Institutions 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 taking 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 research integrity and the responsible conduct of research, 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 to protect these individuals from retaliation by respondents and/or other institutional members;

(e) Provide confidentiality consistent with § 93.106 to all respondents, complainants, and witnesses in a research misconduct proceeding, and to research subjects identifiable from research records or other 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 other evidence;

(g) Cooperate with HHS during any research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by ORI;

(h) Assist in administering and enforcing any HHS administrative actions imposed on its institutional members; and

(i) Have an active research integrity assurance.

(a) General policy. (1) An institution that applies for or receives PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, must provide HHS with an assurance of compliance with this part by establishing and then maintaining an active research integrity assurance.

(2) PHS funding components may only authorize release of funds for extramural biomedical and behavioral research, biomedical and behavioral research training, or activities related to that research or research training, to institutions with an active research integrity assurance on file with ORI.

(b) Research integrity assurance. The Institutional Certifying Official must assure on behalf of the institution, initially and then annually thereafter, that the institution:

(1) Has written policies and procedures for addressing allegations of research misconduct, in compliance with this part.

(2) Complies with its policies and procedures for addressing allegations of research misconduct.

(3) Complies with all provisions of this part.

(a) Compliance with this part. ORI considers an institution in compliance with this part when it:

(1) Has policies and procedures for addressing allegations of research misconduct according to this part, keeps those policies in compliance with this part, and upon request, provides them to ORI and other HHS components.

(2) Complies with its policies and procedures for addressing allegations of research misconduct.

(3) Complies with all provisions of this part.

(4) Takes all reasonable and practical specific steps to foster research integrity consistent with § 93.300, including but not limited to:

(i) Informing the institution's members about its policies and procedures for addressing allegations of research misconduct, and the institution's commitment to compliance with the policies and procedures; and

(ii) Making its policies and procedures for addressing allegations of research misconduct publicly available.

(b) 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. The Institutional Certifying Official is responsible for certifying the content of this report and for ensuring the report is submitted as required.

(c) Additional information. Along with its annual report, an institution must send ORI such other 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.

(a) Small institutions may file a Small Institution Statement with ORI in place of the institutional policies and procedures required by §§ 93.300(a), 93.301, and 93.304, upon approval by ORI.

(b) The Small Institution Statement does not relieve the institution from complying with any other provision of this part.

(c) By submitting a Small Institution 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/or advise on a process for handling allegations of research misconduct consistent with this part.

(d) If a small institution has or believes it has a conflict of interest during any phase of a research misconduct proceeding, the small institution may contact ORI for guidance.

Institutions seeking an approved research integrity assurance must have written policies and procedures for addressing allegations of research misconduct. Such policies and procedures must:

(a) Address and be consistent with all applicable requirements pertaining to institutional responsibilities included in this part;

(b) Include and be consistent with applicable definitions in this part; and

(c) Provide for 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.

(a) Sequestration of research records and other evidence. An institution must promptly take all reasonable and practical steps to obtain all research records and other evidence, which may include copies of the data or other evidence so long as those copies are substantially equivalent in evidentiary value, needed to conduct the research misconduct proceeding; inventory the research records and other evidence; and sequester them in a secure manner. Where the research records or other evidence are located on or encompass scientific instruments shared by multiple users, institutions may obtain copies of the data or other evidence from such instruments, so long as those copies are substantially equivalent in evidentiary value to the instruments. Whenever possible, the institution must obtain the research records or other evidence:

(1) Before or at the time the institution notifies the respondent of the allegation(s); and

(2) Whenever additional items become known or relevant to the inquiry or investigation.

(b) Access to research records. Where appropriate, an institution must give the respondent copies of, or reasonable supervised access to, the research records that are sequestered in accordance with paragraph (a) of this section.

(c) Maintenance of sequestered research records and other evidence. An institution must maintain the sequestered research records and other evidence as required by § 93.318.

(d) Multiple respondents. If an institution identifies additional respondents during an inquiry or investigation, the institution is not required to conduct a separate inquiry for each new respondent. However, each additional respondent must be provided notice of and an opportunity to respond to the allegations, consistent with this subpart.

