Implementing risk-stratified screening for common cancers: a review of potential ethical, legal and social issues

Abstract

BackgroundThe identification of common genetic variants associated with common cancers including breast, prostate and ovarian cancers would allow population stratification by genotype to effectively target screening and treatment. As scientific, clinical and economic evidence mounts there will be increasing pressure for risk-stratified screening programmes to be implemented.MethodsThis paper reviews some of the main ethical, legal and social issues (ELSI) raised by the introduction of genotyping into risk-stratified screening programmes, in terms of Beauchamp and Childress's four principles of biomedical ethics—respect for autonomy, non-maleficence, beneficence and justice. Two alternative approaches to data collection, storage, communication and consent are used to exemplify the ELSI issues that are likely to be raised.ResultsUltimately, the provision of risk-stratified screening using genotyping raises fundamental questions about respective roles of individuals, healthcare providers and the state in organizing or mandating such programmes, and the principles, which underpin their provision, particularly the requirement for distributive justice.ConclusionsThe scope and breadth of these issues suggest that ELSI relating to risk-stratified screening will become increasingly important for policy-makers, healthcare professionals and a wide diversity of stakeholders.

Family History Attributes and Risk Factors for Breast Cancer in Turkey

“…The identification of age as a risk factor is critical in planning screening strategies. Various studies have shown that screening using a mammography is effective in women between the ages of 50 to 70 (Health, 2007;Hall et al, 2013;Tria, 2013).…”

Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women’s Cancer: Points to Consider

“…For instance, the possibility of taking preventive measures, or whether the condition is treatable, will be key criteria in the decision to offer or not this information to women [24,26,27]. If such unsolicited findings are expected to be found through risk prediction testing, a clear explanation of the implications of these findings should also be provided as part of consent information before the test is administered [17].…”

“…In particular, patients should be informed whether the intensity of subsequent screening or medical examinations may be modified (e.g., more or less frequent mammography screening), and what additional health services may be available for individuals with similar risk levels. Finally, risk prediction may raise the issue of distributive justice with respect to individuals deemed to be in the lowest risk level of developing the disease (low-risk group) following testing [17]. Indeed, attention must be paid to any reduction in the health services offered to those at low risk (e.g., change in screening intervals).…”

“…Indeed, attention must be paid to any reduction in the health services offered to those at low risk (e.g., change in screening intervals). Careful planning of the strategy and clear communication with the population should be adopted to avoid any perception that lowrisk individuals are being withheld health services [17].…”

“…may also prevent certain subgroups from fairly benefiting from the risk prediction approach. Approaches based on genomics may exacerbate current inequities related to socioeconomic status, education, or ethnicity [17,18]. The complexity of information involved in genomic-based approaches is a major challenge when communicating with people with low health literacy or numeracy [19].…”