CoR NEWSAugust 22, 2018
To: APLU Council on ResearchFrom: APLU CoR Staff
- 2018 CoR & CIMA Joint Summer Meeting Wrap-Up
- White House Nominates Kelvin Droegemeier for OSTP Director
- APLU-AAU Accelerating Public Access to Research Workshop – Deadline to Apply Extended to August 27
- Send Sarah Rovito to SXSW EDU 2019 – Your Vote Needed
- Call for Proposals by IRIS Member Institutions for Panel Discussion at IRIS Data Summit
- Nominations Open for National Science Board 2019 Honorary Awards
- MIT Op-Ed on China and American Leadership in Science
- Research Regulatory Reform Article
- USDA to Realign ERS with Chief Economist, Relocate ERS & NIFA Outside DC
- FY2019 NDAA Signed by President Trump
- OMB and OSTP Release FY2020 R&D Priorities Memo
- Associations Submit Letter on EPA Proposed Rule
- Associations Submit Comments on NIST Return on Investment RFI
- Updated DoD T&Cs to Implement OMB Memo 18-18
- NSF Important Notice No. 144 Update
- OHRP Announces Availability of Three Draft Guidance Documents Related to Revised Common Rule
- OHRP GDPR Guidance
- NIH Releases Proposal to Streamline Review of Gene Therapy Trials, Restore Original Version of RAC
- New NIH “Under the Poliscope” Blog About Streamlining Gene Therapy Oversight
- NIH Delays Some Requirements on Clinical Trial Case Studies
- New NIH “Under the Poliscope” Blog About Recommendations for Moving to a Process for Returning Research Results
- National Academies of Sciences, Engineering, and Medicine Report on Returning Individual Research Results to Participants
- National Academies of Sciences, Engineering, and Medicine Report on Open Science by Design
- National Academies of Sciences, Engineering, and Medicine Report on Science Breakthroughs to Advance Food and Agricultural Research
- Registration Open for Rally for Medical Research Hill Day
- Registration Open for NIH Workshop on Single IRB Resource and Infrastructure Development
- Registration Open for Responsible Conduct of Research Instruction Workshop (RCRIW) at Emory University
- Registration Open for Seeking Solutions in Research Integrity Workshop at The Ohio State University
- Registration Open for NSF Materials Research Science & Engineering Centers (MRSEC) Workshop at UCLA
- Registration Open for NIST Controlled Unclassified Information Security Requirements Workshop
- Registration Open for Together We Can Do Better Convocation for Leaders in Academia on Preventing Sexual Harassment
Thank you to the 150 CoR Summer Meeting attendees who joined us in Bozeman in July! Slides are now posted on the 2018 CoR Summer Meeting website, and we continue to accept feedback via the 2018 CoR Summer Meeting Evaluation. An attendee list will be shared with meeting attendees via a final email update shortly. Nominations for the CoR Executive Committee Class of 2021 + Chair-Elect will be accepted through September 14, 2018; please email Sarah Rovito if you would like to nominate a colleague or yourself. Finally, make sure to mark your calendars for the 2018 APLU Annual Meeting on November 11 – 13, 2018 in New Orleans, Louisiana. We look forward to seeing many of you there, as we tackle challenges facing public universities and contemplate Resilience.
On July 31, President Trump announced that he will nominate Kelvin Droegemeier to be the Director of the White House Office of Science and Technology Policy (OSTP). Dr. Droegemeier is a meteorologist and has served as Vice President for Research at the University of Oklahoma since 2009. An active member and past Chair of the APLU Council on Research, his public service also includes his role as Secretary for Science and Technology to Oklahoma Governor Mary Fallin and past Vice Chair of the National Science Board. Shortly after the official nomination, APLU President Peter McPherson released a statement praising the administration’s decision. Droegemeier’s confirmation hearing before the Senate Commerce, Science and Transportation Committee is scheduled for tomorrow, August 23, 2018 at 10:15am ET. More information regarding a livestream of the hearing is expected soon. Kelvin, congratulations from your CoR colleagues!!!
APLU and AAU are seeking applications for an invitation-only two-day workshop for research universities interested in drafting institutional plans for public access to research data. The Workshop on Accelerating Public Access to Research Data has been graciously sponsored by NSF and will be held in Washington, D.C. on October 29 – 30, 2018. The deadline for applications has been extended to August 27. For more information, please contact Kacy Redd at APLU or Katie Steen at AAU.
