Issue 16 (September 8)

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Congress Returns for a Busy Fall

Following a month-long August recess, Congress returns to work this week to a full agenda of must-pass items. At the top of the list will be passing a continuing resolution (CR) to keep the government funded and avert a shutdown come October 1. However, unrelated controversies dealing with Planned Parenthood and the Confederate flag will likely make the road to a CR difficult in the coming weeks.

Assuming we get to October 1 without the government shutting down, the next big issue on the agenda is brokering some sort of deal to reverse or at least mitigate the impacts of sequestration, which include the current spending caps that are tamping down funding across federal agencies and programs. As previously reported, work on the fiscal year (FY) 2016 appropriations bills sputtered out as Congress headed for recess because, among other reasons, Republicans have written the FY 2016 spending bills keeping within the spending caps, while Democrats and the White House vowed to block bills that do not bust through the caps. It does not appear that much has changed during the recess to bridge this divide, leaving many to wonder how any of these issues will get resolved in the remaining months of 2015.

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AAAS Seeks Stories on the Importance of Scientific Conferences

The American Association for the Advancement of Science (AAAS) is soliciting stories about the value scientific conferences bring to collaboration and the progress of science. As you may know, the White House Office of Management and Budget issued government-wide regulations in 2012 that put hard caps on the amounts federal agencies can spend on conference participation and travel. Congress put further restrictions in place, specifically for international conferences. All of this has resulted in the proliferation of onerous and timely approval processes for travel requests by federal employees and ultimately a major decline in attendance by scientists who work for the federal government. The scientific community sent a letter to Congress in April asking for these regulations to be changed. Share your stories to further urge action on this important issue.

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Events Calendar

A list of COSSA members’ annual meetings and other events can be found on the COSSA website. COSSA members who have an upcoming event they would like to see listed in the Events Calendar and on our website should send an email to jmilton@cossa.org.

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COSSA Comments on NSF Reauthorization; Senate Seeks Input on STEM Workforce

As previously reported, the Senate Commerce, Science and Transportation Committee spent the summer engaging with scientific stakeholders to inform possible reauthorization of the America COMPETES Act, or legislation authorizing the National Science Foundation (NSF). In July, the Committee put out a request for input on the topic of “Maximizing the Impact of Basic Research.” COSSA submitted detailed comments to the Committee on August 14.

The Committee is now seeking input on the topic of “Building a STEM Workforce.” Interested parties are invited to comment on any/all of the following questions:

  1. How does the availability of STEM graduates affect corporate decision-making about where to conduct research and manufacture goods?
  2. To maximize the use of limited resources, how can the Federal Government, in coordination with the private sector and academia, best prioritize STEM education investments and help respond to shifting academic and private sector workforce needs?
  3. What factors should Federal agencies consider to measure the impact and success of the Federal STEM education portfolio and to decide whether to expand, modify, or replace individual programs, given limited resources?
  4. How can Federal agencies best identify and encourage implementation of promising, research-driven STEM education teaching models and best practices?
  5. What actions can the Federal Government, private sector, and academia pursue to broaden STEM participation and provide education and research opportunities to students from all backgrounds?

Comments can be sent directly to the Commerce Committee at SciencePolicy@commerce.senate.gov. No deadline has been given for this round of comments.

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Funding Opportunity Announcements

  • NIJ: Graduate Research Fellowship Program in the Social and Behavioral Sciences (NIJ-2016-4321)
  • NSF: Resource Implementations for Data Intensive Research in the Social Behavioral and Economic Sciences (RIDIR) (NSF 15-602)

NIH opportunities:

  • NCI: Sustained Support for Informatics Resources for Cancer Research and Management (U24) (PAR-15-333)
  • NCI: Advanced Development of Informatics Technologies for Cancer Research and Management (U24) (PAR-15-331)
  • NCI: Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01) (PAR-15-332)
  • NCI: Development of Innovative Informatics Methods and Algorithms for Cancer Research and Management (R21) (PAR-15-334)
  • NCI: NCI Exploratory/Developmental Research Grant Program (NCI Omnibus R21) (PAR-15-340)
  • NIAID/NIMH: Ethical, Legal and Policy Issues in HIV Research with Key Populations (R01, R21) (PAR-15-328)
  • NICHD: CAPSTONE Centers for Multidisciplinary Research in Child Abuse and Neglect (P50) (RFA-HD-16-002)
  • NIH: Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp) (PA-15-329) (NCCIH, NCI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCD, NIMH, NIMHD, OAR, OBSSR, ODP, ORWH)
  • NIH: End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R01) (PA-15-324) and (R21) (PA-15-325) (NINR, NCI NICHD, ORWH)
  • NINDS: NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity in Neuroscience Research (K22) (PAR-15-338)
  • NINR: Exploratory Multi-site Palliative Care Research in Diverse Populations Utilizing the Palliative Care Research Cooperative (R21) (PAR-15-337)

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White House Chief Data Scientist Seeks Input

patilEmbracing the use of data to improve government function and its interaction with people, the Obama Administration established the position of Chief Data Scientist (CDS) in February.  DJ Patil joined the White House Office of Science and Technology Policy (OSTP) in February as Deputy Chief Technology Officer for Data Policy and Chief Data Scientist.

