Archive for March, 2016|Monthly archive page

Extending the Welsh Transplantation Opt-out to Biobanks

In Uncategorized on March 8, 2016 at 11:05 am

By Hazel Biggs and Samuel Walker

On the 1st of December 2015 the Human Transplantation (Wales) Act 2013 came into force which created an opt-out system of organ donation in Wales. Additionally, it revised the provisions of the Human Tissue Act 2004 (HTA) to accommodate the operation of this system. This act introduced a system of presumed consent (called ‘deemed consent’ in the Act) for organ donation for those over 18 who have been resident in Wales for at least 12 months[1]. Under the Welsh notion of deemed consent, if a competent adult has not expressed their view regarding organ donation at the time of their death and no relative or ‘friend of longstanding’[2] objects, organs can be lawfully removed for the purposes of transplantation. Deemed consent has been introduced following a wide ranging public awareness campaign on the basis of the clear public health advantages associated with increasing the number of organs available for transplantation. The Welsh Government expects to see an increase in organ donation with an additional 15 donors per year leading to potentially 75 more transplants.


Donated tissue is used not only for the purposes of transplantation, it also provides a valuable resource for tissue banks and biobanks. For example, the Wales Cancer Bank gathers tissue and blood samples from patients, which are banked as a resource for research into cancer. Subject to ethical approval, researchers from Wales and across the world can apply for access to the banked samples to conduct research into various forms of cancer. However, biobanks also face the requirement of obtaining explicit consent for donation which has been a barrier to both increasing the number of organs available for transplantation and to increasing the samples held by biobanks. The protracted process of gaining evidenced informed consent for gathering tissue samples for this research has the potential to limit the size of the biobank and consequently its value as a resource for health research. Using an opt-out system to increase the resource capacity of a biobank has been used before at the Nashville Vanderbilt University Biobank (BioVU) – although this has now switched to an opt-in system due to changes in the National Institutes of Health regulations. Nevertheless, we can draw on the experience of BioVU to inform any opt-out system in Wales, particularly where these concerns relate to conveying information to prospective donors.

At present tissue samples are obtained from patients who have been tested for, diagnosed with or are suffering from cancer and which are surplus to diagnostic requirements, with additional blood samples being taken at the same time as blood is taken for diagnostic purposes. According to the Human Tissue Act 2004 s.3(2) and Schedule One, human material for use in research requires the patient’s consent and currently biobanks like the Wales Cancer Bank acquire samples donated by patients under an opt-in system of consent. However, a deemed consent approach would be likely to increase the number of samples donated and the associated benefits of the biobank. This could be introduced as an amendment of the Human Transplantation (Wales) Act 2013 to extend the opt-out system to tissue and blood samples retained for Cancer Bank. It is unclear, however, whether this would require any amendment to the HTA which simply states that ‘[w]here the person concerned is alive, “appropriate consent” means his consent’.[3] Moreover, sections 1(7) and 1(9) of the HTA specifically include research as an authorised purpose of bodily material collection. This seems to leave open at least the possibility of an opt-out system for biobank tissue and blood collections without the need to amend the HTA.

Noor A. A. Giesbertz, Annelien L. Bredenoord, Johannes J. M. van Delden[4] identify three features which make an opt-out system acceptable in relation to the use of residual or surplus tissues: first, patient awareness must be raised, secondly, information must be provided and, thirdly, patients must be genuinely able to object. Since the law has recently been changed to support on opt-out, or deemed consent system for organ donation in Wales it now seems pertinent to also amend the law to permit the same approach for tissues gathered for biobanking. In this environment it would not be problematic to raise awareness and provide detailed information to patients who are being investigated for or have been diagnosed with cancer about the value of biobanking. Similarly, the nature of investigation and treatment would facilitate mechanisms for patients to object and withdraw consent should they wish to.

It would, of course be imperative that patients’ rights are properly protected to avoid misuse of samples or breaches of confidentiality. Proper ethical scrutiny would be required to avoid the kind of abuses that occurred in the case of Henrietta Lacks[5] whose data was used for unauthorised commercial purposes. Robust governance structures such as those established for organ donation in Wales would safeguard against that. The shift towards an opt-out system of deemed consent for organ donation makes Wales an ideal location for the introduction of a similar system for donation of tissues for biobanking. There is already an awareness of how an opt-out system works, safeguards are already in place to protect patient choice and Wales already hosts the well connected and established Wales Cancer Bank. Deemed consent in this context would introduce greater efficiency in the collection process and result in a vast expansion of biobanks like the Wales Cancer Bank. The public health benefits of this extension of deemed consent could be equal to or greater than those expected to result from the move to an opt-out system for organ donation.


1) An amendment, if needed, to the Human Transplantation (Wales) Act is preferable to new legislation because it would be the most expedient method of introducing the extension and it makes clear the link between the rationale of an opt-out system and biobank sample collection.

2) Cancer banks use two distinct types of sample which may require greater information provision to patients. Tissue samples are residual samples that are not needed for diagnosis but which have already been collected. In contrast, the blood samples are taken in addition to the samples needed for medical treatment purposes. Consequently, it may not be straightforward to treat both the same because the blood collection component requires the active participation of the patient. Given the minimal interference of taking an additional blood sample this is not insurmountable but may require giving information to the patient making it clear that an extra blood sample will be taken.


3) Giesbertz et al only considered residual sample collection – for the collection of blood that is taken solely for research purposes seems to (in their view) require an opt-in system like other clinical research because the material is taken only as a result of and for research. However, if research samples are opportunistically taken when other diagnostic samples are also being taken then an opt-out system may still be appropriate because a discussion of these additional samples can be included when discussing the taking of diagnostic blood samples. Most importantly, once the skin has been penetrated multiple blood samples can be taken without further damage to the skin or multiple insertions.

 [1] Human Transplantation (Wales) Act 2013 s.5(3)(a). The Welsh Act introduces a number of amendments which serves to either exclude Wales from certain restrictions under the Human Tissue Act 2004 or includes the Welsh Act as part of the functions of the Human Tissue Act: see Human Transplantation (Wales) Act 2013 s.16.

[2] Human Transplantation (Wales) Act 2013 s.4(4)(a).

[3] Human Tissue Act 2004 s.3(2).

[4] Inclusion of Residual Tissue in Biobanks: Opt-In or Opt-Out? (2012) 10 PLoS Biology.

[5] Rebecca Skloot, The Immortal Life of Henrietta Lacks (Pan 2011).