Help send Sarah Rovito to SXSW EDU 2019! Sarah is slated to share APLU’s Public Impact-Focused Research efforts on the “Why & How Universities Should Take on Moonshots” panel, along with Tom Kalil of Schmidt Futures, Michelle Popowitz of UCLA Grand Challenges, and Jennifer Lyon Gardner of The University of Texas at Austin’s Bridging Barriers – Planet Texas 2050. The panel will discuss how to launch, sustain, and build external partnerships to solve specific Grand Challenges while demonstrating value to the public. Votes from the public account for 30% of the panel selection process, so your vote here by August 30, 2018 is much appreciated. Thank you!
The Institute for Research on Innovation & Science (IRIS) at the University of Michigan is soliciting proposals for a panel discussion to be developed and led by IRIS members at the IRIS Data Summit on October 15 – 16, 2018 in Ann Arbor, Michigan. The focus can be on technical issues or policy-oriented concerns, and institutions are encouraged to collaborate with other IRIS member institutions on panel submissions. Please submit a 250-word proposal that describes the topic you would like to address and the individuals who would participate on the panel (along with a brief bio and head shot for each panelist) to Nancy Calvin-Naylor by September 7, 2018. The winner will be announced on September 14, 2018.
The National Science Board presents two awards each year during a spring ceremony and dinner. The awards are the Vannevar Bush Award, honoring exceptional service to the nation in science and technology, and the NSB Public Service Award, honoring service in public understanding of science and engineering. Nominations are being accepted for the 2019 Honorary Awards through September 28, 2018. Candidates for these awards are typically nominated by their peers. For questions concerning the awards, please contact Kim Silverman.
China’s Challenge Is America’s Opportunity by MIT President L. Rafael Reif argues that the U.S. must respond urgently as China continues to advance in science and technology. This must-read article advocates that the most important action the U.S. can take to sustain its global leadership role is to redouble its core strength in innovation, starting with federally funded research, and to build a farsighted national strategy for sustaining American leadership in science.
Engage research institutions on research regulatory reform by Lisa Nichols of COGR and David Wynes of Emory University discusses many different regulatory-related issues and argues that “agencies should consult researchers and administrators on how to cut bureaucratic red tape.”
On August 9, U.S. Secretary of Agriculture Sonny Perdue announced further reorganization of the U.S. Department of Agriculture (USDA). The Economic Research Service (ERS), currently under USDA’s Research, Education, and Economics mission area, will realign once again with the Office of the Chief Economist (OCE) under the Office of the Secretary. Additionally, most employees of ERS and the National Institute of Food and Agriculture (NIFA) will be relocated outside of the National Capital Region. New locations have yet to be determined, and it is possible that ERS and NIFA may be co-located when their new homes are found. The movement of employees outside of Washington, D.C. is expected to be completed by the end of 2019.
On August 17, APLU’s Board on Agriculture Assembly (BAA) sent a letter to Secretary Perdue communicating deep concern about the proposed relocation of ERS and NIFA outside of Washington, D.C. We will continue to monitor the situation with respect to research funding (ERS and NIFA account for just over half of the $2.5 billion budgeted by Congress for agricultural research in 2018) and will share updates as available.
On August 13, President Trump signed into law the John S. McCain National Defense Authorization Act (NDAA) for FY2019 while visiting Fort Drum in upstate New York. APLU previously issued a statement in support of a provision in the bill which calls for the Department of Defense to establish an initiative to work with universities that perform defense and engineering research to best determine effective means to address emerging national security issues.
The White House Office of Management and Budget (OMB) and Office of Science and Technology Policy (OSTP) issued an annual joint memo advising heads of executive departments and agencies of the administration’s research and development (R&D) budget priorities for FY2020. The highlighted priority areas include basic medical research, artificial intelligence, quantum information sciences, strategic computing, and manufacturing. The memo also highlights R&D priority practices including managing and modernizing R&D infrastructure, transferring technology from lab to market, and promoting academic, industry, and government collaboration.
