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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Deregulating Social Science Research Ethics – Clipping the Wings of IRBs? – Social Science Space (Robert Dingwall 2015)0

Posted by Admin in on November 6, 2015
 

“The Federal Register is surely not everybody’s bedtime reading. It is where the US Government formally publishes certain official documents, including advance notice of its intention to make rules that implement Executive policies. For social science researchers, one of the most important of these has long been the so-called Common Rule, introduced in 1981 and revised in 1991. This is the legal basis for the whole system of US ethical regulation through Institutional Review Boards. Although nominally confined to US institutions, it has had a much wider reach, since any country involved in scientific collaboration with US scholars has had to adopt a similar regulatory model. The new revisions to the Common Rule, described in a ‘notice of proposed rulemaking’ published in September 2015, are, then, likely to have global implications.

In practice, the present regime’s international impact has been uneven in the social sciences, because few institutions have relevant collaborative relationships with US researchers. Major European countries like France, Italy and Germany have seen very limited regulatory developments, mainly in their health sectors and in a few elite institutions open to US influence. The UK, Ireland and the Nordic countries have, however, been strongly affected by the US model. The extensive deregulation of social science research anticipated by the notice is, then, as much a challenge to their regulators as to those in the USA.

The implementation of the Common Rule has been increasingly criticized. As the history of ethical regulation has become better understood, its origins are seen to lie less in a desire to protect human subjects than to transfer litigation risk from the Federal government to universities and to defuse a political panic over accounts of historic biomedical research misdemeanors – some of which look less scandalous when properly contextualized. The system has been widely criticized, as much by biomedical scientists as by social scientists, for its costs, complexity, and conservatism. Many critics claim that it has created a self-serving bureaucracy and facilitated institutional practices that have less to do with ethics than with liability and reputation management. Its brakes on biomedical innovation have measurable costs in lives lost. There are less measurable costs in the systematic ignorance about social conditions created by the regulators’ resistance to qualitative methods that are difficult to control. Although attempts have been made at Federal level to press IRBs to be more accepting of flexible and emergent research methods and designs, these have had only a limited impact.”

Read the full blog post.
Also see subsequent post about the ‘push-back’ in response to the change.

Ashley Madison Hack Creates Ethical Conundrum For Researchers – Huffington Post (Joe Satran 2015)0

Posted by Admin in on September 3, 2015
 

“When hackers dug into the databases of infidelity-focused dating website Ashley Madison and made the personal information of millions of users publicly available in mid-August, suspicious spouses weren’t the only ones tempted to take a peek. Sex researchers, whose work is often hamstrung by subjects’ reluctance to reveal intimate details in surveys, salivated at the opportunity to get an unvarnished look at the secret desires of a huge swath of Americans.”

Is it ethical to use data from Nazi medical experiments? – The Conversation (Lynn Gillam, 2015)0

Posted by Admin in on June 11, 2015
 

During World War II, Nazi doctors had unfettered access to human beings they could use in medical experiments in any way they chose. In one way, these experiments were just another form of mass torture and murder so our moral judgement of them is clear.

But they also pose an uncomfortable moral challenge: what if some of the medical experiments yielded scientifically sound data that could be put to good use? Would it be justifiable to use that knowledge?

How national security gave birth to bioethics – The Conversation (Jonathan D Moreno 2015)0

Posted by Admin in on June 8, 2015
 

Starting near the end of World War II and continuing until the 1970s, the US government sponsored radiation experiments on human subjects. Some of these experiments were conducted to understand the effects of radiation on atomic bomb workers. Others were to learn about the benefits of radiation for cancer patients. Many of the experiments were conducted in secret or not well understood by the public.

Twenty years ago, a committee appointed by President Bill Clinton reported on decades of radiation experiments conducted under the auspices of the federal government.

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