(e) Multiple institutions. When allegations involve research conducted at multiple institutions, one institution must be designated as the lead institution if a joint research misconduct proceeding is conducted. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.

(f) Using a committee, consortium, or other person for research misconduct proceedings. (1) An institution must address any potential, perceived, or actual personal, professional, or financial conflicts of interest between members of the committee or consortium, or other person, and the complainant, respondent, or witnesses.

(2) An institution must ensure that a committee, consortium, or person acting on its behalf conducts research misconduct proceedings in compliance with the requirements of this part.

(g) Notifying ORI of special circumstances. At any time during a research misconduct proceeding, as defined in § 93.235, an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist:

(1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.

(2) HHS resources or interests are threatened.

(3) Research activities should be suspended.

(4) There is reasonable indication of possible violations of civil or criminal law.

(5) Federal action is required to protect the interests of those involved in the research misconduct proceeding.

(6) HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

(a) Purpose. An assessment's purpose is to determine whether an allegation warrants an inquiry.

(b) Conducting the institutional assessment. Upon receiving an allegation of research misconduct, the RIO or another designated institutional official must promptly assess the allegation to determine whether the allegation:

(1) Falls within the definition of research misconduct under this part;

(2) Is within the applicability criteria of § 93.102; and

(3) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

(c) Assessment results. (1) An inquiry must be conducted if the allegation meets the three assessment criteria in paragraph (b) of this section.

(2) If the RIO or another designated institutional official determines that requirements for an inquiry are met, they must:

(i) Document the assessment; and

(ii) Promptly sequester all research records and other evidence, consistent with § 93.305(a), and promptly initiate the inquiry.

(3) If the RIO or another designated institutional official determines that requirements for an inquiry are not met, they must keep sufficiently detailed documentation of the assessment to permit a later review by ORI of the reasons why the institution did not conduct an inquiry. Such documentation must be retained in accordance with § 93.318.

(a) Criteria warranting an inquiry. An inquiry is warranted if the allegation meets the following three criteria:

(1) Falls within the definition of research misconduct under this part;

(2) Is within the applicability criteria of § 93.102; and

(3) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

(b) Purpose. An inquiry's purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of the evidence related to the allegation.

(c) Notice to the respondent. 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. Only allegations specific to a particular respondent are to be included in the notification to that respondent. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

(d) Sequestration of records. An institution must obtain all research records and other evidence needed to conduct the research misconduct proceeding, consistent with § 93.305(a).

(e) Conducting the inquiry—(1) Multiple institutions. A joint research misconduct proceeding must be conducted consistent with § 93.305(e).

(2) Person conducting the inquiry. Institutions may convene committees of experts to conduct reviews at the inquiry stage to determine whether an investigation is warranted. The inquiry review may be done by a RIO or another designated institutional official in lieu of a committee, with the caveat that if needed, these individuals may utilize one or more subject matter experts to assist them in the inquiry.

(3) Interviews. Institutions may interview witnesses or respondents that would provide additional information for the institution's review.

(f) Inquiry results—(1) Criteria warranting an investigation. An investigation is warranted if:

(i) 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, biomedical or behavioral research training, or activities related to that research or research training, as provided in § 93.102; and

(ii) Preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.

(2) Findings of research misconduct. Findings of research misconduct, including the determination of whether the alleged misconduct is intentional, knowing, or reckless, cannot be made at the inquiry stage.

(g) Inquiry report. (1) The institution must prepare a written report that meets the requirements of this section and § 93.309.

(2) If there is potential evidence of honest error or difference of opinion, the institution must note this in the inquiry report.

(3) The institution must provide the respondent an opportunity to review and comment on the inquiry report and attach any comments received to the report.

(h) Time for completion. (1) The institution must complete the inquiry within 90 days of its initiation unless circumstances warrant a longer period.

(2) If the inquiry takes longer than 90 days to complete, the inquiry report must document the reasons for exceeding the 90-day period.

(a) 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 research integrity assurance.

