The Research and Science Policy Update is a monthly digest of news items related to important developments that impact biomedical researchers on a variety of issues including research funding, government oversight, and regulatory burden. In addition, reports related to research endeavors around the world and from research advisory groups are presented. The information contained in the Research and Science Policy Update is assembled by the ASIP Research and Science Policy Committee, and products of this Committee’s work (position statements, letters, white papers) will be highlighted
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Proposed Common Rule Delay
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A
Notice of Proposed Rulemaking
(NPRM) proposed an additional six-month delay for implementing the revisions to the “Common Rule.” This new NPRM is intended to provide additional time for necessary preparations to implement the 2018 Requirements, moving the deadline until January 21, 2019. The NPRM also requests comment on whether to permit institutions the option of implementing three 2018 Requirements during this interim period as they may reduce regulatory burden. ASIP supports the proposal outlined in the NPRM. See our letter
HERE
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EPA evaluates changes to how it will assess scientific research
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The Environmental Protection Agency issued a
Notice of Proposed Rulemaking
(NPRM) proposing a major change to the way it assesses scientific research. ASIP is supportive of the general principles of research rigor and reproducibility, the importance of identify assumptions used in experimental design and data analysis, transparency in regulatory science and the critical role of independent peer review. However, ASIP has several concerns, including that the NPRM is not sufficiently transparent as it does not propose standards by which past, current and future research will be evaluated. ASIP’s Research & Science Policy Committee submitted a
request for a longer comment
period, as did many others, that has since been
granted
. The Committee is now hard at work analyzing the proposed regulation and developing a complete comment letter.
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Clinical trial definition
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In our last newsletter, ASIP reported that Congress shared our concern about NIH’s recent redefinition of clinical trial such that it now encompasses a broad set of basic research without sufficient notification and research community consultation. The recent omnibus calls for NIH to delay enforcement of the new clinical trials policy, including NIH’s broader interpretation of interventions. ASIP joined a broader community
letter
requesting that the NIH work with the scientific research community to better define the case studies and to develop a reporting structure that works for basic research. ASIP also represented your interests on this issue during a recent meeting with Dr. Tabak, Principal Deputy Director, NIH. We will keep you informed of future developments.
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Scientific research funding in Canada
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The ASIP Research and Science Policy Committee has been monitoring recent developments in Canadian biomedical research funding. The Canadian Institutes of Health Research (CIHR), which is the funding Council for biomedical research, has been chronically underfunded and last year received no budget increase. In addition, CIHR implemented changes in the peer review system which were vigorously opposed by the Canadian scientific community. As a result, a blue-ribbon panel was appointed by the federal government to look at support of fundamental research in Canada. The committee developed a series of recommendations in a report entitled “
Investing in Canada’s Future: Strengthening the Foundations of Canadian Research,”
The report has received significant support within the scientific community through a very strong advocacy movement from scientists, students/ trainees and research institutions. There was much positive press coverage as well. The recently passed
federal budget
included significant funding for CIHR, as well as more predictable equipment funding for four years. Two areas that did not receive attention were funding for graduate/postdocs and overhead expenditures. In Canada, there is a flat rate between 17-20% for overhead, which is insufficient and creates a burden for institutions. The quote from scientists after the budget was “scientists will sleep well tonight, however there is still much advocacy to be done.”
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Sweeping New European Union General Data Protections
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With the ultimate goal of protecting the privacy and confidentiality of data, the European Union (EU) is enacting a General Data Protections Regulations (GDPR) policy effective May 25, 2018 for all EU citizens. The new EU-GDPR regulation has significant implications for research conducted in the United States or sponsored by US institutions and also affects institutions that maintain records of EU citizens. For example, if a US citizen participating in a clinical trial or research study in the US travels to Europe and communicates with the clinical trial sponsors while on vacation or sabbatical (or is on a mobile monitor that constantly sends data back to the clinical center), their data will be subject to the GDPR. Societies such as ASIP, who have members residing in the EU, will also be subject to the GDPR. The US Secretary’s Advisory Committee on Human Research Protections (SACHRP) has drafted a
letter
expressing concern that the EU-GDPR is not consistent with many HIPAA and Common Rule provisions. ASIP suggests that members coordinate with their institutional compliance officers if they are involved in research that may involve citizens of the EU, including the use of biospecimens derived from EU citizens. The EU-GDPR invokes substantial penalties for violation of the new regulations
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NIH developing strategic plan for data sciences
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NIH has released
a draft strategic plan
for data sciences. The plan has five goals, objectives and implementation tactics for each. The overarching goals are:
- Support a highly efficient and effective biomedical research data infrastructure
- Promote modernization of the data-resources ecosystem
- Support the development and dissemination of advanced data management, analytics, and visualization tools
- Enhance workforce development for biomedical data science
- Enact appropriate policies to promote stewardship and sustainability
The Federal of American Societies for Experimental Biology, of which ASIP is a member,
provided feedback
on the draft plan. The final plan was just released and can be found
HERE
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Reports that may be of interest
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American Academy of Arts and Sciences report on
Perception of Science in America
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This report examines the nuances of public perception of science, confidence in science and support for scientific funding. It is an interesting resource for those communicating information to the public, including researchers and advocates.The full report is
HERE
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Next Generation on Biomedical Researchers:
Breaking Through.
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The Committee on the Next Generation Research Initiative, an ad hoc committee of the National Academies released its consensus report, “The Next Generation of Biomedical and Behavioral Scientists: Breaking Through.” The Committee sought to identify policy, funding, and infrastructural barriers early career scientists face trying to transition to independent research careers, and recommending steps to mitigate them. NIH was seen as generally responsive to previous reports and recommendations. Conversely, universities and research institutions were taken to task for not doing enough in response to previous reports and for relying extensively on others for actions. Recommendations were also included for principle investigators and Congress. You can find the full report
HERE
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