The inclusion of children's samples in biobanks brings forward specific ethical issues. Guidelines indicate that children should be involved in the consent procedure. It is, however, unclear how to allocate an appropriate role for children. Knowledge of current practice will be helpful in addressing this issue. Therefore, we conducted an international multiple-case study on the child's role in consent procedures in pediatric biobanks. Four biobanks were included: (1) LifeLines, (2) Prevention and Incidence of Asthma and Mite Allergy (PIAMA), (3) Young-HUNT3 and (4) the Oxford Radcliffe Biobank contribution to the Children's Cancer and Leukaemia Group tissue bank (ORB/CCLG). Four themes linked to the child's role in the consent procedure emerged from the multiple-case study: (1) motives to involve the child, (2) informing the child, (3) the role of dissent, assent and consent and (4) voluntariness of children to participate. We conclude that biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure, and the extent to which children are able to make voluntary decisions as part of the consent procedure. This insight is valuable when designing pediatric biobank governance.
This article poses the question of whether biobanking practices and standards are giving rise to the construction of populations from which various biobanking initiatives increasingly draw on for legitimacy? We argue that although recent biobanking policies encourage various forms of engagement with publics to ensure legitimacy, different biobanks conceptualize their engagement strategies very differently. We suggest that biobanks undertake a broad range of different strategies with regard to engagement. We argue that these different approaches to engagement strategies are contributing to the construction of populations, whereby specific nationalities, communities, societies, patient groups and political systems become imbued or bio-objectified with particular characteristics, such as compliant, distant, positive, commercialized or authoritarian. This bio-objectification process is problematic in relation to policy aspirations ascribed to biobanking engagement since it gives rise to reified notions of different populations.
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Key findings and recommendations from a study comparing clinical research regulation in Finland with those in England, Canada (Ontario) and USA are presented. Data were collected with various methods, including interviewing key experts. While the norms and ethical codes were similar, the interpretation partly differed. In each country there were various actors in regulation and practical arrangements differed. Research ethics committees (REC) were crucial, as well as drug authorities in research with drugs. Recommendations include reforming the medical research law, widening the dimensions of ethics judgment, restricting the REC tasks, including a central committee, and introducing quality assurance and restricting the drug control authority tasks.
Centre for Research on Inner City Health, St Michael's Hospital, the Dalla Lana School of Public Health, University of Toronto, and the Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. email@example.com
We explored current policies and practices on the use of incentives in research involving adult offenders under correctional supervision in prison and in the community (probation and parole) in Canada. We contacted the correctional departments of each of the Canadian provinces and territories, as well as the federal government department responsible for offenders serving sentences of two years or more. Findings indicated that two departments had formal policy whereas others had unwritten practices, some prohibiting their use and others allowing incentives on a case-by-case basis. Given the differences across jurisdictions, it would be valuable to examine how current incentive policies and practices are implemented to inform national best practices on incentives for offender-based research.
Cites: Int J Law Psychiatry. 2001 Jul-Oct;24(4-5):339-5611521413
Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond.
To explore publicly accessible IRB websites for guidance in this area, using summative content analysis.
Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of 'significant new findings' (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.
IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.
This article concerns the legal regulation of medical research on children in Finland. The topic is covered by the Medical Research Act of 1999 and by the Recommendations issued by the Working group on medical research on children in 2003. The Decisions of the Parliamentary Ombudsman also play an important role in this area in Finland. The article focuses on two specific issues: involvement of guardians in decision-making for the child, and the expansion of the right to self-determination of minors. Two case examples on these topics are also discussed. Overall, the author comes to the conclusion that the Finnish legislation, policy-makers, investigators and the industry have succeeded well in taking into account international legislation in this area, although there is also room for improvement.