**Ethical and Legal Considerations in Human Biobanking: Experience of the Infectious Diseases BioBank at King's College London, UK**

Zisis Kozlakidis1,3, Robert J. S. Cason2, Christine Mant1 and John Cason1,3 *1Department of Infectious Diseases, King's College London, 2nd Floor Borough Wing, Guy's Hospital, 2School of Law, Birkbeck College London, 3National Institute of Health Research's (NIHR) comprehensive Biomedical Research Centre (cBRC) at Guy's and St Thomas' NHS Foundation Trust, UK* 

### **1. Introduction**

760 Biomedical Science, Engineering and Technology

Iida A., Sakaguchi K., Sato K., et al. (2010). Metalloprotease-dependent onset of blood

Lundberg G., Luo F., Blegen H., et al. (2002). A rat model for severe limb ischemia at rest.

Nasevicius A & Ekker SC. (2000). Effective targeted gene "knockdown" in zebrafish. *Nat.* 

Nasevicius A., Larson J. & Ekker SC. (2000). Distinct requirements for zebrafish angiogenesis

Neels JG., Thinnes T. & Loskutoff DJ. (2004). Angiogenesis in an in vivo model of adipose

Patton EE., Widlund HR., Kutok JL., et al. (2005). BRAF mutations are sufficient to promote

Peterson RT., Shaw SY., Peterson TA., et al. (2004). Chemical suppression of a genetic mutation in a zebrafish model of aortic coarctation. *Nat Biotechnol*, 22, 5, pp. 595-9 Poss KD., Wilson LG. & Keating MT. (2002). Heart regeneration in zebrafish. *Science*, 298,

Rouhi P., Lee SL., Cao Z., et al. (2010). Pathological angiogenesis facilitates tumor cell

Rouhi P., Jensen LD., Cao Z., et al. (2010). Hypoxia-induced metastasis model in embryonic

Sclafani A. & Springer D. (1976). Dietary obesity in adult rats: similarities to hypothalamic

van Marken Lichtenbelt WD., Vanhommerig JW., Smulders NM., et al. (2009). Coldactivated brown adipose tissue in healthy men. *N Engl J Med*, 360, 15, pp. 1500-8. Vihtelic TS & Hyde DR. (2000). Light-induced rod and cone cell death and regeneration in the adult albino zebrafish (Danio rerio) retina. *J. Neurobiol*, 44, 3, pp. 289-307 Virtanen KA., Lidell ME., Orava J., et al. (2009). Functional brown adipose tissue in healthy

Weinstein BM., Stemple DL., Driever W., et al. (1995). Gridlock, a localized heritable vascular patterning defect in the zebrafish. *Nat. Med*, 1, 11, pp. 1143-7 Winzell MS. & Ahren B. (2004). The high-fat diet-fed mouse: a model for studying

Xue Y., Religa P., Cao R., et al. (2008). Anti-VEGF agent confer survival advantages to

Xue, Y. Petrovic N., Cao R., et al. (2009). Hypoxia-independent angiogenesis in adipose

Yaniv K., Isogai S., Castranova D., et al. (2006). Live imaging of lymphatic development in

tissues during cold acclimation. *Cell Metab*, 9, 1, pp. 99-109.

mechanisms and treatment of impaired glucose tolerance and type 2 diabetes.

tumor-bearing mice by improving cancer-associated systemic syndrome. *Proc. Natl.* 

nevi formation and cooperate with p53 in the genesis of melanoma. *Curr. Biol*, 15, 3

circulation in zebrafish. *Curr Biol*, 20, 12, pp 1110-6

tissue development. *FASEB J*, 18, 9, pp. 983-5.

revealsed by a VEGF-A morphant. *Yeast*, 17, 4, pp. 294-301

Risau W. (1997). Mechanisms of angiogenesis. *Nature*, 386, 6626, pp. 671-4

dissemination and metastasis. *Cell Cycle*, 9, 5, pp. 913-7

and human obesity syndromes. *Physiol Behav*, 17, 3. pp. 461-71.

zebrafish. *Nat Protoc*, 5, 12, pp. 1911-8

adults. *N Engl J Med*, 360, 15, pp. 1518-25.

*Acad. Sci. U S A*, 105, 47, pp. 18513-8

the zebrafish. *Nat. Med*, 12, 6, pp. 711-6

*Diabetes*, 53, 3, pp. S215-9

*Eur. Surg. Res.*, 35, 5, pp. 430-8

*Genet*, 26, 2, pp. 216-20

pp. 249-54

5601, pp. 2188-90

Since the dawn of time *Homo sapiens* have collected human body-parts for a variety of reasons (Lassila &Branch, 2006; Aquaron *et al*., 2009; Daily Telegraph, 2011). Similarly, representations of pathological lesions have been collected for educational purposes for at least three hundred years (*e.g.* the Hunterian Museum in Glasgow has preserved plaster casts of diseased tissues). A biobank is a generic term to describe any collection of biological materials and may take many forms, ranging from the preservation of plant seeds (*e.g* the Svalbard Global Seed Vault, Norway) or, the storage of human materials for transplants (*e.g.* corneal biobanks). Others collect human materials for artificial insemination (sperm, eggs and embryos), for forensic investigations and animal materials to assist in the preservation of endangered species such as the Iberian lynx (Leon-Quinto *et al.*, 2009). Some biobanks only collect a single type of sample such as DNA (genebanks), whilst others archive a wide variety of clinical materials. Until recently the *modus operandi* of most medical researchers was to use fresh clinical materials to test a specific hypothesis. The premise was either proven, or not, and then the process repeated to answer subsequent questions. This approach is incredibly wasteful since materials not directly needed to test each argument were discarded. In contrast, clinical biobanks can archive and distribute complete sets of materials from patients with diseases to multiple researchers thereby maximising the benefit of every donation. They can also revolutionise the understanding of very rare conditions by gradually accumulating sufficient numbers of samples –or, by the exchange of samples between multiple biobanks (networking) - to permit statistically-significant conclusions to be derived.

These advantages of biobanks were recognized by *Time* magazine as '*one of the ten ideas that are changing the world right now'* (Park, 2009). This Chapter will be confined to those issues confronting biobanks which collect human materials for medical research. Such archives can be subdivided into those which have the aim of answering one specific research question (*e.g.* the Multiple Sclerosis Brain bank) as opposed to systematic biobanks such as the Infectious Diseases Biobank (IDB) at King's College London (KCL) (Williams *et al*., 2009), which collects clinical materials with no specific research question in mind. The growing popularity of biobanks in medical research in recent years has inevitably raised new and important ethic and legal questions regarding how they should be managed and regulated. For example, recently, the German Ethics Council has proposed that biobanks should be regulated on the basis of five 'pillars' including the concepts of: confidentiality; open informed consent; careful ethics review; sample qualityassurance; and, a transparency of the biobank's goals (Deutscher Ethikrat, 2010). Here some of the most contentious ethico-legal issues facing clinical archives are considered, including: (i) the nature of the contract (*i.e.* informed consent) between the subject and the researcher; (ii) the concept of property or ownership rights in respect to body tissues and fluids; (iii) the duty of care of a biobank to the donor, the sample, the researcher and, society. This is contextualised against historic turning points which have led to the regulatory structures currently in force in the UK. Finally, the organization of the UK's IDB at KCL is described and proposed as a model system for facilitating research into infectious diseases.
