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Inspections/Investigations by Third Parties: Difference between revisions
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts Policy]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use & Transfer]] | [[International Research Policy]] | [[Health Care Vendor Interactions]] | [[Internal Audit]] | ||
<br /><br /> | <br /><br /> | ||
Policy No.: '''6109'''<br /> | |||
Effective Date: '''10/16/04'''<br /> | |||
Revised Date:<br /> | |||
Reviewed Date:<br /><br \> | |||
<big>Investigations by Government Officials, Regulatory Agencies, and Other Third Parties</big> | '''<big>Investigations by Government Officials, Regulatory Agencies, and Other Third Parties</big>''' | ||
<br /><br \> | <br /><br \> | ||
== Purpose == | == Purpose == | ||
Government investigators, regulatory agencies or other third parties may contact staff or arrive unannounced at UNMC or at the homes of staff members and seek interviews, documents, information or request to search the premises. The purpose of this policy is to establish procedures for an orderly response that protects the interests of UNMC and provides for appropriate cooperation. Examples of regulatory agency visits, investigations, or requests for information that are subject to this policy include but are not limited to the following: | Government investigators, regulatory agencies or other third parties may contact staff or arrive unannounced at UNMC or at the homes of staff members and seek interviews, documents, information or request to search the premises. The purpose of this policy is to establish procedures for an orderly response that protects the interests of UNMC and provides for appropriate cooperation. Examples of regulatory agency visits, investigations, or requests for information that are subject to this policy include but are not limited to the following: | ||
* Routine or investigative visits by regulatory agencies such as the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), Office of Human Research Protections (OHRP), or Internal Revenue Service (IRS), on an announced or unannounced basis; | * Routine or investigative visits by regulatory agencies such as the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), Office of Human Research Protections (OHRP), or Internal Revenue Service (IRS), on an announced or unannounced basis; | ||
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* Sunshine Act requests (allows citizens to request government agency meeting records); | * Sunshine Act requests (allows citizens to request government agency meeting records); | ||
* Subpoenas (including subpoena duces tecum for the inspection or production of documents). | * Subpoenas (including subpoena duces tecum for the inspection or production of documents). | ||
== Procedures == | == Procedures == | ||
#'''Regulatory Agency Visits''' | #'''Regulatory Agency Visits''' | ||
#* UNMC staff members who are notified of a visit by a regulatory agency should notify their supervisor, director and/or dean (as appropriate to the type of visit) and the Compliance Officer at 559-6767. | #* UNMC staff members who are notified of a visit by a regulatory agency should notify their supervisor, director and/or dean (as appropriate to the type of visit) and the Compliance Officer at 559-6767. | ||
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#* '''Debriefing'''. After the Investigator departs the premises, staff involved in the investigation shall take part in a debriefing with the Compliance Officer and/or Associate General Counsel for Health Care. Reports of the investigation shall be provided to senior personnel as appropriate. | #* '''Debriefing'''. After the Investigator departs the premises, staff involved in the investigation shall take part in a debriefing with the Compliance Officer and/or Associate General Counsel for Health Care. Reports of the investigation shall be provided to senior personnel as appropriate. | ||
#* '''After Hours'''. In the unlikely event that an Investigator requests information after hours, staff should contact the Associate General Counsel for Health Care or the Compliance Officer through the operator at 559-4000. | #* '''After Hours'''. In the unlikely event that an Investigator requests information after hours, staff should contact the Associate General Counsel for Health Care or the Compliance Officer through the operator at 559-4000. | ||
==Additional Information== | |||
*Contact the [mailto:tscrogin@unmc.edu Compliance Officer]<br /> | |||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||