[Federal Register Volume 59, Number 95 (Wednesday, May 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12031]
[[Page Unknown]]
[Federal Register: May 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Assistant Secretary for Health; Privacy Act of
1974; Altered System of Records
AGENCY: Public Health Service, HHS.
ACTION: Notification of an altered 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 proposal to
alter system of records 09-37-0151, Public Health Service ALERT Records
Concerning Individuals Found to Have Committed Scientific Misconduct in
PHS Sponsored Research, HHS/OASH/ORI. This system of records has been
transferred from the National Institutes of Health to the Office of
Research Integrity, Office of the Assistant Secretary for Health,
Public Health Service.
The purpose of altering this system of records is to automate the
system of records so that storage will be on computer disks as well as
hard copy. In addition, ORI is proposing to maintain the social
security numbers of the individuals in the system of records solely to
confirm the identify of the subjects of the records.
DATES: PHS invites interested persons to submit comments on the
proposed alterations on or before June 27, 1994. PHS has sent a Report
of Altered System to the Congress and to the Office of Management and
Budget on May 6, 1994. The alteration of this system of records will be
effective 60 days from the date submitted to OMB, unless PHS receives
comments which result in a contrary determination.
ADDRESS: Comments should be addressed to the ORI Privacy Act Officer at
the address listed below. Comments received will be available for
inspection from 9 a.m. to 3 p.m.
FOR FURTHER INFORMATION CONTACT:
Privacy Act Officer, Office of Research Integrity, Rockwall II, suite
700, 5515 Security Lane, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION: PHS proposes to alter this system of
records, 09-37-0151, ALERT Records Concerning Individuals Found to Have
Committed Scientific Misconduct in PHS Sponsored Research, HHS/OASH/
ORI, principally by changing the method of Storage of the records from
hard copy to one that includes storage on computer disks.
This system was maintained by NIH. The system name has been changed
to more accurately describe the records in the system. The number and
title has been changed from 09-25-0151, Administration: ALERT Records
Concerning Individuals under Investigation for Possible Misconduct in
Science or Subject to Sanction for Such Misconduct to ``09-37-0151.
ALERT Records Concerning Individuals Found to Have Committed Scientific
Misconduct in PHS Sponsored Research.''
PHS also proposes to maintain the Social Security numbers of the
subjects of the records. The character, scope and operation of the
system will remain the same. The Division of Policy and Education, ORI
will continue to maintain this system of records and will control
disclosures, as appropriate.
The change in the method of storage will provide a more effective
way for ORI to perform its responsibilities in the award of funds for
scientific research and development. Automating the system will provide
more effective means of communicating necessary information between
agencies. Social Security numbers will be used solely for the purpose
of correctly identifying the subjects of the investigation. In those
instances when the SSN is not available, the date of birth will be
utilized.
This system has had minor modifications since the last publication
of the system notice. These changes were to the System Name and Number,
Categories of Individuals Covered by the System, Categories of Records
in the System, Purposes of the System, Safeguards, System Manager(s)
and Address. They are as follows:
The change in the System Number and Name described above was made
to more accurately describe the records in the system.
The Categories of Individuals covered by the system has been
narrowed. The PHS ALERT no longer contains the names of individuals who
are subject to an investigation of scientific misconduct or where there
has been a determination that misappropriation of federal research
funds had occurred.
Individuals may be the subject of the records if they fall within
the following categories:
(1) ORI has made a finding of scientific misconduct concerning the
individual; (2) the individual is the subject of an administrative
action imposed as a result of a determination that scientific
misconduct has occurred; (3) the Individual has agreed to voluntary
corrective action as result of an investigation of scientific
misconduct; (4) ORI has received a report of an investigation by an
institution in which there was a finding of scientific misconduct
concerning the individual and ORI has determined that PHS has
jurisdiction; (5) FDA has determined that there is sufficient reason to
believe that official action is warranted against the individual for
violation of an FDA regulation governing research.
In addition, the following changes have been made to the system of
records:
The Categories of Records in the system has been changed to more
accurately reflect the information that is maintained in the system.
The Purpose section has been changed in a way that it remains
compatible with the previous published purposes. We have added a
section that deals with those instances in which the information in the
system may be used.
The Safeguards section has been altered as necessary to assure that
the records are maintained in a secure manner compatible with their
content and purposes.
The System Manager and address section has been changed to reflect
changes in the internal organizational structure of the ORI and its
procedures.
Additionally, PHS has made a number of editorial changes throughout
the system notice to clarify and to accommodate normal updating
changes.
The four routine uses for this system are compatible with the
stated purposes of the system. The first routine use allows referral to
the appropriate official(s) of the awardee institution or organization
when in connection with an ORI review of an institution's investigation
or finding of scientific misconduct by an individual employed by or
affiliated with the institution or organization, a PHS agency is taking
an action affecting research and research training awards to that
institution or organization. The second routine use proposed for this
system permits disclosure to a congressional office to allow the
subject individuals to obtain assistance from their representatives in
Congress, should they so desire. Such disclosure would be made only
pursuant to a request from the subject of the record. The third routine
use allows disclosure to the Department of Justice, a court, or
administrative tribunal in the event of litigation. The fourth routine
use allows disclosure by way of an electronic bulletin board to outside
organizations and institutions of investigative findings and
administrative actions when scientific misconduct is found. This
disclosure will provide information that will enable the institutions
and organizations to enforce PHS administrative actions within their
institution or organization.
