UAMS Human Research
July 31, 2002
The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the HRAC that reviewed the investigation refuses to allow an inspection (21CFR56.115; 45CFR).
basis of the HRAC's or the institution's response FDA may schedule a
reinspection to confirm the adequacy of corrective actions. In addition, until
the HRAC or the parent institution takes appropriate corrective action, the
parent institution is presumed to be responsible for the operation of an HRAC,
and the Food and Drug Administration will ordinarily direct any administrative
action under this subpart against the institution. However, depending on the
evidence of responsibility for deficiencies, determined during the
investigation, the Food and Drug Administration may restrict its administrative
actions to the HRAC or to a component of the parent institution determined to be
responsible for formal designation of the HRAC (21CFR56.115; 45CFR).
Disqualification the HRAC or an institution. Whenever
the HRAC or the institution has failed to take adequate steps to correct the
noncompliance stated in the letter sent by the Agency under
the Commissioner of Food and Drugs determines that this noncompliance may
justify the disqualification of the HRAC or of the parent institution, the
Commissioner will institute proceedings in accordance with the requirements for
a regulatory hearing set forth in part 16.
Commissioner may disqualify an HRAC or the parent if the Commissioner determines
1. The HRAC has refused or repeatedly failed to comply with any of the regulations set forth in this part, and;
noncompliance adversely affects the rights or welfare of the human subjects in a
Commissioner determines that disqualification is appropriate, the Commissioner
will issue an order that explains the basis for the determination and that
prescribes any actions to be taken with regard to ongoing clinical research
conducted under the review of the HRAC. The Food and Drug Administration will
send notice of the disqualification to the HRAC and the parent institution.
Other parties with a direct interest, such as sponsors and clinical
investigators, may also be sent a notice of the disqualification. In addition,
the Agency may elect to publish a notice of its action in the Federal
and Drug Administration will not approve an application for a research permit
for a clinical investigation that is to be under the review of a disqualified
HRAC or that is to be conducted at a disqualified institution, and it may refuse
to consider in support of a marketing permit the data from a clinical
investigation that was reviewed by a disqualified HRAC as conducted at a
disqualified institution unless the HRAC or the parent institution is reinstated
as provided in 21 CFR56.123; 45 CFR)..
disclosure of information regarding revocation. A
determination that the Food and Drug Administration has disqualified an
institution and the administrative record regarding that determination are
disclosable to the public under part 20.
of an HRAC or an institution.
or an institution may be reinstated if the Commissioner determines upon an
evaluation of a written submission from the HRAC or institution that explains
the corrective action that the institution or HRAC plans to take, that the HRAC
or institution has provided adequate assurance that it will operate in
compliance with the standards set forth in this part. Notification of
reinstatement shall be provided to all persons notified under
alternative or additional to disqualification. Disqualification of an HRAC or of an
institution is independent of, and neither in lieu of nor a precondition to,
other proceedings or actions authorized by the act. The Food and Drug
Administration may at any time, through the Department of Justice institute any
appropriate judicial proceedings (civil or criminal) and any other appropriate
regulatory action, in addition to or in lieu of, and before, at the time of, or
after, disqualification. The Agency may also refer pertinent matters to another
Federal State, or local government Agency for any action that Agency determines
to be appropriate.