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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A95-329

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** January 6, 1995
- **Citation:** 60 FR 2140

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

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

AGENCY: Public Health Service, HHS.

ACTION: Notification of revised 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 revised notice of its
system of records, 09-37-0021, ``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 36776,
July 19, 1994). In response to the comments received, ORI revised the
system notice making changes to the purpose section and to routine uses
4, 5, 6, 7,9, and 10.

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), established 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 consists 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 are retrieved by
the name of the individual who is the subject of the inquiry or
investigation.
ORI published the notification of the new Privacy Act system of
records in the Federal Register on July 19, 1994. During the comment
period, ORI received several responses from professional associations.
In response to their concerns, ORI has revised the notice. The
revisions address the comments while permitting the ORI to use the
information in the system to fulfill its responsibility for responding
to allegations of scientific misconduct in research supported by the
PHS.
One of the commenters stated that ``ORI has neither the capability
nor the jurisdiction'' to provide information to correct ``inaccuracies
or misleading research results.'' In response to this comment, ORI
changed the ``Purpose'' section of the notice to state its use of the
records in the system of records more clearly. The fourth purpose
originally stated ``to determine whether results of PHS-related
research may be inaccurate * * *.'' now reads that the system of
records is to be used to ``determine whether results of PHS related
research are falsified, fabricated, plagiarized or misrepresented so
that PHS can notify the scientific community or others who may rely on
the results of those findings.''
The majority of the other objections to the system notice pertain
to the routine uses in the notice. Specifically, the commenters were
concerned that the system, as written, would allow for ``the premature
release of information in the system which could seriously and
irreparably undermine the careers of innocent scientists.'' In
addition, there was concern that the new system of records may also
result in inappropriate dissemination of information before there was a
finding of misconduct.
In response to the above comments, ORI revised several of the
routine uses. The revisions narrow the scope of the routine uses but
preserve the ability of ORI to make disclosures where there is a public
need while protecting the interest of those who have not yet been found
to have committed scientific misconduct.
Several commenters raised concern about routine use 4 which allowed
release to ``other Federal Agencies who have supported, are supporting
or are considering support of a research grant, fellowship, cooperative
agreement or [[Page 2141]] contract with an affected individual or
institution''. The commenters believed that this routine use was
inconsistent with the current PHS ALERT which was modified to preclude
disclosure to other Agencies until there was a finding of misconduct.
In response to these concerns and without compromising the ability of
the ORI to conduct thorough oversight and investigation activities ORI
has modified routine use 4 by adding `'after there is an institutional
or agency finding of misconduct.''
ORI modified the fifth routine use which allows ORI to disclose
information to ``any person able to provide information in an inquiry,
investigation or related proceeding, including the relevant PHS-
supported institution(s), Federal, State and local agencies, and the
person(s) making the allegation, provided however, that in each case
HHS determines that such disclosure is necessary.'' ORI still retains
the discretion to disclose information to persons making the
allegations. This routine use is necessary for ORI to effectively
interview witnesses in order to learn necessary information for the
purpose of conducting a fair and objective inquiry and investigation.
This routine use is similar to those used by other investigative units
within the Federal Government. For example, routine use 5 is similar to
the routine use in the National Science Foundation Privacy Act system
of records, NSF-52, ``Office of Inspector General Investigative
Files'', which allows the NSF to disclose information to
nongovernmental parties where those parties may have information that
the Office of the Inspector General (OIG) seeks to obtain in connection
with an OIG investigation.
A commenter was concerned that there was the potential for
premature disclosure of information to ``State licensing boards or
certifying bodies.'' In response to this comment, ORI revised routine
use 6 by adding a phrase that limits any disclosure until after there
is a final agency finding of misconduct, thereby, eliminating any
premature release. In addition, ORI added ``Upon request'' to routine
use 6 which authorizes the release of information only after there is a
request from the licensing board or certifying body for the
information.
In response to the general concern that ORI was able to release
information prematurely, ORI revised routine use 10. Routine use 10 now
allows disclosure to professional journals, news media, other
publications and to the public concerning misconduct findings and the
need to correct falsified, fabricated, plagiarized, or otherwise
misrepresented research results or reports only after there is a final
agency finding of scientific misconduct or remedial actions have been
imposed.
ORI modified routine use 7. Routine use 7 gives the ORI the
discretion to disclose information to ``Institutional Review Boards,
research-sponsoring institutions, individuals research subjects, and
the public regarding information obtained or developed through the
investigation that, in the PHS's judgment, may have implications for
individual's health or for their participation in a research study.''
In addition, for the purpose of ensuring fairness to the parties, the
same information that is released to the parties named above will be
disclosed to the subject of the investigation.
We revised routine use 9 to address the concern that contractors
were not held to the same standard as Federal employees regarding
safeguards to be afforded the records.
Finally, a routine use that allowed public disclosure of records
filed with or generated by the Departmental Appeals Board (DAB), HHS
has been deleted as unnecessary since DAB records are open to the
public.
In addition to revising the routine uses, ORI added the following
introductory statement: ``Any disclosure pursuant to these routine uses
will be limited to the minimum necessary to accomplish the purpose of
the disclosure.'' This statement reinforces the ORI policy that ORI
does not disclose any information that is not necessary in order to
accomplish a fair and thorough inquiry and investigation or as a means
to protect the public interest.
The ORI Privacy Act system notice is consistent with established
ORI practice to protect the confidentiality of the ORI records where
investigations are underway or individuals have been exonerated. ORI
will continue to protect the privacy of individuals and defend the
maintenance of confidentiality in its inquiries and investigations.
These revisions respond to the concerns about the release of
information from the system while permitting the ORI to use that
information to fulfill its responsibilities.

