The Ethics and Laws Governing Biobanking

With a vast number of people suffering from cancer at some point in their life, there are many who argue that searching for cures is worthwhile.

Survival rates vary and depend on a range of different circumstances, from the type of cancer to the location of the sufferer. Early detection can be the key factor and can begin with a liquid biopsy. However, this is not always possible and the rates are still too low, so finding a cure can result in many lives being saved. The process begins in a biorepository.

Reasons for the Use of Human Tissue Samples

Use of human tissue samples in research is the best way to get an accurate result; while some animals have a similar physiology to humans,  animal samples are never as accurate. The use of ffpe tissue from a biobank will provide the opportunity to test drugs that have been formulated for the purpose of curing cancer. This research is essential to the process of seeking a cure as it helps determine whether specific drugs work.  

Legal Requirements of a Biorepository

The specific legal requirements vary according to the country in which the biobank is located, but the privacy of the donor will be one of the most important aspects regardless. The other is not paying the families of the donors; though tissue cannot be sold, reasonable donations are permitted. Consent must be obtained for the use of human tissue samples either from the family or the donor before death.

Human tissue sample procurement is considered a serious matter and effective regulation is necessary to keep up with any changes in the law. Though the regulation may not be as strict as for organ donation, it is still necessary to abide by the requirements of the US Food and Drug Administration (FDA). Failing to comply with the law relating to tissue procurement can have serious consequences.

The Ethical Dilemma of a Biorepository

The seriousness of the process of using ffpe tissue means that it will attract many opinions on the ethics. It can be argued that this is of no consequence as those that take part in the tissue procurement process only need to be concerned with the law relating to this and whether they are abiding by it. It will not be necessary to worry about the process of harvesting human tissue directly or complying with regulations as the biobank will undertake this. It offers a convenient way to obtain ffpe tissue on which to test drugs.

Using a Biorepository will make it possible to take advantage of a tissue microarray, ffpe blocks or a single breast cancer tissue sample.


Ethics, Law and Governance of Research Biobanking: National, European and International Approaches

The Ethics of Research Biobanking