(b) Notice to complainant. The institution is not required to notify a complainant whether the inquiry found that an investigation is warranted. The institution may, but is not required to, provide relevant portions of the report to a complainant for comment. If an institution provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.

(a) Within 30 days of determining that an investigation is warranted, the institution must provide ORI with a copy of the inquiry report, which includes the following information:

(1) The names, professional aliases, and positions of the respondent and complainant;

(2) A description of the allegation(s) of research misconduct;

(3) The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support;

(4) The composition of the inquiry committee, if used, including name(s), position(s), and subject matter expertise;

(5) Inventory of sequestered research records and other evidence and description of how sequestration was conducted;

(6) Transcripts of any transcribed interviews;

(7) Timeline and procedural history;

(8) Any scientific or forensic analyses conducted;

(9) The basis for recommending that the allegation(s) warrant an investigation;

(10) The basis on which any allegation(s) do not merit an investigation;

(11) Any comments on the inquiry report by the respondent or the complainant; and

(12) Any institutional actions implemented, including communications with journals or funding agencies.

(b) The institution must provide the following information to ORI whenever requested:

(1) The institutional policies and procedures under which the inquiry was conducted; and

(2) The research records and other evidence reviewed, and copies of all relevant documents.

(c) Institutions must keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Such documentation must be retained in accordance with § 93.318.

(d) In accordance with § 93.305(g), institutions must notify ORI of any special circumstances that may exist.

Institutions conducting research misconduct investigations must:

(a) Time. Begin the investigation within 30 days after deciding an investigation is warranted.

(b) Notice to ORI. Notify ORI 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.

(c) Notice to the respondent. Notify the respondent in writing of the allegation(s) within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.

(1) The institution must give the respondent written notice of any allegation(s) of research misconduct not addressed during the inquiry or in the initial notice of investigation within a reasonable amount of time of deciding to pursue such allegation(s).

(2) If the institution identifies additional respondents during the investigation, the institution may but is not required to conduct a separate inquiry for each new respondent. If any additional respondent(s) are identified during the investigation, the institution must notify them of the allegation(s) and provide them an opportunity to respond consistent with this subpart.

(3) While an investigation into multiple respondents can convene with the same investigation committee members, separate investigation reports and research misconduct determinations are required for each respondent.

(d) Sequestration of records. Obtain all research records and other evidence needed to conduct the investigation, consistent with § 93.305(a).

(e) Documentation. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and other evidence relevant to reaching a decision on the merits of the allegation(s).

(f) 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 relevant to the investigation. An institution may use the same committee members from the inquiry in their subsequent investigation.

(g) Interviews. During the investigation, an institution must 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.

(1) Interviews during the investigation must be recorded and transcribed.

(2) Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview.

(3) The transcript of the interview must be made available to the relevant interviewee for correction.

(4) The transcript(s) with any corrections and numbered exhibits must be included in the institutional record of the investigation.

(5) The respondent must not be present during the witnesses' interviews but must be provided a transcript of the interview.

(h) Multiple respondents. Consider, consistent with § 93.305(d), the prospect of additional researchers being responsible for the alleged research misconduct.

(i) Multiple institutions. A research misconduct proceeding involving multiple institutions must be conducted consistent with § 93.305(e).

(j) 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. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

(a) Time limit for completing an investigation. An institution must complete all aspects of an investigation within 180 days of beginning it, including conducting the investigation, preparing the draft investigation report for each respondent, providing the draft report to each respondent for comment in accordance with § 93.312, and transmitting the institutional record including the final investigation report and decision by the Institutional Deciding Official to ORI in accordance with § 93.316.

(b) Extension of time limit. If unable to complete the investigation in 180 days, the institution must ask ORI for an extension in writing that includes the circumstances or issues warranting additional time.

(c) Progress reports. If ORI grants an extension, it may direct the institution to file periodic progress reports.

(d) Investigation report. If the investigation takes longer than 180 days to complete, the investigation report must include the reasons for exceeding the 180-day period.

(a) The institution must give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent must submit any comments on the draft report to the institution within 30 days of receiving 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 final investigation report for each respondent must be in writing and include:

(a) Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.

