HHS Publishes Final Debarment RegulationsAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 2, No. 9 (Nov., 1980), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564403 .

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=0 - HHS Publishes Final Debarment Regulations

The Department of Health and Human Services (HHS) has published final regulations on debarment and suspension for eligibility for financial assistance (Federal Register, Vol. 45, No. 198, October 9, 1980, pp. 67262-67269). The regulations, which become effective November 10, amend 45 CFR by adding a new Part 76. (Pro- posed regulations had been published March 19, 1979; see "Update," IRB, June/July 1979, p. 8.)

The regulations are necessary, the Department states, "because there have been instances of fraud or abuse by persons who are responsible for Federal funds, and the effect of the regulations will be to establish a proce- dure, with due process safeguards, to render these persons ineligible to re- ceive HHS financial assistance for rea- sonable periods of time." Although many of the 32 comments received by the Department in response to the pro- posed regulations had questioned their necessity, because the writers felt that existing procedures were adequate, the regulation writers concluded that "these procedures deal with fraud and abuse after they have occurred, and the Secretary believes that, in order to pro- vide the maximum protection of Federal funds, there should be an across-the-board mechanism for the prevention of fraud and abuse."

According to the final regulations, "debarment" means "the exclusion from eligibility for financial assistance awarded or administered by HHS un- der discretionary programs for a rea- sonable, specified period of time, com- mensurable with the seriousness of the cause resulting in the debarment." "Suspension" means, unless the con- text otherwise requires, an "immediate

exclusion from eligibility for financial assistance under discretionary pro- grams without prior hearing pending completion of debarment or other pro- ceedings, as applicable."

An institution or individual may be debarred for several causes: (1) convic- tion for any criminal offense commit- ted in the course of obtaining or attempting to obtain a public or pri- vate contract or financial assistance, or in the performance of such a contract; (2) conviction under the Organized Crime Control Act of 1970, or convic- tion for embezzlement, theft, forgery, bribery, falsification or destruction of records, receiving stolen property, or other such offenses; (3) conviction un- der the Federal Antitrust Statutes aris- ing out of the submission of bids, applications, or proposals; (4) serious violations of the applicable statutes, regulations, or other terms and condi- tions of a previous award of financial assistance; (5) a record of unsatisfac- tory performance or failure to perform under one or more prior awards, unless the reason was beyond the individual's or institution's control; (6) debarment from government contract, or sub- contracting, or financial assistance by a government agency; and (7) any other cause significantly affecting respon- sibility under a federal program of suf- ficiently serious nature as determined by the Secretary to warrant debar- ment. Presumably violation of regula- tions governing research involving human subjects would come under this last category.

In each instance of debarment, the Secretary must make a specific deci- sion; the mere fact of, for example, con- viction of a criminal offense does not automatically bring about debarment. In addition, the Secretary will consider mitigating factors such as the serious- ness of the offense.

The period of debarment is not spec- ified afrd will depend on the offens6; de- barment may be terminated or the period reduced by the Secretary's ac- tion, based on the Secretary's own ini- tiative, or on the submission of new evidence, or elimination of the grounds on which debarment was imposed.

When an institution is involved, the debarment may apply just to the com- ponent of the institution in which the offense occurred. The conduct of an in- dividual may be imputed to an institu- tion, or responsible component of the institution, "where such conduct was accomplished within the scope of authority or employment and under circumstances in which responsible of- ficials of the institution knew or should have known of the conduct." In decid- ing on debarment, the actions of re- sponsible officials of the institution will be considered. The institution will be entitled to notice and a hearing.

If, after a hearing, a debarment deci- sion is made, the debarred institutions and individuals will be ineligible dur- ing the specified period to receive any form of financial assistance from HHS. However, exceptions may be made "in the public interest." The names of de- barred individuals and institutions, along with a brief description of the reasons, and the dates of the period of debarment, will be published in the Federal Register. A notice will also be published if the debarment is ended prior to its specified termination date.

If the Secretary believes that grounds for debarment exist, the Secre- tary may suspend an individual or in- stitution immediately, but "only when there are compelling reasons why the interests of the United States would be jeopardized by waiting for completion of debarment proceedings." Suspen- sion will be for a temporary period pending the completion of an inves- tigation or hearing, and any adminis- trative or legal proceedings that may result. Except when based on criminal indictment, debarment proceedings must be initiated within six months of notice of suspension or the suspension will be automatically terminated.

During the suspension period, the in- stitutions or individuals will be ineligi- ble to receive any form of financial assistance from HHS, except, as in de- barment, when it is essential for the public interest. A notice will be pub- lished in the Federal Register similar to that required for debarred individu- als and institutions. The Secretary will maintain a file listing debarred and suspended individuals and institutions.

Carol Levine

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CALENDAR

FEBRUARY 5-8, 1981: The Institute of Public Health and the International Centre for Diarrhoeal Disease Research, Bangladesh, will sponsor a workshop on ethical considerations in research on human subjects in developing coun- tries. The workshop will be held in Dacca, Bangladesh, and will take up ques- tions of informed consent in a predominantly illiterate society, research involving sick and healthy children, incentives and exploitation, adequate safeguards for subjects, community and field research, psychological aspects and traditional beliefs, the role of the media, benefit to society, pressure of science, and enforcement of ethical standards. Those who attend the workshop must pay their own round-trip airfare and room and board. Applications for participation should be addressed to: Dr. K.M.S. Aziz, Chairman, Ethical Re- view Committee, International Centre for Diarrhoeal Disease Research, Bangladesh, G.P.O. Box 128, Dacca 2, Bangladesh. The application should con- tain a brief biography indicating current interests in research and ethical con- siderations. The final selection of participants will be made by the Committee.

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