Articles on Law, Science, and Engineering

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

Sanctions (PHS proposed rule 1.10)

Factors that should be considered in determining appropriate sanctions include but are not limited to the following:

(a) Need for reasonable consistency in the application of sanctions, i.e., violations of the same type or degree generally would call for the same kind of sanction(s);
(b) The nature of the misconduct, i.e., was the violation deliberate, the result of carelessness, or was it caused by factors that might not have been reasonably foreseen or controlled;
(c) Whether the incident of misconduct was an isolated event or part of a pattern; and
(d) The degree of seriousness or gravity of the violation (e.g., were data fabricated or falsified, or was human life or well-being jeopardized).

The sanctions listed below are not all-inclusive, and are provided for guidance. They are classified by degree of severity, ranging from those that constitute minimal restrictions (Group I) to those that are the most restrictive (Group III). They do not include possible criminal sanctions and/or civil monetary penalties, which may be applicable in some cases. In addition to the following sanctions, PHS may also seek to recover funds if they were expended for research that was fabricated, falsified or otherwise invalid because of misconduct in science and recovery from the institution is otherwise deemed appropriate. In accordance with statutory and regulatory authority, such recovery may be sought through cost disallowances, negotiation with the institution, offset against other PHS grants to the institution or through a civil recovery action in Federal Court.

Group I Sanctions

• Send a letter of reprimand for improper action to the individual and/or institution (see 42 CFR 50.104 (a)(7)).
• Require, for a specified period of time, that an individual, department, and/or institution obtain from the funding agency special prior approval of particular activities as a condition of award (see 42 CFR 52.9 and 45 CFR 74.7).
• Require, for a specified period of time, that an institutional official other than the individual found culpable of misconduct certify the accuracy and integrity of information provided in applications and/or reports generated under an award (see 42 CFR 52.9 and 45 CFR 74.7).
• Require, for a specified period of time, for any application or award, that the institution must provide a plan for supervision or oversight of scientific activities of the individual found guilty of misconduct (see 42 CFR Secs 52.4 (f) and 52.9 and 45 CFR 74.7).

Group II Sanctions

• Pursuant to 42 CFR 52.6 and 52.9 and 45 CFR 74.7, restrict, for a specified period of time, specific activities or expenditures under an active award.
• Pursuant to 42 CFR 52.5 and 52h.8, require, for a specified period of time, special reviews of all requests for funding from the affected individual and/or institution to ensure that all reasonable steps have been taken to prevent repetition of the misconduct.
• Pursuant to the discretionary appointment authority of PHS components, restrict participation of involved individuals on peer review committees, advisory groups or in other related PHS activities for a specified period of time (see 42 CFR 52.5, 52h.3, and 52h.4).

Group III Sanctions

• Immediately suspend/terminate (an) active award(s) in accordance with 45 CFR 74.110-74.116.
• Withhold funding for specific future non-competing grants or contracts in accordance with 45 CFR 52.6 (b) (2) and (3).
• Debar or suspend the individual for specified period of time, declaring him or her ineligible, pursuant to 45 CFR part 76, for any participation in Federal grants and cooperative agreements, and, pursuant to 48 CFR subparts 9.4 and 309.4, contracts. (This action may be taken only by the Deputy Assistant Secretary for Management and Acquisition, OS.)

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