Fostering the responsible use of residual biospecimens and data in medical research in the Netherlands

Last modified: November 8, 2018

Residual tissues and other biospecimens, remaining after diagnosis and treatment, are widely used for subsequent research. About 2000 research projects are conducted with these tissues yearly in Dutch (academic) hospitals and universities. Their use is essential for progress in science and health care. Moreover, tissue samples and data derived from these tissues are increasingly being used to answer research questions in interdisciplinary research fields.

The increased importance of the use of residual tissues and related data for progress in science, and consequently in health care, emphasizes the importance of the responsible use of these tissues. The principles for ethical, legal, and social acceptable use of residual biosamples, and guidelines following these principles have been captured in a Dutch code of conduct. This code was developed and endorsed by relevant stakeholders such as patient organisations, researchers, and pathologists.

However, implementation of these principles and guidelines in Dutch hospitals is slow: for example, patients are often not informed about the potential use of their tissues and the relevant consent procedure, patients’ privacy is often not sufficiently protected, no tissue sample tracking systems are in place, and studies with residual tissue samples are often not reviewed by an appropriate review board. This leaves too much room for the incorrect or even unethical use of these tissue samples and for the conduct of lower quality research. The lack of implementation further decreases the likelihood researchers share data and tissue samples amongst each other. In other words, a gap is forming between the code of conduct and practice.

This therefore directly jeopardizes a large number of initiatives in the Netherlands that are focusing on better sharing of data and reducing research waste. It also may have an indirect and undesirable impact on research data quality if due to lack of consent the necessary approvals for data use are missing and only subsets of data can be used; this will lead to bias and therefore may affect the (clinical) conclusions based on these data. Recent years have seen an upsurge of the development of relevant tools and technologies to foster the responsible use of residual tissues and derived data; we should therefore act now and increase their use.

 

The project

Although the conduct of these responsible research practices related to secondary use of tissue samples and derived data is endorsed by all stakeholders, it is unknown how their implementation can be stimulated. This research project is therefore aimed at identifying the necessary steps to bridge the gap between these principles and guidelines and their implementation in (clinical) practice. Our network of stakeholders including patient representatives, physicians, researchers, patient privacy specialists, and implementation specialists will play an important role in this process. We will identify hindrances to implementation by questionnaires, and conduct site visits to hospitals that vary in their level of implementation. Using stakeholder meetings, we will identify which of the available tools and technologies that are currently available are best able to further implementation of the guidelines, and develop quality indicators to measure the level of implementation. We will develop strategies, such as an informative website, including case examples of best practices, or providing technological applications, to increase the uptake of these tools and technologies, taking into account the hindrances identified.

This implementation plan, or ‘implementation toolbox’, will be offered free of charge and actively distributed through the involved stakeholders to all Dutch hospitals and other relevant institutions. These strategies will assure the sustained availability of tissues for research, while improving the consent procedure, ethical use of tissues, patient awareness, review procedures, and research quality and integrity. This will lead to the continued support of patients and the general population for use of human tissues in research.

NRIN devotes a great deal of attention to the website’s content and would greatly appreciate your suggestions of documents or links you believe to belong on this website.

This selection is an incomplete convenience sample, and does not reflect NRIN’s vision or opinion. Including an item does not necessarily mean that we agree with the authors nor does it imply we think unmentioned items are of poorer quality.

Please report any suggestions, inaccuracies or nonfunctioning hyperlinks etc. that you discover. Thanks in advance!

Contact
Icon