Administrative Action: an HHS action taken in response to a research misconduct proceeding 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 taken 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.

Agency Extramural Research Integrity Officer (AERIO): provides oversight and coordination of NIH activities related to research misconduct and promotion of research integrity by the NIH Extramural Program. The AERIO initiates and executes, or supervises the execution of, preliminary reviews of allegations of research misconduct received by members of the NIH Extramural Program, and assures prompt reporting to ORI of research misconduct allegations.

The AERIO receives research misconduct inquiries, investigations, and findings for the NIH Extramural Program, and ensures prompt reporting of research misconduct findings to the ARILO. The AERIO notifies the ARILO of NIH actions proposing the recovery of unallowable costs.

Agency Research Integrity Liaison Officer (ARILO): oversees and coordinates NIH activities and policies related to research integrity in both extramural and intramural research. The ARILO represents the NIH on matters of policies pertaining to research integrity through membership on the PHS Research Integrity Liaison Group, and provides input to the Director of ORI, as appropriate, on policies related to the conduct of research misconduct inquiries and investigations, and promotion of research integrity. The ARILO provides information to the AERIO and AIRIO on policies and procedures related to research misconduct and research integrity.

Allegation: a disclosure of possible research misconduct by written or oral statement or other means of communication to an institutional or HHS official.

Appeal: an option available to respondents whereby they may contest a finding of research misconduct with the Departmental Appeals Board, HHS, which designates an Administrative Law Judge to conduct an administrative hearing.

Complainant: a person who, in good faith, makes an allegation of research misconduct.

Debarment (or suspension): 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 (non-procurement) and 48 CFR Part 9, subpart 9.4 and 48 CFR Part 3, subpart 104 (procurement).

Evidence: 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.

Good Faith: having a belief in the truth of one's allegation or testimony, as applied to a complainant or witness, 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.

Finding: a final judgment of research misconduct, which is made by ORI, transmitted to NIH by ORI and published in the Federal Register, The NIH Guide for Grants and Contracts, and the ORI Newsletter.

Inquiry: preliminary information-gathering and preliminary fact-finding that meet the criteria and follow the procedures of Sec 93.307-93.309.

Institution: any organization that applies for or receives PHS support for an 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.

Investigation: 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 recommend a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.

PHS ALERT System: a Privacy Act system of records, 09-37-0151, “Public Health Service ALERT Records Concerning Individuals Found to Have Committed Research Misconduct in PHS Sponsored Research, HHS/OASH/ORI” that is used for collecting, controlling, and disseminating within the PHS the names of these persons.

Pre-inquiry Assessment: an initial determination by ORI of whether an allegation involves PHS support, and if so, whether the information at hand is accurate, the allegation is appropriate for consideration as an allegation of research misconduct, and sufficient evidence exists to warrant an inquiry.

Preliminary Review: an initial determination by NIH of whether an allegation involves PHS support, and if so, whether the information at hand is accurate, the allegation is appropriate for consideration as an allegation of research misconduct, and sufficient evidence exists to warrant notification of ORI.

Preponderance of the Evidence: proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.

Public Health Service (PHS): 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, the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.

PHS Support: PHS funding, or applications or proposals for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through PHS grants, cooperative agreements, contracts, subgrants or subcontracts under PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts.

Research: 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; 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.

Research Integrity Officer (RIO): the NIH I/C official designated to receive and communicate allegations of research misconduct, or the institutional official designated to receive, consider and manage allegations of research misconduct, including inquiries.

Research Misconduct Proceeding: 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.

Research Record: 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.

Respondent: the person against whom an allegation of research misconduct is directed or the person whose conduct is the subject of the inquiry or investigation.