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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.

Read the rest of this news story

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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National and International Compliance Tools (Papers: Pamela Andanda, et al 2016)0

Posted by Admin in on January 10, 2017
 

Creating and enhancing TRUSTworthy, responsible and equitable partnerships in international research
A report for TRUST

Executive Summary

The main challenge in the governance of research at the global level is the existence of varying ethics review practices across countries. While differences in approaches per se do not necessarily create a problem, such varying practices can lead to “ethics dumping”; the purposeful exploitation of third country research participants/resources, as well as exploitation based on insufficient ethics awareness.

The TRUST project develops three tools to counter ethics dumping:

1. A Global Code of Conduct for North‐South Collaboration

2. A Fair Research Contracts Webtool, and

3. A Compliance and Ethics Follow‐up Tool.

This report provides the first step towards the Compliance and Ethics Follow‐up Tool. It was produced based on the following activities.

The resource developed which covers the first two activities can be found on pages 18‐32, structured according to the Horizon 2020 ethics review template.

An overview of self‐regulatory mechanisms operated by 13 pharmaceutical companies, as presented in their public sources, can be found on pages 33‐44. An overview of existing compliance tools can be found on pages 45‐54.

Andanda P, Wathuta J, Leisinger K and Schroeder D, a report for TRUST http://trust-project.eu/wp-content/uploads/2016/10/TRUST-664771-National-and-International-Compliance-Tools-Final.pdf

The risk of re-identification versus the need to identify individuals in rare disease research (Papers: Mats G Hansson, et al | 2016)0

Posted by Admin in on January 8, 2017
 

Abstract
There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders. In this article, we identify the needs and arguments related to de-identification and re-identification of patients and research subjects and suggest how the different needs may be balanced within a framework of using unique encrypted identifiers.

Hansson MG, Lochmüller H, Riess O, Schaefer F, Orth M, Rubinstein Y, Molster C, Dawkins H, Taruscio D, Posada M and Woods S (2016) The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics 24, 1553–1558; doi:10.1038/ejhg.2016.52
Publisher (open access): http://www.nature.com/ejhg/journal/v24/n11/full/ejhg201652a.html

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