Articles on Law, Science, and Engineering

Scientific Misconduct: Part I - The Federal Rules (cont'd)

Definitions (NSF proposed rule, s 1.4)

Investigator means the principal investigator, the coinvestigator(s), the program director or trainee(s) on a training grant, the recipient of a career award or fellowship or any other individual who conducts or is responsible for research or research training funded under the PHS Act.

Inquiry, as defined at 42 CFR 50.102, means information-gathering and initial fact-finding to determine whether an allegation or apparent instance of misconduct warrants an investigation.

Investigation, as defined at 42 CFR 50.102, means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred. As carried out by the OSI, investigations evaluate the seriousness of misconduct, and, if possible, determine responsibility. If misconduct has already been confirmed, an investigation may nonetheless be necessary to determine the extent of any adverse effects resulting from the misconduct and any necessary remedial or follow-up actions (e.g., publications requiring retraction).

The PHS ALERT or "Public Health Service ALERT Records Concerning Individuals Under Investigation for Possible Misconduct in Science or Subject to Sanctions for Such Misconduct" is a system of records under the purview of the Privacy Act (47 FR 20381, May 12, 1982 (original publication), 56 FR 1310, January 11, 1991 (last publication)). The PHS ALERT is used for collecting, controlling, and disseminating to PHS officials on a need-to-know basis information that an individual applying for or currently (1) is under investigation for possible misconduct or a decision has been made to undertake such an investigation, or (2) has been subjected to a sanction at the conclusion of an investigation for misconduct (e.g. debarment by the Secretary, PHS, from government-wide eligibility, including for research funding, for non-procurement activities under non-procurement debarment and suspension common rule and for procurement activities under the Federal Acquisition Regulations; disqualification by the Food and Drug Administration (FDA) from use of investigational drugs or other restrictions placed on such use; or in the case of scientists employed by the PHS, termination of employment). The information is used to aid PHS officials in making informed decisions regarding PHS funds or other benefits to that individual, but such information does not automatically result in a withholding of funds or other benefits. More detailed information on this system may be requested from the Director, OSI.

MPO means Misconduct Policy Officer, i.e., the official designated by the agency administrator or component director to oversee and coordinate PHS, agency, or component implementation of policies related to misconduct in science. Such designation need not entail creation or change in title of a position, provided the functions described in this issuance can be appropriately discharged.

OSI, as defined at 42 CFR 50.102, means the Office of Scientific Integrity, a component of the Office of the Director, of the National Institutes of Health (NIH), which oversees the implementation of all PHS policies and procedures related to scientific misconduct; monitors the individual investigations into alleged or suspected scientific misconduct conducted by institutions that receive PHS funds for biomedical or behavioral research projects or programs; and conducts investigations as necessary. OSI conducts inquiries or investigations upon request by the institution or, if in the judgment of the OSI, an institution cannot conduct or has not conducted an investigation that adequately resolves the issue(s). (See 54 FR 11080, March 16, 1989, for a statement of organization, functions, and delegations of authority relating to OSI).

OSIR, as defined at 42 CFR 50.102, means the Office of Scientific Integrity Review, a component of the Office of the Assistant Secretary for Health (OASH), which is responsible for establishing overall PHS policies and procedures for dealing with misconduct in science, overseeing the activities of PHS research agencies, including the OSI, to ensure that these policies and procedures are implemented, and reviewing all final reports of investigations to assure that any findings and recommendations are sufficiently documented. The OSIR also makes final recommendations to the Assistant Secretary for Health on whether any sanctions should be imposed and, if so, what they should be in any case where scientific misconduct has been established. (See 54 FR 11080, March 16, 1989, for a statement of organization, functions, and delegations of authority relating to OSIR).

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