This system notice is written in the present, rather than the
future tense, to avoid the unnecessary expenditure of public funds to
republish the notice after the notice becomes effective.
Dated: May 9, 1994.
Wilford J. Forbush,
Director, Office of Management.
09-37-0151
Public Health Service ALERT Records Concerning Individuals Found to
Have Committed Scientific Misconduct in PHS Sponsored Research, HHS/
OASH/ORI.
None.
Office of Research Integrity, Public Health Service, Rockwall II,
suite 700, 5515 Security Lane, Rockville, Maryland 20852.
Subjects may include (1) researchers currently or formerly employed
by the Federal Government; (2) individuals being considered for
appointment to Public Health Service (PHS) advisory committees; (3)
investigators on research grants, fellowships, cooperative agreements,
or contracts awarded by any PHS agency, (``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
PHS); (4) research investigators, such as guest workers, not employed
by PHS but who conduct research in PHS facilities or are closely
associated with research conducted by PHS; (5) other individuals, such
as subgrantees, subcontractors or assistants on research or research
training grants, contracts or cooperative agreements, who by training,
experience, occupation or other qualifications are potential candidates
for research or research training grants, contracts, cooperative
agreements or other benefits.
Such individuals would be subjects of records in this system if
they fall within the following categories:
(1) ORI has made a finding of scientific misconduct concerning the
individual;
(2) The individual is the subject of administrative actions imposed
as a result of a determination that scientific misconduct has occurred.
Such administrative actions include but are not limited to: (a)
Restrictions on specific activities or expenditures under an active
award, (b) a requirement for special reviews of all requests for
funding; (C) actions affecting eligibility for appointment as an
individual or member of a committee providing advice to PHS; (d)
debarment from participation in covered transactions which may include
grants, contracts, and cooperative agreements; (e) suspension or
termination of an active award; (f) special restrictions on regulated
research, such as disqualification by the Food and Drug Administration
(FDA) from use of investigational drugs or other products, or other
restrictions place on such use; and (g) termination of employment or
other disciplinary action against an employee of PHS.
(3) The individual has agreed to a voluntary corrective action as a
result of an investigation of scientific misconduct.
(4) ORI has received a report of an investigation by an institution
in which there is a finding of scientific misconduct concerning the
individual and ORI has determined that PHS has jurisdiction.
(5) The FDA has determined after an investigation that there is
sufficient reason to believe that official action is warranted against
the individual for violation of FDA regulations governing research.
This system contains records relating to findings of scientific
misconduct and to actions that PHS has taken in connection with such
findings including voluntary exclusion agreements. This information is
limited to (1) the ORI Case Reference number, (2) the name of the
subject of the investigation, (3) the individual's social security
number, (4) the date of birth of the individual, (5) the type of
misconduct, (6) the institution that conducted the investigation, (7) a
summary of the administrative actions imposed as a result of the
misconduct and the effective and expiration dates, (8) the involved PHS
support and the involved PHS agencies or funding components including
identification of the specific office responsible for the
investigation, (9) the record creation date, and (10) the last entry
date. 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
differences in interpretations or judgement of data.
Authority for this system comes from the legislation which
authorizes PHS to make awards for biomedical and behavioral research
and research training, and from PHS's concomitant responsibility to
assure both that funds disbursed under awards are spent for authorized
purposes and that recipients of such funds conform to all appropriate
laws and regulations. (5 U.S.C. 301; 29 U.S.C. 669; 42 U.S.C. 241,
242b, 242c, 2421, 242m, 247c, 281-289h, 285n, 285n-2, 285o, 285o-2,
300a-2, 300b-1-b-3, 300c-12, 300z-7, as these provisions relate to
biomedical and behavioral research and research training).
This system of records enables PHS agencies to discharge
effectively their responsibilities in the award and administration of
research and training grants, cooperative agreements and contracts,
while protecting the privacy and other rights of individuals. The PHS
ALERT system is used to collect, control and disseminate to PHS agency
officials on a need-to-know basis information that: (1) The PHS has
made a finding of scientific misconduct or (2) the PHS has imposed
administrative action(s) at the conclusion of an investigation for
scientific misconduct; or (3) has received a report of an investigation
by an institution in which there is a fining of scientific misconduct
and ORI has determined that the PHS has jurisdiction, or (4) the FDA
has determined after an investigation that there is sufficient reason
to believe that official action is warranted against such persons for
violation of FDA regulations governing research or (5) an individual
has agreed to a voluntary corrective action relative to findings of
scientific misconduct.
