Blog Archives

Alex Azar, Former Pharmaceutical Executive, Nominated to Lead HHS

President Trump has nominated Alex Azar to lead the U.S. Department of Health and Human Services (HHS), which would include oversight of the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), among other federal agencies. Azar served as general counsel and deputy secretary to the Department under the George W. Bush administration and served as the president of Lilly Co., part of the pharmaceutical company Eli Lilly and Co., until earlier this year. Azar’s nomination comes following former HHS Secretary Tom Price’s resignation after news surfaced of improper use of private jets for government business. Azar must be confirmed by the Senate; no date for a confirmation hearing has been announced at this time.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

Linda Capuano Nominated as Head of Energy Information Administration

Linda Capuano, energy technology fellow at the Baker Institute for Public Policy’s Center for Energy Studies at Rice University, has been nominated to lead the Energy Information Administration (EIA), the principal statistical agency located within the U.S. Department of Energy. Prior to joining the Baker Institute, Capuano worked at Marathon Oil Corporation and Solectron Flextronics. She holds a Ph.D. in Materials Science and Engineering from Stanford University. EIA’s most recent Administrator, Adam Sieminski, left the agency in January. John Conti, EIA’s Deputy Administrator is currently serving as Acting Administrator. Capuano’s nomination next goes to the Senate for a confirmation hearing and vote, although the hearing has not yet been scheduled.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

OBSSR to Host Annual Research Festival on December 8

The National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) is hosting the “NIH Behavioral and Social Science Research Festival: Connecting People to Advance Health” on Friday, December 8. The festival will bring together behavioral and social scientists from inside and outside NIH to network, collaborate, and share ideas. The agenda will include a keynote address from Dr. Eliseo Perez-Stable of the National Institute on Minority Health and Health Disparities as well as plenary sessions on international research, behavioral neuroscience, and social factors and health. This event will not be webcast. More details and registration information can be found here.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

COSSA Joins Societies in Requesting Changes to NIH Clinical Trial Policy

In a letter sent to National Institutes of Health (NIH) Director Francis Collins on October 27, COSSA and 21 other scientific societies and associations requested that NIH revisit a new policy that alters the definition of “clinical trials” funded by the agency and institutes new reporting requirements for such research (see COSSA’s coverage of this issue). While the letter is supportive of the goal of enhancing transparency of NIH-funded research, including introducing registration and reporting requirements, the signatories express concern that “basic science research is being redefined as a clinical trial at NIH and that “basic science investigators will be unnecessarily burdened with requirements relating to conducting clinical trials that have nothing to do with their own research.” The organizations hope to work with NIH leadership to find a solution that addresses the concerns of the basic science community while still improving transparency for true clinical trial research.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

William Beach, Former Budget Committee Economist, Nominated as BLS Commissioner

The White House has nominated William Beach for a four-year term as Commissioner of the Bureau of Labor Statistics (BLS), succeeding Erica Groshen, whose term expired in January, and William J. Wiatrowski, the Acting Commissioner since Groshen’s departure. Currently Vice President for Policy Research at George Mason University’s Mercatus Center, Beach holds a Ph.D. in economics from the UK’s Buckingham University. Prior to joining the Mercatus Center, Beach served as the Chief Economist for the Senate Budget Committee’s Republican staff and the Lazof Family Fellow in Economics director of the Center for Data Analysis at the Heritage Foundation. BLS Commissioners must be confirmed by the Senate, and no date for a confirmation hearing has been announced at this time.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

GAO to Study Potential Federal Interference in Science

According the Washington Post, the Government Accountability Office (GAO) will undertake a study of federal agencies’ scientific integrity policies and potential federal interference in the scientific process at the request of Sen. Bill Nelson (D-FL). Nelson, the Ranking Member on the Senate Commerce, Science, and Transportation Committee, made the request in a letter dated September 25, 2017. Citing concerns stemming from reports of possible interference in the scientific process at the Environmental Protection Agency, changes to agencies’ public information related to climate change, and the cancellation of a study that might be damaging to the fossil fuel industry, Nelson asked the GAO to assess whether “the administration has violated scientific integrity policies by suppressing federally funded science, interfering with research grant activities, interfering in typical scientific processes, or restricting the freedom of federal scientists to communicate findings with the public.” While GAO agreed to Nelson’s request, it does not expect to begin work on the study for about four months, due to limited resources. The American Institute of Physics has published a more in-depth look at some of the context surrounding Nelson’s request.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

