Universal Understanding? Stakeholder Interpretations of Consent Terminology in the Context of Newborn Bloodspot Screening
1. School of Epidemiology, Public Health & Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada; 2. Clinical Epidemiology, Memorial University, St. John’s, Newfoundland and Labrador, Canada; 3. Health Research Unit, Division of Community Health and Humanities, Faculty of Medicine, Memorial University, St. John’s, Newfoundland and Labrador, Canada; 4. Clinical Epidemiology Program, Centre for Practice Changing Research, Ottawa Hospital Research Institute, Ottawa, Canada; 5. Division of Community Health and Humanities, Faculty of Medicine, Memorial University, St. Johns, Newfoundland and Labrador, Canada; 6. Program in Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada; 7. Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; 8. Newborn Screening Ontario, Children’s Hospital of Eastern Ontario (CHEO), Ottawa, Ontario, Canada; 9. Eastern Health, St. John’s, Newfoundland and Labrador, Canada
Introduction: Empirical studies of attitudes toward consent practices for newborn screening indicate varied perspectives, depending on jurisdiction. An assumption within the literature is that terminology such as ‘informed consent’ is consistently interpreted by all stakeholders, and that as a result the differences in expressed opinions are a result of different attitudes toward consent. Recent studies call into question this assumption, and indicate that at least in some cases attitudes may be dependent on individual meaning, which may differ between respondents. This study examines understandings of consent terminology within two divergent newborn bloodspot screening programs in Canada.
Methods and Analysis: Semi-structured interviews were conducted with parents whose children had been offered screening (n=28), healthcare professionals (n=19), and policy decision-makers (n=17). The study was undertaken in parallel at within Ontario and Newfoundland & Labrador. These sites vary in terms of both screening program structure and content, which may be presumed to influence experiences. Interviews were audio-recorded and transcribed verbatim prior to analysis. The examination of the transcripts followed a thematic analysis approach, in which textual data are coded and labelled in an inductive manner.
Results: Terms such as informed consent, implied consent, and standard-of-care were found to have different meanings to individuals. Understandings varied in terms of the perceived level and type of information required, whether authorization by the parent was necessary, as well as documentary evidence required. While variation between individuals was found, no consistent differences were identified between the two sites. For policy decision makers, a lack of formal policy may serve to propagate uncertainty and varied meanings.
Discussion: These data indicate that meaning of terms such as ‘informed consent’ may not be universal, and as such attitudes toward different consent approaches cannot be assumed to be based on consistent conceptualisations of terms. Detailed investigations of meaning are required to unpack the relevant elements upon which stakeholder attitudes toward consent approaches are based.