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(US) Rounding up the Belmont Report Retrospectives – Amp@sand (May 2019)0

Posted by Admin in on June 27, 2019
 

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report.

Safeguards for human studies can’t cope with big data
Nature
This provocative piece explores the ways in which the Belmont Report is insufficient for dealing with revolutionary digital technologies, arguing that “data science overlooks risks to human participants by default” and that it is “past time for a Belmont 2.0.” That new summit, the author argues, would need to engage with the currently “poorly understood risks and harms” that big data researches poses to humans.

A Belmont Report for Health Data (abstract available)
The New England Journal of Medicine
HIPAA offers robust protection of a limited range of data, but in 2019, the demands on humans’ health data come from far more directions than the 1996 legislation could anticipate. The authors of this NEJM piece call for a coordinated expansion of the scope of ethical review of the gathering, use, and manipulation of health data to account for sources such as “social-media platforms, health and wellness apps, smartphones [and] life insurers,” citing concerns about reidentification of deidentified data, discrimination, health profiling, and more.

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(US) UCSD has not told women with HIV of data breach, despite researchers’ pleas – inewsource (Jill Castellano & Brad Racino | May 2019)0

Posted by Admin in on June 22, 2019
 

University of California San Diego officials stonewalled attempts to notify women in an HIV research study that their confidential data was breached more than seven months ago, an inewsource investigation has found.

The commentary sidebar on the inewsource website sums up well why this is a big deal. If the story is correct, the breach is serious enough, but the failure to warn the women was a complete betrayal of trust.

UCSD researchers conducting the EmPower Women study told university officials in October that participants’ names, audio-taped conversations and other sensitive materials were made accessible to everyone working at Christie’s Place, a San Diego nonprofit supporting women with HIV and AIDS. They called the situation “very serious” and said the women affected are “within one of the most vulnerable and marginalized populations.”
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But internal emails, reports and meeting minutes chronicle months of communication between lead researcher Jamila Stockman — who pushed for telling two dozen women enrolled in the project about the breach — and UCSD officials concerned about the consequences.
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(US) ‘Banished’ blood, stool samples from San Diego veterans used in research article, despite federal probe – ienewsource (Brad Racino & Jill Castellano | May 2019)0

Posted by Admin in on June 6, 2019
 

Two prominent doctors associated with the University of California San Diego and the local VA used blood and stool samples taken from sick veterans to bolster a paper published this month in an academic research journal.

The specimens were not supposed to be used, according to the project’s lead researcher, because they were part of a study that unethically collected biological samples from living subjects without their consent, which investigators called “serious noncompliance.”

When people volunteer to be human research subjects, they accept potential health risks in order to contribute to a growing bank of scientific and medical knowledge.

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(Japan) 158 ethics violations found in research by Japan’s NCVC medical institute – The Japan Times (May 2019)0

Posted by Admin in on June 4, 2019
 

SUITA, OSAKA PREF. – The National Cerebral and Cardiovascular Center said Thursday it has found 158 cases of research that was conducted in violation of the country’s ethical standards.

The violations include the use of patients’ information without their consent, the NCVC said. There have been no reports of health damage linked to these cases that involved follow-up research, the institute said.

“We deeply apologize for the misconduct,” NCVC President Hisao Ogawa said at a news conference in Suita, where the institute is based.

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