Ethics and data protection in human biomarker studies in environmental health

Casteleyn, Ludwine; Dumez, Birgit; Damme, Karel Van; Anwar, Wagida A.

doi:10.1016/j.ijheh.2013.03.016

Cited by 9 publications

(7 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The EU states that participants in HBM studies have the right to know their individual results, but also not to know them if they wish (Casteleyn et al, 2013;Sepai et al, 2008). A key aim of the communications strategy was to be transparent and open so CO-PHES recommended that each country report-back all results even though for some of the chemicals (e.g.…”

Section: Discussionmentioning

confidence: 99%

Communication in a Human biomonitoring study: Focus group work, public engagement and lessons learnt in 17 European countries

Exley

Cano

Aerts

et al. 2015

Environmental Research

Self Cite

View full text Add to dashboard Cite

A communication strategy was developed by The Consortium to Perform Human Biomonitoring on a European Scale (COPHES), as part of its objectives to develop a framework and protocols to enable the collection of comparable human biomonitoring data throughout Europe. The framework and protocols were tested in the pilot study DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human biomonitoring on a European Scale). The aims of the communication strategy were to raise awareness of human biomonitoring, encourage participation in the study and to communicate the study results and their public health significance. It identified the audiences and key messages, documented the procedure for dissemination of results and was updated as the project progressed. A communication plan listed the tools and materials such as press releases, flyers, recruitment letters and information leaflets required for each audience with a time frame for releasing them. Public insight research was used to evaluate the recruitment material, and the feedback was used to improve the documents. Dissemination of results was coordinated in a step by step approach by the participating countries within DEMOCOPHES, taking into account specific national messages according to the needs of each country. Participants received individual results, unless they refused to be informed, along with guidance on what the results meant. The aggregate results and policy recommendations were then communicated to the general public and stakeholders, followed by dissemination at European level. Several lessons were learnt that may assist other future human biomonitoring studies. Recruitment took longer than anticipated and so social scientists, to help with community engagement, should be part of the research team from the start. As a European study, involving multiple countries, additional considerations were needed for the numerous organisations, different languages, cultures, policies and priorities. Therefore, communication documents should be seen as templates with essential information clearly indicated and the option for each country to tailor the material to reflect these differences. Future studies should consider setting up multidisciplinary networks of medical professionals and communication experts, and holding training workshops to discuss the interpretation of results and risk communication. Publicity and wide dissemination of the results helped to raise awareness of human biomonitoring to the general public, policy makers and other key stakeholders. Effective and timely communication, at all stages of a study, is essential if the potential of human biomonitoring research to improve public health is to be realised.

show abstract

Section: Discussionmentioning

confidence: 99%

Communication in a Human biomonitoring study: Focus group work, public engagement and lessons learnt in 17 European countries

Exley

Cano

Aerts

et al. 2015

Environmental Research

Self Cite

View full text Add to dashboard Cite

show abstract

“…However, the issues raised are pertinent to the increasing demand within medical research for secondary use of data which may entail linking data from different sources into larger datasets or using data for purposes not known by the original study participants [24]. Similar issues also arise in relation to genetics and genomics research where there have been calls for consensus on the appropriate use of archived data and consent procedures for future unspecified research [25].…”

Section: Discussionmentioning

confidence: 99%

“…Casteleyna et al [24] suggest ethics committees could play a key role in assessing competing needs and building trust in science amongst (potential) study participants and the wider community. They argue the perceived tension between privacy and data sharing within health research should not be overemphasized, as studies have highlighted public willingness to participate in research with a view to advancing scientific knowledge in the interests of all.…”

Section: Discussionmentioning

confidence: 99%

Young people’s views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study

et al. 2016

View full text Add to dashboard Cite

Background: Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees.Methods: Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management.Results: The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. Conclusions: There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance the rights of individuals with the wider benefits from research. The suggestion that public opinion should be represented through random selection similar to jury duty may be worth pursuing in the light of the need to ensure diversity of opinion and establish trust amongst the general public about the use of 'big data' for the wider public good.

show abstract

“…Templates to facilitate harmonized approaches were provided. Because of ethical and democratic rules, European individuals are entitled to be informed on uses, users and results related to their samples and data (Casteleyn et al, 2010). Templates for reporting results to the individual study participants contained information on the health relevance of the data.…”

Section: Communication Strategymentioning

confidence: 99%

A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities

Casteleyn

Dumez

Becker

et al. 2015

Environmental Research

View full text Add to dashboard Cite

In 2004 the European Commission and Member States initiated activities towards a harmonized approach for Human Biomonitoring surveys throughout Europe. The main objective was to sustain environmental health policy by building a coherent and sustainable framework and by increasing the comparability of data across countries. A pilot study to test common guidelines for setting up surveys was considered a key step in this process. Through a bottom-up approach that included all stakeholders, a joint study protocol was elaborated. From September 2011 till February 2012, 17 European countries collected data from 1844 mother-child pairs in the frame of DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale (DEMOCOPHES).(1) Mercury in hair and urinary cadmium and cotinine were selected as biomarkers of exposure covered by sufficient analytical experience. Phthalate metabolites and Bisphenol A in urine were added to take into account increasing public and political awareness for emerging types of contaminants and to test less advanced markers/markers covered by less analytical experience. Extensive efforts towards chemo-analytical comparability were included. The pilot study showed that common approaches can be found in a context of considerable differences with respect to experience and expertize, socio-cultural background, economic situation and national priorities. It also evidenced that comparable Human Biomonitoring results can be obtained in such context. A European network was built, exchanging information, expertize and experiences, and providing training on all aspects of a survey. A key challenge was finding the right balance between a rigid structure allowing maximal comparability and a flexible approach increasing feasibility and capacity building. Next steps in European harmonization in Human Biomonitoring surveys include the establishment of a joint process for prioritization of substances to cover and biomarkers to develop, linking biomonitoring surveys with health examination surveys and with research, and coping with the diverse implementations of EU regulations and international guidelines with respect to ethics and privacy.

show abstract

Ethics and data protection in human biomarker studies in environmental health

Cited by 9 publications

References 24 publications

Communication in a Human biomonitoring study: Focus group work, public engagement and lessons learnt in 17 European countries

Communication in a Human biomonitoring study: Focus group work, public engagement and lessons learnt in 17 European countries

Young people’s views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study

A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities

Contact Info

Product

Resources

About