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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Recruiting a Study Coordinator from waaaay outside the box0

Posted by Admin in on June 5, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

Recruiting a good Study Coordinator isn’t easy so we may look outside the box, but maybe not this far.

Should We Purposely Infect Healthy Volunteers With Covid-19? – WIRED (Victoria Turk | May 2020)0

Posted by Admin in on June 4, 2020
 

Such studies could speed up the development of a vaccine—but would mean deliberately giving people a disease that could kill them.

IN LATE MARCH, Josh Morrison was sitting in his apartment in Brooklyn, New York, feeling miserable. Work had slowed down at the nonprofit he runs, which advocates for living organ donors, and he was worried about his parents and whether they were following the guidelines to stay safe during the coronavirus pandemic. He’d been planning to visit them in early April for their 40th anniversary in Florida, but had to cancel. “That was hard, and that was really sad,” he says. “I really want to be able to see my parents as soon as I can, and be back to a situation where you can do that.”

Ethical reflections when they are theoretical can be entertaining and engaging, but the stakes and consequences here are frightening and real.  In a world desperate for a cure, a vaccine or just an efficacious treatment, how far should we go?  Should we allow people to expose themselves to a risk of death or potentially longterm disability?

Morrison, who is 34, felt powerless. He wanted to be able to do something constructive. It was in this context that he came across a paper in The Journal of Infectious Diseases which put forward the case for human challenge studies of Covid-19 vaccine candidates. Challenge studies purposely infect healthy volunteers with a pathogen in order to study a disease or test a treatment or vaccine. This paper suggested that using human challenge studies could speed up the development of a Covid-19 vaccine by months, potentially saving thousands of lives. “The idea of speeding that all up and getting this stuff done with is pretty appealing,” Morrison says. “And also, I thought that I personally could participate in one of these.”
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After contacting some friends, Morrison set up 1 Day Sooner, a group that advocates on behalf of volunteers for Covid-19 human challenge studies. No such studies are yet being conducted, but at the time of writing, more than 24,000 people from 102 countries have signed up on the 1 Day Sooner website to express an interest in taking part in one. Globally, there have now been more than five million reported cases of Covid-19, and 300,000 deaths. Should we let people volunteer to be purposely exposed to a virus we know can sometimes be fatal?
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Read the rest of this discussion piece

(China, Australia) Journals have retracted or flagged more than 40 papers from China that appear to have used organ transplants from executed prisoners – Retraction Watch (Ivan Oransky | April 2020)0

Posted by Admin in on May 29, 2020
 

Journals have retracted 30 papers, and added expressions of concern to 13 more, because the research likely involved organs from executed prisoners in China.

The issue surfaced as early as 2016, and two of the retractions occurred in 2017, but all of the other retractions, and all of the expressions of concern, happened after a February 2019 paper by Wendy Rogers of Macquarie University, in Sydney, Australia, and colleagues calling for the retraction of more than 400 papers

reporting research based on use of organs from executed prisoners, and an international summit to develop future policy for handling Chinese transplant research.

Read the rest of this discussion piece

Multimedia in improving informed consent for caesarean section: A randomised controlled trial (Papers: Alice Truong, et al | January 2020)0

Posted by Admin in on May 28, 2020
 

Abstract
Background

Multimedia modules have been used as an adjunct to improve patient knowledge and recall for various elective surgical procedures, but have been incompletely evaluated in patients undergoing caesarean section.

Aims

To compare the use of a supplementary multimedia module with written information in improving the informed consent process prior to elective caesarean section.

Materials and methods

This was a prospective randomised controlled trial (ACTRN12616000430437). Primary outcomes were knowledge and anxiety scores immediately following the intervention and on the day of surgery. Secondary outcomes were patient satisfaction, length of stay, time to cessation of analgesia, and patient assessment of the consent types.

While this is about the use of digital media in the context of consent for a surgical procedure, it’s findings are significant for researchers across many disciplines.

Results

Seventy‐five patients completed the study. Both multimedia module and written information groups demonstrated a significant increase in knowledge scores with no difference between the groups. In the multimedia‐assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery. In the written information group, scores improved by +1.76 (P < <0.001), and +2.31 (P < 0.001) respectively. There was no adverse impact on anxiety in either group. Patient‐reported understanding (92.4% vs 78.5%, P = 0.001), and helpfulness (90.1% vs 73.3%, P = 0.001) was significantly higher in the multimedia module group than in the written information group. The multimedia module was assessed as ‘slightly too long’ and provided ‘slightly too much information’.
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Conclusions

Multimedia modules are a valuable adjunct to traditional processes of obtaining informed consent for elective caesarean section and should be offered and made available to patients prior to surgery.
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Keywords

anxiety, caesarean section, informed consent, knowledge, multimedia
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Truong, A., Ellett, L., Hicks, L., Pell, G. and Walker, S.P. (2020), Multimedia in improving informed consent for caesarean section: A randomised controlled trial. Aust N Z J Obstet Gynaecol. doi:10.1111/ajo.13124

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