[Federal Register Volume 59, Number 110 (Thursday, June 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13939]
[[Page Unknown]]
[Federal Register: June 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[GN #2252]
Hearing Procedures for Scientific Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: The Office of Research Integrity (ORI) is publishing the
revised Guidelines for Hearings Before the Research Integrity
Adjudications Panel of the Departmental Appeals Board (DAB).
Publication is intended to provide notice to the scientific community
and the general public of the procedures followed by the DAB, based on
their experience and applicable legal principles, on conducting
hearings on ORI findings of scientific misconduct. These hearings are
provided upon the request of the accused scientist and are made
available for scientists who receive or apply for Public Health Service
(PHS) support under grants, contracts, or cooperative agreements or who
conduct research in PHS laboratories. The availability of hearings was
first announced by ORI in November 1992. See 57 FR 53125, Nov. 6, 1992.
These Guidelines were revised by the DAB on May 5, 1994, and will apply
to any request for a hearing that occurs after the date of publication.
They are published below.
FOR FURTHER INFORMATION CONTACT: Director, Division of Policy and
Education, Office of Research Integrity, 5515 Security Lane, Rockville,
MD 20852, (301) 443-5300.
Lyle W. Bivens,
Director, Office of Research Integrity.
Departmental Appeals Board Guidelines, Hearings Before the Research
Integrity Adjudications Panel
I. What These Guidelines Are for and How To Get More Information
These guidelines will help you understand how to proceed before the
Research Integrity Adjudications Panel, which is part of the
Departmental Appeals Board in the Office of the Secretary of HHS. The
Board may modify these guidelines to fit the needs of a particular
case. In all cases, our objective is to fairly and promptly develop and
consider a complete record of relevant and material evidence so that we
can issue a sound decision.
These guidelines are intended for use in cases where HHS (through
the Office of Research Integrity of the Public Health Service or the
Deputy Assistant Secretary for Grants and Acquisition Management)
proposes debarment or other administrative actions for scientific
misconduct.
Below, we use the term ``Respondent'' to mean the person or
organization which received a notice of proposed findings of scientific
misconduct from HHS. The Respondent and HHS are the ``parties'' in the
case.
Soon after a case is docketed at the Board, we will inform the
parties of the name of a Board staff attorney who can respond to
questions about procedures for the case. If you have general questions,
there is a contact listed at the end of these guidelines.
II. How the Review Process Starts; Time Limits
HHS provides written notice to the Respondent of proposed findings
of scientific misconduct. The Respondent has thirty days after
receiving the HHS notice to request a hearing by submitting a written
request to the Research Integrity Adjudications Panel, Departmental
Appeals Board, room 637-D, Humphrey Building, 200 Independence Avenue
SW., Washington, DC 20201. At the same time, the Respondent must send a
copy of the request to the official who sent the HHS notice.
If the Respondent does not file the hearing request within thirty
days, the proposed HHS findings and remedies will be made final.
The filing date is the postmark date (or, if hand delivered or
transmitted by fascimile, the date received by the Board). If the
deadline falls on a Saturday, Sunday, or legal holiday, the filing date
is the next business day.
III. How the Dispute Is Framed and What the Respondent's Hearing
Request Must Include
The HHS written notice should clearly summarize the basis for the
HHS proposed findings of misconduct and proposed administrative
actions. HHS may, however, include with the notice an investigative
report, and refer to that report (or specific parts of it) for any
findings or legal conclusions underlying the proposed findings of
misconduct or proposed administrative actions.
The Respondent's hearing request must include a succinct statement
identifying specific factual findings and administrative actions, set
out in the written notice or report and relied on by HHS, which
Respondent disputes. Factual findings that are stated or adopted in the
notice and that are not specifically disputed by Respondent must be
considered as facts to which Respondent has admitted. Administrative
actions which are not specifically disputed in the request will be
considered accepted. The hearing request should also identify any legal
issues which the Respondent intends to raise.
Thus, the written notice, any parts of the report relied upon in
the notice, and Respondent's hearing request together frame the dispute
before the Panel. If HHS wishes to add new proposed findings of
misconduct to the Panel proceeding, HHS must timely move to amend its
findings.