(b) Description and documentation of the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.

(c) Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.

(d) Composition of investigation committee, including name(s), position(s), and subject matter expertise.

(e) Inventory of sequestered research records and other evidence, except records the institution did not consider or rely on; and a description of how any sequestration was conducted during the investigation. This inventory must include manuscripts and funding proposals that were considered or relied on during the investigation.

(f) Transcripts of all interviews conducted, as described in § 93.310(g).

(g) Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that allegedly contained the falsified, fabricated, or plagiarized material.

(h) Any scientific or forensic analyses conducted.

(i) If not already provided to ORI, the institutional policies and procedures under which the investigation was conducted.

(j) Any comments made by the respondent and complainant on the draft investigation report and the investigation committee's consideration of those comments.

(k) A statement for each separate allegation of whether the investigation committee recommends a finding of research misconduct.

(1) If the investigation committee recommends a finding of research misconduct for an allegation, the investigation report must, for that allegation:

(i) Identify the individual(s) who committed the research misconduct.

(ii) Indicate whether the research misconduct was falsification, fabrication, and/or plagiarism.

(iii) Indicate whether the research misconduct was committed intentionally, knowingly, or recklessly.

(iv) State whether the other requirements for a finding of research misconduct, as described in § 93.103, have been met.

(v) Summarize the facts and the analysis which support the conclusion and consider the merits of any explanation by the respondent.

(vi) Identify the specific PHS support.

(vii) Identify whether any publications need correction or retraction.

(2) If the investigation committee does not recommend a finding of research misconduct for an allegation, the investigation report must provide a detailed rationale.

(3) List of any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.

The Institutional Deciding Official is responsible for making a final determination of research misconduct findings. This determination must be provided in a written decision that includes:

(a) Whether the institution found research misconduct and, if so, who committed the misconduct; and

(b) A description of relevant institutional actions taken or to be taken.

(a) If a respondent appeals an institution's finding(s) of research misconduct or institutional actions, the institution must promptly notify ORI.

(b) If the institution has not transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must wait until the appeal is concluded to transmit its institutional record. The institution must ensure that the complete record of the appeal is included in the institutional record consistent with § 93.220(a)(5).

(c) If the institution has transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must provide ORI a complete record of the appeal once the appeal is concluded.

After the Institutional Deciding Official has made a final determination of research misconduct findings in accordance with § 93.314, the institution must transmit the institutional record to ORI. The institutional record must be consistent with § 93.220 and logically organized.

(a) ORI expects institutions to carry inquiries and investigations through to completion and to pursue diligently all significant issues and credible allegations of research misconduct. Institutions must notify ORI in advance if the institution plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or appeal stage on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.

(b) A respondent's admission of research misconduct must be made in writing and signed by the respondent. An admission must specify the falsification, fabrication, and/or plagiarism that occurred and which research records were affected. The admission statement must meet all elements required for a research misconduct finding under § 93.103 and must be provided to ORI before the institution closes its research misconduct proceeding. The institution must also provide a statement to ORI describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent's culpability.

(c) 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) Directing the institution to address deficiencies in the institutional record;

(4) Referring the matter for further investigation by HHS; or

(5) Taking a compliance action.

(a) Maintenance of institutional record and all sequestered evidence. An institution must maintain the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record) in a secure manner for seven years after completion of the proceeding or the completion of any HHS proceeding involving the research misconduct allegation under subparts D and E of this part, whichever is later, unless custody has been transferred to HHS under paragraph (b) of this section or ORI advises otherwise in writing.

(b) Provision for HHS custody. On request, institutions must transfer custody, or provide copies, to HHS of the institutional record or any component of the institutional record and any sequestered evidence (regardless of whether the evidence is included in the institutional record) for ORI to conduct its oversight review, develop the administrative record, or present the administrative record in any proceeding under subparts D and E of this part.

Institutions may have standards of conduct different from the standards for research misconduct under this part. ORI findings of research misconduct or HHS settlements of research misconduct proceedings, or the absence thereof, do not affect institutional findings or actions taken based on an institution's standards of conduct.