Biotechnology is closely controlled. It does not take place in a legal vacuum.

At European and national levels laws and guidelines provide a framework of strict obligations within which biotechnology users must operate. So researchers must, for instance, provide details of research plans and any changes must be reported to committees responsible to governments. They must also record all results. In addition, medical research in patients or healthy volunteers is covered by specific medical rules and conventions, and subject to scrutiny by ethics committees.

From an ethical point of view, it is obvious that all data on the genetic constitution of an individual - which may include information on defects or abnormalities - should be kept in absolute confidentiality. This is provided for in the new EU directive on data protection.