We break down a potential shutdown: What will and won’t happen?

Yes, the federal government will likely shut down at midnight.

Temporary funding for the federal government will expire at midnight tonight (Jan. 19, 2018) unless both houses of Congress approve a temporary extension or a longer-term funding deal that includes several pieces of legislation that have been negotiated for the past couple of weeks. The House of Representatives yesterday approved a one-month Continuing Resolution (CR), the fourth since September 30, 2017, when the 2018 fiscal year began.

Were we expecting this shutdown? We at the American Psychological Association and many of our advocate colleagues assumed the party that controls majorities in both houses of Congress and the White House would work very hard to avoid a shutdown, since, let’s be honest, it looks bad. A government shutdown causing employee furloughs has never occurred under unified party control of Congress and the White House. Still, all the trends we have observed and written about over the past couple of years combine to make it very difficult for the congressional leadership to negotiate win-win deals.  These include the broken budget process (Budget Control Act of 2011) which makes passing any regular appropriations bills challenging due to strict spending caps, the Freedom Caucus wing of the Republican Party rebelling against the Republican leadership with the result that bills can seldom pass with only Republican votes, and the fact that so little legislation passing means that ‘must-pass” bills are freighted with controversial high-impact provisions.  

What are the sticking points of these negotiations? The House leadership says the only path to keeping the government open is for the Senate to approve the short-term CR. Senate Democrats are circulating a counter-proposal that would fund the government through Feb. 16, pass the DREAM Act (to stop deportation of and provide a path to citizenship for, undocumented immigrants who came to the U.S. as children), extend the expired Children's Health Insurance Program (CHIP), deliver $90 billion of disaster aid, and increase defense and non-defense spending by more than $50 billion apiece so that final appropriations for Fiscal Year 2018 can be approved.  The pending CR does include additional funding for CHIP and several other key public health programs. However, the bill neither raises the budget caps, nor shores up science funding. The Senate Republicans do not have the 60 votes to pass the short-term CR that the House approved, so some negotiation with the Democrats is necessary.

What happens during a shutdown? Each federal department is supposed to have a plan that governs how the shutdown will be implemented. Here is the Department of Health and Human Services plan.  For example, at the National Institutes of Health, grant program and management activity will be suspended and staff responsible for grant review and administration will not come to work. Only those involved with direct patient care at the NIH Clinical Center, animal care, and security of the physical plant will remain at work. The White House has some latitude over how stringently a shutdown is managed. The Centers for Disease Control and Prevention (CDC) will continue minimal support to protect the health and well-being of US citizens here and abroad, though its capacity to respond to outbreak investigations, process laboratory samples, and maintain the agency’s 24/7 emergency operations center would be reduced. The plan calls for CDC staff who are currently supporting the ongoing hurricane response to continue to respond to immediate and ongoing public health needs in the affected areas.

(See shutdown plans for the National Aeronautics and Space Administration and the National Science Foundation.)

Would a shutdown save any money? Probably not, judging by what happened in 2013, according to Nature:

“The GAO reports that 850,000 government employees — roughly 40% of the federal workforce — were “furloughed”, or ordered to stay home without pay. But Congress eventually approved about $2 billion in retroactive compensation for these workers, erasing any payroll savings.

“More broadly, a report released in November 2013 by the Obama administration concluded that the shutdown had led to 6.6-million lost work days for civilian federal employees, and prevented the creation of up to 120,000 private-sector jobs.”

With several hours left before the current funding expires, the President and Congress could yet make a deal that would avoid a shutdown. APA will provide additional information as soon as it becomes available. For more information please contact Pat Kobor in the Science Government Relations Office.

Implementation of revised Common Rule delayed by at least six months

Revision raises complex challenges for research institutions. 

On January 17, 2018, just two days before the newly revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule) was scheduled to go into effect, the Department of Health and Human Services’ Office for Human Research Protections announced an Interim Final Rule that delayed the effective and general compliance date of the new rule by six months, making it effective on July 19, 2018.

The delay is an acknowledgement of the complexity of the new rule, the yet-to-be-drafted federal guidance on numerous new requirements (e.g., determining research that is exempt, standards for protecting privacy of participants and confidentiality of data) and the onerous task of redesigning institutional policies, procedures, and electronic systems for institutional review boards (IRBs).

However, the delay also affords the federal departments and agencies that are signatories to the Common Rule the time to develop another notice of proposed rulemaking for public comment on further delaying implementation of the revised rule until January 21, 2019.

So, what does this mean for the research community? It maintains status quo, with the original Common Rule in effect until either July 19, 2018 or January 21, 2019.

Perhaps even indefinitely, if the recommendations of a Congressionally-mandated report by The Academies were to be adopted.  That 2016 report called for Congress to establish a national commission to take a fresh look at the “ethical, legal, and institutional frameworks governing human subjects research.”

