Director's Voice
New Guidance for Basic Experimental Studies Involving Humans. On April 28, the Office of Extramural Research (OER) released a new webpage that provides additional guidance to investigators conducting Basic Experimental Studies with Humans (BESH). The NIH definition of a clinical trial includes basic research manipulating an independent variable, resulting in some basic research studies being subject to NIH clinical trials policies.
Based on prior feedback from the research community, NIH provided temporary leniency to basic research applications subject to the clinical trials policies to allow flexibility on the platform used for registration and results reporting and on applications submitted to an incorrect FOA based on the study-type designation (NOT-OD-18-212). Soon after this notice, the NIH issued parent FOAs on Basic Experimental Studies With Humans (e.g., PA-19-091), and only submissions to these BESH FOAs have the continued registration and reporting leniency that now extends through September 24, 2023 (NOT-OD-21-088).
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When given quiet moments, a person’s mind often wanders to future events such as tomorrow’s plans, to-do list items, or an upcoming trip. During these instances, the brain network called the default mode network (DMN) is being activated, but researchers have never fully understood how it functioned. In a study funded by NIDA, researchers evaluated brain activity in independent regions and found that the DMN uses two complimentary networks to create the imagined event (the “constructive” function) and assess whether this constructed event is positive or negative (the “evaluative” function). Using fMRI, the research team examined the brain activity of 24 subjects (13 female, 11 male) in response to different prompts to imagine a future event. Read More
The novel coronavirus, SARS-CoV-2, has had a major impact on vulnerable communities. While measures to mitigate risk of infection have been undertaken, many communities still face higher risk of poor outcomes. Higher risk in minority communities is associated with lower socioeconomic status and inability to practice mitigation efforts due to societal constraints. Location can pose even more risk with rural communities facing unique challenges due to historically lower access to healthcare. Research funded by NIGMS sought to identify factors related to low levels of COVID-19 testing among rural communities to provide testing insights and pinpoint where testing needs can be improved in rural minority populations. Learn More
Atypical eye gazing is a well-studied early symptom of toddlers/children with autism spectrum disorder (ASD). However, current eye-tracking methods require special equipment and the process can be cost prohibitive. Is it possible to develop a low-cost software application (app) that can be used on mobile phones or tablets to help diagnose abnormal eye gazing patterns of toddlers with ASD? If so, can this software produce reliable results that can be used by clinicians in a cost-effective manner? A study sponsored by the NICHD and the NIMH pursued these questions by assessing the effectiveness of an app that analyzes vision on an iPhone or iPad to discern and quantify differences in eye gaze patters of toddlers with ASD versus typical development. Go There Now
Register: Music and Health Virtual Webinar on June 18
Music and Health: Assessing and Measuring Target Engagement—Mechanistic and Clinical Outcome Measures for Brain Disorders of Aging
Friday, June 18, 2021
1:00 p.m. to 4:00 p.m. ET
This is the second of three meetings that are part of Phase I of a NIH/Foundation for the National Institutes of Health (FNIH) project to develop evidence-based music therapies for brain disorders of aging.
This meeting will gather input from participants in the music therapy/music medicine, neuroscience, behavioral intervention development, clinical trial methodology, and patient advocacy/art organization communities. The NIH planning committee will assess, evaluate, and identify the most feasible and relevant functional outcome measures in domains relevant to brain disorders of aging: cognition, emotion, and motor and sensory functions. This core dataset of outcome measures will be used in future NIH-funded music-based intervention protocols.
Download the program book, which includes abstracts, bios, and panelists' questions.
Save the Date: August 25, 2021: Relating Target Engagement to Clinical Benefit: Biomarkers for Brain Disorders of Aging
Register Now
NINDS Strategic Plan 2021–2026: Investing in the Future of Neuroscience
The NINDS Strategic Plan 2021–2026: Investing in the Future of Neuroscience was released in May and is available at https://www.ninds.nih.gov/strategic-plans/2021. The plan has been designed to live online in order to allow NINDS to more easily track our progress in implementing its goals by linking implementation activities (e.g., new programs, initiatives, policies, scientific advances) to specific objectives in the plan and easily communicate these to our stakeholders.
The NINDS Strategic Plan 2021–2026: Investing in the Future of Neuroscience presents an overarching strategic framework to accelerate science that we hope will result in improvements in quality of life for all people with neurological disorders, and ultimately prevent or cure these diseases.
Then plan has four overall goals:
- NINDS supports and performs a broad array of rigorous and important neuroscience research from fundamental studies of basic nervous system function to studies to improve treatments and prevent neurological disorders.
- NINDS funds and conducts neuroscience research training and career development programs to ensure a vibrant, talented, and diverse neuroscience workforce.
- NINDS promotes dynamic communication and diverse stakeholder engagement to accelerate scientific progress and reduce the burden of neurological disorders.
