Mothering a population: How Danish mothers experience newborn dried blood spot samples and their considerations about re-use of samples for research purposes.

INTRODUCTION: Newborn dried blood spot (NDBS) samples have a primary clinical purpose of screening, but often also a secondary purpose of re-use for research purposes. This study investigates how Danish mothers experience the sample being taken, their considerations about potential re-use for research, and their reflections on the level of information they receive about NDBS samples and their re-use for research purposes. METHODS: This study is based on semi-structured interviews with 19 mothers of newborn babies, conducted within the first year after the birth. Mothers were recruited through online media and interviewed in their own homes or at the university. All interviews were coded thematically with an abductive approach. RESULTS: Generally, mothers have difficulties in recollecting the NDBS sample. Overall, they are pleased with the re-use of samples for research purposes. However, some mothers are concerned about the consent procedure. The mothers did not have one specific attitude towards more information about the research done using newborn samples. Based on our findings, we recommend a higher level of transparency regarding national genetic research in general; and, for the NDBS samples specifically, a more complete information and consent procedure. Further, we encourage more studies into what kinds of information parents might find useful about research based on NDBS samples. CONCLUSIONS: Mothers do not always remember experiencing the NDBS sample, are generally positive towards re-use for research purposes, but unsure about best information level.

The rise and fall of an opt-out system.

Introduction: In Denmark, citizens participate in register-based research without the possibility of opting out. However, in 1995 it was made possible for Danish citizens to register an opt-out called 'researcher protection' [forskerbeskyttelse], which implied that researchers could not contact people to invite them to participate in research projects, such as clinical trials or questionnaries, based on their registrations in national registers. Data already registered could still be used for research. In 2014, this possibility of opt-out was revoked by law. Aims: The aims of this paper are to understand how the Danish researcher protection system came about, why it was terminated and what we can we learn from this example. Methods: We conducted a descriptive analysis of a copy of the former researcher protection register along with policies and media debate surrounding the rise and revocation of the researcher protection system. Results: Our results show how both the inception and the abolishment of researcher protection appear to be ad hoc and without specified criteria of success. An examination of the recorded entries in the researcher protection registry could have led to changes in its administration as an alternative to its total abolition. Conclusions: In future opt-out systems, there should be focus on monitoring register practices and the purpose and criteria for evaluation must be defined prior to implementation.

Newborn dried blood spot samples in Denmark: the hidden figures of secondary use and research participation.

Each year millions of newborns are part of a newborn disease-screening program in which, after initial screening, the newborn dried blood spot (NDBS) samples can be stored and used as a population-based research resource. However, very little knowledge exists about how these samples are used for secondary purposes. Our objective is to estimate and describe the usage of a NDBS-based national population biobank for secondary research purposes. We therefore conducted a scoping study with a literature search for all published articles using samples from the Danish Newborn Screening Biobank. Our main inclusion criteria were that the articles had to have actively used and analyzed one or more of the Danish NDBS samples for a purpose beyond the primary screening. Our search led to a final 104 articles, which were coded for three main purposes: (1) how many samples were used in each article, (2) the field of their research, and (3) information on consent and ethics approval as research. From our analysis, we present two main findings: an estimated use of up to 37.5% of all samples in the newborn screening biobank have been part of published research, and a shift in the research areas from methodological and metabolic studies to studies concerning mental illness. This paper provides new insights into the use of a national biobank, and we hope that the results will contribute to the discussions on the use of biological samples for research purposes, and also inspire a greater transparency in the future use of NDBS samples.

From motivation to acceptability: a survey of public attitudes towards organ donation in Denmark.

BACKGROUND: Over the past three decades, public attitudes to organ donation have been a subject of numerous studies focusing on donor motivation. Here, we present a fresh approach. We suggest focusing on public acceptability instead of motivation. The point is to understand public attitudes well enough to avoid risking public support for organ transplantation. We conducted the study in Denmark because there have been significant developments in public attitudes to organ donation in this country. In the 1990s, Denmark was a country with very low public support for organ donation and Denmark was the last country in Europe to introduce brain death as a legal criterion of death, whereas today Eurobarometer surveys rate Denmark as one of the European countries with the highest support for deceased organ donation from brain dead donors. METHODS: We conducted a telephone survey in Denmark (N = 1195). A questionnaire was developed on the basis of preceding qualitative studies and pilot testing and included reuse of one item from earlier surveys to facilitate historical comparison. The analysis of the data was carried out using IBM SPSS Statistics 22 and focused on descriptive statistics. RESULTS: A clear majority of 91.9 % are positive or very positive towards organ donation; 85.8 % like the idea of their body being used after their death, 85.0 % is willing to donate their own organs, 82.1 % to donate their tissue and only 2.3 % find that too much has been done to promote organ donation. There is limited support for monetary incentives for organ donation (5.8 %) and presumed consent (30.4 %), while a majority (63.9 %) supports making it mandatory to register a personal decision. Religious self-identification has limited impact on attitudes. CONCLUSIONS: We can identify a shift over the past three decades from marked opposition to organ transplantation to strong support as well as a pattern in the contemporary public attitudes, which can help explain what is central to public acceptability: self-determination. Policies fostering choice are met with a majority of positive attitudes, while presumed consent and monetary incentives are met with more negative attitudes. Our approach calls for comparative studies in other countries to generate a better overall understanding of the conditions of acceptability, which need to be in place to ensure the long-term social robustness of organ donation and thereby safeguard this important medical technology.