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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – How many people does it take?0

Posted by Admin in on January 19, 2018
 

Cartoon by Don Mayne www.researchcartoons.com

Some research projects can require the involvement of 20 or more people, and that’s without the research team, actual participants, the regulators or those involved with the research outputs. And then there are the friendly consultants (like AHRECS!) on hand to advise and assist to make the process as collegiate, effective and efficient as possible. 🙂

The Nuremberg Code 70 Years Later – The JAMA Network (Jonathan D. Moreno, et al | September 2017)0

Posted by Admin in on December 31, 2017
 

VIEWPOINT

Seventy years ago, on August 20, 1947, the International Medical Tribunal in Nuremberg, Germany, delivered its verdict in the trial of 23 doctors and bureaucrats accused of war crimes and crimes against humanity for their roles in cruel and often lethal concentration camp medical experiments. As part of its judgment, the court articulated a 10-point set of rules for the conduct of human experiments that has come to be known as the Nuremberg Code. Among other requirements, the code called for the “voluntary consent” of the human research subject, an assessment of risks and benefits, and assurances of competent investigators. These concepts have become an important reference point for the ethical conduct of medical research. Yet, there has in the past been considerable debate among scholars about the code’s authorship, scope, and legal standing in both civilian and military science. Nonetheless, the Nuremberg Code has undoubtedly been a milestone in the history of biomedical research ethics.1- 3

Many of us point to the Nuremberg Code as the first formal codification of precepts for the ethical conduct of human biomedical research. And while some pretty awful cases of misconduct and mistreatment of participants still occurred after its release, and documents like the Declaration of Helsinki and the Belmont Report gave us research ethics review as we know it, seventy or so years on the Nuremberg Code is still a worthy progenitor of some of the ethical principles we hold dear today.

Writings on medical ethics, laws, and regulations in a number of jurisdictions and countries, including a detailed and sophisticated set of guidelines from the Reich Ministry of the Interior in 1931, set the stage for the code. The same focus on voluntariness and risk that characterizes the code also suffuses these guidelines. What distinguishes the code is its context. As lead prosecutor Telford Taylor emphasized, although the Doctors’ Trial was at its heart a murder trial, it clearly implicated the ethical practices of medical experimenters and, by extension, the medical profession’s relationship to the state understood as an organized community living under a particular political structure. The embrace of Nazi ideology by German physicians, and the subsequent participation of some of their most distinguished leaders in the camp experiments, demonstrates the importance of professional independence from and resistance to the ideological and geopolitical ambitions of the authoritarian state.
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The circumstances in which the code was promulgated thus signified a tension between professional standards and duties to the state. There had long been an intense debate within the medical profession about its ethical obligations in the course of human experiments, dating back to 18th- and 19th-century objections against objectifying human beings for scientific purposes. The increased demands placed on modern states to promote the health and welfare of citizens in the 20th century required state agencies to respond to public pressure to protect participants in clinical trials. These debates were often stimulated by medical ethics transgressions or medical errors that attracted the wider attention of state agencies and the public at large, or by concerned physicians who regarded themselves as reformers and wished to improve their colleagues’ practices. At the center of that debate is the question of how to balance participants’ rights and welfare with the progress of medical science, for example, through professional guidelines and ethics codes or through greater state intervention, laws, and regulations. That the Nazi doctors’ crimes occurred despite the vigorous and sophisticated ethical debates of the time and place should serve as a cautionary tale for physicians today.
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Opinion: Where’s the data? Missing trial results undermine pandemic preparedness – Devex (Till Bruckner | November 2017)0

Posted by Admin in on December 17, 2017
 

In the fight to control global pandemics, public health agencies and governments face a monumental challenge: The results of around half of all clinical trials are not public, leaving huge gaps in medical knowledge. The invisibility of medical research results may make it difficult, if not impossible, to tell which drugs and vaccines work.

Although the basic premise is not new, the application to pandemics is

Drug companies have long been criticized for their failure to publish the results of some trials, notably those that cast an unflattering light on their products. However, universities and government agencies often perform even worse. Many funders and institutions fail to monitor whether the results of research are shared, and researchers often find it hard to get trials that return disappointing results published in prestigious medical journals. This missing data can cost missed opportunities, misdirected programs, or even billions of dollars on the wrong drug.
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Transparency is improving, but slowly. A handful of countries have passed transparency laws, but they only cover a minority of trials and have not been properly enforced. In the U.S., for example, research institutions are required to post the results of some trials on ClinicalTrials.gov within 12 months of examining the last patient. Yet in 2015, health news site STAT found that pharmaceutical companies, universities and even government agencies routinely violate this disclosure law.
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Who Owns Patient Data in Clinical Research? – CollabPx (Charlotte J. Haug | October 2017)0

Posted by Admin in on December 7, 2017
 

Q: Many people are coming to believe that active patient participation will be a key to more rapid movement forward in cancer research. Data sharing can help. But who owns the data? And what rights and responsibilities are thus conferred? Your recent NEJM article provides helpful background. Can you help us better understand?

A: Exchange of data between patients and doctors is essential for the practice of medicine – and patient data are essential for medical research and progress.

Traditionally, doctors collected patients’ health information (typically the medical history, laboratory tests, drugs prescribed, outcome of treatment, etc.) and sometimes shared that information, in confidence, with colleagues to seek advice and advance science. The medical record was the physician’s property, and still is in many countries and legislations. But do physicians own the patient data?

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