- NINDS aspires to create and sustain a supportive work culture for the Institute’s workforce that becomes the model for biomedical research and the neuroscience community.
The plan also includes 11 core strategies that cut across all NINDS scientific goals and will be essential to implementation of the Strategic Plan.
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NIH Joint 40th Anniversary of the Morbidity and Mortality Report Related to the Naming of AIDS Statement
It has been 40 years since the landmark 1981 CDC Morbidity and Mortality Weekly Report (MMWR) was published—a report that first recognized the syndrome of diseases later named AIDS. June 5 also marks HIV Long-term Survivors Awareness Day.
The scientific community did not know at the time exactly what the observations meant, nor that the human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) pandemic was underway. In retrospect, the responses by leaders were staggering and a tribute to what we can achieve together.
NIH investment in HIV research has produced nearly 40 years of groundbreaking discoveries and innovation. Through a multi-disciplinary, comprehensive, and increasingly integrated research approach, NIH research products contribute to the implementation of prevention, care, and treatment interventions that match the needs of a given community—and are delivered at the scale needed to achieve the goals of the research priorities. Go There Now
FDA Seeking to Hire Behavioral and Social Scientists
The Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER), located at the White Oak campus in Silver Spring, MD, is recruiting psychometricians, outcomes researchers, epidemiologists, survey methodologists/instrument developers, patient preference researchers and behavioral/social scientists (including psychology, cognitive science and neuroscience) to serve as experts in the evaluation and use of clinical outcome assessments (COAs), such as instruments and questionnaires (including use of innovative platforms for data collection) to measure health outcomes in the dynamic, challenging, and innovative atmosphere of drug development and research.
Selected candidates will join the Division of Clinical Outcome Assessment (DCOA) where they will contribute to a culture that ensures the patient voice is integrated into medical product development through incorporation of clinical trial endpoints that are meaningful to patients, valid, reliable, and responsive to treatment. DCOA members provide advice and consultation on endpoint development, instrument development, validation, and interpretation for use in drug development.
Team members also participate in guidance and policy development to ensure that meaningful drug product information is available to health care providers, caregivers, and patients.
Team members collaborate with diverse stakeholders both internally and externally across a variety of therapeutic areas including representatives from academia, medical product industry, consortia, instrument developers, patient groups, regulators and other government agencies to advance the science of clinical outcome assessment and enhance the development and implementation of appropriate assessment tools in drug development.
SALARY AND BENEFITS: Salary is commensurate with education and experience. We offer an excellent benefits package (health insurance, life insurance, thrift savings plan, retirement, etc.) and many opportunities to continue professional development.
EXPERIENCE AND SKILLS SOUGHT:
- Relevant doctoral degree
- At least 1year instrument development experience preferred
- Ability to adapt to a changing environment and handle multiple priorities
- Excellent communication, critical thinking and analytical skills
INTERESTED CANDIDATES: Please submit your Curriculum Vitae to [email protected]. Additional information may also be found at www.fda.gov/coa.
2021 NIH Behavioral and Social Sciences Research Festival
SAVE THE DATE: Friday, November 19, 2021
The Annual NIH Behavioral and Social Sciences Research Festival will be hosted by OBSSR and the NIH Behavioral and Social Sciences Research Coordinating Committee. The purpose of the festival is to highlight recently funded behavioral and social sciences research that the NIH supports; bring together behavioral and social scientists within the NIH extramural and intramural communities to network with each other and share scientific ideas; and explore ways to advance behavioral and social sciences research.
View Past Research Festival Materials
BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)
FOA Number
RFA-NS-21-026
Key Dates
Open Date (Earliest Submission Date): September 29, 2021
Expiration Date: October 28, 2023
Purpose
Understanding the dynamic activity of brain circuits is central to the NIH BRAIN Initiative. This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). This FOA seeks exceptionally creative approaches to address major challenges associated with recording and modulating CNS activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high-risk, but if successful, could profoundly change the course of neuroscience research.
View RFA-NS-21-026
BRAIN Initiative: Optimization of Transformative Technologies for Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)
FOA Number
RFA-NS-21-027
Key Dates
Open Date (Earliest Submission Date): September 29, 2021
Expiration Date: October 28, 2023
Purpose
Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative. The invention, proof-of-concept investigation, and optimization of new technologies through iterative feedback from end users are key components of the BRAIN Initiative. This FOA seeks applications to optimize existing or emerging technologies through iterative testing with end users. The technologies and approaches should have potential to address major challenges associated with recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). These technologies and approaches should have previously demonstrated their transformative potential through initial proof-of-concept testing and are now ready for accelerated refinement. In conjunction, the manufacturing techniques should be scalable toward sustainable, broad dissemination and user-friendly incorporation into regular neuroscience research.
View RFA-NS-21-027
