Policy & Compliance

Is received by an institution?
Flow chart of the handling of an allegation of research misconduct when received from a complainant at an institution:

This is a flow chart depicting the handling of an allegation of research misconduct when received from a complainant at an institution.  The allegation is received by an institutional official.  The institution conducts an inquiry and makes a determination whether an investigation is warranted.  If an investigation is warranted, the respondent institution provides with a written finding from the inquiry.  ORI handles all future interactions between HHS and the respondent institution until the investigation is concluded.  If a finding is made, the case goes to HHS for administrative sanctions.  The institution is responsible for re-enforcing sanctions and may take further action.

For more detailed information

Process followed when an allegation of research misconduct is received by an institution as defined by 42 CFR Parts 50 and 93 - Public Health Service Policies on Research Misconduct (PDF - 224 KB). Please note that the allegation is handled by the institution and ORI. The NIH is largely not involved in this process.

  1. An individual at an institution alleges research misconduct to university officials.

  2. The institution notifies the presumed respondent in writing and conducts an inquiry to determine if the allegation warrants an investigation. An investigation is warranted if there is:

    1. A reasonable basis for concluding that the allegation falls within the definition of research misconduct and involves PHS supported research; and
    2. Preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.

  3. The inquiry must be completed within 60 calendar days of its initiation unless circumstances clearly warrant a longer period. The institution prepares a written report and provides the respondent an opportunity to review and comment on the inquiry report. The institution must notify the respondent whether the inquiry found that an investigation is warranted and may also notify the complainant who made the allegation.

  4. Within 30 days of finding that an investigation is warranted, the institution must provide ORI with the written finding of the inquiry and a copy of the inquiry report which includes the following information:

    1. Name and position of respondent
    2. Description of the allegation of research misconduct;
    3. The PHS support, such as grant numbers, grant applications, contracts, and publications listing PHS support;
    4. The basis for recommending that the alleged actions warrant an investigation; and
    5. Any comments on the report by the respondent or the complainant.
  1. The investigation must begin within 30 days after determining that an investigation is warranted, and the ORI director and the respondent must be notified. The institution must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding before or at the time the institution notifies the respondent and whenever additional items become known or relevant to the investigation. An institution must complete all aspects of an investigation within 120 days of beginning it.

  2. 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 respondent's copies on the draft report must be submitted within 30 days of the date the respondent received the draft report. The institution may also provide the complainant a copy of the draft report.

  3. The final institutional investigation report must be in writing and include:

    1. Allegations-a description of the nature of the allegations of research misconduct.
    2. PHS support-grant numbers, grant applications, contracts, and publications listing PHS support.
    3. Institutional charge-a description of the specific allegations of research misconduct for consideration in the investigation.
    4. Policies and procedures-institutional policies and procedures under which the investigation was conducted.
    5. Research records and evidence-identification and summary of the research records and evidence reviewed.
    6. Statement of findings- for each separate allegation of research misconduct, findings as to whether research misconduct did or did not occur, and if so:
      1. Whether the research misconduct was falsification, fabrication, or plagiarism, and was intentional, knowing, or in reckless disregard;
      2. Summary of the facts and the analysis which supports the conclusion and consider the merits of any reasonable explanation by the respondent;
      3. Identification of the specific PHS support;
      4. Identification of whether any publications need correction or retraction;
      5. Identification of the person(s) responsible for the misconduct; and
      6. A list of any current support or known applications or proposals for support that the respondent has pending with non-PHS agencies.
    1. Comments-inclusion and consideration of any comments made by the respondent and complainant on the draft investigation report.
    2. Maintain and provide records- maintenance of 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.

  1. The institution provides ORI with:

    1. Investigation Report, including a copy of the report, all attachments, and any appeals.
    2. Final institutional action, stating whether the institution found research misconduct, and if so, who committed the misconduct.
    3. Whether the institution accepts the investigation's findings.
    4. Institutional administrative actions pending or completed against the respondent.

  2. ORI may conduct an oversight review of the institution's handling of the case and take action including 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.

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This page last updated on August 25, 2010 
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