Guidance for considering ethical, legal, and social issues in health technology assessment: Application to genetic screening

Abstract

A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods.

Ethics in Health Technology Assessment: Understanding Health Technologies as Policies

“…Internationally, policy makers and researchers alike promote routine "ethical, legal, and social impacts" analyses of health technologies to better inform policy. 11,12 Approaching technology assessment as policy analysis suggests a more fundamental conception of technologies as policies. Technologies not only get things done, like policies, they also change what gets done, how and by whom it gets done, and who gains or loses as a consequence.…”

Informationen zu rechtlichen Aspekten von Gesundheitstechnologien: Methodenvorschlag zur systematischen und nachvollziehbaren Identifizierung

“…Wenngleich auch weltweit rechtliche Aspekte in der Bewertung von medizinischen Technologien (Health Technology Assessment, HTA) nicht routinemäßig explizit dargestellt werden, sind sie doch anerkanntermaßen Bestandteil von umfassenden Technologiebewertungen [1,2]. Rechtliche Regularien bilden sowohl den Rahmen für die Bewertung von Gesundheitstechnologien als auch für deren Implementierung [3][4][5].…”

Points to consider in assessing and appraising predictive genetic tests

“…Consequently, the estimate of benefit from the early detection of genetic disorders typically must rely on observational evidence relating to separate components of a program (e.g., evidence relating to the accuracy of predictive testing/screening for early disease detection, and evidence on the health impact of early treatment) which frequently is uncertain as well (Rogowski 2007;Potter et al 2008;Teutsch et al 2009). …”

“…One gives an informed consent to an intervention if (perhaps only if) one is competent to act, receives a thorough disclosure, comprehends the related information, acts voluntarily, and consents to the intervention (Beauchamp and Childress 2009, p. 120). There have been concerns that the results of genetic tests can very easily be misunderstood; patients may not be familiar with epidemiological concepts of risks and over-or underestimate the precision of a prediction as well as the meaning of relative risk information for their personal health (Potter et al 2008). Informed consent is also difficult to obtain if parents make decisions on behalf of their children (e.g., in the case of newborn screening).…”

“…Informed consent is also difficult to obtain if parents make decisions on behalf of their children (e.g., in the case of newborn screening). Thorough genetic counseling may be particularly difficult in the case of a mass screening program (Potter et al 2008). Research results have reported difficulties inherent in obtaining truly informed and voluntary consent (Sugarman and Sulmasy 2001, 269f).…”