NIH Process For Handling Research Misconduct Allegations
NIH Process for Handling Research Misconduct Allegations
Allegations of research misconduct are treated seriously and confidentially at the NIH. Allegations are reviewed promptly and if they meet the definition of research misconduct according to 42 C.F.R. 93, they will be forwarded to the HHS Office of Research Integrity (ORI) for their oversight. The authority to oversee and investigate potential research misconduct involving Public Health Service (PHS) funding lies with ORI. Whenever feasible, allegations that may be of concern to other federal agencies and/or NIH offices will also be redirected as appropriate.
After ORI has made a finding of research misconduct, NIH will help ensure the administrative actions imposed by ORI are respected and may also consider additional administrative actions (see section "What Happens if there is a Finding of Research Misconduct?") when appropriate. However, everyone is treated as innocent until proven otherwise. NIH will only take administrative actions when ORI has made a finding of research misconduct.
The following is a flow chart on how NIH processes allegations of research misconduct (RM) received by NIH Extramural staff. Each NIH Institute and Center (IC) has a research integrity officer (RIO) to receive the allegations received by their staff. These are then centrally handled by the RIO at the Office of Extramural Research-Research Integrity (OER-RI).
Details on how allegations of research misconduct received by NIH extramural staff are processed:
An NIH extramural staff member receives an allegation of research misconduct and reports it to their IC Research Integrity Officer (RIO).
NIH IC RIO then forwards the allegation to the Office of Extramural Research = Research Integrity (OER-RI) for processing centrally. OER-RI performs a preliminary review to assess for accuracy and sufficiency of the information provided, involvement of NIH applications/awards, and appropriateness for consideration as an allegation of research misconduct as defined in 42 C.F.R part 93.
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).
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.
Alternatively, the allegation may be reported directly to ORI. In this case, ORI performs the preliminary review.
(For details on the section that follows, please consult 42 C.F.R 93, subpart B)
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
A reasonable basis for concluding that the allegation falls within the definition of research misconduct and involves PHS supported research; and
Preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.
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.
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.
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.
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.
The institution provides ORI with:
Investigation Report, including a copy of the report, all attachments, and any appeals.
Final institutional action, stating whether the institution found research misconduct, and if so, who committed the misconduct.
Whether the institution accepts the investigation's findings.
Institutional administrative actions pending or completed against the respondent.
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.
The institution is responsible for enforcing sanctions. The institution and NIH may add additional sanctions.