Public Health Service Regulation
[Final rule: June 16, 2005]
§ 93.100 General policy.
- Research misconduct involving PHS support is contrary to the interests of the PHS and the Federal government and to the health and safety of the public, to the integrity of research, and to the conservation of public funds.
- The U.S. Department of Health and Human Services (HHS) and institutions that apply for or receive Public Health Service (PHS) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training share responsibility for the integrity of the research process. HHS has ultimate oversight authority for PHS supported research, and for taking other actions as appropriate or necessary, including the right to assess allegations and perform inquiries or investigations at any time. Institutions and institutional members have an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS supported work, and primary responsibility for responding to and reporting allegations of research misconduct, as provided in this part.
§ 93.101 Purpose.
The purpose of this part is to--
- Establish the responsibilities of HHS, PHS, the Office of Research Integrity (ORI), and institutions in responding to research misconduct issues
- Define what constitutes misconduct in PHS supported research
- Define the general types of administrative actions HHS and the PHS may take in response to research misconduct and
- Require institutions to develop and implement policies and procedures for--
- Reporting and responding to allegations of research misconduct covered by this part
- Providing HHS with the assurances necessary to permit the institutions to participate in PHS supported research.
- Protect the health and safety of the public, promote the integrity of PHS supported research and the research process, and conserve public funds.
§ 93.102 Applicability.
- 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.
- This part applies to allegations of research misconduct and research misconduct involving:
- 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
- PHS supported biomedical or behavioral extramural or intramural research
- PHS supported biomedical or behavioral extramural or intramural research training programs
- 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
- Plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training.
- 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.
- 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.
- 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.
§ 93.103 Research misconduct.
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
- Fabrication is making up data or results and recording or reporting them.
- Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
- Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
- Research misconduct does not include honest error or differences of opinion.
§ 93.104 Requirements for findings of research misconduct.
A finding of research misconduct made under this part requires that--
- There be a significant departure from accepted practices of the relevant research community and
- The misconduct be committed intentionally, knowingly, or recklessly and
- The allegation be proven by a preponderance of the evidence.
§ 93.105 Time limitations.
- Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.
- Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:
- Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized.
- Health or safety of the public exception. If ORI or the institution, following consultation with ORI, determines that the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.
- "Grandfather'' exception. If HHS or an institution received the allegation of research misconduct before the effective date of this part.
§ 93.106 Evidentiary standards.
The following evidentiary standards apply to findings made under this part.
- Standard of proof. An institutional or HHS finding of research misconduct must be proved by a preponderance of the evidence.
- Burden of proof.
- 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.
- 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.
- 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.
§ 93.107 Rule of interpretation.
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.
§ 93.108 Confidentiality.
- Disclosure of the identity of respondents and complainants in research misconduct proceedings is limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding, and as allowed by law. Provided, however, that:
- The institution must disclose the identity of respondents and complainants to ORI pursuant to an ORI review of research misconduct proceedings under § 93.403.
- Under § 93.517(g), HHS administrative hearings must be open to the public.
- Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who have a need to know to carry out a research misconduct proceeding.
§ 93.109 Coordination with other agencies.
- When more than one agency of the Federal government has jurisdiction of the subject misconduct allegation, HHS will cooperate in designating a lead agency to coordinate the response of the agencies to the allegation. Where HHS is not the lead agency, it may, in consultation with the lead agency, take appropriate action to protect the health and safety of the public, promote the integrity of the PHS supported research and research process and conserve public funds.
- In cases involving more than one agency, HHS may refer to evidence or reports developed by that agency if HHS determines that the evidence or reports will assist in resolving HHS issues. In appropriate cases, HHS will seek to resolve allegations jointly with the other agency or agencies.
§ 93.200 Administrative action.
Administrative action means--
- 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
- 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.
§ 93.201 Allegation.
Allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional or HHS official.
§ 93.202 Charge letter.
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.
§ 93.203 Complainant.
Complainant means a person who in good faith makes an allegation of research misconduct.
§ 93.204 Contract.
Contract means an acquisition instrument awarded under the HHS Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any small purchases awarded pursuant to FAR Part 13.
§ 93.205 Debarment or suspension.
Debarment or suspension means the Government wide exclusion, whether temporary or for a set term, of a person from eligibility for Federal grants, contracts, and cooperative agreements under the HHS regulations at 45 CFR part 76 (nonprocurement) and 48 CFR subparts 9.4 and 309.4 (procurement).
§ 93.206 Debarring official.
Debarring official means an official authorized to impose debarment or suspension. The HHS debarring official is either--
- The Secretary or
- An official designated by the Secretary.
