Source: http://www.fordham.edu/academics/office_of_research/office_of_sponsored_/research_integrity__/phs_regulation_74319.asp
Timestamp: 2014-08-02 06:34:27
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42 CFR Part 93 - PHS Policies on Research Misconduct
[Final rule: June 16, 2005] Subpart A--General
(d) Require institutions to develop and implement policies and procedures for--
(1) This part applies to allegations of research misconduct and research misconduct involving:
(3) "Grandfather'' exception. If HHS or an institution received the allegation of research misconduct before the effective date of this part.
The following evidentiary standards apply to findings made underthis part.
Debarring official means an official authorized to impose debarment or suspension. The HHS debarring official is either-- (a) The Secretary; or (b) An official designated by the Secretary.
Departmental Appeals Board or DAB means, depending on the context-- (a) The organization, within the Office of the Secretary, established to conduct hearings and provide impartial review of disputed decisions made by HHS operating components; or (b) An Administrative Law Judge (ALJ) at the DAB.
Good faith as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping an institution meet its responsibilities under this part.A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
(b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution--
(a) Compliance with assurance. ORI considers an institution in compliance with its assurance if the institution--
(2) Takes all reasonable and practical specific steps to foster research integrity consistent with § 93.300, including--
(a) If an institution is too small to handle research misconduct proceedings, it may file a "Small Organization Statement'' with ORI in place of the formal institutional policies and procedures required by §§ 93.301 and 93.304.
(a) Consistent with § 93.108, protection of the confidentiality of respondents, complainants, and research subjects identifiable from research records or evidence;
(a) Criteria warranting an inquiry. An inquiry is warranted if the allegation--
(2) Is within § 93.102; and
(d) Criteria warranting an investigation. An inquiry's purpose is to decide if an allegation warrants an investigation. An investigation is warranted if there is--
(1) A reasonable basis for concluding that the allegation falls within the definition of research misconduct under this part and involves PHS supported biomedical or behavioral research, research training or activities related to that research or research training, as provided in § 93.102; and
(e) Inquiry report. The institution must prepare a written report that meets the requirements of this section and § 93.309.
(a) Within 30 days of finding that an investigation is warranted, the institution must provide ORI with the written finding by the responsible institutional official and a copy of the inquiry report which includes the following information--
(b) The institution must provide the following information to ORI on request--
(c) Documentation of decision not to investigate. Institutions must keep sufficiently detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to conduct an investigation. Consistent with § 93.317, institutions must keep these records in a secure manner for at least 7 years after the termination of the inquiry, and upon request, provide them to ORI or other authorized HHS personnel.
(d) Notification of special circumstances. In accordance with § 93.318, institutions must notify ORI and other PHS agencies, as relevant, of any special circumstances that may exist.
(b) Notice to ORI. Notify the ORI Director of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of § 93.307 and § 93.309.
(d) Custody of the records. To the extent they have not already done so at the allegation or inquiry stages, take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records--
(a) Time limit for completing an investigation. An institution must complete all aspects of an investigation within 120 days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment in accordance with § 93.312, and sending the final report to ORI under § 93.315.
(f) Statement of findings. For each separate allegation of research misconduct identified during the investigation, provide a finding as to whether research misconduct did or did not occur, and if so--
§ 93.314 Institutional appeals. (a) While not required by this part, if the institution's procedures provide for an appeal by the respondent that could result in a reversal or modification of the findings of research misconduct in the investigation report, the institution must complete any such appeal within 120 days of its filing. Appeals from personnel or similar actions that would not result in a reversal or modification of the findings of research misconduct are excluded from the 120-day limit.
(a) Definition of records of research misconduct proceedings. As used in this section, the term "records of research misconduct proceedings'' includes:
(a) ORI review. ORI may respond directly to any allegation of research misconduct at any time before, during, or after an institution's response to the matter. The ORI response may include, but is not limited to--
(c) HHS administrative actions.
