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TJUHBB

Protecting Confidential Information

Standard Operating Procedures (SOP 01.002)

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PURPOSE

Employees at the TJUHBB biobank have access to confidential information in the form of patient medical records. Medical information is protected under federal and provincial privacy laws and under the terms of the consent process. Furthermore, information may also be bound under non-disclosure or confidentiality agreements. Employees with access to this information may not disclose it.

SCOPE

This standard operating procedure (SOP) outlines a process that should be followed to ensure that employees keep sensitive information confidential. The process covers information that is protected under privacy laws as well as information that may be protected because of an agreement between the tumor biobank and a third party.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

  • TJUHBB Policy: POL 8 Personnel Training and Records
  • TJUHBB SOP 08.02.004: Records and Disposition

ROLES AND RESPONSIBILITIES

The policy applies to all personnel from the TJUHBB biobank that have access to sensitive and personal information.

Tumor Biobank PersonnelResponsibility
All employeesComplete Collaborative Institutional Training Initiative (CITI) Training
Tumor Biobank Director, Manager, or Principal Investigator (PI)Ensure that CITI Training is complete before personnel are given access to any patient or research information. Maintain record of completed CITI Training.

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials, Equipment, & FormsSite Specific Materials
CITI (Collaborative Institutional Training Initiative) Traininghttps://about.citiprogram.org/en/homepage/

DEFINITIONS

See TJUHBB Glossary.

PROCEDURES

These procedures outline steps that should be followed to ensure that employees who have access to confidential information complete CITI Training that addresses privacy issues. It is intended to protect the rights of the patient and researchers that share proprietary information in the process of transactions with the tumor biobank.

CITI Training – Important Elements

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CITI Training

TJUHBB must require an employee to complete CITI training in order to protect sensitive and personal information to which the employee may have access.

The CITI Training should contain at least the following elements:

  • Definition of confidential information
  • Knowledge of the appropriate relevant policies
  • Exclusions (if any) from confidential information
  • Obligations of the employees
  • Miscellaneous provisions if relevant

CITI Training – Completion

  • Request that all employees at the tumor biobank (that will have access to patient or research information) complete CITI Training.
  • Obtain, in duplicate, a completion certificate of CITI training prior to the employee being granted any access to sensitive information.
  • Retain one copy for the tumor biobank records.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

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