§ 93.207 Departmental Appeals Board or DAB.
Departmental Appeals Board or DAB means, depending on the context--
- 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
- An Administrative Law Judge (ALJ) at the DAB.
§ 93.208 Evidence.
Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.
§ 93.209 Funding component.
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.
§ 93.210 Good faith.
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.
§ 93.211 Hearing.
Hearing means that part of the research misconduct proceeding from the time a respondent files a request for an administrative hearing to contest ORI findings of research misconduct and HHS administrative actions until the time the ALJ issues a recommended decision.
§ 93.212 Inquiry.
Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of §§ 93.307-93.309.
§ 93.213 Institution.
Institution means any individual or person that applies for or receives PHS support for any activity or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training. This includes, but is not limited to colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, small research institutions, and independent researchers.
§ 93.214 Institutional member.
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.
§ 93.215 Investigation.
Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.
§ 93.216 Notice.
Notice means a written communication served in person, sent by mail or its equivalent to the last known street address, facsimile number or email address of the addressee. Several sections of Subpart E of this part have special notice requirements.
§ 93.217 Office of Research Integrity or ORI.
Office of Research Integrity or ORI means the office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities.
§ 93.218 Person.
Person means any individual, corporation, partnership, institution, association, unit of government, or legal entity, however organized.
§ 93.219 Preponderance of the evidence.
Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
§ 93.220 Public Health Service or PHS.
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.
§ 93.221 PHS support.
PHS support means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through: Funding for PHS intramural research PHS grants, cooperative agreements, or contracts or subgrants or subcontracts under those PHS funding instruments or salary or other payments under PHS grants, cooperative agreements or contracts.
§ 93.222 Research.
Research means a systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) relating broadly to public health by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to, biological causes, functions or effects, diseases, treatments, or related matters to be studied.
§ 93.223 Research misconduct proceeding.
Research misconduct proceeding means any actions related to alleged research misconduct taken under this part, including but not limited to, allegation assessments, inquiries, investigations, ORI oversight reviews, hearings, and administrative appeals.
§ 93.224 Research record.
Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to HHS or an institutional official by a respondent in the course of the research misconduct proceeding.
§ 93.225 Respondent.
Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
§ 93.226 Retaliation.
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--
- A good faith allegation of research misconduct or
- Good faith cooperation with a research misconduct proceeding.
§ 93.227 Secretary or HHS.
Secretary or HHS means the Secretary of HHS or any other officer or employee of the HHS to whom the Secretary delegates authority.
Subpart C--Responsibilities of Institutions
Compliance and Assurance
§ 93.300 General responsibilities for compliance.
Institutions under this part must--
- Have written policies and procedures for addressing allegations of research misconduct that meet the requirements of this part
- 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
- 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
- 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
- Provide confidentiality to the extent required by § 93.108 to all respondents, complainants, and research subjects identifiable from research records or evidence
- 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
- Cooperate with HHS during any research misconduct proceeding or compliance review
- Assist in administering and enforcing any HHS administrative actions imposed on its institutional members and
- Have an active assurance of compliance.
§ 93.301 Institutional assurances.
- 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.
- Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution--
- Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct and
- Complies with its own policies and procedures and the requirements of this part.
§ 93.302 Institutional compliance with assurances.
- Compliance with assurance. ORI considers an institution in compliance with its assurance if the institution--
- Establishes policies and procedures according to this part, keeps them in compliance with this part, and upon request, provides them to ORI, other HHS personnel, and members of the public
- Takes all reasonable and practical specific steps to foster research integrity consistent with § 93.300, including--
- Informs the institution's research members participating in or otherwise involved with PHS supported biomedical or behavioral research, research training or activities related to that research or research training, including those applying for support from any PHS funding component, about its policies and procedures for responding to allegations of research misconduct, and the institution's commitment to compliance with the policies and procedures and
- Complies with its policies and procedures and each specific provision of this part.
- Annual report. An institution must file an annual report with ORI which contains information specified by ORI on the institution's compliance with this part.
- Additional information. Along with its assurance or annual report, an institution must send ORI such other aggregated information as ORI may request on the institution's research misconduct proceedings covered by this part and the institution's compliance with the requirements of this part.
§ 93.303 Assurances for small institutions.
- 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.
- 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.
- The Small Organization Statement does not relieve the institution from complying with any other provision of this part.
§ 93.304 Institutional policies and procedures.
