Biobanks and the genomics of disease susceptibility and treatability

Biobanks are being assembled and maintained in the EU and China, ranging from databases of genomic information and medical records, through tissue banks to sperm, embryo and stem cell banks. The ethical and regulatory issues concerning biobanking thus cut across both the two substantive areas outlined above. Regulatory issues concerning bio- and tissue banking are raised in both reproductive medicine and in genomics, and raise, in a slightly different context, the key ethical issues of informed consent, benefit sharing and intellectual property, data protection and ethical standards for the conduct, review and evaluation of biomedical research and for the storage and protection of samples, materials, records and data. Many research teams in the EU and China are also conducting genomic research into disease susceptibility and treatability. This includes research seeking the SNP (single nucleotide polymorphisms) or HAP (haplotype) markers for increased susceptibility to common complex disorders such as heart disease, diabetes and asthma. It also includes pharmacogenetic research seeking to identify genetic markers, in drug targets and/or in drug metabolising enzymes, that account for the diversity in efficacy and/or adverse effects of particular drugs in different patient groups, aiming to aid physicians in matching the drug and the dosage to the genomics of individual patients, perhaps though the use of genetic testing in the clinical context. Ethical issues raised include those of informed consent, confidentiality, feedback, traceability, but also, crucially, those of benefit sharing in the event of medically or commercially significant findings.