CoR NEWSJanuary 24, 2018
To: APLU Council on ResearchFrom: APLU CoR Staff
- FY2018 Appropriations Update
- Issues in Science and Technology Article on Facilities and Administrative (F&A) Costs
- NSF 2018 Science and Engineering Indicators Report
- NSF PAPPG Policy Changes and Proposed Compliance Checking Updates
- NIH Clinical Trials Definition Update
- Animal Research Regulations Update
- Request for Comments: Federal Policy for the Protection of Human Subjects (Common Rule)
- Request for Comments: Air Force Science and Technology 2020
- Funding Opportunity: AAAS Dialogue on Science, Ethics, and Religion (DoSER) Program
- Funding Opportunity: Research on Research Integrity
- Funding Opportunity: Conference Grants on Research Integrity
- Science Policy and Communication Training in Washington, D.C.
- Science Communication Training in Portland, Oregon
After three days of a government shutdown, Congress passed a short-term Continuing Resolution (CR) on Monday. President Trump signed the spending bill into law shortly thereafter. The CR funds the government through February 8. As reported, the agreement which resulted in the Senate’s passage of the three-week CR includes a commitment from Majority Leader Mitch McConnell (R-KY) that the Senate will consider and vote on legislation to address the future of Dreamers and the expiring Deferred Action for Childhood Arrivals (DACA) program.
APLU continues to urge Congress to reach a bipartisan budget agreement that will lift the defense and nondefense discretionary caps and allow for much needed investments in higher education and research. APLU also continues to advocate strongly for swift Congressional action that would, at a minimum, codify the provisions of the DACA policy into law.
Perspective: Knee-Capping Excellence by Johns Hopkins University President Ronald J. Daniels explores the history, rationale, and criticism surrounding facilities and administrative (F&A) costs of research. This must-read article finds that the F&A cost reimbursement formula is an “essential component” of the research partnership between the federal government and universities and demonstrates that a proposed cap would amount to a “deep and inextricable cut to the private-public partnership at the foundation of the nation’s biomedical research enterprise.”
On January 18, 2018, the National Science Board released the biennial Science and Engineering Indicators report, a compilation of statistics and analyses on the global R&D landscape. The report finds that while the U.S. continues to be the global leader in many S&T measures including total R&D spending, other nations are rapidly closing the gap. It notes in particular that China’s R&D spending has grown at an average annual rate of 18 percent, comprising almost one-third of the global increase in R&D expenditures from 2000 to 2015.
Effective January 29, 2018, NSF will implement changes in FastLane and Research.gov to support the following policy updates in the Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 18-1) and to run updated Budget Justification page limit automated compliance checks in FastLane:
Standard Collaborators and Other Affiliations Template Implementation: The revised PAPPG (NSF 18-1) incorporates the standard Collaborators and Other Affiliations (COA) template that has been in pilot phase in FastLane since April 2017. FastLane system instructions will be updated in accordance with the new policy. Frequently Asked Questions (FAQs) on the COA template are available here.
Budget Justification Page Limitation Increase: The Budget Justification page limitation will increase from three pages to five pages. To align with the new policy, FastLane will run an automated compliance check for the Budget Justification page limitation across several proposal types and will generate an error or warning when the submission validation compliance check is not met. Compliance checks are run during “Check Proposal,” “Forward to SPO,” and “Submit Proposal.” The complete list of FastLane automated compliance checks effective January 29, 2018, is available here.
New “Substitute Negotiator” Associated Document for Change of Principal Investigator (PI) Requests: A new “Substitute Negotiator” Associated Document will be available in FastLane’s Notifications and Requests module when a “Change of PI” request is made (e.g., to be utilized in cases where a former employee or Intergovernmental Personnel Act (IPA) is being reappointed as a PI or Co-PI to an award they were previously involved with).
New “Other Request” Type: A new “Other Request” type will be added to Research.gov’s Notifications and Requests module. This request will be reviewed and approved by the NSF Program Officer.
New Award Abstract Text: In connection with NSF’s transparency and accountability efforts for award abstracts, the Foundation will add the following final paragraph to all award abstracts for awards with start dates of March 1 or later: “This award reflects NSF’s statutory mission and has been deemed worthy of support through evaluation using the Foundation’s intellectual merit and broader impacts review criteria.”