Dated: December 22, 1994.
Ellen Wormser,
Director, Office of Organization and Management Systems.
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 (AIRIOs) for those agencies covered by this
notice; (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, findings of misconduct in science, or 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
interpretations or judgements of data. [[Page 2142]]
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), Departmental 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 to (1) 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 and the confidentiality of information
sources; (2) determine whether there has been scientific misconduct in
PHS supported research; (3) assure the institutions applying for or
receiving PHS funds have appropriate mechanisms for dealing with
allegations of scientific misconduct and the protection of
whistleblowers; (4) determine whether results or reports of PHS-related
research are falsified, fabricated, misrepresented, or plagiarized so
that PHS can notify the scientific community or others who may rely on
the results; (5) 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) investigate allegations of misconduct and take appropriate remedial
and corrective actions with respect to individuals who are found to
have committed misconduct; and (7) ensure that inquiries and
investigations are timely, thorough, complete and objective in
accordance with applicable Federal regulations and procedures.
Any disclosure pursuant to these routine uses will be limited to
the information necessary to accomplish the purpose of the disclosure:
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 tribunal 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 after there is an initial institutional or agency finding of
misconduct.
5. To any person able to provide information in an inquiry,
investigation or related proceeding, including the relevant PHS-
supported institution(s), Federal, State and local agencies, and the
person(s) making the allegation, provided however, that in each case
HHS determines that such disclosure is necessary in order to conduct a
thorough and fair investigation into allegations of scientific
misconduct.
6. Upon request 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 after there is an
agency finding of misconduct or remedial actions have been imposed.
7. To Institutional Review Boards, research-sponsoring
institutions, individual research subjects, and the public, regarding
information obtained or developed through the investigation that, in
PHS's judgement, may have implications for individuals' health or for
their participation in a research study. The subject of the
investigation will be provided with a copy of the information that is
released.
8. 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, and whether arising by general
statute or particular program statute or by regulation, rule or order
issued pursuant there to, 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 or charged with enforcing or implementing the statute,
or rule, or regulation, or order issued pursuant thereto, if the
information disclosed is relevant to any enforcement, regulatory,
investigative or prosecutive responsibility of the receiving entity.
9. To agency contractors who have been engaged by the agency to
assist in the performance of a service related to this system of
records and who need to have access to the records in order to perform
the activity. Recipients shall be required to comply with the
requirements of the Privacy Act of 1974.
10. To notify professional journals, news media, other publications
and the public concerning misconduct findings and the need to correct
falsified, fabricated, plagiarized or otherwise misrepresented research
results or reports after there is a final agency finding of scientific
misconduct or [[Page 2143]] remedial actions have been imposed. No
information will be released that would reveal a confidential source.
11. 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, ORI, and to other
appropriate ORI staff when they have a need to know. Records 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 (AIRIOs), 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
when there is a need to know in the performance of their duties.
2. Procedural safeguards: For records located in the ORI, access is
strictly controlled by the system manager and the Director, ORI. For
records located at the other sites, access is strictly controlled by
the PHS Agency Heads, Deputy Director for Intramural Research, the
ARILOs, the AIRIOs, AERIO, and MPOs and other appropriate PHS officials
in their respective offices. 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 cabinet
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 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. Records at other locations are protected
from unauthorized access by PHS Agency heads, the Deputy Director
Intramural Research, 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, Rockwall 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)).
[FR Doc. 95-329 Filed 1-5-95; 8:45 am]
BILLING CODE 4160-17-M

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-329. Public record. Not legal advice.