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The Importance – and the Complexities – of Data Sharing (Papers: Jeffrey M. Drazen, M.D. et al 2016)0

Posted by Admin in on October 14, 2016
 

We at the Journal are committed to making the sharing of clinical trial data an effective, efficient, and sustainable part of biomedical research. This issue of the Journal includes three Perspective articles on the topic of data sharing. Grossman et al. describe the Genomic Data Commons, which will initially house raw genomic data and diagnostic, histologic, and clinical outcome data from National Cancer Institute–funded projects.1 Lo and DeMets recommend steps for addressing clinical trialists’ primary reservations about sharing their data.2 And Rockhold et al. consider progress to date and a path forward that could avert the creation of a fragmented data-sharing landscape.3 In August 2016, we published four Perspective articles on the same topic — two by experts who favored rapid open access to clinical trial data and two by other experts who were more reserved in their enthusiasm, focusing on the hurdles to be overcome.4-7 With these articles, and with others to come, our goal is to bring to the table a wide variety of opinions about the value, risks, unknowns, and rewards that accompany data sharing in the context of clinical trials. We firmly believe that complex issues are best clarified through open discussion and the airing of various viewpoints. Only by seeing the issue through many sets of eyes can we achieve the clarity we need to move forward. We hope that you will read each of these pieces with this idea in mind. Our enemy is disease and the human toll it takes. We need to use every means possible to come closer to vanquishing the real foe.

Drazen JM, Morrissey S, Malina D, Hamel MB, and Campion EW (2016) The Importance – and the Complexities – of Data Sharing. New England Journal of Medicine. 375 pp1182-1183 DOI: 10.1056/NEJMe1611027
Publisher (Open Access): http://www.nejm.org/doi/full/10.1056/NEJMe1611027
Interview with Jeffrey Drazen: Listen | Download

Please Share – Proto (Anita Slomski September 2016)0

Posted by Admin in on October 3, 2016
 

Troves of data are gathered during clinical trials, but most of it stays locked away. Could freeing it lead to new cures?

When Myra agreed to participate in a clinical trial testing an epilepsy drug, she understood that the medication might not help her and that its side effects could be harmful. But she figured that even if the treatment failed, she would be providing crucial information. The investigators running the trial would use the data they had gathered on her to develop a better drug or figure out why she and others didn’t respond to existing epilepsy therapies. What Myra didn’t know is that the results from her experiment—and those of hundreds of thousands of other people who participate in human clinical trials—are frequently buried, sometimes forever. Without those results, patients don’t benefit. Medical research doesn’t progress.

Data from a medical trial are a crucial resource that can potentially help many more people than the original trial envisions, says Harlan Krumholz, professor of medicine at Yale School of Medicine. “But results from half of clinical trials are not published within three years of the trials’ completion, and many are never published,” Krumholz says. A researcher might sit on that data because an experiment’s hypothesis didn’t pan out, or the new drug or medical device may have failed to work as planned. Negative trial results are difficult to publish in medical journals, and the data from those experiments may never see the light of day.

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Are Research Ethics Obsolete In The Era Of Big Data? (Papers: June 2016)0

Posted by Admin in on July 14, 2016
 

This story began simply enough as I was writing this past May about the OkCupid data release. The researchers involved in the study had mass downloaded the profiles of more than 70,000 OkCupid users, republishing for the world the most intimate details of these users right down to their wildest sexual

This thought provoking and troubling discussion piece brings together recent commentary about the OkCupid, Ashley Maddison and Emotional Contagion cases, as well as the research use of data dumps by whitleblowers and hackers. It raises important ethical questions of researchers, research ethics reviewers and regulators. Truly sobering stuff.

 fantasies. In their now-unavailable paper the authors had argued that “Some may object to the ethics of gathering and releasing this data. However, all the data found in the dataset are or were already publicly available, so releasing this dataset merely presents it in a more useful form.” In a now-famous tweet, the lead author said that no effort had been put into anonymizing the data because “[The] Data is already public.”

The academic community reacted swiftly to the data release, condemning it as a stark violation of research ethics. Many cited the American Psychological Associations’ Code of Conduct which places strong limitations on when informed consent can be ignored and general human subjects protections, suggesting that if only the researchers had gone through an Institutional Review Board (IRB) approval process, the study would have been stopped before it began. Yet, this suggests that universities and their IRBs have finally caught up to the digital “big data” era and would have actually declined this study if it had been brought before them for review.

For those unfamiliar with how academic research works, some countries like the United States require most research institutions like universities receiving federal funds to have what is called an Institutional Review Board (IRB) that essentially is a panel of campus experts who review proposed research and determine whether any potential ethical concerns it might pose are mitigated by the methodology or nature of the specific project. These IRBs largely follow the so-called federal Common Rule. Before conducting a given study, a researcher submits it to the IRB board at her university and only after the IRB approves the research may the study actually begin. If the IRB declines to authorize the study, the researcher must work with the IRB to alter its nature or methods to address the IRB’s concerns, but if the researcher is unable to meet the IRB’s demands then the research, in theory, must not be conducted.

Leetaru K (2016, 17 June) Are Research Ethics Obsolete In The Era Of Big Data? Forbes/Tech
http://www.forbes.com/sites/kalevleetaru/2016/06/17/are-research-ethics-obsolete-in-the-era-of-big-data/#1a083ad31cb9

(US Story) Researchers Sue the Government Over Computer Hacking Law – Wired (Kim Zetter June 2016)0

Posted by Admin in on July 11, 2016
 

IN THE AGE of big data analytics, the proprietary algorithms web sites use to determine what data to display to visitors have the potential to illegally discriminate against users. This is particularly troublesome when it comes to employment and real estate sites, which could prevent users from having a fair crack at jobs and housing simply by failing to display certain listings to them based on their race or gender.

But four academic researchers who specialize in uncovering algorithmic discrimination say that a decades-old federal anti-hacking statute is preventing them from doing work to detect such discrimination. They say a provision of the Computer Fraud and Abuse Act could be used to criminally prosecute them for research that involves scraping publicly available data from these sites or creating anonymous user accounts on them, if the sites’s terms of service prohibit this activity.

The researchers, along with First Look Media Works, which publishes The Intercept, filed a lawsuit today against the Justice Department, asserting that opening fake profiles to pose as job and housing seekers constitutes speech and expressive activity that is protected under the First Amendment. They further argue that because sites can change their terms of service at any time without informing visitors, this can suddenly turn any speech or activity on the site into a criminal act—a violation, they say, of the Fifth Amendment right to due process, which requires proper notice to the public of what constitutes criminal behavior…

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