Patil is credited with helping to coin the term “data scientist.” The former Vice President of Product at RelateIQ, Patil has also held positions at LinkedIn, Greylock Partners, Skype, PayPal, and eBay.  Prior to his stint in the private sector, he worked at the Department of Defense, where he directed efforts to bridge computational and social sciences in fields like social network analysis to help anticipate emerging threats to the U.S.

As Chief Data Scientist, Patil has focused on four activities:

  1. Providing a vison on how to provide maximum social return on federal data.
  2. Creating nationwide data policies that enable shared services and forward-leaning practices to advance the U.S.’ leadership in the data age.
  3. Working with federal agencies to establish best practices for data management and ensure long-term sustainability for databases.
  4. Recruiting and retaining the best minds in data science for public service to address these data science objectives and act as conduits among government, academia, and industry.

Patil’s priority areas include precision medicine, usable data projects, and responsible science.

In August, Patil issued a follow-up memorandum discussing his team’s progress regarding these priorities and goals.  Noting that “data science is a team sport,” Patil urges community input on these initiatives.

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NIH Issues Guidelines for HIV/AIDS Research Priorities

In August, the National Institutes of Health (NIH) released a Notice, NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (NOT-OD-15-137), outlining its overarching HIV/AIDS research priorities along with the guidelines the agency will use to determine AIDS funding for the next three to five years beginning in fiscal year (FY) 2016 (see related story).  NIH’s Office of AIDS Research (OAR) is legislatively mandated to coordinate, plan, evaluate, and budget for the agency’s AIDS research program (see Update, June 16, 2014).

The notice highlights NIH’s overarching HIV/AIDS research priorities:

  1. Research to reduce the incidence of HIV/AIDS, including the development of safe and effective vaccines;
  2. Development of the next generation of HIV therapies with improved safety and ease of use;
  3. Research towards a cure for HIV/AIDS; and
  4. HIV-associated comorbidities and co-infections.

The cross-cutting areas of basic research, health disparities, and training are also highlighted.

NIH has also developed a series of guidelines for determining whether a research project falls into a high, medium, or low priority for receiving AIDS-designated funding.

Among the high-priority research topics are:

  • Reducing the incidence of HIV/AIDS, including developing, testing, and implementing strategies to improve HIV testing and entry into prevention services;
  • Implementation research to ensure initiation of treatment as soon as diagnosis has been made, retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses; and
  • Cross-cutting areas of basic research, health and training, including research to reduce health disparities in the incidence of new HIV infections or in treatment outcomes of those living with HIV/AIDS and research training of the workforce required to conduct high priority HIV/AIDS or HIV/AIDS-related research.

Medium-priority topics may include health and social issues that are clearly linked to HIV (transmission/acquisition, pathogenesis, morbidity and mortality, stigma).

The notice states, however, low-priority topics will not be supported with AIDS-designated funds.  But projects could be eligible for support with non-AIDS funds by an NIH institute or center.  This includes studies of behaviors (e.g., sexual activities, drug use activities) or social conditions that have multiple negative outcomes where HIV/AIDS is one of many outcomes being studies without a focus on HIV/AIDS is unique in that context.

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OAR Outlines Overarching AIDS Research Priorities; Studies of Behavior and Social Conditions with Multiple Negative Outcomes Deemed Low Priority

At the September 1 meeting of the National Institutes of Health (NIH) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils, Acting Associate Director for AIDS Research and Acting Director for the Office of AIDS Research (OAR) Robert Eisinger provided the Council with an update on OAR’s activities, including the recent release of NIH’s high-priority areas of HIV/AIDS research and accompanying guidelines for determining funding for this research (see related story).

Eisinger highlighted NIH director Francis Collins’ August 12 statement extolling the ”extraordinary progress that has been made in HIV/AIDS research over the past 34 years, transforming what was once a terrifying and almost inevitably fatal disease into a treatable disorder.” The NIH recently issued a Notice, NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (NOT-OD-15-137), based on the recommendations of an external working group of the OAR Advisory Council in coordination with OAR scientific staff and NIH ICs (see Update, June 16, 2014).

Eisinger emphasized that the guidelines will be used “to determine the priority for receiving AIDS funding not the scientific merit of grants, contracts, and intramural projects.” The guidelines will also be used in standardizing prorating levels of support for projects containing both AIDS and non-AIDS aims and subprojects. Special areas will be considered for priority, including the Clinical and Translation Science Awards (CTSAs), National Primate Research Centers (NPRCs), and Cancer Centers.

The guidelines, however, designate “studies of behaviors (e.g., sexual activities, drug use activities) or social conditions that have multiple negative outcomes where HIV/AIDS is one of many outcomes being studied without a focus on HIV/AIDS is unique in that context” as low priority when it comes to AIDS funding.

