Science Policy For All

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Science Policy Around the Web – January 20, 2017

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By: Jessica Hostetler, PhD

Climate Change

Earth Sets a Temperature Record for the Third Straight Year

The New York Times reports that scientists named 2016 the hottest year on record. This follows the record set in 2015, which followed the record set in 2014 and marks the first time in history a temperature record was set three years in a row. The data is in agreement from three governmental institutions: the USA’s NOAA and NASA and the United Kingdom’s Met Office. The findings were based on “measurements from ships, buoys and land-based weather stations” used to compute an average global temperature of the earth’s surface. The El Niño weather pattern “released a huge burst of energy and water vapor into the atmosphere” and intensified warming in 2015 and 2016, but scientists agree the upward trend over many years is caused by increasing carbon dioxide and greenhouse gasses in the atmosphere.

The warming increases were particularly pronounced in the arctic with “temperatures in the fall running 20 to 30 degrees Fahrenheit above normal across large stretches of the Arctic Ocean” potentially exacerbating sea ice melting and coastal erosion. The heating of the ocean has implications for rises in ocean levels and increased tidal flooding. The calculations from NASA showed over a half a degree Fahrenheit of warming from 2013 to 2016 which is the largest three-year increase since records were started in 1880 and of “the 17 hottest years on record, 16 have now occurred since 2000.” Both NOAA and NASA will soon report to cabinet members appointed by the Trump Administration, with concerns raised from “agencies about whether their data will now be subject to political manipulation.” (Justin Gillis, New York Times)

Human Research Policy

New Rules Ease Consent Requirements for Scientists Using Patient Specimens

STAT News reports that the outgoing Obama Administration issued new rules on Wednesday, January 18th for conducting research with human participants referred to as the “Common Rule” , which include “stepping back from proposals that would have imposed significant new regulatory requirements on scientists.” Earlier versions of the proposal would have required informed, written consent for the use of biospecimens such as “cells, blood, tumor samples, DNA” etc. that were obtained during medical procedures even if the samples had all identifying information removed. Scientists argued that such a change would stifle research; for instance if researchers wanted to use specimens from a previous study where consent was given for a new study, a new consent would be required which would require tracking down each participant.  This would prove challenging for several new White House initiatives such as the Precision Medicine Initiative or the Cancer Moonshot. The proposed change drew 2100 comments during a 90-day public comment period following release in September 2015, and the Department of Health and Human Services responded by making changes to the proposal. (Sharon Begley, STAT News)

The final rule, as posted by the HHS website, includes the following:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

(Sharon Begley, STAT News)

Have an interesting science policy link?  Share it in the comments!

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Written by sciencepolicyforall

January 20, 2017 at 10:58 am

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