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Creation and Maintenance of a Living Biobank - How We Do It
Published on: April 10, 2021
Biobanking residual tissues
Peter H J Riegman1, Evert-Ben van Veen
1Erasmus Medical Center, Department of Pathology, Be 235b, Josephine Nefkens Institute, Dr. Molewaterplein 40, PO Box 2040, 3000 CA Rotterdam, The Netherlands. p.riegman@erasmusmc.nl
Human Genetics
|August 5, 2011
Summary
Using residual human tissues for medical research offers alternatives to traditional biobanking. An opt-out consent system, with transparency and confidentiality, is proposed as a balanced approach for ethical research.
Area of Science:
- Biomedical research
- Translational medicine
- Biobanking and tissue research
Background:
- Health-care research heavily utilizes human materials stored in specialized biorepositories.
- Secondary use of pathology archives and residual surgical tissues are common resources for medical research.
- Regulations for using residual tissues, especially in clinical trials, can be complex and differ from specific biobanking projects.
Purpose of the Study:
- To explore the implications of using residual human materials from various sources in distinct research scenarios.
- To evaluate the necessity and practicality of signed informed consent for residual tissue research.
- To advocate for an opt-out consent system under specific conditions for residual tissue utilization.
Main Methods:
- Review of existing practices in medical translational research involving human tissues.
- Analysis of regulatory frameworks and ethical considerations surrounding residual tissue use.
- Comparative assessment of informed consent models (opt-in vs. opt-out) in research contexts.
Main Results:
- Signed informed consent may be overly burdensome and not always the preferred or most practical approach for residual tissue research.
- An opt-out system, ensuring transparency, clear research purposes, and data confidentiality, presents a balanced ethical alternative.
- International exchange of biological samples should adhere to the originating countries' laws and regulations.
Conclusions:
- The use of residual human tissues in research requires careful consideration of ethical and regulatory landscapes.
- Implementing an opt-out system can facilitate research while upholding ethical standards, provided transparency and confidentiality are maintained.
- Adherence to international regulations is crucial for the ethical cross-border transfer and utilization of human biological samples.
