TABLE C-1Draft Accreditation Outcomes and Remedial Action

OutcomeDescriptionCriteriaProgrammatic OutcomeActions by ORCAActions by ORDActions by Accreditor
FullMeets all standards at acceptable level.Score above xx points on 100-point scale; performance meets all threshold standards.Research continues.
Resurvey in 3 years.
Reviews accreditation report. [Note: May independently comment or request additional information from the VAMC.]Reviews accreditation report. [Note: May independently comment or request additional information from the VAMC.]Resurvey in 3 years.
ConditionalMeets most standards at acceptable level.Score between yy and xx points on 100-point scale; performance meets all threshold standards.Research may proceed. Submit Remediation Action Plan (RAP) to accreditor, ORCA, and ORD within 30 days.Reviews accreditation report. [Note: May independently comment or request additional information from the VAMC. Monitors performance against RAP via periodic VAMC reporting at least until Full Accreditation is achieved. May require education and development (TED) program.]Reviews accreditation report. [Note: May independently comment or request additional information from the VAMC. Monitors performance against RAP via periodic VAMC reporting at least until Full Accreditation is achieved.]Monitors performance against periodic VAMC reporting at least until Full Accreditation is achieved. Followup survey may advance to Full Accreditation when RAP is fully implemented.
Resurvey in 3 years (from date of original accreditation determination).
ProbationalMeets some standards at acceptable level, but inadequate performance on many others.Score between zz and yy points on 100-point scale; performance meets all threshold standards.No new projects may be initiated until all deficiencies are corrected. Submit RAP to accreditor, ORCA, and ORD within 30 days.Reviews accreditation report [Note: May independently comment or request additional information from the VAMC. Monitors performance against RAP via periodic VAMC reporting at least until Full Accreditation is achieved. May require TED program. Consider ORCA site visit.]Reviews accreditation report. [Note: May independently comment or request additional information from the VAMC. Monitors performance against RAP via periodic VAMC reporting at least until Full Accreditation is achieved. In addition, withhold funding for new projects and may withdraw funding for current projects until at least Conditional Accreditation is achieved.]Follow-up survey required to advance to Conditional Accreditation.
Resurvey in 1 year (from date of Accreditation upgrade to Conditional).
Not AccreditedFails to meet basic accreditation standards.Score below zz points on 100-point scale; OR unacceptable performance on one or more threshold standards.All research must cease until corrections are made. A patient already enrolled in studies may continue only if that is in the subject's best interest. No new subjects may be enrolled and no new projects may be started. Submit RAP to accreditor, ORCA, and ORD within 30 days.Reviews accreditation report [Note: May independently add comments or request additional information from VAMC. Monitors performance against RAP via periodic VAMC reporting at least until Full Accreditation is achieved. May require TED program. Consider ORCA site visit.]Reviews accreditation report. [Note: May independently add comments or request additional information from the VAMC. Monitors performance against RAP periodic VAMC reporting at least until Full Accreditation is achieved. Withdraw funding for all research (except amounts required to assure patient safety) until at least Probational Accreditation is achieved.]Decides when to determine if site can advance to Probational Accreditation.
Resurvey in 1 (one) year (from date of Accreditation upgrade to Probational).

NOTE: At the accreditor's discretion, a site may not need to have a follow-up survey to move out of Conditional status to Full Accrediation. Rev. 12/21/00

From: C, VA Human Research Protection Accreditation Program Draft Accreditation Standards

Cover of Preserving Public Trust
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Subjects.
Washington (DC): National Academies Press (US); 2001.
Copyright © 2001, National Academy of Sciences.

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