Issue 17 (September 4)
COSSA in Action
- State of Play: FY 2019 Appropriations for Social Science Research
- Senate Committee Considers Droegemeier Confirmation
- Senate HELP Committee Hears Update on NIH Cures Implementation
Federal Agency & Administration News
- NIH Releases RFI, Delays Enforcement of New Clinical Trials Policy
- White House Seeks Input on New Government Effectiveness Research Center
- NSF Launches 2026 Idea Machine
- White House to Appoint J. Scott Angle to Lead NIFA
- NSF Taps Karen Marrongelle to Lead Education and Human Resources Directorate
- OHRP Releases Information on Clinical Trial Consent Form Posting, GDPR Guidance
- Nomination Opportunities
- Funding Opportunities
- Notices & Requests for Comment
- Open Positions
Community News & Reports
In August, the U.S. Department of Agriculture (USDA) announced that it plans to move two science agencies, the Economic Research Service (ERS) (one of USDA’s two principal statistical agencies) and the National Institute of Food and Agriculture (NIFA) (USDA’s main extramural research agency), out of the Washington, D.C. region. USDA cited high attrition rates at these agencies as justification for moving them out of the region, although no data was provided. The Department also plans to administratively realign ERS from its current place within the Research, Education, and Economics (REE) mission area to the Office of the Chief Economist, citing their “similar missions,” although ERS is an official statistical agency bound by a set of directives and standards, while the Office of the Chief Economist primarily serves a policy-focused role. ERS’ longtime administrator, Mary Bohman, was reassigned ahead of this announcement.
The announcement has raised concerns for many in the science community. The move outside the D.C. area would almost certainly lead to a loss of highly specialized, expert staff at both agencies, and many are skeptical of the Department’s argument that retention is a problem for these agencies (both of which had been operating under a long-term hiring freeze). In addition, moving ERS from the research and data arm of USDA (which also includes ERS’s sister statistical agency, the National Agricultural Statistics Service) to a policy-focused area of the Department raises concerns about the agency’s ability to safeguard the independence of its data and findings.
USDA plans to proceed with these moves without Congressional or stakeholder approval. A Federal Register notice asking jurisdictions to volunteer to host one or both agencies (the deadline is September 14), but no other public feedback was requested. The Department expects the move to be completed by the end of 2019. COSSA has joined two letters (available here and here) asking Congress to intervene to stop USDA from moving ERS (a letter focused on NIFA is forthcoming).
Recent Why Social Science? guests posts have addressed how social science can identify strategies to stop the spread of misinformation and how social science research has challenged the conventional wisdom surrounding “ban-the-box” policies. Read the post on misinformation from Melanie C. Green, Associate Professor of Communication at the University at Buffalo here, and the post on “ban-the-box” from Olugbenga Ajilore, Associate Professor of Economics at the University of Toledo here.
Both chambers of Congress are back in Washington after the Labor Day holiday and have only a few weeks to make progress on the fiscal year (FY) 2019 appropriations bills before adjourning again for the November midterm elections. At the time of this writing, 6 bills have been passed by the full House of Representatives and 9 by the Senate. None have been sent to the President for his signature. FY 2019 begins on October 1, 2018.
Upon returning to work in September, Congress faces a full plate of must-pass spending legislation, not to mention a Supreme Court nomination and several federal agency nominations. Among the countless unknowns surrounding a possible endgame strategy for appropriations is one certainty— the need to pass a stopgap funding measure, known as a continuing resolution (CR), to avoid a partial government shutdown come October 1. The length of a likely CR, though, is still up for debate. With the leadership of the House and possibly the Senate up for grabs in the November elections, we could see a CR as short as a few weeks or a few months or stretching into next calendar year in the event either chamber changes partisan control.
COSSA has been reporting on the status of the FY 2019 appropriations bills over the last several months. Read on for a recap of where FY 2019 funding proposals currently stand for federal agencies important to the social science research community.
On August 23, the Senate Committee on Commerce, Science, and Transportation held a hearing to consider the nomination of Kelvin Droegemeier to lead the White House Office of Science and Technology Policy. Both Senators from Droegemeier’s home state of Oklahoma took the opportunity to introduce the nominee, highlighting his public and community service, as well as his dedication to separating politics and science.