Institutions seeking an approved assurance must have written policies and procedures for addressing research misconduct that include the following--
- Consistent with § 93.108, protection of the confidentiality of respondents, complainants, and research subjects identifiable from research records or evidence
- 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
- Notice to the respondent, consistent with and within the time limits of this part
- Written notice to ORI of any decision to open an investigation on or before the date on which the investigation begins
- Opportunity for the respondent to provide written comments on the institution's inquiry report
- 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
- Protocols for handling the research record and evidence, including the requirements of § 93.305
- Appropriate interim institutional actions to protect public health, Federal funds and equipment, and the integrity of the PHS supported research process
- 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
- Institutional actions in response to final findings of research misconduct
- 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
- 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
- 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.
§ 93.305 Responsibility for maintenance and custody of research records and 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--
- Either before or when the institution notifies the respondent of the allegation, inquiry or investigation, promptly 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
- Where appropriate, give the respondent copies of, or reasonable, supervised access to the research records
- Undertake all reasonable and practical efforts to take custody of additional research records or evidence that is discovered during the course of a research misconduct proceeding, 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 and
- Maintain the research records and evidence as required by § 93.317.
§ 93.306 Using a consortium or other person for research misconduct proceedings.
- 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.
- A consortium may be a group of institutions, professional organizations, or mixed groups which will conduct research misconduct proceedings for other institutions.
- A consortium or person acting on behalf of an institution must follow the requirements of this part in conducting research misconduct proceedings.
The Institutional Inquiry
§ 93.307 Institutional inquiry.
- Criteria warranting an inquiry. An inquiry is warranted if the allegation--
- Falls within the definition of research misconduct under this part
- Is within § 93.102 and
- Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
- Notice to respondent and custody of research records. At the time of or before beginning an inquiry, an institution must make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the institution must notify them. To the extent it has not already done so at the allegation stage, the institution must, on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, promptly 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.
- Review of evidence. The purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. Therefore, an inquiry does not require a full review of all the evidence related to the allegation.
- Criteria warranting an investigation. An inquiry's purpose is to decide if an allegation warrants an investigation. An investigation is warranted if there is--
- 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
- Preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation may have substance.
- Inquiry report. The institution must prepare a written report that meets the requirements of this section and § 93.309.
- Opportunity to comment. The institution must provide the respondent an opportunity to review and comment on the inquiry report and attach any comments received to the report.
- Time for completion. The institution must complete the inquiry within 60 calendar days of its initiation unless circumstances clearly warrant a longer period. If the inquiry takes longer than 60 days to complete, the inquiry record must include documentation of the reasons for exceeding the 60-day period.
§ 93.308 Notice of the results of the inquiry.
- Notice to respondent. The institution must notify the respondent whether the inquiry found that an investigation is warranted. The notice must include a copy of the inquiry report and include a copy of or refer to this part and the institution's policies and procedures adopted under its assurance.
- Notice to complainants. The institution may notify the complainant who made the allegation whether the inquiry found that an investigation is warranted. The institution may provide relevant portions of the report to the complainant for comment.
§ 93.309 Reporting to ORI on the decision to initiate an investigation.
- 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--
- The name and position of the respondent
- A description of the allegations of research misconduct
- The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support
- The basis for recommending that the alleged actions warrant an investigation and
- Any comments on the report by the respondent or the complainant.
- The institution must provide the following information to ORI on request--
- The institutional policies and procedures under which the inquiry was conducted
- The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents and
- The charges for the investigation to consider.
- 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.
- 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.
The Institutional Investigation
§ 93.310 Institutional investigation.
Institutions conducting research misconduct investigations must:
- Time. Begin the investigation within 30 days after determining that an investigation is warranted.
- 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.
- Notice to the respondent. Notify the respondent in writing of the allegations within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins. The institution must give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of investigation.
- 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-
- Before or at the time the institution notifies the respondent and
- Whenever additional items become known or relevant to the investigation.
- Documentation. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations.
- Ensuring a fair investigation. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation.
- Interviews. Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation.
- Pursue leads. Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion.
§ 93.311 Investigation time limits.
- 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.
- Extension of time limit. If unable to complete the investigation in 120 days, the institution must ask ORI for an extension in writing.
- Progress reports. If ORI grants an extension, it may direct the institution to file periodic progress reports.
§ 93.312 Opportunity to comment on the investigation report.
- 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.
- 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.
§ 93.313 Institutional investigation report.
The final institutional investigation report must be in writing and include:
- Allegations. Describe the nature of the allegations of research misconduct.
- PHS support. Describe and document the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.
- Institutional charge. Describe the specific allegations of research misconduct for consideration in the investigation.
- 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.
- Research records and evidence. Identify and summarize the research records and evidence reviewed, and identify any evidence taken into custody but not reviewed.
