Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt42.1.93&rgn=div5
Timestamp: 2020-05-28 14:46:23
Document Index: 347957640

Matched Legal Cases: ['art 93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', 'art 76', 'arts 9', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93', '§93']

Title 42 → Chapter I → Subchapter H → Part 93
§93.25 Organization of this part.
§93.50 Special terms.
§93.101 Purpose.
§93.103 Research misconduct.
§93.104 Requirements for findings of research misconduct.
§93.105 Time limitations.
§93.106 Evidentiary standards.
§93.107 Rule of interpretation.
§93.200 Administrative action.
§93.201 Allegation.
§93.202 Charge letter.
§93.203 Complainant.
§93.204 Contract.
§93.205 Debarment or suspension.
§93.206 Debarring official.
§93.207 Departmental Appeals Board or DAB.
§93.208 Evidence.
§93.209 Funding component.
§93.210 Good faith.
§93.211 Hearing.
§93.212 Inquiry.
§93.213 Institution.
§93.214 Institutional member.
§93.215 Investigation.
§93.216 Notice.
§93.217 Office of Research Integrity or ORI.
§93.218 Person.
§93.219 Preponderance of the evidence.
§93.220 Public Health Service or PHS.
§93.221 PHS support.
§93.222 Research.
§93.223 Research misconduct proceeding.
§93.224 Research record.
§93.225 Respondent.
§93.226 Retaliation.
§93.227 Secretary or HHS.
§93.300 General responsibilities for compliance.
§93.301 Institutional assurances.
§93.303 Assurances for small institutions.
§93.304 Institutional policies and procedures.
§93.305 Responsibility for maintenance and custody of research records and evidence.
§93.306 Using a consortium or other person for research misconduct proceedings.
The Institutional Inquiry
§93.309 Reporting to ORI on the decision to initiate an investigation.
The Institutional Investigation
§93.311 Investigation time limits.
§93.312 Opportunity to comment on the investigation report.
§93.313 Institutional investigation report.
§93.314 Institutional appeals.
§93.315 Notice to ORI of institutional findings and actions.
§93.316 Completing the research misconduct process.
Authority: 42 U.S.C. 216, 241, and 289b.
Source: 70 FR 28384, May 17, 2005, unless otherwise noted.
This part is subdivided into five subparts. Each subpart contains information related to a broad topic or specific audience with special responsibilities as shown in the following table.
B Definitions of terms used in this part.
C Responsibilities of institutions with PHS support.
D Responsibilities of the U.S. Department of Health and Human Services and the Office of Research Integrity.
E Information on how to contest ORI research misconduct findings and HHS administrative actions.
This part uses terms throughout the text that have special meaning. Those terms are defined in Subpart B of this part.
(a) Establish the responsibilities of HHS, PHS, the Office of Research Integrity (ORI), and institutions in responding to research misconduct issues;
(b) Define what constitutes misconduct in PHS supported research;
(c) Define the general types of administrative actions HHS and the PHS may take in response to research misconduct; and
(d) Require institutions to develop and implement policies and procedures for—
(1) Reporting and responding to allegations of research misconduct covered by this part;
(2) Providing HHS with the assurances necessary to permit the institutions to participate in PHS supported research.
(e) Protect the health and safety of the public, promote the integrity of PHS supported research and the research process, and conserve public funds.
(a) Each institution that applies for or receives PHS support for biomedical or behavioral research, research training or activities related to that research or research training must comply with this part.
(b)(1) This part applies to allegations of research misconduct and research misconduct involving:
(i) Applications or proposals for PHS support for biomedical or behavioral extramural or intramural research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information;
(ii) PHS supported biomedical or behavioral extramural or intramural research;
(iii) PHS supported biomedical or behavioral extramural or intramural research training programs;
(iv) PHS supported extramural or intramural activities that are related to biomedical or behavioral research or research training, such as the operation of tissue and data banks or the dissemination of research information; and
(v) Plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training.
(2) This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support.
(c) This part does not supersede or establish an alternative to any existing regulations or procedures for handling fiscal improprieties, the ethical treatment of human or animal subjects, criminal matters, personnel actions against Federal employees, or actions taken under the HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR subparts 9.4 and 309.4.