IV. Establishing the Panel For the Case
The Research Integrity Adjudications Panel will consist of three
members. Immediately after we receive the request for hearing, the
Chair of the Board will designate from Board staff a Presiding Panel
Member of the Research Integrity Adjudications Panel which will hear
and decide the case. The Panel is assisted by a staff attorney who also
functions as the parties' contact for questions about case status and
procedures. The Presiding Panel Member chairs the Panel, sets
procedures, presides at the preliminary conference and the hearing, and
generally leads development of the case.
Upon request of either party, one of the other two Panel Members
for the case will be a scientist or other expert from outside the
board. This request should be timely made in order to avoid any delay
in these proceedings.
Only unbiased and disinterested experts will be appointed.
V. Acknowledgement of Request for Hearing
The Presiding Panel Member will send the parties a written notice
that we received the hearing request. This acknowledgment will describe
the next steps and may include special information (such as earlier
Board decisions which may be relevant) or requests for clarification.
The acknowledgment will tell HHS to promptly notify the Presiding Panel
Member and the Respondent of the name, address and telephone number of
HHS's representative.
The acknowledgment also will tentatively schedule the preliminary
conference (see VI below), usually for a date and time within two weeks
of the acknowledgment. The date and time are tentative. Please advise
the Board staff attorney immediately whether the proposed date and time
are convenient and what telephone number we should use. Note that we
will not permit any substantial delay, so that if the date is
inconvenient, a party generally should request a postponement of no
more than a few days.
VI. Preliminary Conference
The next step is the preliminary conference, which is designed for
the Presiding Panel Member to discuss scheduling and other matters with
the parties. Generally, this conference is conducted by telephone. The
parties should be prepared to discuss anything that will enable the
case to proceed fairly and efficiently, including: (1) Whether HHS has
sufficiently defined the findings to which the Respondent must respond;
(2) what documents, if any, should be submitted by whom and deadlines
for submission; (3) the date, location and anticipated length of the
hearing; (4) who the parties' witnesses will be and the general nature
of their proposed testimony; (5) specification of disputes of fact and
their materiality to the findings of scientific misconduct; (6) whether
there is any need for briefing of issues prior to hearing; (7)
simplifying, narrowing and clarifying issues; (8) stipulations or
admissions of undisputed facts, authenticity of documents,
admissibility of documents, and qualifications of expert witnesses; and
(9) any other matter which the Presiding Panel Member finds it
appropriate to discuss.
The conference will be audiotaped. At the end of the conference,
after consulting the parties, the Presiding Panel Member will decide
how the results of the conference will be noted for the record (for
example, we may keep a copy of the tape in the record or summarize the
results of the conference in a written document kept in the record).
VII. The Right To A Hearing; Waiver
The Respondent is entitled to an in-person hearing.
The Respondent may choose to waive his or her right to an in-person
hearing so that the Panel will review and decide the case on the basis
of the written record (including briefs and documents which both
parties would be allowed to submit). This review may be accompanied by
oral presentation by telephone.
If the Respondent chooses to proceed this way, the Presiding Panel
Member will ask whether the HHS representative agrees to dispense with
an in-person hearing (since HHS may have witnesses it wishes to
present). Even if both parties agree to a review on the written record,
the Presiding Panel Member may require the parties to participate in a
telephone conference to respond to questions about issues in the case.
VIII. Hearing Procedures
The Presiding Panel Member will determine the place and time of the
hearing after consulting the parties in the preliminary conference (see
VI above). Generally, hearings are set at a site which is most
convenient for the largest number of participants and which has
appropriate facilities.
The Presiding Panel Member will preside at the hearing. Other Panel
Members will attend as much of the hearing as the Members decide among
themselves; all Members, of course, will have full access to the
transcript of the hearing and the rest of the record. The hearings will
be as informed as reasonably possible, consistent with the need to
establish an orderly record. There are no formal rules of evidence
applicable; however, the Presiding Panel Member may refer to the
Federal Rules of Evidence for guidance.
The Presiding Panel Member generally will admit documents and
testimony into the record unless clearly irrelevant, immaterial or
unduly repetitious, so the parties should avoid frequent objections to
questions and documents.