- 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--
- Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard
- Summarize the facts and the analysis which support the conclusion and consider the merits of any reasonable explanation by the respondent
- Identify the specific PHS support
- Identify whether any publications need correction or retraction
- Identify the person(s) responsible for the misconduct and
- List any current support or known applications or proposals for support that the respondent has pending with non-PHS Federal agencies.
- Comments. Include and consider any comments made by the respondent and complainant on the draft investigation report.
- 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.
§ 93.314 Institutional appeals.
- 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.
- 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.
- ORI may grant requests for extension for good cause. If ORI grants an extension, it may direct the institution to file periodic progress reports.
§ 93.315 Notice to ORI of institutional findings and actions.
The institution must give ORI the following:
- Investigation Report. Include a copy of the report, all attachments, and any appeals.
- Final institutional action. State whether the institution found research misconduct, and if so, who committed the misconduct.
- Findings. State whether the institution accepts the investigation's findings.
- Institutional administrative actions. Describe any pending or completed administrative actions against the respondent.
§ 93.316 Completing the research misconduct process.
- 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.
- 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:
- Approving or conditionally approving closure of the case
- Directing the institution to complete its process
- Referring the matter for further investigation by HHS or,
- Taking a compliance action.
Other Institutional Responsibilities
§ 93.317 Retention and custody of the research misconduct proceeding record.
- Definition of records of research misconduct proceedings. As used in this section, the term "records of research misconduct proceedings" includes:
- The records that the institution secures for the proceeding pursuant to §§ 93.305, 93.307(b) and 93.310(d), except to the extent the institution subsequently determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that are being retained
- The documentation of the determination of irrelevant or duplicate records
- The inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate as required by § 93.309(d)
- The investigation report and all records (other than drafts of the report) in support of that report, including the recordings or transcriptions of each interview conducted pursuant to § 93.310(g) and
- The complete record of any institutional appeal covered by § 93.314.
- Maintenance of record. Unless custody has been transferred to HHS under paragraph (c) of this section, or ORI has advised the institution in writing that it no longer needs to retain the records, an institution must maintain records of research misconduct proceedings in a secure manner for 7 years after completion of the proceeding or the completion of any PHS proceeding involving the research misconduct allegation under subparts D and E of this part, whichever is later.
- Provision for HHS custody. On request, institutions must transfer custody of or provide copies to HHS, of any institutional record relevant to a research misconduct allegation covered by this part, including the research records and evidence, to perform forensic or other analyses or as otherwise needed to conduct an HHS inquiry or investigation or for ORI to conduct its review or to present evidence in any proceeding under subparts D and E of this part.
§ 93.318 Notifying ORI of special circumstances.
At any time during a research misconduct proceeding, as defined in § 93.223, an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist:
- Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
- HHS resources or interests are threatened.
- Research activities should be suspended.
- There is reasonable indication of possible violations of civil or criminal law.
- Federal action is required to protect the interests of those involved in the research misconduct proceeding.
- The research institution believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
- The research community or public should be informed.
§ 93.319 Institutional standards.
- Institutions may have internal standards of conduct different from the HHS standards for research misconduct under this part. Therefore, an institution may find conduct to be actionable under its standards even if the action does not meet this part's definition of research misconduct.
- An HHS finding or settlement does not affect institutional findings or administrative actions based on an institution's internal standards of conduct.
Subpart D--Responsibilities of the U.S. Department of Health and Human Services
§ 93.400 General statement of ORI authority.
- 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--
- Conducting allegation assessments
- Determining independently if jurisdiction exists under this part in any matter;
- Forwarding allegations of research misconduct to the appropriate institution or HHS component for inquiry or investigation;
- Recommending that HHS should perform an inquiry or investigation or issue findings and taking all appropriate actions in response to the inquiry, investigation, or findings;
- Notifying or requesting assistance and information from PHS funding components or other affected Federal and state offices and agencies or institutions;
- Reviewing an institution's findings and process;
- Making a finding of research misconduct; and
- Proposing administrative actions to HHS.
- Requests for information. ORI may request clarification or additional information, documentation, research records, or evidence from an institution or its members or other persons or sources to carry out ORI's review.
- HHS administrative actions.
- 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.
- ORI may propose to the HHS debarring official that a person be suspended or debarred from receiving Federal funds and may propose to other appropriate PHS components the implementation of HHS administrative actions within the components' authorities.
- ORI assistance to institutions. At any time, ORI may provide information, technical assistance, and procedural advice to institutional officials as needed regarding an institution's participation in research misconduct proceedings.
- Review of institutional assurances. ORI may review institutional assurances and policies and procedures for compliance with this part.