(d) This part does not prohibit or otherwise limit how institutions handle allegations of misconduct that do not fall within this part's definition of research misconduct or that do not involve PHS support.
The following evidentiary standards apply to findings made under this part.
(a) Standard of proof. An institutional or HHS finding of research misconduct must be proved by a preponderance of the evidence.
(b) Burden of proof. (1) The institution or HHS has the burden of proof for making a finding 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 the institution or HHS establishes by a preponderance of the evidence that the 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 that 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 HHS or the institution has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.
(3) 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 administrative actions following a research misconduct proceeding.
Any interpretation of this part must further the policy and purpose of the HHS and the Federal government to protect the health and safety of the public, to promote the integrity of research, and to conserve public funds.
Administrative action means—
(a) An HHS action in response to a research misconduct proceeding taken to protect the health and safety of the public, to promote the integrity of PHS supported biomedical or behavioral research, research training, or activities related to that research or research training and to conserve public funds; or
(b) An HHS action in response either to a breach of a material provision of a settlement agreement in a research misconduct proceeding or to a breach of any HHS debarment or suspension.
Charge letter means the written notice, as well as any amendments to the notice, that are sent to the respondent stating the findings of research misconduct and any HHS administrative actions. If the charge letter includes a debarment or suspension action, it may be issued jointly by the ORI and the debarring official.
Debarring official means an official authorized to impose debarment or suspension. The HHS debarring official is either—
(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.
Funding component means any organizational unit of the PHS authorized to award grants, contracts, or cooperative agreements for any activity that involves the conduct of biomedical or behavioral research, research training or activities related to that research or research training, e.g., agencies, bureaus, centers, institutes, divisions, or offices and other awarding units within the PHS.
Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of §§93.307-93.309.
Institutional member or members means a person who is employed by, is an agent of, or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, clinical technicians, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and subawardees, and their employees.
Notice means a written communication served in person, sent by mail or its equivalent to the last known street address, facsimile number or e-mail address of the addressee. Several sections of Subpart E of this part have special notice requirements.
Public Health Service or PHS means the unit within the Department of Health and Human Services that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.
Retaliation for the purpose of this part means an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to—
Institutions under this part must—
(a) Have written policies and procedures for addressing allegations of research misconduct that meet the requirements of this part;
(b) Respond to each allegation of research misconduct for which the institution is responsible under this part in a thorough, competent, objective and fair manner, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, respondent or witnesses;
(c) Foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct;
(d) Take all reasonable and practical steps to protect the positions and reputations of good faith complainants, witnesses and committee members and protect them from retaliation by respondents and other institutional members;
(e) Provide confidentiality to the extent required by §93.108 to all respondents, complainants, and research subjects identifiable from research records or evidence;
(f) Take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to, their providing information, research records, and evidence;
(g) Cooperate with HHS during any research misconduct proceeding or compliance review;
(h) Assist in administering and enforcing any HHS administrative actions imposed on its institutional members; and
(i) Have an active assurance of compliance.
(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI.
(b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution—
(1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and
(2) Complies with its own policies and procedures and the requirements of this part.
(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.
(b) By submitting a Small Organization Statement, the institution agrees to report all allegations of research misconduct to ORI. ORI or another appropriate HHS office will work with the institution to develop and implement a process for handling allegations of research misconduct consistent with this part.
(c) The Small Organization Statement does not relieve the institution from complying with any other provision of this part.