FDA shuts down nicotine research study, overlooking concerns of scientific organizations

American Psychological Association Science Alert

Background In September 2017, the American Psychological Association, the American College of Neuropsychopharmacology, and the College on Problems of Drug Dependence wrote to Food and Drug Administration Commissioner Scott Gottlieb, MD, following the FDA announcement that it was suspending a program of nicotine research with nonhuman primates on the advice of Dr. Jane Goodall and the White Coat Waste Project, an organization that is fundamentally opposed to all research with non-human animals. Dr. Gottlieb announced that FDA would conduct an independent review of the research program and release a report. The scientific organizations asked that FDA provide public information about the review including naming members of the review committee and explaining its timeline and rationale. The FDA has not responded.

Update — There are indications that prior to completion of the FDA review and promised report, the agency has already taken multiple steps to effectively end the research program. Even if the reviews are positive, the research cannot be resumed with those animals, and the FDA is preparing to transfer the study animals to new locations, some of which may not ensure adequate protections. This process upends procedures of the National Center for Toxicological Research, which sponsors the research, and ultimately wastes public dollars since the study cannot be followed to its conclusion.

Conclusion  FDA appears to be ignoring the concerns of established scientists and scientific organizations, while placing nonhuman animals at potential risk and failing to fund research in the public interest.

Note: The full text of the letter to FDA Commissioner Scott Gottlieb, MD, is available here. It references a letter opposing the claims of White Coat Waste and Dr. Goodall, signed by 46 researchers and endorsed by 78 additional scientists, including well-known experts in substance use disorders, and an article in the Washington Post that detailed the original FDA decision.

National Science Foundation considers future needs of social and behavioral sciences

NSF advisors seek to broaden training of scientists, strengthen research infrastructure, and enhance understanding and use of scientific findings.

The Advisory Committee for the Social, Behavioral, and Economic Sciences (SBE) Directorate of the National Science Foundation met on November 2-3, 2017, at the new NSF headquarters in Alexandria, VA. The Advisory Committee meets twice yearly to provide advice, recommendations, and oversight to the SBE Directorate. The committee discussed a broad range of topics relating to science across academia, government, and private organizations.

Although budget details for FY2018 remain in flux, NSF looks like to be on stable, albeit stagnant, financial footing moving forward. Appropriations committees in the House and Senate both rejected the draconian cuts requested by the administration. Report language for each chamber’s bill also reiterated support for historically Black colleges and universities as well as Hispanic-serving institutions. Importantly, these bills also fail to specify directorate-level funding levels, leaving greater authority in funding allocations to NSF leadership. In previous years, the SBE Directorate has been targeted for reduced funding levels (e.g., a 42% proposed, but not enacted, cut to funding authorization in H.R. 4186 introduced in the House in 2014).

Addressing gaps in graduate education in the social and behavioral sciences emerged as one of the themes at the meeting. As observed by advisory committee members, many faculty emulate their own graduate training and career experiences, even as the job market for social and behavioral scientists has shifted and broadened considerably. There remains an unmet need for training to prepare graduates for more interdisciplinary environments and non-academic opportunities. Accordingly, committee members discussed the need for further examinations of what has worked in terms of interdisciplinary training, diversity initiatives, and other training issues.

Advisory Committee members also expressed support for recent legislation, H.R. 4174, resulting from the final report from the Commission on Evidence-Based Policy. The report focused primarily on strengthening privacy protections, improving access to data, and enhancing the government’s evidence-building capacity, with the bill adopting many of the report’s recommendations. The bill represents a tangible outcome of the Commission,  established by the bipartisan Evidence-Based Policymaking Commission Act of 2016 (P.L. 114-140) and tasked with increasing the availability and use of data with the goal of building evidence about government programs.

Improving coordination and management of data for social surveys, including the American National Election Studies (ANES), General Social Survey (GSS), and Panel Study of Income Dynamics (PSID), represents an ongoing concern at NSF, as these are important sources of data for addressing social and behavioral science questions. In particular, committee members advocated for NSF to continue development and implementation of data standards, including those for data linking, big data, and the use of social media data with a specific focus on integrating “organic” and administrative data with more traditional survey data.

NSF’s SBE Directorate and the advisory committee are also asking important questions regarding the state of the science and its relationship to the public. For example, committee members discussed topics addressed by the National Academies’ Roundtable on the Communication and Use of Social and Behavioral Sciences, such as why decision makers struggle to use the social and behavioral sciences, how to communicate SBE science responsibly, improving SBE education at the K-12 levels, and how the public views and understands science, in general. In line with the focus on public recognition of the value of social and behavioral science, they pointed to a number of notable scientists who have recently received recognition for their work, including the Yidan Prize for Carol Dweck.

NSF is also considering a number of “grand ideas” to focus on moving science forward in coordination with ongoing strategic plan development at the SBE Directorate. Among these grand ideas are initiatives on further understanding the impact of diversity on work, innovation, and creativity; addressing shortcomings in the information ecosystem to better serve democracy; and furthering our knowledge of the growing interplay among artificial intelligence, machine learning, big data, and society.

Finally, NSF is currently looking to fill a number of positions of interest to psychologists and other social and behavioral scientists, including Assistant Director for the Social, Behavioral, and Economic Sciences Directorate, Division Director for the Behavioral and Cognitive Sciences, and Division Director of the National Center for Science and Engineering Statistics.