Note about Proposal File Updates (PFU): The automated compliance checks also apply when a PFU is performed on a proposal. The compliance checks will be run on all sections of the proposal, regardless of which section was updated during the PFU. Proposers should be aware that if a proposal was previously submitted successfully, a PFU performed on the proposal will be prevented from submission if the proposal does not comply with the compliance checks in effect at the time.
To learn about all the changes to the PAPPG (NSF 18-1), be sure to view the latest webinar. For IT system-related questions, please contact FastLane User Support at 1-800-673-6188 or fastlane@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.
APLU previously joined COGR, AAMC, and AAU in sending a letter to Dr. Michael Lauer, NIH Deputy Director for Extramural Research, on September 17, 2017, expressing concern that NIH’s definition of “clinical trial” has been significantly expanded through the set of case studies published by the agency in the summer of 2017. The associations have had subsequent exchanges with Dr. Lauer on this topic, including discussions on alternative reporting structures for basic health research involving human subjects.
Yesterday, the Federation of Associations in Behavioral and Brain Sciences (FABBS) provided an update on progress that has been made with respect to the NIH clinical trial case studies. In addition, a dialogue on this topic between Jeremy Wolfe, immediate past president of FABBS, and Mike Lauer addressing related concerns that have been raised by the community was published in Nature Human Behaviour on January 22, 2018. The article provides information and clarifications that should be helpful to investigators.
As indicated in the FABBS blog, case study 18 (a-f) has been revised such that there does not appear to be anything in 18 that would suggest that basic health research involving functional Magnetic Resonance Imaging (fMRI) is a clinical trial. This would appear to include fMRI research involving manipulations that result in transient changes to physiology or behavior with no therapeutic intent. Further, case studies 24 and 26, which have been of concern, have been removed from the website and could potentially be under revision. We remain concerned about other case studies that capture basic health research, including case studies 9 and 14 as highlighted in our letter, and those that continue to occupy grey areas and further stretch the boundaries of what has traditionally been defined as a clinical trial.
APLU will continue its dialogue with NIH and other associations and societies engaged on this issue and seek further revisions as necessary. Investigators should continue to consult the case studies, and those uncertain of whether their research meets the definition of a clinical trial should reach out to their program officer and NIH will uphold that opinion. (With thanks to COGR.)
On January 9, 2018, NIH, USDA, and FDA held a listening session to engage the community in agency efforts to reduce administrative work associated with the conduct of federally-funded research involving animals. Section 2034(d) of the 21st Century Cures Act, Animal Care and Use in Research, directs the agencies to “complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.” A set of introductory slides was presented with the goal of understanding what NIH, USDA, and FDA can change to reduce burden on researchers. Nine speakers commented on Section 2034(d), and a public request for information will be announced in the Federal Register in February or March 2018. A 90 day comment period is expected, and additional listening sessions are planned for later in 2018. Please direct any questions on the 21st Century Cures Act to the NIH Office of Laboratory Animal Welfare (OLAW) at olaw@od.nih.gov.
On January 22, 2018, 16 federal departments and agencies published an Interim Final Rule (IFR) titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects” with the Federal Register for public inspection. This IFR delays the effective date and general compliance date of the final rule published in the Federal Register on January 19, 2017, and of the final rule published by the Consumer Product Safety Commission in the Federal Register on September 18, 2017, to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay put forward by this IFR both provides additional time to regulated entities for the necessary preparations to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process allowing for public engagement on the proposal for a further implementation delay.
To be assured consideration, comments must be identified by docket ID number HHS-OPHS-2017-0001 and received by March 19, 2018 at 11:59pm EST. Comments may be submitted via the Federal eRulemaking Portal or via mail/hand delivery/courier to Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted online without change. Please direct any questions to Jerry Menikoff, M.D., J.D., OHRP at jerry.menikoff@hhs.gov.
In September 2017, Secretary of the U.S. Air Force Heather Wilson launched an initiative to update the Air Force’s science and technology strategy. Over the course of a year, the Air Force will listen and learn from the scientific community, higher education, and business professionals through a series of conversations and outreach events. Submit your ideas and check out upcoming events to help the Air Force continue its technological advantage and meet the national security challenges of 2030 and beyond.
