• About The Program

About the program

The objective of this program is to provide standards and education for personnel within a pathology laboratory who are involved in the decisions or the processes of providing support for research involving biobanking. The education will provide a general overview of key issues for consideration by a diagnostic pathology department with respect to supporting research involving biobanking.

Target audience:

• Pathologists, pathologist assistants, pathology fellows, pathology and lab technicians and technologists making decisions about and working with research biospecimens
• Researchers and researcher administrators/coordinators wishing to apply for support from pathology to harvest biospecimens
• Researchers and researcher administrators/coordinators wishing to access biospecimens and data from pathology archives

To complete the program:

1. Sign Up for an online account (1 min)
2. Complete two online education modules
   • “Overview of research biobanking” and
   • “Pathology Support for Research Biobanking”
3. Review the CTRNet Required Operational Practices (ROP) 14 – Recommended practices for handling research biospecimens in pathology labs and biobanks
• ROP 14: “Pathology access and support for research use of biospecimens” (30 mins)
• ROPs 1-13: General biobanking-focused standards (optional background)

Education: “Pathology Support for Research Biobanking” covers special topics and processes primarily relevant to clinical pathology support of research involving biobanking

Standards: ROP 14 is a standard that covers elements that delineate a standard approach and the practices to be implemented to provide research access and support

Following the educational modules, a short test is presented. You must achieve 80% (8/10) to complete the Certificate process.

• Engagement with the program will give individuals working in pathology departments
• Information about key principles to be incorporated into the practices of pathology departments in order to support researchers and biobanks
• An orientation to considerations for providing biospecimens to third party researchers or biobanks
• Access to education about handling and distributing research biospecimens
• Opportunities to standardize local practices with recommended national standards

1. Overview of Research Biobanking (Read more)

   This module gives you a general overview of research biobanking and the key issues involved in establishing, maintaining, and using a biobank. The overall objective of this module is to orient you to standard biobank terminology, describe principles related to the handling of human biospecimens and provide you with information on acceptable practices and standards in biobanking.

   Learning Objectives

   By the end of this module, you should be able to:

   • Outline the need for biobank standardization and training
   • Define the following terms: biobank, biospecimen, annotating data, informed consent
   • List the prime functions of a biobank
   • Explain the need for classification of biobanks
   • Describe the organizational structure of a biobank
   • Outline operational practices relevant to biobanking
   • Outline important ethical, legal and social issues relevant to biobanking

   It takes 15 min to 3 hours to complete this course depending on your engagement and familiarity with the content. This course is the overview module of a nine module course called ‘Introduction to Biobanking’. Please see here for more information on the whole course

   (Read less)

2. Pathology Support for Research Biobanking (Read more)

   The objective of the education module is to give you information about special issues for consideration by a diagnostic pathology department with respect to supporting research involving biobanking. Pathology departments are experts at handling biospecimens for clinical purposes, but research requirements and context introduces important and distinct issues. It takes one to two hours to complete this course depending on your familiarity and engagement with the content This module is principally focused on tissue biospecimens collected from surgical or autopsy procedures. While clearly most applicable to the discipline of “Anatomical Pathology”, the principles described in this module are equally applicable across all clinical subspecialties that handle patient biospecimens within Pathology and Laboratory Medicine.

   This module begins with an overview of the intersection between clinical Pathology and research biobanking, and the objectives, requirements, and perspectives of relevant stakeholders. The subsequent sections cover the practical and operational considerations relevant to supporting research biobanking. The final sections highlight additional topics and specialized services relevant to support of research biobanking by Pathology.

   Learning Objectives

   By the end of this module, you should be able to:

   • Describe the major operational elements of clinical and research biobanking as relevant to a Pathology department.
   • Identify operational considerations for a Pathology department when approached by researchers requesting biospecimens.
   • Describe research intent for use of biospecimens.
   • Identify the different types and focuses of research biobanks.
   • Describe how research biobanking intersects with the clinical pathway.
   • Describe how Pathology departments can support third party biobanks.
   • Identify special issues that pertain to sharing biospecimens with researchers and third-party biobanks.

   (Read less)

The Required Operational Practices (ROPs) contain the key principles of biobank operations distilled from international best practice standards. ROPs are high-level standards in a format that can be absorbed by a range of health and research professionals and are applicable to all types of biobanks and entities that support biobanking such as Pathology departments. ROPs serve as a direct guide for the implementation of internal controlled documents, such as SOPs, within a biobank or Pathology department that in turn set out the specific details of operations and how these conform to standards relating to research biobanking.