New Release protocol for research using human biological material

New Release protocol for research using human biological material

Before use of human biological material, a researcher needs an approval from the Biobank Research Ethics Committee (Dutch: TCBio). As of 1st June, an updated version of the release protocol form is available here. As of  1st September 2022, the new form is mandatory for all requests for research use of human biological material.

In the new version, especially the questions regarding privacy during the use of data (section D) are clarified. In addition, explanations have been added to these questions. Also, a glossary (Definition of Terms) has been added at the start of the form. Therefore, the new version helps the researcher in answering the questions regarding the processing of personal data. Additionally, further support is provided on the TCBio website in the form of a decision tree outlining the (U)AVG-WGBO requirements when processing medical and genetic data. A direct link to the decision tree is also available in the release protocol form. Altogether, these changes aim to help researchers provide the required information as complete and correct as possible at the start of the review process. This should reduce the number of resubmissions and thereby speed up the review process. 

As before, for use of human biological material as part of a research protocol approved under the Medical Research Involving Human Subjects Act (in Dutch: WMO) by the Medical Research Ethics Committee (Dutch METC) no additional approval is required by TCBio.

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