Senators from both parties, including Committee Chair Sen. John Thune (R-SD) and Ranking Member Bill Nelson (D-FL), praised Droegemeier’s qualifications and reputation for impartiality in science. Senators questioned Droegemeier on research and development competition from China, sexual harassment in science and academia, and climate change. Dr. Droegemeier took opportunities to highlight the importance of social and behavioral science in responding to questions about natural disasters and advancements in social media and technology, reminding Senators that it is important to consider and research the human and social elements of these issues.
The committee is expected to vote on Dr. Droegemeier’s confirmation on September 5. Following committee approval, the nomination must be approval by the full U.S. Senate. A recording of the hearing is available on the committee’s website.
On July 20, the National Institutes of Health (NIH) issued a Guide Notice (NOT-OD-18-212) outlining its plans to delay enforcement of key clinical trials reporting requirements for projects traditionally considered basic research.
The Notice, Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants, follows months of feedback and pressure on NIH from the external research community, including COSSA and several COSSA members, to rescind or at least delay implementation of NIH’s clinical trials policy announced in 2016. As previously reported, in an effort to enhance its stewardship of and increase transparency over the clinical trials it funds, NIH established a new definition of “clinical trials,” which now captures some basic behavioral and social sciences research and comes with new reporting requirements (see COSSA’s Hot Topic piece for details).
NIH has now released a Request for Information (RFI) (NOT-OD-18-217) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants. A blog post from the NIH Office of Extramural Research outlines the following specific topics for which the RFI is seeking comments:
- “Examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
- Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
- Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
- Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
- Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.”
Responses to the RFI must be submitted by November 12, 2018.
The White House Office of Management and Budget (OMB) recently issued a request for information (RFI) to inform the establishment of a new Government Effectiveness and Advanced Research (GEAR) Center. The GEAR Center was proposed in the White House’s plan to reorganize the federal government, Delivering Government Solutions in the 21st Century, released in June (see COSSA’s analysis for details). The Center was described as a public-private partnership that would “engage researchers, academics, non-profits, and private industry from disciplines ranging from behavioral economics, to computer science, to design thinking to use creative, data-driven, and interdisciplinary approaches to re-imagine and realize new possibilities in how citizens and Government interact.”
The RFI is seeking recommendations and models to emulate related to the mission, structure, funding, and early focus areas for the new center, as well as information on how existing federal data resources can be used to support its work. A full list of questions is available here. Responses are requested by September 15, 2018.
The National Science Foundation (NSF) has launched the NSF 2026 Idea Machine. As COSSA has reported, the Idea Machine is a competition to help set the agenda for fundamental research in U.S. science and engineering for the next decade, including the next set of Big Ideas. According to the agency, the NSF 2026 Idea Machine is an opportunity to contribute to NSF’s mission, spur research that will cross traditional scientific boundaries, and address significant societal and scientific questions. Details about eligibility, timeline, and the judging process are available on the NSF website. Submissions of “Big Ideas” for the 2026 Idea Machine are due by October 26, 2018.
On August 31, the White House announced that it intends to appoint Dr. J. Scott Angle to be Director of the National Institute of Food and Agriculture (NIFA), the Department of Agriculture’s main extramural research agency. Dr. Angle is a soil microbiologist who most recently was the President and CEO of the International Fertilizer Development Center and has held administrative positions at the College of Agricultural and Environmental Sciences at the University of Georgia and University of Maryland College of Agriculture and Natural Resources. Dr. Angle would serve a six-year term, succeeding Dr. Sonny Ramaswamy, whose term ended in May. As NIFA Director, Dr. Angle would be tasked with overseeing the agency’s move away from the National Capitol Region, which stakeholders are concerned could threaten the agency’s ability to operate effectively (see other article).
The National Science Foundation (NSF) announced on August 21 that it has chosen Dr. Karen Marrongelle to lead the Education and Human Resources (EHR) Directorate. Dr. Marrongelle has served as a professor of mathematics and statistics at Portland State University since 2001 and as the dean of the College of Liberal Arts and Science since 2014. Dr. Marrongelle holds a bachelor’s degree in mathematics and philosophy, a master’s degree in mathematics, and a doctorate in mathematics education.