Institutions seeking an approved assurance must have written policies and procedures for addressing research misconduct that include the following—
(a) Consistent with §93.108, protection of the confidentiality of respondents, complainants, and research subjects identifiable from research records or evidence;
(b) A thorough, competent, objective, and fair response to allegations of research misconduct consistent with and within the time limits of this part, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the complainant, respondent, or witnesses;
(c) Notice to the respondent, consistent with and within the time limits of this part;
(d) Written notice to ORI of any decision to open an investigation on or before the date on which the investigation begins;
(e) Opportunity for the respondent to provide written comments on the institution's inquiry report;
(f) Opportunity for the respondent to provide written comments on the draft report of the investigation, and provisions for the institutional investigation committee to consider and address the comments before issuing the final report;
(g) Protocols for handling the research record and evidence, including the requirements of §93.305;
(h) Appropriate interim institutional actions to protect public health, Federal funds and equipment, and the integrity of the PHS supported research process;
(i) Notice to ORI under §93.318 and notice of any facts that may be relevant to protect public health, Federal funds and equipment, and the integrity of the PHS supported research process;
(j) Institutional actions in response to final findings of research misconduct;
(k) All reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct but against whom no finding of research misconduct is made;
(l) All reasonable and practical efforts to protect or restore the position and reputation of any complainant, witness, or committee member and to counter potential or actual retaliation against these complainants, witnesses, and committee members; and
(m) Full and continuing cooperation with ORI during its oversight review under Subpart D of this part or any subsequent administrative hearings or appeals under Subpart E of this part. This includes providing all research records and evidence under the institution's control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.
An institution, as the responsible legal entity for the PHS supported research, has a continuing obligation under this part to ensure that it maintains adequate records for a research misconduct proceeding. The institution must—
(a) An institution may use the services of a consortium or person that the institution reasonably determines to be qualified by practice and experience to conduct research misconduct proceedings.
(c) A consortium or person acting on behalf of an institution must follow the requirements of this part in conducting research misconduct proceedings.
(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—
(1) The name and position of the respondent;
(b) The institution must provide the following information to ORI on request—
(1) The institutional policies and procedures under which the inquiry was conducted;
(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.
(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.
(b) Extension of time limit. If unable to complete the investigation in 120 days, the institution must ask ORI for an extension in writing.
(c) Progress reports. If ORI grants an extension, it may direct the institution to file periodic progress reports.
(a) The institution must give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. The comments of the respondent on the draft report, if any, must be submitted within 30 days of the date on which the respondent received the draft investigation report.
(b) The institution may provide the complainant a copy of the draft investigation report or relevant portions of that report. The comments of the complainant, if any, must be submitted within 30 days of the date on which the complainant received the draft investigation report or relevant portions of it.
(a) Allegations. Describe the nature of the allegations of research misconduct.
(b) PHS support. Describe and document the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.
(c) Institutional charge. Describe the specific allegations of research misconduct for consideration in the investigation.
(d) Policies and procedures. If not already provided to ORI with the inquiry report, include the institutional policies and procedures under which the investigation was conducted.
(e) Research records and evidence. Identify and summarize the research records and evidence reviewed, and identify any evidence taken into custody but not reviewed.
(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—
(1) Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard;
(2) Summarize the facts and the analysis which support the conclusion and consider the merits of any reasonable explanation by the respondent;
(3) Identify the specific PHS support;
(4) Identify whether any publications need correction or retraction;
(5) Identify the person(s) responsible for the misconduct; and
(6) List any current support or known applications or proposals for support that the respondent has pending with non-PHS Federal agencies.
(g) Comments. Include and consider any comments made by the respondent and complainant on the draft investigation report.
(h) Maintain and provide records. Maintain and provide to ORI upon request all relevant research records and records of the institution's research misconduct proceeding, including results of all interviews and the transcripts or recordings of such interviews.
(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.
(b) If unable to complete any appeals within 120 days, the institution must ask ORI for an extension in writing and provide an explanation for the request.
(c) ORI may grant requests for extension for good cause. If ORI grants an extension, it may direct the institution to file periodic progress reports.
The institution must give ORI the following:
(a) Investigation Report. Include a copy of the report, all attachments, and any appeals.
(b) Final institutional action. State whether the institution found research misconduct, and if so, who committed the misconduct.
(c) Findings. State whether the institution accepts the investigation's findings.
(d) Institutional administrative actions. Describe any pending or completed administrative actions against the respondent.
(a) ORI expects institutions to carry inquiries and investigations through to completion and to pursue diligently all significant issues. An institution must notify ORI in advance if the institution plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage, which must be reported to ORI under §93.315.
(b) After consulting with the institution on its basis for closing a case under paragraph (a) of this section, ORI may conduct an oversight review of the institution's handling of the case and take appropriate action including:
(1) Approving or conditionally approving closure of the case;
(2) Directing the institution to complete its process;
(3) Referring the matter for further investigation by HHS; or,
(4) Taking a compliance action.