Standard based Deposit Guideline for Distribution of Human Biological Materials in Cancer Patients

Abstract

<b>Background:</b> Human biological materials from cancer patients are linked directly with public health issues inmedical science research as foundational resources so securing “human biological material” is truly importantin bio-industry. However, because South Korea’s national R and D project lacks a proper managing systemfor establishing a national standard for the outputs of certain processes, high-value added human biologicalmaterial produced by the national R and D project could be lost or neglected. As a result, it is necessary todevelop a managing process, which can be started by establishing operating guidelines to handle the outputof human biological materials. Materials and <br/><b>Methods</b>: The current law and regulations related to submittingresearch outcome resources was reviewed, and the process of data ‘acquisition’ and data ‘distribution’ from thepoint of view of big data and health 2.0 was examined in order to arrive at a method for switching paradigms tobetter utilize human biological materials. <br/><b>Results</b>: For the deposit of biological research resources, the originalprocess was modified and a standard process with relative forms was developed. With deposit forms, researchinformation, researchers, and deposit type are submitted. The checklist’s 26 items are provided for publishing.This is a checklist of items that should be addressed in deposit reports. Lastly, XML-based deposit procedureforms were designed and developed to collect data in a structured form, to help researchers distribute theirdata in an electronic way. <br/><b>Conclusions</b>: Through guidelines included with the plan for profit sharing betweendepositor and user it is possible to manage the material effectively and safely, so high-quality human biologicalmaterial can be supplied and utilized by researchers from universities, industry and institutes. Furthermore,this will improve national competitiveness by leading to development in the national bio-science industry.