For further information, please contact Steve Newell, of APA’s Science Government Relations Office. 

A psychological scientist goes to Washington to rally for NIH funding

More than 350 advocates and organizations met with Congress to urge for increased medical research funding.

By Dawn K. Wilson

The fifth annual Rally for Medical Research on Capitol Hill took place on September 14, 2017 with more 350 advocates and organizations participating. The Rally for Medical Research has been held annually since 2013 to raise awareness of the urgent need for investment in the National Institutes of Health (NIH) in order to improve health, spur scientific progress, inspire hope, and save lives.

The American Psychological Association (APA), an active participating organization in this event, invited me to be a psychologist advocate given my NIH-funded research at the University of South Carolina.  I participated alongside other advocates from South Carolina, including fellow researchers from the University of South Carolina and the Medical University of South Carolina and a team of patients.  The theme of this event was “Together for More Progress More Hope More Life.”  The 2017 rally, the largest one to date, included advocates from 37 states and the District of Columbia who conducted more than 250 meetings with House of Representatives and Senate offices. 

In fiscal years (FY) 2016 and 2017, Congress provided the first significant increases in funding for the NIH in more than a decade. This year’s rally aimed to build on that momentum by urging Congress to continue making medical research a national priority by providing robust, sustained and predictable funding increases for NIH in 2018 and beyond.  Given the administration’s FY 2018 budget proposal that called for massive cuts to NIH and other federal agencies, as well as more than a decade (since 2004) of near flat-funding for NIH when adjusted for inflation, we expressed our deep gratitude to Congress for its support of a spending bill that included a $2 billion funding increase for NIH in FY 2018.

Our South Carolina team of advocates met with Sen. Tim Scott (R-SC) to discuss our funding request.  Sen. Scott  is a strong advocate for youth with rare diseases and became a champion for an 11-year old girl who has had two brain surgeries for encephalitis, a disease that has seen little medical advancements in the past 50 years. Sen. Scott was supportive of our requests to increase NIH funding in the coming year (he also shared his birthday cake with us during our visit).

Sen. Tim Scott (R-SC) and Dr. Dawn Wilson

Sen. Tim Scott (R-SC) and Dr. Dawn Wilson

We also met with South Carolina Congressmen Rep. Ralph Norman (R-SC) and Rep. Joe Wilson (R-SC).  Although Rep. Norman had not previously considered voting for the NIH funding increase, after we spoke with him and his staff for an hour (!), he agreed it was a worthwhile cause and he might have to reconsider.  Meanwhile, Rep. Norman will be in South Carolina soon to engage in efforts to increase health care access to rural health areas.

Rep. Ralph Norman (R-SC; 3rd from left), Dr. Dawn Wilson (2nd from right), and other South Carolina advocates during the Rally for Medical Research.

Rep. Ralph Norman (R-SC; 3rd from left), Dr. Dawn Wilson (2nd from right), and other South Carolina advocates during the Rally for Medical Research.

I was fortunate to share my work at the University of South Carolina with the senators and representatives with whom we met.  As the principal investigator on a $2.5 million NIH-funded project, “Families Improving Together (FIT) for Weight Loss,” I shared the importance of this program that targets overweight African American adolescents and their parents who are at high risk for diabetes and related chronic diseases.  Health care costs associated with managing these chronic diseases are expensive. This project is testing the efficacy of integrating cultural tailoring, positive parenting skills, motivational strategies, and behavioral skills into a comprehensive curriculum aimed at reducing obesity in African American teens and their parents.  It is one of the few large-scale NIH funded trials that specifically targets underserved ethnic minority populations using a family-based behavioral intervention for long-term lifestyle change. 

Our next steps are to disseminate this intervention on a population level, and test it in an effectiveness trial, through an online tailored program in community settings.  The critical point is not only that without the continued funding from the NIH, this work would not happen, but that the benefits that might be derived from the work, namely improvements in the rates of adolescent obesity for highly impacted, underserved ethnic minorities, would be lost.

APA is a strong advocate for science, working to protect and increase federal funding for psychological science.  Let’s continue to support these efforts by thanking our senators and representatives for the last two years of $2 billion dollar per year increases, but also letting them know that we need to see the same increase in the coming year.

Dawn K. Wilson is the advocacy liaison to, and member of, the Health Policy Council

of the Society for Health Psychology (APA Division 38).

Twenty-six organizations ask NIH to delay and reconsider clinical trials policy

Policy would reclassify basic research as “clinical trials.”

The American Psychological Association and 25 other organizations representing a broad range of scientific disciplines sent a letter to Francis Collins, director of the National Institutes of Health, asking that NIH delay implementing its policy reclassifying much basic research as clinical trials. The letter concludes, “We urge NIH to work with the affected basic science communities to identify a reasonable solution.”

An earlier petition to Collins asking that the policy be changed has been signed by more than 3,500 scientists.

See here for previous coverage of this issue.  Additional materials can be found on the website of the Federation of Associations in Behavioral and Brain Sciences, of which APA is a member.