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Update: U.S. abandons controversial consent proposal on using human research samples – Science (Jocelyn Kaiser | January 2017)0

Posted by Admin in on February 16, 2017
 

Federal officials have dropped a controversial plan to impose new rules that researchers say would have made it much harder to use patient blood and tissue samples in research. The final Common Rule released this morning omits these provisions, but leaves some other changes intact.

Biomedical and university research groups that lobbied against the biospecimens provisions are relieved. “We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked,” says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.

The 26-year-old Common Rule protects people who volunteer for federally funded research studies. The Department of Health and Human Services (HHS) and other agencies began an overhaul in 2011 to incorporate changes in how medical research is done, such as a growing number of clinical trials, the use of electronic medical health records, and privacy concerns raised by advances in genomics.

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Other news about the update to the US ‘Common rule’

 

Common Rule revisions: Comparing changes in US and Singaporean research regulations – CentresBLOG (Owen Schaefer | January 2017)0

Posted by Admin in on February 5, 2017
 

While Singapore will see a new regulatory regime for research as the Human Biomedical Research Act (HBRA) comes into force, the US has undergone one of the most major revisions to its own ‘Common Rule’ regulating research in decades. Interestingly, the new Common Rule overall relaxes restrictions on various aspects of research in the US. In this post I’ll briefly summarise some of the big takeaways, and draw some comparisons to the HBRA.

Softening in the face of Public Comment

The previous draft of the revised Common Rule had several provisions that did not make it into the final draft due to strong public backlash during the comment period. Most prominently: the draft would have required broad consent for research on de-identified biological samples. Researchers reacted very negatively, stating that this would significantly interfere with important biomedical research without providing significant additional protection to participants (as the main risks are informational). Patient groups were in agreement, concerned that innovative treatments would be delayed due to excessive bureaucratic regulation. The requirement was scrapped, and broad consent is now only required for research on identifiable samples.

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We must urgently clarify data-sharing rules – Nature (Jan-Eric Litton | January 2017)0

Posted by Admin in on January 29, 2017
 

In a little over 12 months, the European Commission will roll out a new legal framework to govern the protection of personal data. There were many debates and discussions about the controversial regulations, which passed last year, and scientists and scientific bodies raised concerns over restrictions that the framework could have placed on the use of research data. We won several concessions, but the fight is not over yet. Scientists must now come together to work out a consistent way to implement the rules, and they must do so quickly.

Once in place, the European regulations will have to be interpreted by lawyers, administrative staff and others across a diverse patchwork of legal systems and cultures. To smooth their introduction and implementation, the European Commission is encouraging organizations that represent data users to prepare formal codes of conduct that would set out — in simple language — what can and cannot be done. Scientists need to help prepare these codes to ensure that the hard-won concessions for research are not lost in translation.

Legal texts are not easily accessible to non-lawyers. By developing codes of conduct that are as understandable as possible, we can help to guide researchers and administrative staff, reduce unnecessary fear about compliance and enhance data sharing for the sake of progress in research.

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HHS and 15 other Federal Departments and Agencies Announce Revisions to the US Federal Policy for the Protection of Human Subjects (the Common Rule) – Statement from the HHS0

Posted by Admin in on January 19, 2017
 

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

This change applies only to research that is reviewed by an IRB/research ethics committee that utilises the HHS framework. Nevertheless it might portend changes to the frameworks in other jurisdictions.

These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
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The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents…. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
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HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.

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