Records are retrieved by name of the individual who is the subject 
of an allegation, inquiry or investigation.
    1. Authorized users. Extramural and Intramural records in ORI are 
available to the system manager, to the Director of ORI, and to other 
appropriate ORI staff. Records specifically related to the Intramural 
Research Program are available to the system manager, to the Deputy 
Director for Intramural Research, and to other appropriate HHS 
officials, including the Agency Research Integrity Liaison Officer 
(ARILOs), the Agency Intramural Research Integrity Officer, and the 
Misconduct Program Officers (MPOs) located in the Bureaus, Centers, and 
Divisions of the NIH that are associated with the allegation, inquiry 
or investigation.
    2. Procedural safeguards. For records located in the ORI, access is 
strictly controlled by the system manager and the ORI, Director. For 
records located at the other sites, access is strictly controlled by 
the PHS Agency Heads, Deputy Director for Intramural Research, the 
AIRLOs, and MPOs and other appropriate PHS officials. HHS employees who 
receive disclosures from this system are informed that the information 
is confidential. 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 is 
protected by access and intrusion alarms at the front and emergency 
entrances. Access to computer files are protected through access 
permissions and user-invisible encryption. Special measures 
commensurate with the sensitivity of the record are taken to prevent 
unauthorized copying or disclosure of the records. Records at other 
locations are protected from unauthorized access by the AERIO's, 
ARILOs, MPOs, or AIRIOs.
    Allegation, inquiry and investigative files are retained and 
disposed of in accordance with the OASH Record Control Schedule.
    Director, Division of Research Investigations, Office of Research 
Integrity, Rockwell II, suite 700, 5515 Security Lane, Rockville, 
Maryland 20852.
    This system is exempt from access; however, consideration will be 
given to requests addressed to the system manager. For general 
inquiries, state your name, the name of the institution, and the date 
of the award.
    Same as notification procedures. Requestors should also reasonably 
specify the record contents being sought.
    Exempt. However, consideration will be given 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.
    Information in this system is obtained: (1) Directly from the 
individual, (2) derived from materials supplied by the individual, (3) 
from information supplied by the institutions, informants, witnesses, 
and others and (4) from existing government files.
    This system is exempted under subsections (k)(2) and (k)(5) of the 
Privacy Act from access, notification, correction, and amendment 
provisions of the Privacy Act [5 U.S.C. 552a (c)(3), (d) (1)-(4), 
(e)(4)(G)-(H), and (f)], to the extent that it includes (1) 
investigatory materials compiled for law enforcement purposes, 
including criminal law enforcement, where access would be likely to 
prejudice the conduct of the investigation, and (2) material, whose 
disclosure would reveal the identity of a source who furnished 
information to the Government under an express promise of 
confidentiality.

[FR Doc. 94-17483 Filed 7-18-94; 845 am]
BILLING CODE 4160-17