(1) In response to a research misconduct proceeding, ORI may propose administrative actions against any person to the HHS and, upon HHS approval and final action in accordance with this part, implement the actions.
(b) If ORI conducts an assessment, it considers whether the allegation of research misconduct appears to fall within the definition of research misconduct, appears to involve PHS supported biomedical or behavior research, research training or activities related to that research or research training, as provided in § 93.102, and whether it is sufficiently specific so that potential evidence may be identified and sufficiently substantive to warrant an inquiry. ORI may review all readily accessible, relevant information related to the allegation.
(d) If ORI decides that an inquiry is not warranted it will close the case and forward the allegation in accordance with paragraph(e) of this section.
(a) Makes findings of research misconduct and proposes and obtains HHS approval of administrative actions based on the record of the research misconduct proceedings and any other information obtained by ORI during its review; or§
§ 93.405 Notifying the respondent of findings of research misconduct and HHS administrative actions. (a) When the ORI makes a finding of research misconduct or seeks to impose or enforce HHS administrative actions, other than debarment or suspension, it notifies the respondent in a charge letter. In cases involving a debarment or suspension action, the HHS debarring official issues a notice of proposed debarment or suspension to the respondent as part of the charge letter. The charge letter includes the ORI findings of research misconduct and the basis for them and any HHS administrative actions. The letter also advises the respondent of the opportunity to contest the findings and administrative actions under Subpart E of this part.
(d) Acceptance of responsibility. Has the respondent accepted responsibility for the misconduct by--
§ 93.409 Settlement of research misconduct proceedings.
§ 93.410 Final HHS action with no settlement or finding of research misconduct.
§ 93.411 Final HHS action with settlement or finding of research misconduct.
(b) ORI may decide that an institution is not compliant with this part if the institution shows a disregard for, or inability or unwillingness to implement and follow the requirements of this part and its assurance. In making this decision, ORI may consider, but is not limited to the following factors--
§ 93.413 HHS compliance actions.
(d) If the institution's actions constitute a substantial or recurrent failure to comply with this part, ORI may also revoke the institution's assurance under §§ 93.301 or 93.303.
Subpart E--Opportunity To Contest ORI Findings of Research Misconduct and HHS Administrative Actions
(b) A respondent has an opportunity to contest ORI research misconduct findings and HHS administrative actions under this part, including debarment or suspension, by requesting an administrative hearing before an Administrative Law Judge (ALJ) affiliated with the HHS DAB, when--
§ 93.501 Opportunity to contest findings of research misconduct and administrative actions.
(a) Opportunity to contest. A respondent may contest ORI findings of research misconduct and HHS administrative actions, including any debarment or suspension action, by requesting a hearing within 30 days of receipt of the charge letter or other written notice provided under § 93.405.
(b) Form of a request for hearing. The respondent's request for a hearing must be--
(c) Contents of a request for hearing. The request for a hearing must--
(d) Extension for good cause to supplement the hearing request.
(1) After receiving notification of the appointment of the ALJ, the respondent has 10 days to submit a written request to the ALJ for supplementation of the hearing request to comply fully with the requirements of paragraph (c) of this section. The written request must show good cause in accordance with paragraph (d)(2) of this section and set forth the proposed supplementation of the hearing request. The ALJ may permit the proposed supplementation of the hearing request in whole or in part upon a finding of good cause. (2) Good cause means circumstances beyond the control of the respondent or respondent's representative and not attributable to neglect or administrative inadequacy.
§ 93.504 Grounds for dismissal of a hearing request.
(a) The ALJ must dismiss a hearing request if the respondent--
(2) Does not raise a genuine dispute over facts or law material to the findings of research misconduct and any administrative actions, including debarment and suspension actions, in the hearing request or in any extension to supplement granted by the ALJ under § 93.501(d);
(b) The ALJ may dismiss a hearing request if the respondent fails to provide ORI with notice in the form and manner required by § 93.501.
§ 93.505 Rights of the parties.