On July 11, APLU along with the Association of American Universities (AAU), the Association of American Medical Colleges (AAMC), and the Council on Governmental Relations (COGR) sent a letter to Environmental Protection Agency (EPA) Acting Administrator Andrew Wheeler in response to the proposed rule which would allow the EPA to limit what science it considers in its policymaking. In the letter, the Associations urge the withdrawal of the proposed rule and invite the EPA to engage with the scientific community to discuss how evidence-based policy should be developed to protect human health and the environment. APLU also joined with 68 other associations, scientific societies, and patient advocacy groups in issuing a statement on July 16 (in advance of the public hearing on the proposal held at EPA Headquarters on July 17) to express concern with the EPA’s proposed rule.
On July 27, APLU, along with the Association of American Universities (AAU), Council on Governmental Relations (COGR), the Association of American Medical Colleges (AAMC), and the American Council on Education (ACE), submitted comments in response to a Request for Information (RFI) published by the National Institute of Standards and Technology (NIST) aimed at gathering information about the current state of federal technology transfer and the public’s ability to access federally funded R&D through collaborations, licensing, and other mechanisms.
The Department of Defense has updated its terms and conditions in order to implement OMB Memo 18-18, which was issued to implement statutory changes to the Micro-Purchase and Simplified Acquisition Thresholds for Financial Assistance. The new DoD R&D General T&Cs dated July 2018 can be found here.
NSF recently sent the letter below concerning NSF Important Notice No. 144:
Dear Colleagues:
On February 8th, 2018, the National Science Foundation (NSF) issued Important Notice No. 144 which articulated the Foundation’s policy that it will not tolerate sexual harassment, or any kind of harassment within the agency, at grantee organizations, field sites, or anywhere NSF-funded science and education are conducted. The notice also specified steps NSF is taking to bolster our commitment to safe research and learning environments.
On March 5th, NSF posted a draft award term and condition in the Federal Register for public comment that would require awardees to notify NSF of any findings/determinations regarding an NSF-funded PI or co-PI relating to sexual or other form of harassment, as well as if the PI or co-PI is placed on administrative leave relating to a harassment finding or investigation. In response to this posting, the Foundation received 192 insightful comments from both individuals and organizations. Each comment was carefully considered. A revised term and condition that reflects the feedback provided will be published in the Federal Register in August 2018. Awardees are strongly encouraged to conduct a thorough review of the term and condition to determine whether the new requirements necessitate any changes to the institution’s policies and procedures. The new term and condition will apply to new awards and funding amendments on existing awards made on or after the effective date.
NSF has also been working to enhance our web resource, nsf.gov/harassment, by adding NSF’s Promising Practices. This portal will serve as a living resource for the community to utilize in bolstering anti-harassment policies and practices at NSF-funded organizations. This resource houses a collection of standards of behaviors tailored to field sites, facilities, ships, and conferences. It also provides a collection of federal definitions, reporting practices, organizational responses to reporting, and other practices that were established to improve climate and culture. NSF welcomes feedback from the community on this portal; feedback, suggestion for practices, and other comments may be submitted via NSF’s Harassment Portal Feedback Form.
We are greatly appreciative to have received such a large response to the Foundation’s sexual harassment policy and we look forward to continued engagement with the community on this important topic. Together, we can foster safe scientific workspaces where people can learn, grow, and thrive.
Rhonda Davis
Head,
Office of Diversity and Inclusion
National Science Foundation
On July 27, the HHS Office for Human Research Protections (OHRP) announced the availability of three draft guidance documents that relate to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July 19, 2018 through January 20, 2019) for general compliance with the revised Common Rule. The three draft documents are:
- Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements;
- When Continuing Review is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements; and
- Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.
OHRP will be issuing a Federal Register Notice of Availability (NOA) about these draft guidance documents in the near future, but is posting the draft guidance documents in recognition of the general compliance delay period, which began July 19, 2018. The NOA that will be issued will include a docket for each draft document in which the public can submit comments during a 30-day period (starting from the day the NOA publishes). Additional information on the revised Common Rule and the three burden-reducing provisions is available here.
The HHS Office for Human Research Protections (OHRP) has developed a new resource for IRBs, researchers, and sponsors that are involved in human subjects research in Europe. Titled “Compilation of European GDPR Guidances,” the document lists the data protection authorities of all European countries that fall under the new E.U. General Data Protection Directive (GDPR). For each country, the compilation also provides the links to any general GDPR guidances, as well as specific guidances on the topics of Research, Legal Basis, Consent, and International Data Transfer.