Specifically,
(1) PHS records the existence of such administrative actions in the
system so that PHS agencies can track and implement the administrative
actions, for example by refusing to accept an application or proposal
from a debarred person. In addition, PHS informs members of technical
merit review groups of actions taken if the disclosure is necessary to
ensure an unbiased review by providing an accurate account of the case,
for example, when information concerning the conduct investigated has
been disclosed by other sources, such as the press or other
communications media.
(2) The ORI will transmit the names and, if available, the SSN or
date of birth of those individuals against whom there was a finding of
scientific misconduct and administrative action(s) to the Division of
Research Grants (DRG), National Institutes of Health (NIH) and to other
appropriate officials within the PHS. DRG will use this file to screen
automatically PHS research contract and grant award records;
applications for PHS funding of research grants, fellowships and
cooperative agreements; and nominations/appointments to PHS advisory
committees.
(3) If the ORI's review of the institutional investigation findings
or the Departmental Appeals Board (DAB) hearing on the findings fail to
confirm misconduct (a) the individual's name is removed from the PHS
ALERT system of records and the individual is notified in writing; (b)
responsible PHS agency officials are notified of the outcome; (c) if
any interim administrative actions had been imposed, they are
withdrawn.
(4) Appropriate agency officials are notified of additions to the
PHS ALERT for the purpose of communicating and disseminating
information about scientific misconduct.
(5) PHS Committee Management Officers are notified of
administrative actions restricting or prohibiting PHS advisory service
in order to assist in the appointment of candidates for the advisory
committees.
(6) Upon request, the System Manager may disclose information to
PHS agency officials who are considering hiring a subject individual.
(7) Upon request, the System Manager may disclose information in
the PHS ALERT to contracting officers in order to assist them in the
award of a contract.
1. PHS may notify responsible officials of the awardee institutions
or organizations when, in connection with an ORI review of an
institution's investigation or a finding of scientific misconduct by an
individual employed by or affiliated with the institution or
organization, a PHS agency takes an action affecting research and
research training awards to the institution or organization.
Information disclosed will be limited to the name of the subject
individual, description of the action and the reason for it.
2. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
3. Disclosure may be made from this system of records to the
Department of Justice, or to a court or other tribunal, when (a) HHS,
or any component thereof; or (b) any HHS employee in his or her
official capacity or (c) any HHS employee in his or here 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, and HHS determines that the use of such records by the
Department of Justice, court or other tribunal is relevant and
necessary to the litigation and would help in the effective
representation of the governmental party, provided, however, that in
each case, HHS determines that such disclosure is compatible with the
purpose for which the records were collected.
4. Disclosure may be made via an electronic bulletin board to
institutions, organizations and persons connected to the electronic
bulletin boards outside the DHHS and components within the DHHS of the
names of individuals against whom there was a finding of scientific
misconduct and an imposition of administrative actions including
voluntary exclusion agreements. The information will enable applicant
institutions to enforce PHS administrative actions within their
institutions.
Records are stored in file folders and computer disks.
Records are retrieved by name of the individual who is the subject
of an ORI investigation or review of an institution's investigation or
subject to an administrative action.
1. Authorized users: Records are available only to the system
manager, Director of Division of Policy and Education (DPE), ORI, or
designee. Any disclosure to other individuals must be authorized by the
Director, DPE.
2. Procedural safeguards: Access to records is strictly controlled
by the system manager and the officials specified under ``Authorized
Users.'' Individuals who receive disclosures from this system before
there is a final agency finding, are informed that the information is
confidential.
3. Physical safeguards: Sensitive records stored in file folder and
on computer discs are kept in locked file cabinets in areas which are
locked when not in use. Special measures, commensurate with the
sensitivity of the records, are taken to prevent unauthorized copying
or disclosure of records.
These practices are in compliance with the standards of chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and the Department's Automated Information System Security Handbook.
Records are retained and disposed of in accordance with the OASH
Records Control Schedule. If an institutional finding of scientific
misconduct is reversed by ORI or DAB, the PHS ALERT records are
destroyed. If an investigation results in an official administrative
action or voluntary exclusion agreements, a record of such
administrative action is maintained for the duration of the
administrative action and then destroyed.
PHS ALERT System Manager, Division of Policy and Education, Office
of Research Integrity, Rockwall II, suite 700, 5515 Security Lane,
Rockville, MD 20852.
Individuals are routinely notified in writing when they become the
subject of a record in this system, unless a law enforcement agency has
instructed PHS not to do so. Subject individuals are also informed
routinely when their records are deleted from the system.
Individuals may write to the system manager at the address above
and provide their full name and the name of this Privacy Act system of
records to request a copy of the record. Requesters should also
reasonably specify the record contents being sought. Individuals may
also request a listings of accountable disclosures that have been made
of their records, if any.
Individuals may write to the system manager and reasonably identify
the record and the information being contested; and state the reasons
for requesting the change, along with supporting information to show
that the record is untimely, incomplete, irrelevant, or inaccurate. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect or untimely (obsolete).
Information in these records is obtained from awardee institutions
or organizations, and PHS agencies and organizations responsible for
investigations.
None.
[FR Doc. 94-12031 Filed 5-17-94; 8:45 am]
BILLING CODE 4168-17-M