(b) Except as otherwise limited by this subpart, the parties may--
(9) Submit written post-hearing briefs, proposed findings of fact and conclusions of law, and reply briefs within reasonable time frames agreed upon by the parties or established by the ALJ as provided in § 93.522; and
§ 93.506 Authority of the Administrative Law Judge.
(b) Subject to review as provided elsewhere in this subpart, the ALJ may--
(c) The ALJ does not have the authority to--
(b) Forms. (1) Unless the ALJ provides otherwise, all submissions filed in the proceeding must include an original and two copies. The ALJ may designate the format for copies of nondocumentary materials such as videotapes, computer disks, or physical evidence. This provision does not apply to the charge letter or other written notice provided under § 93.405.
(2) Every submission filed in the proceeding must include the title of the case, the docket number, and a designation of the nature of the submission, such as a "Motion to Compel the Production of Documents'' or "Respondent's Proposed Exhibits.''
(c) Service. A party filing a submission with the ALJ must, at the time of filing, serve a copy on the other party. Service may be made either to the last known principal place of business of the party's attorney if the party is represented by an attorney, or, if not, to the party's last known address. Service may be made by--
§ 93.509 Computation of time.
(c) Where a document has been filed by placing it in the mail, an additional 5 days must be added to the time permitted for any response. This paragraph does not apply to a respondent's request for hearing under § 93.501.
(b) The ALJ may use the initial prehearing conference to discuss--
§ 93.512 Discovery.
(c) Nondisclosable items. This section does not authorize the disclosure of--
(3) The ALJ must compel the production of a requested document and deny a motion for a protective order, unless the requested document is--
(e) Refusal to produce items. If a party refuses to provide requested documents when ordered by the ALJ, the ALJ may take corrective action, including but not limited to, ordering the noncompliant party to submit written answers under oath to written interrogatories posed by the other party or taking any of the actions at § 93.515.
§ 93.514 Amendment to the charge letter.
§ 93.515 Actions for violating an order or for disruptive conduct.
(b) The actions may include--
(b) Burden of proof. (1) ORI bears the burden of proving the findings of research misconduct. The destruction, absence of, or respondent's failure to provide research records adequately documenting the questioned research is evidence of research misconduct where ORI establishes by a preponderance of the evidence thatthe respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and the respondent's conduct constitutes a significant departure from accepted practices of the relevant research community.
(2) The respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised. In determining whether ORI has carried the burden of proof imposed by this part, the ALJ shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent. (3) ORI bears the burden of proving that the proposed HHS administrative actions are reasonable under the circumstances of the case. The respondent has the burden of going forward with and proving by a preponderance of the evidence any mitigating factors that are relevant to a decision to impose HHS administrative actions following a research misconduct proceeding.
(c) A hearing under this subpart is not limited to specific findings and evidence set forth in the charge letter or the respondent's request for hearing. Additional evidence and information may be offered by either party during its case-in-chief unless the offered evidence is--
§ 93.518 Witnesses.
(b) The ALJ may admit written testimony if the witness is available for cross-examination, including prior sworn testimony of witnesses that has been subject to cross-examination. These written statements must be provided to all other parties under § 93.513.
(d) The ALJ may exercise reasonable control over the mode and order of questioning witnesses and presenting evidence to--
(2) Avoid undue repetition or needless consumption oftime.
(f) Upon request of a party, the ALJ may exclude a witness from the hearing before the witness' own testimony. However, the ALJ may not exclude--
(e) The ALJ may take judicial notice of matters upon the ALJ's own initiative or upon motion by a party as permitted under FRE 201 (Judicial Notice of Adjudicative Facts). (1) The ALJ may take judicial notice of any other matter of technical, scientific, or commercial fact of established character. (2) The ALJ must give the parties adequate notice of matters subject to judicial notice and adequate opportunity to show that the ALJ erroneously noticed the matters.
§ 93.520 The record.
§ 93.522 Filing post-hearing briefs.
Edited by: Kris Wolff	©2014 Fordham University