ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesMerit and integrity

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) Ideological ‘rectification’ hits social sciences research – University World News (Yojana Sharma | December 2019)0

Posted by Admin in on December 15, 2019
 

Social sciences research in China, not as well funded in the past as the hard sciences, is undergoing an even further narrowing so that research more closely serves the purposes of the state, experts have said, with some going as far as to say social sciences in China have undergone political rectification under Chinese leader Xi Jinping.

As part of China’s control over the intelligentsia, there has been greater focus on moulding the social sciences, including law, economics, political science, sociology and ethnic studies, to be politically correct, according to Carl Minzner, professor of law at Fordham University, New York, and an expert on Chinese law and politics.

“In the past four or five years they [the Chinese leadership] have been in an effort to politically sanitise the social sciences in China,” Minzner told University World News. “They were worried that they had lost control over the narrative, and that there were too many critical voices emerging within university classrooms in China.”

Read the rest of this discussion piece

(China) China’s Genetic Research on Ethnic Minorities Sets Off Science Backlash – New York Times (By Sui-Lee Wee and Paul Mozur | December 2019)0

Posted by Admin in on December 12, 2019
 

Scientists are raising questions about the ethics of studies backed by Chinese surveillance agencies. Prestigious journals are taking action.

BEIJING — China’s efforts to study the DNA of the country’s ethnic minorities have incited a growing backlash from the global scientific community, as a number of scientists warn that Beijing could use its growing knowledge to spy on and oppress its people.

Two publishers of prestigious scientific journals, Springer Nature and Wiley, said this week that they would re-evaluate papers they previously published on Tibetans, Uighurs and other minority groups. The papers were written or co-written by scientists backed by the Chinese government, and the two publishers want to make sure the authors got consent from the people they studied.

Springer Nature, which publishes the influential journal Nature, also said that it was toughening its guidelines to make sure scientists get consent, particularly if those people are members of a vulnerable group.

Read the rest of this discussion piece

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.
.

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.
.

Read the rest of this discussion piece

0