On August 16, the National Institutes of Health (NIH) issued a notice in the NIH Guide to Grants and Contracts and the Federal Register seeking comment on a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Specifically, the NIH seeks to streamline the oversight of human gene transfer clinical research protocols (i.e. gene therapy research) and reduce duplicative reporting requirements already captured within the existing regulatory framework. As part of the proposal, NIH would remove the protocol submission, review, and reporting requirements under Appendix M of the NIH Guidelines and modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC). Comments on the proposal will be accepted through October 16, 2018, and can be made electronically by visiting here.
For more information about the importance of these proposed changes, please see the New England Journal of Medicine Perspective article authored by NIH Director Dr. Francis Collins and FDA Commissioner Dr. Scott Gottlieb; and the NIH Director’s Statement. Questions about this proposal may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov.
A new blog from “Under the Poliscope” is now available. This latest entry, “From Emerging to Emerged: Streamlining Gene Therapy Oversight,” discusses the exciting proposal NIH has put out for public comment regarding gene therapy oversight and the re-envisioning of the Recombitant DNA Advisory Committee (RAC). As with all of our blogs, we invite you to add your voice to the conversation by providing your thoughts in the comment section of the blog. If you have any questions or require further information about the OSP blog or any of OSP’s activities, please contact us at SciencePolicy@od.nih.gov.
On July 20, the National Institutes of Health (NIH) issued a guidance notice delaying the enforcement for some requirements affecting prospective basic science studies involving human participants. The notice specifies that “through September 24, 2019, NIH will continue to expect registration and reporting for prospective basic science studies involving human participants, with additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be transported to ClinicalTrials.gov.” Additionally, a Request for Information (RFI) will be issued for more input on “registration and results reporting standards best suited for prospective basic science studies involving human participants.” Last September, APLU joined the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), and Council on Governmental Relations (COGR) in sending a letter to NIH in response to the agency’s revised definition of a clinical trial, which included fundamental and basic health-related research.
- New NIH “Under the Poliscope” Blog About Recommendations for Moving to a Process for Returning Research Results
A new blog from “Under the Poliscope” is now available. This latest entry, “Recommendations for Moving to a Process for Returning Research Results,” gives some insider tips on how to maximize the power of stakeholder-provided comments to NIH. As with all of our blogs, we invite you to add your voice to the conversation by providing your thoughts in the comment section of the blog. If you have any questions or require further information about the OSP blog or any of OSP’s activities, please contact us at SciencePolicy@od.nih.gov.
- National Academies of Sciences, Engineering, and Medicine Report on Returning Individual Research Results to Participants
The National Academies of Sciences, Engineering, and Medicine released Returning Individual Research Results to Participants: Guidance for a New Research Paradigm on July 10. The report presents a review of the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. In addition to evidence-based findings, the report offers an approach to returning individual research results that considers the desires of the participant, the risks and feasibility of return, and the quality of the research laboratory. A press release, report highlights, and video recording from the report release meeting are also available.
The National Academies of Sciences, Engineering, and Medicine released Open Science by Design: Realizing a Vision for 21st Century Research on July 17. The report is aimed at overcoming barriers and moving toward open science as the default approach across the research enterprise and explores specific examples of open science and discusses a range of challenges, focusing on stakeholder perspectives. The report is meant to provide guidance to the research enterprise and its stakeholders as they build strategies for achieving open science and taking the next steps. A press release, report highlights, and video recording from the report release meeting are also available.
- National Academies of Sciences, Engineering, and Medicine Report on Science Breakthroughs to Advance Food and Agricultural Research
The National Academies of Sciences, Engineering, and Medicine released Science Breakthroughs to Advance Food and Agricultural Research by 2030 on July 18. The report develops a compelling scientific strategy for food and agricultural research for the next decade and beyond that will drive transformational change in the food and agricultural system by catalyzing new research directions and partnerships, attracting new research talent, stimulating entrepreneurial activities, increasing funding opportunities, and ultimately opening new paths to a safe, healthful, and sustainable supply of food and fiber. A press release, report highlights, and video recording from the report release meeting are also available.
The 2018 Rally for Medical Research Hill Day will be held on September 12 – 13, 2018. The event urges robust funding for NIH and raises awareness of the urgent need for continued investment in the NIH to improve health, spur more progress, inspire more hope, and save more lives. Registration is now open; please direct any questions to info@rallyformedicalresearch.org.
