Public Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research

Abstract

WHAT'S KNOWN ON THIS SUBJECT:The retention and use of residual bloodspots is a practice of many state newborn screening programs. This practice has become controversial, and little is known about public attitudes on the retention and research use of newborn residual bloodspots. WHAT THIS STUDY ADDS:This study offers a detailed analysis of public attitudes regarding bloodspot retention and use for biomedical research. The results also offer insights on how education regarding this practice influences support for newborn screening and residual bloodspot use. abstract BACKGROUND AND OBJECTIVES: Many state newborn screening (NBS) programs retain residual NBS bloodspots after the completion of screening. Potential uses for residual specimens include laboratory quality assurance, biomedical research, and, rarely, forensic applications. Our objective was to evaluate public opinion about the policies and practices relevant to the retention and use of residual bloodspots for biomedical research. METHODS:A total of 3855 respondents were recruited using 3 methods: focus groups (n = 157), paper or telephone surveys (n = 1418), and a Knowledge Networks panel (n = 2280). Some participants (n = 1769) viewed a 22-minute movie about the retention and use of residual specimens while other participants were provided only written information about this practice. All participants were surveyed using a 38-item questionnaire. RESULTS:A diverse set of participants was recruited. Respondents were very supportive of NBS in general and accepting of the use of residual bloodspots for important research activities. Respondents were evenly divided on the acceptability of NBS without parental permission, but the majority of respondents supported the use of an "optin" process for parental permission for residual bloodspot retention and use. Viewing the educational movie was associated with greater support for bloodspot retention and use. CONCLUSIONS:Our results show that the general public surveyed here was supportive of NBS and residual sample retention and research use. However, there was a clear preference for an informed permission process for parents regarding these activities. Education about NBS was associated with a higher level of support and may be important to maintain public trust in these important programs.

Public concerns regarding the storage and secondary uses of residual newborn bloodspots: an analysis of print media, legal cases, and public engagement activities

“…Many public health officials, researchers, ethicists, and policymakers around the world have expressed concern regarding the ethical, legal, and social implications of using RBS specimens for research unrelated to the NBS process (e.g., Norgaard-Pedersen and Hougaard 2007; Rothwell et al 2010Rothwell et al , 2011; United Kingdom Newborn Screening Programme Centre 2005; University of Michigan Health System 2011). Importantly, some parents of children whose RBS are being stored, and in some cases used for purposes beyond the initial screening, have also expressed strong concerns (e.g., Carmichael 2011;Armstrong 2010;Cohen 2010;Botkin et al 2012;Rothwell et al 2012;Tarini et al 2009). This section will summarize public concerns identified in (1) print media, (2) lawsuits, and (3) public engagement activities.…”

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

“…The majority of the public supports the use of biobanked samples for research-but not without permission (Tarini et al 2010;Botkin et al 2012). But participants expressed divergent attitudes and a variety of ideas about which consent models should be implemented by Michigan's BioTrust.…”

Using Newborn Screening Bloodspots for Research: Public Preferences for Policy Options

“…Policy and practice related to the storage and retention of residual NBS bloodspots for medical research remain variable and contentious. [1][2][3][4][5] Lawsuits have challenged NBS programs' right to retain samples for research without explicit parental consent, resulting in the destruction of some populationlevel biospecimen collections. [6][7][8][9][10][11] However, supporters of the "opt-out" (ie, nonexplicit consent) model argue that it ensures high participation rates and is simply more feasible than seeking explicit permission from the entire population of pre/postpartum parents.…”

“…[12][13][14] When engaged in deliberation about the tensions between individual and collective interests, US and Canadian publics are generally supportive of research use of stored samples. 1,15,16 Where concrete policy options have been proposed, however, majorities favor active permissionbased approaches over passive notification/opt-out processes. 1,[17][18][19][20][21] Even genetics professionals perceive risk to secondary uses of bloodspots without permission, including reduced uptake and loss of public trust.…”

“…1,15,16 Where concrete policy options have been proposed, however, majorities favor active permissionbased approaches over passive notification/opt-out processes. 1,[17][18][19][20][21] Even genetics professionals perceive risk to secondary uses of bloodspots without permission, including reduced uptake and loss of public trust. 22 Seeking to sustain research capacity while recognizing these concerns, recent guidance emphasizes the importance of transparency regarding the storage and research uses of dried bloodspots but remains ambivalent on the question of consent.…”