Genotype-driven recruitment: a strategy whose time has come?

backgroundGenotype-Driven Recruitment (GDR) is a research design that recruits research participants based on genotype rather than based on the presence or absence of a particular condition or clinical outcome. Analyses of the ethical issues of GDR studies, and the recommendations derived from these analyses, are based on GDR research designs that make use of genetic information already collected in previous studies. However, as genotyping becomes more affordable, it is expected that genotypic information will become a common part of the information stored in biobanks and held in health care records. Furthermore, individuals will increasingly gain knowledge of their own genotypes through Direct-to-Consumer services. One can therefore foresee that individuals will be invited to participate not only in follow-up GDR studies but also in original GDR studies because genetic information about them is available. These individuals may or may have not participated in research before and may or may not be aware that their genetic information is available for research. DISCUSSION: From a conceptual point of view, we investigate whether the current ethics-related recommendations for the conduct of GDR suffice for a broader array of circumstances under which genetic information can be available. Our analysis reveals that the existing recommendations do not suffice for a broader use of GDR. SUMMARY: Our findings refocus attention on ethical issues which are neither new nor specific to GDR but which place greater demand on coordinated solutions. These challenges and approaches for addressing them are discussed.