Eisinger announced that beginning in fiscal year (FY) 2016, NIH will introduce new OAR processes, including:

  • Revising the Center for Scientific Review Referral Guidelines and restructuring of AIDS Integrated Review Group study sections;
  • Reviewing draft funding opportunity announcements (FOAs) and Request for Proposals (RFPs);
  • Following the FY 2016 appropriation, OAR in consultation with the NIH director may utilize its three percent transfer authority to transfer AIDS funds between ICs;
  • Requiring all new and competing renewal projects (grants and contracts) to be aligned with the highest overarching AIDS priorities; and
  • Prorating all new and competing renewal projects on the basis of their AIDS proportion.

Eisinger recounted that OAR and a panel of IC scientific staff conducted an AIDS portfolio review of all FY 2014 grants, contracts, and intramural projects scheduled to re-compete in FY 2016 with the goal of identifying projects considered “low priority” research. These projects will not be supported with AIDS funding when they re-compete in FY 2016, he explained. The identified associated funds will go into a common, high AIDS-relevance pool. The results of the review will be presented at the NIH Advisory Committee to the Director (ACD) in December 2015.

In FY 2016, there will also be third and fourth quarter reviews and analysis with the goal to ensure projects are aligned with the highest priorities. OAR staff will review the coding of all new projects reported in the OAR trans-NIH AIDS Research Information System (ARIS) database to ensure appropriate coding. ARIS is used by OAR to facilitate tracking and analysis. Accordingly, OAR requires ICs to report all AIDS-related expenditures, including extramural, intramural, and research management and support, on a quarterly basis, to the database. Expenditures are coded by the ICs to the objective(s) of the annually-mandated Trans-NIH Plan for HIV-Related Research. ARIS serves as the primary resource for AIDS research information in the Research Conditions and Diseases Categorization (RCDC) system. OAR, Eisinger reported, will work with ICs “to resolve any issues of matching to priorities and coding.”

Pointing to the FY 2017 Trans-NIH AIDS budget, Eisinger noted that OAR will provide guidance shortly for development of ICs’ AIDS budget submissions. Each new, re-competing, and expanding initiative will have to be aligned to one or more of the overarching AIDS research portfolios. OAR will develop the NIH AIDS budget in consultation with the NIH director and provide each IC a list of initiatives that will be supported and the associated funding level.

Search for OAR Director

There is currently an ongoing search or a new OAR director. The search committee is being led by the National Center for Complementary and Integrative Health (NCCIH) director Josephine Briggs and National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) director Griffin Rodgers.

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HHS Releases Proposed Updates to the Common Rule

The Department of Health and Human Services has released its proposal to update the regulations that govern research involving human subjects (the Common Rule). The long-awaited Notice of Proposed Rulemaking (NPRM) explains the proposed changes and poses a number of questions for which the department is seeking public comment, to be submitted within 90 days of the NPRM’s publication. The Office of Human Research Protections (OHRP) plans to hold several webinars in the coming weeks to explain the changes as well as an in-person town hall meeting in Washington, DC in October.

The Common Rule has not been updated since 1991. The NPRM is the next step in a process that began in 2011 with the issuance of an Advanced Notice of Proposed Rulemaking (ANPRM) that asked for input. In response, COSSA, along with 21 other organizations, submitted a white paper that gave the perspective of the social and behavioral science community. The National Academies also issued a consensus report in 2014 that discussed proposed revisions to the Common Rule in the context of the social and behavioral sciences. A number of the proposed changes attempt to address concerns raised by the social and behavioral science community, particularly those that attempt to make the level of review proportional to the potential level of harm. The NPRM states the drafters’ intention to “more thoroughly addresses behavioral and social science research perspectives and the broader types of research conducted or otherwise supported by the other Common Rule agencies” and cites the consensus report as a source of guidance. (more…)

NIH Plans for Redirection of National Children’s Study Funds

National Institutes of Health (NIH) Principal Deputy Director Lawrence Tabak provided an update on the “redirection” of National Children’s Study (NCS) appropriated funding at the September 1 meeting of the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils.

Despite the NIH’s discontinuation of the NCS, in FY 2015, Congress provided $165 million for the study with direction to the agency to continue to support the mission and goals of the study, along with flexibility on how to carry this task out. Tabak announced that the awards associated with this funding will be made in September. As a consequence of not knowing whether Congress would continue to provide the funding associated with the discontinued study (see Update, July 17, 2015), however, NIH fully funded the FY 2015 awards via three initiatives:

  1. Development of Tools to Enhance Studies of Environmental Influences on Pediatric Diseases
  2. Influence of Environment on In Utero Development with the Goal of Identifying the “Seeds” of Future Diseases and Conditions
  3. Expand Examination of Environmental Influences on Later Child Development by Leveraging Extant Programs

Tabak reported that the remaining funds will be used to close out the former NCS program. (more…)

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