The HHS written notice, any report (or part of a report) relied on
in the notice, and the Respondent's hearing request will be included in
the record in any scientific misconduct hearing. They do not themselves
constitute evidence, but frame the dispute; the notice and report may
also contain findings which are considered admitted because not
disputed in the hearing request. (See section III above). The
Respondent should not consider the written notice and report to be a
comprehensive summary of all the evidence that HHS may present at a
hearing. HHS may present other relevant evidence at the hearing if HHS
identifies it in a timely manner and no later than its final witness
and exhibit list (which generally is submitted at least 30 days prior
to the hearing), according to the procedures set by the Presiding Panel
Member.
Both parties may make opening and closing statements, may present
witnesses as agreed upon in the prehearing conference and may cross
examine opposing witnesses. The Panel Members may ask questions as
well. Witnesses will be warned that any false statement may be a basis
for criminal prosecution.
Hearings are open to the public. Generally, the witnesses' presence
in the hearing room when not testifying will be restricted if a party
requests it.
The hearing will be transcribed at Department expense and each
party will be provided a copy of the transcript (this usually takes
about ten days, unless the transcript is lengthy). Generally, the
transcript and all other materials in the record are matters of public
record.
IX. Post-Hearing Briefing
The Presiding Panel Member, after consulting the parties at the end
of the hearing, will decide whether post-hearing briefs will be allowed
or required and will set deadlines for briefing.
X. The Panel's Decision
Generally, the Panel will complete its review and issue a written
decision within 45 days after the last action in the proceeding.
The Panel's decision will be the final agency action on remedies
specific to the Public Health Service (such as prohibiting service on
advisory committees, boards or peer review groups). On debarment under
45 CFR part 76 and 48 CFR 9.4 and 309.4, the Panel's decision will be a
recommendation to the Deputy Assistant Secretary for Grants and
Acquisition Management (DASGAM), who generally will make a final
decision within thirty days of the Panel recommendation. DASGAM may
reject findings of fact which form the basis for the Panel decision
only if DASGAM determines them to be arbitrary and capricious or
clearly erroneous.
XI. Burden of Proof
HHS must always prove scientific misconduct by a preponderance of
the evidence.
XII. Submitting Material to Panel, Contacts With Panel
Whenever a party submits anything to the Panel, that party must
include a statement that he or she has at the same time given a copy to
the other party.
Time limits for filing briefs and documents will be set by the
Presiding Panel Member. Calculating filing deadlines is done in the
same manner as for the request for hearing (see II above).
No party may engage in any ex parte contact with Panel Members or
any other Board staff. This means that you must never provide written
materials to the Panel without giving a copy to the other party, and
you must never communicate orally with Panel Members or other Board
staff about matters in the case outside the presence of the other
party. Exceptions: you may speak to the Board staff attorney assigned
to your case on purely procedural matters. For guidance, the Panel may
refer to the provision on ex parte contacts contained in the Board's
published procedures (45 CFR 16.17).
The materials submitted to the Panel during a proceeding under
these Guidelines are considered public records and may be disclosed to
any person requesting such record. See 58 FR 29228 (May 19, 1993).
XIII. Panel's Powers
A. In General
The Panel, operating through the Presiding Panel Member, may
exercise the Board's plenary authority to take whatever actions the
Panel deem necessary for fair, complete, and expeditious resolution of
the case. For guidance, the Panel may refer to 45 CFR part 16 (in
particular, 45 CFR 16.13).
B. Discovery
The Presiding Panel Member may order a party to submit information
which the Presiding Panel Member determines may be directly relevant
and material to dispositive issues in the case and likely to be
important to a sound decision. Failure of a party to comply with such
an order may result in the panel drawing a negative inference from the
failure (that is, the panel may assume that the evidence would
substantiate the proposition for which the evidence was sought). The
Respondent may also have rights to certain information under the
Freedom of Information Act, but this is independent of the process in
these guidelines.
* * * * *
Questions? If you have any questions about these procedures, call
Andrea M. Selzer, Senior Attorney, at 202/690-6012. In her absence,
please call the Departmental Appeals Board at 202/690-5501 and ask for
assistance with the Research Integrity Adjudications Panel guidelines.
Issuance: September 30, 1992.
Revised: May 5, 1994.
[FR Doc. 94-13939 Filed 6-8-94; 8:45 am]
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