As part of AAAS’s ongoing “Engaging Scientists” project, the “Dialogue on Science, Ethics, and Religion” (DoSER) program seeks proposals from higher education institutions in the US that are interested in hosting on-campus science engagement events in 2018-2019. The goal of these events is to promote constructive dialogue and engagement on science by scientists with diverse (and especially with religious/spiritual) publics. The DoSER program, established by AAAS in 1995, facilitates communication between scientific and religious communities, and supports the AAAS mission to relate scientific knowledge and new technological advances to society at large. The ‘Engaging Scientists’ project, developed in collaboration with the AAAS Center for Public Engagement, will complement and build upon prior DoSER initiatives. These include the “Perceptions” project (which explored the relationship between scientists and religious leaders through facilitated workshops and a national symposium, with the goal to develop approaches for better dialogue), and the ongoing “Science for Theological Education” project (which supports seminaries and theological schools in integrating science into their core curricula).
Application guidelines for Campus Events proposals and a flyer with full instructions are available. Submissions must be made via email by the extended deadline of February 9, 2018, and further details can be found on the project website. Please direct any questions to doser@aaas.org with “Engaging Scientists Proposal Inquiry” in the subject line.
The Office of Research Integrity (ORI) announces the anticipated availability of funds for Fiscal Year (FY) 2018 grant awards under the authority of Sec. 301 of the Public Health Service Act, 42 U.S.C. Section 241, as delegated to the Director of ORI. This notice solicits applications for projects to conduct innovative research related to the prevention of research misconduct, protection of whistleblowers, and the furtherance of research integrity in this country and internationally. The goal of the program is to further develop the evidence base for ORI and others to create or modify educational programs to encourage the responsible conduct of research (RCR). Specifically, ORI seeks to: (a) identify risk factors that make misconduct more likely; (b) create an evidence base for proactive interventions; (c) build on lessons learned through previous research and the experiences of those who have been involved in guiding research misconduct proceedings; and, (d) support the development of tools that can be used to more easily identify research misconduct in images and statistical results. ORI anticipates that the Research on Research Integrity Program awards will have a ceiling of up to $150,000 for a period of 12 months. ORI anticipates making up to four awards, and applications are to be submitted via Grants.gov by March 23, 2018 at 6pm EST.
The Office of Research Integrity (ORI) seeks to support conference grants on research integrity. Anticipated grant applications must be designed to provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: responsible conduct of research training, fostering an environment that promotes research integrity, prevention of research misconduct, handling research misconduct allegations, whistleblowing, or other topics clearly linked to research integrity and in compliance with 42 C.F.R. Part 93. ORI anticipates awarding a total of four grants, up to $50,000 each. Applications are due March 26, 2018 at 6pm EST.
Join the National Council for Science and the Environment (NCSE) and COMPASS for a day of science policy & communication training on January 25, 2018, following NCSE’s 18th National Conference and Global Forum: The Science, Business, and Education of Sustainable Infrastructure: Building Resilience in a Changing World. This interactive training, held in partnership with COMPASS and hosted by New America in Washington, DC, will help scientists practice tools and build skills to use science effectively in policy discussions and policymaking. The training will be designed specifically for scientists, researchers, deans, and directors, to address the common challenges in communicating in ways that enhance the use of science in decision-making. The training will also provide a unique opportunity for participants to meet and work in small groups with policy experts. Register through the conference website. Note: you do not need to be registered for the conference to sign up for the training.
Have you ever struggled to explain why your science matters to someone else? Have you ever been frustrated at the way science is covered in media and used in policy? Have you ever wondered just what they’re teaching about science these days? Join Science Talk, a non-profit organization seeking to promote the best ideas in science communication, at our annual conference and find out! SCIENCE TALK ’18, to be held on March 1-2, 2018 in Portland, Oregon, will unite active scientists, science communicators, journalists, policymakers, content providers, students, and trainees for two exciting days of learning how to talk science to non-scientists or those outside your discipline. The event will feature presentations, workshops, and expert panels. Spaces are limited (and early-bird registration ends on January 31), so please sign up early. Student travel support is available. Come network with other like-minded individuals and learn new ways to tackle some of the impediments scientists face every day.
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