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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Reconsidering the ethics of sham interventions in an era of emerging technologies (Papers: Sophie Niemansburg 2015)0

Posted by Admin in on April 17, 2016
 

Abstract: Our aim was to ethically evaluate the arguments in favor and against sham interventions, as presented in literature. Two developments underscore the need to reconsider the ethics of sham interventions. First, the number of clinical trials investigating interventions in the field of regenerative medicine are increasing, in which the choice for a placebo requires an invasive intervention. Second, the increased awareness of the lack of systematic research in surgery stresses the need to discuss the necessity and acceptability of sham-controlled clinical trials.

A systematic search in Medline was performed, of which 104 articles were considered relevant.

Arguments in favor of a sham controlled design are that it increases the scientific validity and the benefits to society while at the same time the risks and harm can be acceptable. Arguments against sham controls include that they pose unacceptable risks to participants, present difficulties with informed consent, that the use of deceptive tactics is unethical, and that the feasibility of such controls is compromised because of a lack of public support.

None of the published literature fully rejects sham interventions, and many regard sham interventions acceptable provided the conditions of scientific necessity, reasonable risks, and valid informed consent are fulfilled. Further debate should no longer address whether a sham control is ethically acceptable but rather when these conditions are fulfilled.

Niemansburg SL, van Delden JJ, Dhert WJ and Bredenoord AL (2015) Reconsidering the ethics of sham interventions in an era of emerging technologies. Journal of the Society of University Surgeons. 157(4), pp801-10. doi: 10.1016/j.surg.2014.12.001
ScienceDirect: http://www.sciencedirect.com/science/article/pii/S0039606014007867

Ethics in Evaluating a Sociotechnical Intervention With Socially Isolated Older Adults (Jenny Waycott et al 2015)0

Posted by Admin in on April 14, 2016
 

Abstract: The purpose of this article is to consider how ethical principles can inform the effective design and implementation of technology-based interventions that aim to promote the well-being of socially isolated older adults. We evaluated a new iPad application with small groups of older adults. In this article, we reflect on the ethical issues encountered at each stage of the research process. Drawing on the ethical principles of beneficence, research merit and integrity, justice, and respect, we identify key issues to consider in the future design and implementation of social isolation interventions that use new technologies. Key issues include (a) providing sufficient support to facilitate ongoing social interactions, (b) managing older adults’ expectations, (c) providing encouragement without coercion, and (d) responding to individual needs. We conclude that it is important to report on ethical challenges incurred when evaluating social isolation interventions to inform future research in this important area.

Keywords
ethics / moral perspectives; older people; participation, social; technology; vulnerable populations

Waycott J, Morgans A, Pedell S, Ozanne E, Vetere F, Kulik L and Davis H (2015) Ethics in Evaluating a Sociotechnical  Intervention With Socially Isolated Older  Adults. Qualitative Health Research. 1518-28. doi: 10.1177/1049732315570136.
Publisher: http://qhr.sagepub.com/content/25/11/1518.long

E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards (Papers: Pietro Refolo et al 2015)0

Posted by Admin in on April 11, 2016
 

Abstract: Patient recruitment is a critical point of today’s clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

Refolo P, Sacchini D, Minacori, Dalosio V and Spagnolo A G (2015) E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards. European Review for Medical & Pharmacological Sciences. Vol. 19 Issue 5, pp800-804
Publisher (Free download): http://www.europeanreview.org/article/8625

A decision tool to guide the ethics review of a challenging breed of emerging genomic projects (Yann Joly et al 2016)0

Posted by Admin in on April 10, 2016
 

Abstract: Recent projects conducted by the International Cancer Genome Consortium (ICGC) have raised the important issue of distinguishing quality assurance (QA) activities from research in the context of genomics. Research was historically defined as a systematic effort to expand a shared body of knowledge, whereas QA was defined as an effort to ascertain whether a specific project met desired standards. However, the two categories increasingly overlap due to advances in bioinformatics and the shift toward open science. As few ethics review policies take these changes into account, it is often difficult to determine the appropriate level of review. Mislabeling can result in unnecessary burdens for the investigators or, conversely, in underestimation of the risks to participants. Therefore, it is important to develop a consistent method of selecting the review process for genomics and bioinformatics projects. This paper begins by discussing two case studies from the ICGC, followed by a literature review on the distinction between QA and research and a comparative analysis of ethics review policies from Canada, the United States, the United Kingdom, and Australia. These results are synthesized into a novel two-step decision tool for researchers and policymakers, which uses traditional criteria to sort clearly defined activities while requiring the use of actual risk levels to decide more complex cases.

Joly Y, So D, Osien G, Crimi L, Bobrow M, Chalmers D, Wallace S E, Zeps N and Knoppers B (2016) A decision tool to guide the ethics review of a challenging breed of emerging genomic projects. European Journal of Human Genetics advance. Online publication. doi:10.1038/ejhg.2015.279
Publisher: http://www.nature.com/ejhg/journal/vaop/ncurrent/full/ejhg2015279a.html
ResearchGate: https://www.researchgate.net/publication/291341753_A_decision_tool_to_guide…

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