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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials (Papers: Tanya J. Symons, et al | November 2019)0

Posted by Admin in on December 17, 2019
 

Abstract

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.

This article examines whether international ethical guidelines and the policy frameworks in three countries—the United States, England, and Australia—permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.

The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

Symons, T.J., Zeps, N., Myles, P.S., Morris, J.M. & Sessler, D.I. (2019) International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 2020;132(1):44-54. doi: https://doi.org/10.1097/ALN.0000000000003020.
Publisher: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2756350

(China) Five ways China must cultivate research integrity – Nature (Li Tang | November 2019)0

Posted by Admin in on December 14, 2019
 

A swift increase in scientific productivity has outstripped the country’s ability to promote rigour and curb academic misconduct; it is time to seize solutions.

How researchers in China behave has an impact on the global scientific community. With more than four million researchers, China has more science and technology personnel than any other nation. In 2008, it overtook the United Kingdom in the number of articles indexed in the Web of Science, and now ranks second in the world. In 2018, China published 412,000 papers.

But China also produces a disproportionate number of faked peer reviews and plagiarized or fraudulent publications. Its share of retracted papers is around three times that expected from its scientific output (see ‘Outsized retractions’).

The past few years have witnessed high-profile cases of faked peer reviews, image manipulations and authorships for sale, some involving prominent Chinese scientists. In May last year, China asked two groups to foster research integrity and manage misconduct cases: its Ministry of Science and Technology (MOST) and the Chinese Academy of Social Sciences (CASS) . In November 2018, 41 national government agencies endorsed a set of 43 penalties for major academic misconduct. These range from terminating grants to restricting academic promotion and revoking business licences. This year, the government issued a foundational document to promote the scientific enterprise and foster a culture of academic integrity1.

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A consensus-based transparency checklist (Papers: Balazs Aczel, et al | December 2019)0

Posted by Admin in on December 11, 2019
 

We present a consensus-based checklist to improve and document the transparency of research reports in social and behavioural research. An accompanying online application allows users to complete the form and generate a report that they can submit with their manuscript or post to a public repository.

Good science requires transparency
Ideally, science is characterized by a ‘show me’ norm, meaning that claims should be based on observations that are reported transparently, honestly and completely1. When parts of the scientific process remain hidden, the trustworthiness of the associated conclusions is eroded. This erosion of trust affects the credibility not only of specific articles, but—when a lack of transparency is the norm—perhaps even entire disciplines. Transparency is required not only for evaluating and reproducing results (from the same data), but also for research synthesis and meta-analysis from the raw data and for effective replication and extension of that work. Particularly when the research is funded by public resources, transparency and openness constitute a societal obligation.

In recent years many social and behavioural scientists have expressed a lack of confidence in some past findings2, partly due to unsuccessful replications. Among the causes for this low replication rate are underspecified methods, analyses and reporting practices. These research practices can be difficult to detect and can easily produce unjustifiably optimistic research reports. Such lack of transparency need not be intentional or deliberately deceptive. Human reasoning is vulnerable to a host of pernicious and often subtle biases, such as hindsight bias, confirmation bias and motivated reasoning, all of which can drive researchers to unwittingly present a distorted picture of their results.

Aczel, B., Szaszi, B., Sarafoglou, A. et al. (2019) A consensus-based transparency checklist. Nature Human Behaviour doi:10.1038/s41562-019-0772-6
Publisher (Open Access): https://www.nature.com/articles/s41562-019-0772-6

Also see
repliCATS project at University of Melbourne

Disaster-zone research needs a code of conduct – Nature (JC Gaillard & Lori Peek | November 2019)0

Posted by Admin in on December 10, 2019
 

Study the effects of earthquakes, floods and other natural hazards with sensitivity to ethical dilemmas and power imbalances.

A magnitude-7.0 earthquake rocked Anchorage, Alaska, in late November 2018. Roads buckled and chimneys tumbled from rooftops. Business operations were disrupted. Schools were damaged across the district. This was the largest earthquake to shake the region in a generation, and there was much to learn. What was the state of the infrastructure? Might further quakes occur? How did people respond? Teams of scientists and engineers from across the United States mobilized to conduct field reconnaissance in partnership with local researchers and practitioners. These efforts were coordinated through the clearing house set up by the Earthquake Engineering Research Institute in Oakland, California, which provided daily in-person and online briefings, as well as a web portal for sharing data.

This discussion is especially relevant at the moment given the bushfires/megafires raging in Australia (and California) and the volcano eruption on White Island, New Zealand.  Our sincere best wishes and hopes to anyone affected by these awful disasters.

But researchers are not always so welcome in disaster zones. After the deadly Indian Ocean earthquake and tsunami on 26 December 2004, hundreds of academics from countries including Japan, Russia, France and the United States rushed to the region to collect perishable data. This influx of foreign scientists angered and fatigued some locals; many declined researchers’ requests for interviews. The former governor of Aceh province, Indonesia, where more than 128,000 people died, described foreign researchers as “guerrillas applying hit-and-run tactics”1. Yet research on tsunami propagation and people’s response to the event has led to improved warnings and emergency-response plans.
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When, on 28 September 2018, an earthquake and tsunami hit the Indonesian island of Sulawesi, dozens of researchers found themselves unable to enter the country2. Indonesian law now requires foreign scientists to obtain a special visa before they can begin research. Data-collection protocols must be submitted to the government in advance and projects must have an Indonesian partner. Violators could face criminal charges and even prison.
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