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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Infecting healthy people in vaccine research can be ethical and necessary – The Conversation (Michael Selgelid & Euzebiusz Jamrozik | June 2019)0

Posted by Admin in on July 1, 2019
 

Medical experiments involving intentionally infecting people with bacteria, viruses, and parasites are surprisingly common. And they are becoming more common worldwide, particularly in developing countries.

The ultimate aim of these “human challenge studies” is usually to test potential new vaccines.

However, because of the risks involved, this kind of research raises difficult ethical questions. For example, who should be infected? And which pathogens would be too dangerous to use?

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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) FDA says HCMC doctors kept ketamine study going after pledging to stop – Star Tribune (Andy Mannix | June 2019)0

Posted by Admin in on June 23, 2019
 

Medical staff at HCMC continued to sedate people with ketamine and collect data for a study for months after the hospital’s leadership told elected officials they had voluntarily halted the research in response to questions over ethics and patient safety.

New inspection reports from federal regulators also say that doctors involved in the research failed to disclose incidents of patients suffering serious medical complications — such as trouble breathing or high blood pressure — to the committee in charge of keeping study subjects safe.

HCMC officials have already responded to the reports, vigorously rebutting many of the findings.

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People want to be able to influence the risk – The Ethics Blog (Pär Segerdahl | May 2019)0

Posted by Admin in on June 16, 2019
 

We need to do research to know what people think is important in genetic risk information. What they prefer to know. But how do we find out? One way is to ask people to answer questionnaires.

One problem with questionnaires is that they ask one thing at a time. Do you prefer a hotel room with a sea view when you are on vacation? You probably answer yes. But do you prefer the sea view even if the room is above the disco, or costs 500 EUR per night? If you only ask one thing at a time, then it is difficult to know how different factors interact, how important they are relative to each other.

One way to get past this limitation is to ask people to choose between two alternatives, where the alternatives have several different attributes.

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