What is the NIH process for handling research misconduct if the allegation is received by NIH extramural staff
U.S. Department of Health & Human Services Logo
 
Grants and Funding
Grants Policy
Policy & Guidance
Compliance & Oversight
Research Involving Human Subjects
Office of Laboratory Animal Welfare (OLAW)
Animals in Research
Peer Review Policies & Practices
Intellectual Property Policy
Acknowledging NIH Funding
Invention Reporting (iEdison)
NIH Public Access
Research Integrity
Is received by ORI?
Flow chart of the handling of an allegation of research misconduct when received by NIH Extramural Staff or ORI:

This is a flow chart depicting the handling of an allegation of research misconduct when received by NIH Extramural staff or ORI.  If received by NIH Extramural staff, that staff member contacts their IC RIO.  The IC RIO sends it on to the apporpriate parties, and NIH conducts a preliminary review.  Results of this review are sent to ORI for review and recommendations.  If the allegation of research misconduct is reported directly to ORI, this is where the process starts.  ORI determines whether it does or does not meet criteria for research misconduct.  If it does meet criteria for research misconduct, the institution is instructed to initiate 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):

  1. An NIH extramural staff member receives an allegation of research misconduct and reports it to their IC Research Integrity Officer (RIO).

  2. The NIH Agency Research Integrity Liaison Officer (ARILO)/Extramural Research Integrity Liaison Officer (ERILO) performs a preliminary review (accuracy and sufficiency of the information, involvement of NIH applications/awards, and appropriateness for consideration as an allegation of research misconduct).

  3. If appropriate, the allegation is sent to ORI. Reasons for an allegation NOT being sent to ORI include lack of specific information or cases involving other situations, such as protection of human subjects (sent to the Office of Human Research Protections, DDHS), animal welfare (sent to the Office of Laboratory Animal Welfare, NIH; or allegations of misuse of funds, sent to the Office of Management Assessment, NIH).

  4. ORI receives and assesses the allegation. If the allegation contains sufficient specific information, involves PHS funding, and fits the criteria for research misconduct, the respondent institution is requested to initiate an inquiry. From this point forward, ORI handles all interactions between HHS and the respondent institution.

  5. Alternatively, the allegation may be reported directly to ORI. In this case, ORI performs the preliminary review.

  6. 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.

  7. 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.

  8. Within 30 days of finding that an investigation is warranted, the institution must provide ORI with the written finding and a copy of the inquiry report.

  9. 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.

  10. 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.

  11. 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.
  1. If a finding of research misconduct is made, the case goes to HHS for administrative sanctions. The Assistant Secretary for Health (ASH) makes the final PHS/HHS decision on the imposition of administrative actions after reviewing the recommendations made by ORI, except when the administrative actions include debarment or suspension. The ASH may accept, modify, or reject the administrative actions recommended by ORI.

  2. The institution is responsible for enforcing sanctions. The institution and NIH may add additional sanctions.

Related Resources
 

This page last updated on August 25, 2010
Technical Issues: E-mail OER Webmaster

Social Media Links