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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review (Papers: Elizabeth R. Eisenhauer, et al | 2017)0

Posted by Admin in on August 7, 2019
 

Abstract
Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants’ understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

Keywords
biological specimen banks, biobanking, informed consent, moral risks, understanding

Eisenhauer, E. R., Tait, A. R., Rieh, S., Y. & Arslanian-Engoren, C., M. (2017) Participants’ understanding of informed consent for biobanking: a systematic review. Clinical Nursing Research. 28(1) pp30-51
Publisher: https://journals.sagepub.com/doi/10.1177/1054773817722690

(Australia) Medicare data used to recruit people with bipolar for research – Sydney Morning Herald (Kate Aubusson | July 2019)0

Posted by Admin in on July 29, 2019
 

A letter sent to almost 50,000 patients prescribed lithium inviting them to take part in a bipolar study has raised questions about how Medicare stores and uses private healthcare information.

Shocking cases like this highlight the need for caution when recruiting using data held by a third party.  Even if a strategy is legal, did the potential participants understand their information was being held in an identified form and consent to being contacted about participating in future research projects (even if, as in this case their information won’t be shared)?

UNSW psychiatrist Professor Gordon Parker first became aware of a study investigating the genetics of bipolar when a former patient sent him an angry email accusing him of breaching her privacy.
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“She was furious with me, believing that she was contacted by Medicare because I had blown her confidentiality,” he said.
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But the letter had been sent by the Department of Health Services (DHS) on behalf of a research team at QIMR Berghofer Medical Research Institute inviting recipients to participate in a study exploring potential biomarkers for bipolar disorder.
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A Russian Biologist Wants To Create More Gene-Edited Babies – NPR (Rob Stein | June 2019)0

Posted by Admin in on July 20, 2019
 

A Russian scientist says he wants to create more genetically modified babies, flouting international objections that such a step would be premature, unethical and irresponsible.

Denis Rebrikov, a molecular biologist who heads a gene-editing lab at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology in Moscow, claims he has developed a safe — and therefore acceptable — way to create gene-edited babies.

“How it can be unethical if we will make [a] healthy baby instead of diseased?” Rebrikov told NPR during his first broadcast interview. “Why? Why [is it] unethical?”

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Pragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)0

Posted by Admin in on July 9, 2019
 

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used.

This radical and controversial idea isn’t currently permissible in many jurisdictions (including Australia), but that doesn’t mean it isn’t worth serious discussion.

Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior.

All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

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