Doc type: Guideline
Doc No.: GL2007_016
Functional Group - Sub Group:
Clinical/ Patient Services - Research
Clinical/ Patient Services - Human Tissue
Summary
Three standardised Patient Information Sheets (1) Clinical Trials (excluding genetic testing and collection/storage of human tissue), (2) Trials involving genetic testing and collection of human tissue, and (3) Tissue 'Banking' or storage of tissue samples) provide a 'proforma' for researchers and industry to use when developing patient information sheets to be used with potential research participants. They have been developed in clear, non-technical language in a 'question and answer' format to aid understanding by potential participants for three kinds of activities: participation in clinical trials, participation in trials involving genetic testing and tissue sampling, and where tissue 'banking' or storage is proposed for future unspecified research.
Date of Publication: 22 August 2007
Replaces: N/A
Author Branch: Health Research and Ethics
This document applies to: Area Health Services/Chief Executive Governed Statutory Health Corporation, Affiliated Health Organisations - Non Declared, Affiliated Health Organisations - Declared, Public Health System Support Division, Dental Schools and Clinics, NSW Dept of Health, Public Health Units, Public Hospitals
Audience: Clinical and research staff involved in development of research trial protocols
Distributed to: Public Health System, Dental Schools and Clinics, Divisions of General Practice, Government Medical Officers, Health Professional Associations and Related Organisations, NSW Ambulance Service , NSW Department of Health, Public Health Units, Public Hospitals, Private Hospitals and Day Procedure Centres , Tertiary Education Institutes
Review Date: 22 August 2012
File No: 06/7722
Status: Active
File link: Human Research Ethics Committees - Standardised Patient Information Sheets (PIS)
File size: 74Kb
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