Dr. Marrongelle will arrive at EHR with experience in the directorate, having worked as program director in the Division on Research and Learning from 2007 to 2009. EHR supports fundamental research in learning and teaching, and broad efforts to achieve excellence in U.S. science, technology, engineering and mathematics (STEM) education. Dr. Marrongelle will begin her appointment on October 1. The full press release can be read on the NSF website.
As part of the revisions to the Common Rule (the set of regulations that govern research involving human participants) going into full effect in January 2019 (see COSSA’s coverage for more details), clinical trials covered by these regulations must publicly post copies of the consent forms used to enroll participants. The Office of Human Research Protections (OHRP) has announced that these consent forms must be posted either on clinicaltrials.gov or to a docket folder on regulations.gov (docket ID: HHS-OPHS-2018-0021).
OHRP has also made available guidance related to the European General Data Protection Directive (GDPR) to assist stakeholders conducting human subjects research in the E.U. The compilation is available on the OHRP website.
On August 23, the Senate Health, Education, Labor and Pensions (HELP) Committee held an oversight hearing featuring leadership from the National Institutes of Health (NIH). The hearing, Prioritizing Cures: Science and Stewardship at the National Institutes of Health, was chaired by HELP Committee Chairman Lamar Alexander (R-TN) and included testimony from NIH Director Francis Collins. Dr. Collins was joined by Diana Bianchi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID); Richard Hodes, National Institute on Aging (NIA); and Norman Sharpless, National Cancer Institute (NCI). A similar hearing was held in the House in July.
In his opening statement, Chairman Alexander acknowledged the continued enthusiastic, bipartisan support for NIH, evidenced by the passage of the 21st Century Cures Act in 2016 and by substantial budgetary increases provided to the agency over the last four years (see COSSA’s funding analysis for details). He further stated, “It’s hard to think of a major scientific advancement since World War II that has not been supported by federal research funding. But we’re not the only country that’s figured that out. Other countries have seen that investments in basic research can lead to breathtaking new discoveries,” pointing specifically to China.
Chairman Alexander raised concern about reports that some federally funded research is being conducted by “bad actor” foreign nationals who may be trying to assert undue foreign influence on NIH research. Dr. Collins explained that through an internal investigation, NIH found that the risks to the security of intellectual property and the integrity of the peer review process are increasing in magnitude. In response, Dr. Collins recently wrote to 10,000 NIH grantee institutions requesting that they “review their records for evidence of malfeasance,” specifically: (1) failure by researchers to disclose substantial contributions of resources from other organizations, including foreign governments; (2) diversion of intellectual property to other entities, including foreign governments; and (3) failure by some peer reviewers to keep grant applications confidential or other attempts to influence funding decisions. In addition, Dr. Collins has formed a Working Group on Foreign Influences on Research Integrity, which will continue to look at these challenges.
Dr. Collins used his prepared remarks to highlight NIH advancements made possible with the infusion of new funds from the 21st Century Cures Act. He outlined what he called the five keys to success in science today. They include: (1) a stable trajectory of support (i.e. funding); (2) a vibrant workforce (e.g. training programs); (3) computational power, which is enabling activities like the BRAIN initiative and the All of Us Precision Medicine Initiative; (4) new technologies and facilities; and (5) scientific inspiration.
Of particular interest to the social and behavioral science community, Senator Michael Bennet (D-CO) asked about whether our society is becoming addicted to technology and about the public health effects of social networking, citing findings from a recent study on daily use of technology and social media among teens (Psychology of Popular Media Culture, APA). Senator Bennet called for more priority to be placed on research in these areas and asked what NIH is doing in this space. Dr. Collins cited the Adolescent Brain Cognitive Development (ABCD) Study, which will follow 10,000 children ages 9-10 into early adulthood, studying brain, social, cognitive and emotional development and the factors that influence them. The issue of “screen time” is among the factors to be studied. In addition, Dr. Bianchi mentioned a recent NICHD workshop looking at new research directions in these areas, including early childhood language development, reading comprehension, parent-child interactions, and technology addiction.
Other Senators asked questions on a variety of specific diseases and topics of interest to them, including opioid and other addictions, the societal costs of obesity, development of a universal flu vaccine, maternal health, and bolstering researchers from underrepresented groups.
Dr. Collins’ testimony and a video of the hearing can be found on the HELP Committee website.