ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Clarifying ethical responsibilities in paediatric biobanking (Papers Merle Spriggs & Craig L. Fry)0

Posted by Admin in on May 11, 2016


Background: The creation of biobanks for storage of human specimens and use in health and medical research is expanding globally. Biobanks hold significant potential to facilitate such research. However, important ethical questions arise, particularly in the pediatric setting, in relation to consent, future use, and the balance of benefits against potential harms. To date, these ethical issues have been undertheorized and under-researched in the biobanks domain. The aim of this study was to examine stakeholder attitudes regarding the ethical responsibilities of researchers, biobank custodians, Human Research Ethics Committees (HRECs), research institutions, and parents.

Methods: A qualitative study using semistructured interviews with a purposive sample of key informants (n = 14) with relevant expertise was conducted. Participants were interviewed about their pediatric biobank experiences, the main ethical issues observed as an HREC member, researcher, or custodian, and future needs.

Results: Participants expressed concerns about consent processes in the biobanking context, including issues regarding the provision of information, level of understanding, voluntariness, and the point at which children have a role or can consent for themselves. Other major issues raised were biobank quality management, the return of results, and the idea of human tissue as a scarce precious resource. Key informants also highlighted uncertainties about the custodianship of biobank samples and reasonable limits on the custodian’s role.

Conclusions: Pediatric biobanks are a valuable resource, presenting unique opportunities to advance children’s health and well-being. Properly run pediatric biobanks entail responsibilities for institutes, custodians, researchers, and research ethics committees. We discuss ethical implications for pediatric biobank policy and practices, as well as future information needs in light of the study findings.

Spriggs, M. & Fry, C. (2015). Clarifying ethical responsibilities in paediatric biobanking. AJOB Empirical Bioethics DOI:10.1080/23294515.2015.1049718 xxxx

Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa (Papers: Joyce Mahlako Tsoka-Gwegweni and Douglas Wassenaar 2014)0

Posted by Admin in on May 8, 2016

Abstract: The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC.

Keywords: Emanuel framework; RECs; South Africa; assessment of ethics review; ethical review framework; health research ethics; research ethics committee review outcomes

Tsoka-Gwegweni JM, Wassenaar DR.(2014) Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa. Journal of Empirical Research on Human Research Ethics. 9(5):36-45. doi: 10.1177/1556264614553172

Children, Biological Samples, and Broad Consent (Papers: Merle Spriggs 2015)0

Posted by Admin in on May 7, 2016

Abstract: Broad consent for the collection and use of biological samples in research may be ethically appropriate but when children are involved, things are different. Adults who donate their samples may lack detailed information about future research, but they can still give valid consent. They can choose ignorance in the interest of supporting valuable research. Alternatively, they can exercise their right to say no and not donate their sample. Children need someone else to make these decisions for them and arguably, when parents make these decisions for their children, the responsibility is greater than when they are making decisions for themselves.

Spriggs, M. & Fry, C. (2015). Children, biological samples and broad consent. American Journal of Bioethics. 15(9): 70-72

Should we tell children and young people about the positive experience of taking part in clinical trials? (Papers: Merle Spriggs 2015)0

Posted by Admin in on May 4, 2016

Abstract: Should we tell children and young people that they could gain personal benefit from taking part in clinical trials and that they have a moral duty to take part? Should we tell them that they may come to feel “special,” gain “more confidence,” deal more effectively with their disease, and have their lives enriched (Luchtenberg et al. 2015)? Luchtenberg and colleagues (2015) report on young people’s positive experiences of taking part in clinical trials and recommend that professionals give children and young people more information about how research participation“ can affect their life in a positive way” and more information about opportunities to take part. They report that children and young people, between the ages of 10 and 23 years, often feel a moral duty to participate, are often altruistic, and while they may take part in research in the hope of improving their health, they are not necessarily under the “therapeutic misconception.”

Spriggs, M. (2015). Should we tell children and young people about the positive experience of taking part in clinical trials? American Journal of Bioethics. 15(11): 35-36