By: Nivedita Sengupta, PhD
Human Research Regulation
US Agency Releases Finalized ‘Common Rule’, Which Govern Human-Subjects Research
On September 8, 2015 the US Department of Health and Human Services (HHS) proposed significant revisions to the Federal Policy for the Protection of Human Subjects which is also known as the “Common Rule”. “Common Rule” is the set of federal regulations governing the conduct of clinical research involving human subjects. Among the proposed changes, an important one was regarding getting peoples’ consent before using the biological samples for subsequent studies. On 18th January 2017, the final version of the rule was released in which the proposed change was abandoned. This is a blow to the patient-privacy advocates, however the US National Academies of Sciences, Engineering and Medicine argued against that requirement and others citing that the changes would impose an undue burden on researchers and recommended that it be withdrawn.
The current version of Common Rule has generated mixed feelings among people. Researchers are happy that the government listened to scientists’ fears about increased research burdens whereas people like Twila Brase, president and co-founder of Citizens’ Council for Health Freedom in St Paul, Minnesota, are disappointed as they believe that these specific changes are ought to be made. Moreover the new version of the Common Rule requires that scientists include a description of the study, along with the risks and benefits, on the consent forms used by patients, and federally-funded trials should post patient consent forms online. However, these requirements do not extend to trials that are conducted with non-federal funds. (Sara Reardon, Nature News)
An Open-Science Effort to Replicate Dozens of Cancer-Biology Studies is Off to a Confusing Start
The Reproducibility Project on Cancer Biology was launched in 2013 to scrutinize the findings of 50 cancer papers from high-impact journals. The aim is to determine the fraction of influential cancer biology studies that are sound. In 2012, researchers at the biotechnology firm Amgen performed a similar study and announced that they had failed to replicate 47 of 53 landmark cancer papers but they did not identify the studies involved. In contrast, the reproducibility project makes all its findings open. Full results should appear by the end of the year and eLife is already publishing five fully analyzed reports in January. Out of the five, one failed to replicate and the remaining four showed replication results that are less clear.
These five results paint a muddy picture for people waiting for the outcome to determine the extent of impact of these studies. Though some researchers praised the project, others feared unfair discredit of their work and career. According to Sean Morrison, a senior editor at eLife, the reason for the “uninterpretable” results is “Things went wrong with tests to measure the growth of tumors in the replication attempts and the replication researchers were not allowed to deviate from the protocols, which was agreed at the start of the projects in consultation with the original authors”. “Doing anything else — such as changing the experimental conditions or restarting the work — would have introduced bias”, says Errington, the manager of the reproducibility project.
According to Errington, the clearest finding from this project is that the papers include very few details about their methods. The replication researchers had to spend hours to work out the detailed protocols and reagents along with the original authors. Even after following the exact protocols, the final reports include many reasons why the replication studies might have turned out differently, including variations in laboratory temperatures to tiny variations in how a drug was delivered. He thinks that the project helps to bring out such confusing details to the surface, and it will be a great service for future follow up work to develop a cure for cancer. However, scientists think that such conflicts mean that the replication efforts are not very informative and couldn’t be compared to the original and will only cause delays in advancing future clinical trials. (Monya Baker and Elie Dolgin, Nature News)
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