NSF’s Statistical Division Seeks Director

The National Science Foundation (NSF) is accepting applications for the position of Division Director of the National Center for Science and Engineering Statistics (NCSES), NSF’s principal statistical agency housed within the Social, Behavioral, and Economic Sciences Directorate (SBE). The NCSES Division Director “assesses needs and trends involving the national surveys, implements overall strategic planning and policy setting for the Division, provides leadership and guidance to Division staff members, determines funding requirements, prepares and justifies budget estimates, balances program needs, allocates resources, oversees the evaluation of proposals and recommendations for awards and declinations, and represents NSF to relevant external groups.” More information is available in the posting on USAjobs. Applications must be submitted by December 4, 2017.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

GAO Report on Firearm Storage Highlights Lack of Federal Funding for Gun Research

The Government Accountability Office (GAO) recently released a report entitled Personal Firearms: Programs that Promote Safe Storage and Research on Their Effectiveness that compiles information on public and non-profit programs promoting safe storage of personal firearms and the results of research on the effectiveness of such programs. The report was produced at the request of 19 Democratic senators, including Sen. Patty Murray (D-WA), the Ranking Member of the Committee on Health, Education, Labor, and Pensions (HELP). The report finds that “there is relatively little research on safe firearm storage,” and that “lack of funding and data” is often cited as a primary reason. According to the report, funding shortages and instability has limited the research on firearm safety and storage that could have been conducted by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Justice (DOJ).

The report cites an analysis published in the Journal of the American Medical Association that compared available funding and publication volume for research on various leading causes of death and found that “research on firearms receives disproportionately low funding and has fewer publications compared to other top causes of death.” The lack of funding can lead to shortage of expertise in the field. One researcher interviewed told the GAO that “he discourages new students from firearm research exclusively because they will not be able to make a living in that research area alone.” Further, a shortage of high-quality data on firearms exacerbates the difficulty of conducting research in this area. The CDC’s Behavioral Risk Factor Surveillance System (BRFSS) has not included questions related to firearm safety since 2004. However, the CDC does plan to add a module on firearms in the 2017 survey, on the recommendation of the National Academy of Medicine.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

HHS May Delay Common Rule Implementation

On October 7, the White House Office of Information and Regulatory Affairs issued a notice that it is reviewing a rule that would delay the implementation date for most of the changes to the Common Rule, the set of regulations governing research involving human participants, by one year, pushing the effective date for the changes from January 2018 to January 2019 (see COSSA’s analysis of the changes, which were announced in January of this year). The delay would still allow “the use of three burden-reducing provisions during the delay year,” but there is little clarity on what those provisions are or when more details will be made available.

One hint may be found in a letter sent by four higher education associations in June that asked for a year-long delay in the compliance date for most of the changes to the regulations, while allowing burden-reducing provisions to move forward. The letter identified those provisions as “certain exclusions and exemptions, elimination of the continuing review requirement for certain types or stages of research and elimination of IRB [internal review board] review of grant applications.” If the Department of Health and Human Services (HHS) concurs with the recommendations in the letter, the provisions allowed to go into effect as originally scheduled may well include several of the changes that aim to make research involving human participants less burdensome for low-risk social and behavioral research.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

NIH Provides Guidance on New Human Subjects, Clinical Trials Form

As previously reported, the National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. COSSA described the planned changes and their impact on the social science research community in a Hot Topic piece earlier this month. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial.”

NIH released a blog post and short video on October 11 that provides specific guidance on how to complete the new PHS Human Subjects and Clinical Trial Information form, which will now be required for all grant applications submitted on or after the January 25, 2018 due dates. All researchers are encouraged to familiarize themselves with the new form.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

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