[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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