The consent forms restrict use of the 1958BC biomedical resource for non-commercial purposes. For example, in relation to blood samples obtained in the Biomedical Survey, they include the following statement: “I understand that the blood samples and related information will be coded and used anonymously for non-commercial research purposes only, and will not be tested for HIV.”
Unfortunately, the term “non-commercial research purposes” is ambiguous. This fact was explicitly recognised when ethical clearance was awarded by the North West Research Ethics Committee in 2009, and remains so despite extensive consideration since. The ambiguity has at least two elements:
- what does “non-commercial research purposes” mean from a legal perspective in the specific context of the statement in the consent form?
- what did participants understand they were agreeing to when they signed the consent form?
METADAC Restrictions on Users
METADAC has adopted a conservative working definition that will allow no use that:
- is led by a commercial organisation
- could lead on to a commercial product or benfit or
- could lead to a commercial organisation gaining control or ownership over some part, or derivative, of the 1958BC resource
However, METADAC does allow researchers to use commercial biotechnology firms to undertake their genotyping (or other high-throughput bioassays) as is the standard approach used across bioscience, with full control and ownership of samples and data remaining with the researchers. METADAC also allows bona-fide scientists working for a commercial organisation to use data and samples for purposes that are clearly not aimed at direct commercial gain but rather at providing an infrastructure for new research opportunities in bioscience in the future. For example, a scientist working for a commercial organisation in India has been awarded access to 1958BC data in order to help him to develop the statistical methods and techniques required to develop a “population ancestry map” for India that will be made freely available.