Restricted Access to Specimen Storage Sites
Standard Operating Procedures (SOP 05.004)
PURPOSE
The purpose of this document is to outline standardized procedures for the TJUH Brain Biorepository to follow during the process of specimen storage. Specimens are collected from patients that have given their consent to participate in the tumor biobank program only if there is tissue in excess of that required for clinical diagnosis. It is the responsibility of the TJUH Brain Biorepository to responsibly store all specimens and to monitor access to samples.
SCOPE
This standard operating procedure (SOP) outlines a process that should be followed to ensure that employees maintain limited access to patient samples.
REFERENCE TO OTHER TJUHBB SOPS OR POLICIES
- TJUHBB Policy: POL 8 Personnel Training and Records
ROLES AND RESPONSIBILITIES
The policy applies to all personnel from the TJUHBB biobank that have access to sensitive and personal information.
Tumor Biobank Personnel | Responsibility |
---|---|
All employees | Maintain limited access to sites of specimen storage. |
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 | Materials & Equipment (Site Specific) |
---|---|
Security Codes for Room Access |
DEFINITIONS
See TJUHBB Glossary.
PROCEDURES
These procedures outline steps that should be followed to ensure that employees who have access to patient specimens maintain restricted access to these locations.
Maintaining Restricted Access to Specimens
- Only the employees of the TJUH Brain Biorepository and Molecular Laboratory are allowed the access code to the location of the specimens.
- Other individuals are not permitted access to this room without the accompaniment of a member from the TJUHBB Brain Biorepository or affiliate Molecular Laboratory.
- Due to the presence of the only ice machine in the building, other individuals may require access to this room.
- All other individuals must request access to the room through the Molecular Laboratory who will then accompany individuals to the room.
- Freezers containing specimens should be locked.
- Drawers containing histology slides should be locked.
APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES
-
Declaration of Helsinki
http://www.wma.net/en/30publications/10policies/b3/index.html -
Tri-Council Policy Statement 2; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, December 2010.
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ -
Human Tissue and Biological Samples for use in Research. Operational and Ethical Guidelines. Medical Research Council Ethics
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420 -
Best Practices for Repositories I. Collection, Storage and Retrieval of Human Biological Materials for Research. International Society for Biological and Environmental Repositories (ISBER).
http://www.isber.org/Search/search.asp?zoom_query=best+practices+for+repositories -
US National Biospecimen Network Blueprint
http://biospecimens.cancer.gov/resources/publications/reports/nbn.asp
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