On September 12, 2018, NIH will be holding a public workshop on successful strategies and lessons learned for modifying and enhancing institutional IRB infrastructure for single IRB review of multi-site studies. The meeting will take place at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center in Rockville, MD.
The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research establishes the expectation that the domestic sites of all NIH-funded multi-site studies involving non-exempt human subjects research will use a single Institutional Review Board. NIH has heard a great deal of positive feedback in support of the policy and believes that streamlining IRB review for multi-site studies will reduce unnecessary delays and costs caused by duplicative review. Additionally, NIH previously funded seven administrative supplements that provided one year of support to develop widely applicable approaches for modifying and enhancing institutional IRB infrastructure and related resources to allow for efficient and effective single IRB review of multi-site studies. This workshop will bring together those awardees to share the innovative strategies they have developed.
More information about this workshop, including how to register can be found here. While there is no fee to register, seating is limited. The workshop will also be webcast. If you have any questions, please contact SciencePolicy@od.nih.gov.
- Registration Open for Responsible Conduct of Research Instruction Workshop (RCRIW) at Emory University
The U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) will be partnering with Emory University and Public Responsibility in Medicine (PRIM&R) to host a Responsible Conduct of Research Instruction Workshop (RCRIW) on September 19 – 20, 2018 at the Emory Conference Center Hotel in Atlanta, Georgia. The RCRIW will provide intensive training for novice and early-stage RCR instructors to enhance their ability to teach the fundamentals of research ethics to scientists at every stage of their career. The RCRIW will be led by senior teachers and researchers in RCR instruction along with ORI staff. The registration fee is $275.00 per person; please direct any questions to Tracey Randolph.
The Ohio State University Research Summit, a free, one-day national conference taking place on September 23, 2018 at The Blackwell Inn and Conference Center in Columbus, Ohio, will bring together multiple stakeholders – researchers, institutions, publishers, funders, scientific societies, the press, and federal agencies – to discuss concerns in research integrity from different perspectives and to reflect on current efforts being taken to address these concerns. A broad collaboration between multiple partners in the research community will lay the foundation to detail next steps in fostering changes to enhance integrity in research. For additional information, please contact ResearchIntegrity@osu.edu or visit research.osu.edu/risummit.
UCLA is hosting a MRSEC Workshop on September 25, 2018, specifically for campuses near the West Coast. This workshop will share information about the NSF solicitation for Materials Research Science & Engineering Centers and will include presentations by NSF MRSEC Program Director Dan Finotello and UCSB Materials Research Laboratory Director Ram Seshadri. Appointment slots for dedicated Campus Sessions with MRSEC Program Director Dan Finotello will be available. RSVPs are requested by September 5, 2018; please direct any questions to ovcr@conet.ucla.edu.
On October 18, 2018, the National Institute of Standards and Technology (NIST), in coordination with the Department of Defense (DoD) and the National Archives and Records Administration (NARA), will host an informational workshop providing an overview of Controlled Unclassified Information (CUI), the Defense Acquisition Regulations System (DFARS) Safeguarding Covered Defense Information and Cyber Incident Reporting Clause, and NIST Special Publications 800-171 and 800-171A. This workshop will also feature panels of Federal Government representatives discussing expectations for evaluating evidence and implementing the CUI Security Requirements and industry representatives sharing best practices and lessons learned. A draft agenda is available.
The CUI Security Requirements Workshop is open to all interested stakeholders and is free to attend. All in-person attendees must register by October 11, 2018 in order to gain entry to the NIST campus in Gaithersburg, Maryland. The workshop will also be available via webcast; advanced registration is not required.
- Registration Open for Together We Can Do Better Convocation for Leaders in Academia on Preventing Sexual Harassment
The persistence of sexual harassment and its adverse impact on women’s careers in our nation’s colleges and universities is jeopardizing more rapid and sustained progress in closing the “gender gap” in science, engineering, and medicine. On November 9, 2018, join colleagues, leaders in academia, and other experts at the National Academies of Sciences, Engineering, and Medicine to build on the recent report Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Science, Engineering, and Medicine and to develop and strategize plans on how to prevent sexual harassment in academia. Registration for the Together We Can Do Better Convocation is available here.
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