Limitations, challenges and ethics

There are particular ethical issues for genetics in medicines development, and many of these also apply to the area of pharmacogenomics and pharmacogenetics. Some people feel that there is now plenty of agreement on some of the ethical issues, but other areas are still being debated.

Many people see genetic information as powerful and private. This is partly because it can predict the risk of a patient’s future disease, and partly because it can give information both about the patient and about family members. Others point out that researchers should consider if the genetic information has clinical significance (in other words, that it will actually affect someone’s health). Not all genetic information is significant, so perhaps not all genetic information is ‘sensitive’.

Pharmacogenomics and pharmacogenetics research needs access to blood or tissue samples (sometimes from a large number of people). Sometimes these samples are stored along with detailed personal and medical information. Biobanking is the term used for large, organised sets of samples and data.

Three important debates about the ethics of biobanking for genetic research revolve around informed consent, disclosure of findings and privacy/confidentiality of data. These are described further in the following sections.