U.S. Department Of Health And Human Services
Departmental Appeals Board Guidelines
Hearings Before The Research Integrity Adjudications Panel

*29809 AGENCY: Office Of The Secretary, HHS

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. ln 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, S.W., 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 facsimile, the date received by the Board). If the deadline falls on a Saturday, Sunday, or legal holiday, the filing date is the next business

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 will 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. Acknowledgment 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 presentations 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 informal 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 C.F.R. Part 76 and 48 C.F.R. Subparts 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 C.F.R. 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 records. See 58 Fed. Reg. 29,228 (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 C.F.R. Part 16 (in particular, 45 C.F.R. 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.