5
Aug2016

This week’s Research Ethics Roundup explores ClinicalTrials.gov transparency issues, a potentially controversial citywide study of a new procedure for gunshot and stabbing victims in Philadelphia, charges against an Indian drug developer accused of fraudulent research, and a rebuttal to researchers who have resisted including female mice and rats in pain research.

Want to Enroll in a Clinical Trial? NIH Database is Huge—But Lacks a Few Key Details: Emily Bazar of the Washington Post offers a critique of the NIH website ClinicalTrials.gov. Most trials listed on the website are free and “some pay participants to take part because of possible risks and inconvenience involved,” but critics have noted that the website does not require sponsors to disclose costs to patients when they are present, nor it is the government “legally required to verify information provided by study sponsors.” Ethicists and medical experts worry that these features of the site pose risks to prospective study participants because, as one expert put it, there’s “room for misleading and incomplete information.”

Doctors lifting patient into ambulanceHospitals in Philadelphia Test a Counterintuitive Approach to Save Gunshot Victims: In this STAT News article, AP reporter Erin Haines Whack discusses a citywide study that will test an alternative emergency procedure on a random sample of gunshot and stabbing victims sent to Philadelphia’s trauma hospitals. Any “resident of or visitor to Philadelphia could become a study subject” if they were to be wounded by gunshot or stabbing; however, anyone can opt out of the study by filling out a form. This study framework has already been exempted from the FDA’s informed-consent regulations, but organizers also had to obtain approval from city and hospital review boards on human subjects research in addition to holding community meetings to inform the public about the study.

European Regulator Recommends Suspending Numerous Drugs Over Clinical Trial Problems: Ed Silverman reports for STAT News that the European Medicines Agency has called for suspension of the sales of “dozens of generic medicines” due to flaws in studies conducted by the Semler Research Center in Bangalore, India. These recommendations follow an FDA review of Semler that discovered “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.” Prior to the FDA review, the World Health Organization also voiced concern, noting that an inspection found “a spreadsheet file containing detailed instructions for manipulating drug samples that were used in clinical trials for its clients.”

Equality Need Not Be Painful: In tAlbino (Wistar) laboratory rat sitting on a cage with human silouette on backgroundhis Nature opinion piece, neuroscientist Jeffrey S. Mogil (a keynote speaker at PRIM&R’s 2016 IACUC Conference) debunks an argument for excluding female mice and rats in pre-clinical pain studies. Mogil says researchers frequently argue that including both sexes of mice and rats will require an increase in the number of animal models used. Mogil argues this concern is unfounded, explaining that NIH policy does not require doubling sample size (the policy just requires that “half of the subjects are female,” so population sizes need not be increased) and emphasizing that including both sexes will not increase the variability of the pain data collected.

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