- Institutional compliance. ORI may make findings and impose HHS administrative actions related to an institution's compliance with this part and with its policies and procedures, including an institution's participation in research misconduct proceedings.
§ 93.401 Interaction with other offices and interim actions.
- ORI may notify and consult with other offices at any time if it has reason to believe that a research misconduct proceeding may involve that office. If ORI believes that a criminal or civil fraud violation may have occurred, it shall promptly refer the matter to the Department of Justice (DOJ), the HHS Inspector General (OIG), or other appropriate investigative body. ORI may provide expertise and assistance to the DOJ, OIG, PHS offices, other Federal offices, and state or local offices involved in investigating or otherwise pursuing research misconduct allegations or related matters.
- ORI may notify affected PHS offices and funding components at any time to permit them to make appropriate interim responses to protect the health and safety of the public, to promote the integrity of the PHS supported research and research process, and to conserve public funds.
- The information provided will not be disclosed as part of the peer review and advisory committee review processes, but may be used by the Secretary in making decisions about the award or continuation of funding.
Research Misconduct Issues
§ 93.402 ORI allegation assessments.
- When ORI receives an allegation of research misconduct directly or becomes aware of an allegation or apparent instance of research misconduct, it may conduct an initial assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.
- 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.
- If ORI decides that an inquiry is warranted, it forwards the matter to the appropriate institution or HHS component.
- 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.
- ORI may forward allegations that do not fall within the jurisdiction of this part to the appropriate HHS component, Federal or State agency, institution, or other appropriate entity.
§ 93.403 ORI review of research misconduct proceedings.
ORI may conduct reviews of research misconduct proceedings. In conducting its review, ORI may--
- Determine whether there is HHS jurisdiction under this part
- Consider any reports, institutional findings, research records, and evidence
- Determine if the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity, and competence to support the conclusions
- Obtain additional information or materials from the institution, the respondent, complainants, or other persons or sources
- Conduct additional analyses and develop evidence
- Decide whether research misconduct occurred, and if so who committed it
- Make appropriate research misconduct findings and propose HHS administrative actions and
- Take any other actions necessary to complete HHS' review.
§ 93.404 Findings of research misconduct and proposed administrative actions.
After completing its review, ORI either closes the case without a finding of research misconduct or--
- 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
- Recommends that HHS seek to settle the case.
§ 93.405 Notifying the respondent of findings of research misconduct and HHS administrative actions.
- 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.
- The ORI sends the charge letter by certified mail or a private delivery service to the last known address of the respondent or the last known principal place of business of the respondent's attorney.
§ 93.406 Final HHS actions.
Unless the respondent contests the charge letter within the 30-day period prescribed in § 93.501, the ORI finding of research misconduct is the final HHS action on the research misconduct issues and the HHS administrative actions become final and will be implemented, except that the debarring official's decision is the final HHS action on any debarment or suspension actions.
§ 93.407 HHS administrative actions.
- In response to a research misconduct proceeding, HHS may impose HHS administrative actions that include but are not limited to:
- Clarification, correction, or retraction of the research record.
- Letters of reprimand.
- Imposition of special certification or assurance requirements to ensure compliance with applicable regulations or terms of PHS grants, contracts, or cooperative agreements.
- Suspension or termination of a PHS grant, contract, or cooperative agreement.
- Restriction on specific activities or expenditures under an active PHS grant, contract, or cooperative agreement.
- Special review of all requests for PHS funding.
- Imposition of supervision requirements on a PHS grant, contract, or cooperative agreement.
- Certification of attribution or authenticity in all requests for support and reports to the PHS.
- No participation in any advisory capacity to the PHS.
- Adverse personnel action if the respondent is a Federal employee, in compliance with relevant Federal personnel policies and laws.
- Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts 9.4 and 309.4, or both.
- In connection with findings of research misconduct, HHS also may seek to recover PHS funds spent in support of the activities that involved research misconduct.
- Any authorized HHS component may impose, administer, or enforce HHS administrative actions separately or in coordination with other HHS components, including, but not limited to ORI, the Office of Inspector General, the PHS funding component, and the debarring official.
§ 93.408 Mitigating and aggravating factors in HHS administrative actions.
The purpose of HHS administrative actions is remedial. The appropriate administrative action is commensurate with the seriousness of the misconduct, and the need to protect the health and safety of the public, promote the integrity of the PHS supported research and research process, and conserve public funds. HHS considers aggravating and mitigating factors in determining appropriate HHS administrative actions and their terms. HHS may consider other factors as appropriate in each case. The existence or nonexistence of any factor is not determinative: