Taking another look at the BRAIN Initiative

NIH seeks input on next phase: understanding brain circuitry.

The National Institutes of Health (NIH) recently released a  Request for Information (RFI; NOT-NS-18-075) soliciting feedback on the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative  The purpose of the RFI is to gain feedback on the vision, priorities and goals outlined in BRAIN 2025: A Scientific Vision, the strategic plan for the BRAIN Initiative issued in 2014.

As discussed at the BRAIN Initiative Multi-Council Working Group in May (co-chaired by National Institute of Neurological Disorders and Stroke director Walter Koroshetz and National Institute of Mental Health director Joshua Gordon), the BRAIN Initiative turned five years old in April 2018.  Due to the new opportunities that have emerged from the initiative’s first five years, there are plans to review the main priority areas in BRAIN 2025, reassess its goals and bolster areas that could benefit from further support.  A major aim is to identify new topics and questions in high priority research areas that can now be explored with the new tools and technologies that have been developed.  The timeline is to update the scientific vision by the summer of 2019 to guide the next five years of the research.

The RFI is soliciting input in five main areas:  1) ideas for new tools and technologies that have the potential to transform brain circuit research, 2) questions about brain circuit function in humans or animal models that could be addressed with new technologies, 3) considerations for data sharing infrastructure and policies, 4) questions about ethical implications of BRAIN-supported neurotechnologies and advancements, and 5) approaches for disseminating new tools and technologies, and training the broader neuroscience research community.

The BRAIN Initiative, launched by President Obama in April 2013, seeks to better understand the structure and function of the human brain and how it guides behavior through neural activity--from the level of the whole brain down to the level of a single cell.  In addition to the National Institutes of Health, there are a broad range of participants across many sectors: other federal agencies including the National Science Foundation and the Defense Advanced Research Projects Agency, and non-federal partners including foundations, research institutes, universities and industry, as well as several international organizations.

As discussed at the January 2018 meeting of the BRAIN Initiative Multi-Council Working Group, in the early years of the BRAIN Initiative, with the push to develop and validate tools and technologies that would allow scientists to better study brain connectivity and circuitry, more engineers than neuroscientists applied for BRAIN Initiative grants.  However, some psychological scientists have received BRAIN Initiative funding.  These include Desmond Oathes (Univ. of Pennsylvania), whose lab is using interleaved transcranial magnetic stimulation and functional magnetic resonance imaging to probe and modulate circuits relevant to affective disorders and cognitive deficits, and Russell Poldrack (Stanford University), who is working on the development of standards for the sharing of neuroimaging data as well as with the OpenNeuro data archive to enable sharing of data from BRAIN Initiative studies.

The American Psychological Association plans to submit a formal response to the RFI by the November 15, 2018 deadline, and welcomes your thoughts and ideas. You can also submit your responses directly to NIH.  Responses must be submitted electronically using the web-based form or via email to BRAINFeedback@nih.gov with "BRAIN RFI" in the subject line.  For further information or to provide APA with input on the RFI, please contact Craig Fisher of APA’s Science Government Relations Office at cfisher@apa.org.

NIH seeks feedback from scientists on registration and reporting of basic human research

Submit comments and share with APA for inclusion in APA’s response.

The National Institutes of Health (NIH) has taken two steps this summer toward clarifying and possibly revising its recent policy that would include basic research conducted with humans within its definition of clinical trials and would impose requirements designed for clinical trials on the registration and reporting of basic research.

On July 20, the NIH issued a Guide Notice (NOT-OD-18-212) explaining its plan to loosen enforcement for basic research projects of clinical trials registration and reporting requirements through September 24, 2019.  (See previous report.)

Next, on August 10, NIH released a Request for Information (RFI), NOT-OD-18-217.  The RFI asks for responses in the following areas:

  • “Specific 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.”

Scientists should submit their comments to NIH by the deadline of November 12, 2018.  See the RFI for instructions on submitting comments.

The American Psychological Association will also submit comments in response to the RFI.  Scientists are encouraged to share their ideas with Pat Kobor (pkobor@apa.org) of APA’s Science Government Relations Office by November 5, 2018, so that APA’s response reflects your views. 

Please encourage your colleagues to respond as well.  APA aims to ensure that NIH hears a range of persuasive comments to prompt a change in a policy that is sowing confusion among basic scientists.

 

GEARing up to focus on applied research

Psychologists can submit ideas for enhancing effectiveness of federal government.

The Office of Management and Budget (OMB) recently released a Request for Information (RFI) to gather input to be used in establishing a Government Effectiveness Advanced Research (GEAR) Center.  It appears to be a ripe opportunity for applying psychological science to improve the functioning of the federal government.  As described in the RFI overview: “This non-governmental, public-private partnership would address operational and strategic challenges facing the Federal Government, both now and into the future, by engaging researchers, academics, non-profits, and private industry across an array of disciplines, such as data science, organizational behavior, and user-centered design.”

The RFI seeks responses to a set of eight questions in three sections: (1) Informing the GEAR Center, (2) Establishing the GEAR Center, and (3) Anticipated Early Focus Areas.  In the first two sections, the RFI aims to learn from examples of other successful partnerships that could inform the design and operation of the Center.

In the third, the focus is on reskilling/upskilling the federal workforce and leveraging federally owned data. As one example, the RFI specifically asks: “What approaches could be piloted for possible application and scalability across the Federal sector in various learning domains (e.g., cognitive, affective, behavioral) – such as gamification, use of massively open on-line courses (MOOCs), apprenticeship models, and other new approaches?”

Scaling up psychological research is not a new idea.  In 2015, the Social and Behavioral Sciences Team was formed as a subcommittee of the National Science and Technology Council to do just that.  Psychologist Matthew Johnson of Binghamton University was the American Psychological Association’s Executive Branch Science Fellow that year.  He was placed in the Department of Justice where he worked with the SBST to advance the Obama administration’s interest in bringing more data and science to bear on issues of policing.  The SBST produced two annual reports highlighting its achievements in 2015 and 2016 but was disbanded in the transition to the current administration.

And while concerns have been raised about how the current administration views science, this RFI and the recent nomination of a highly regarded meteorologist, Kelvin Droegemeier, to direct the White House Office of Science and Technology Policy may herald a change in attitude. 

To further explain and discuss the GEAR Center, OMB is hosting a virtual conference on August 23, 2018, from 1:30-3:00 Eastern.  OMB invites the public to submit questions in advance to help inform the question-and-answer period at the conference. 

APA plans to submit a formal response to the RFI by the September 14 deadline and is eager to include your ideas. For further information or to provide input to APA’s response to the RFI, contact Steve Newell (snewell@apa.org) of APA’s Science Government Relations Office.

Flexibility announced regarding NIH clinical trials policy

Enforcement will be delayed until September 24, 2019, but issues remain.

The National Institutes of Health announced, in a notice in the NIH Guide, a series of “interim policy flexibilities” for some basic research studies that have recently been subsumed under the expanded reporting and registration requirements for clinical trials. From now until September 24, 2019, NIH will reassess its approach to registration and results reporting for prospective basic science studies involving human participants while delaying enforcement.

NIH will delay enforcement of its policy, published in the Federal Register on September 21, 2016, that defines a clinical trial as any research with human participants not excluded by separately listed cases, and establishes the expectation that investigators will register and report their studies in ClinicalTrials.gov. NIH will continue to expect registration and reporting for all human studies but allow reporting on existing basic science portals in addition to ClinicalTrials.gov.

NIH continues to expect Good Clinical Practice training, in accordance with NOT-OD-16-148, for all personnel involved in the conduct, oversight, or management of prospective basic science studies involving human participants during this interim period.  There are free and short-duration training modules available, including one targeted towards behavioral research offered by the NIH Office of Behavioral and Social Sciences Research.

The American Psychological Association has worked closely with sister scientific organizations including the Federation of Associations in Behavioral and Brain Sciences to encourage NIH to reconsider its requirements that represent a significant burden to scientists who conduct basic research with human participants. As reported in Science, these organizations are continuing to push for basic science to be excluded from the definition of clinical trials.

Taking stock of science on the third anniversary of "Innovation: An American Imperative"

Progress report identifies successes and challenges for U.S. science infrastructure.

June 23, 2018, marks the third anniversary of the call to action from Innovation: An American Imperative, a coalition of more than 500 organizations, including the American Psychological Association, in science, engineering, higher education, and industry.  The call urged Congress to increase federal investment and enact policies aimed at stimulating innovation and scientific progress.

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