Key Dates

Related Announcements

• May 10, 2021 - Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional). See NOFO PA-21-219.
• May 7, 2020 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed). See NOFO PA-20-200.
• May 5, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183.
• May 5, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184.
• May 5, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

Research Objectives and Approaches

Ethical considerations are intrinsic to the responsible conduct of neuroscience research and the translation of neuroscience advances (scientific and technological) into practice. This Notice of Special Interest (NOSI) highlights interest in receiving grant applications to advance research on ethical questions relevant to the NINDS mission of pursuing important work to gain a deeper understanding of the brain and nervous system to develop effective therapies for all people.

Proposed approaches may include but are not limited to data-generating qualitative and quantitative approaches, normative analyses, and other types of analytical and conceptual research methodologies, such as those involving the direct engagement of stakeholders. Applications may aim to further characterize a particular ethical challenge, or may propose studies using either single or mixed methods. Applications for PA-20-183 should refer to the R01 Clinical Trial Required IC-Specific Scientific Interests and Contact website. 

Applications not within the NINDS mission or nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative. Applicants are strongly encouraged to contact a program officer prior to submitting an application.

Overarching areas of interest include but are not limited to:

Challenges/questions in the domain of research ethics:

• Differing stakeholder views on trial design, return of research results to participants (including genetic results that may have impacts on family members), informed consent-related issues (including but not limited to waivers of informed consent or exceptions from informed consent), or therapeutic misconception, including for rare diseases
• Issues related to human donors of biological materials, including research with brain organoids or ex vivo human brain tissue
• Clinical and non-clinical data sharing; big data and data science analytics; integration of different types of data for research; secondary data analyses on existing datasets; countering biases in datasets and algorithms; data de-identification, privacy, and re-use practices
• Precision and personalized medicine
• Development and/or application of gene therapy and gene editing technologies for neurological/neuromuscular disorders
• Patient/participant representation in research oversight and study design
• Advances in neural recording and/or neuromodulation in children, or people with a limited ability or inability to consent for themselves
• Individual or community health, treatment, and/or research disparities; accessing and sharing benefits of research; post-trial obligations
• International research including research in resource-constrained settings, trans-national research, and research in low- and middle- income countries
• The development and use of neuromodulation and neuroimaging technologies, such as device maintenance, data security, and intended and unintended uses of these technologies
• Emergency medical care research conducted under Exception from Informed Consent Requirements for Emergency Research

Challenges/questions related to ethical or societal implications of research and advancements (for individuals, groups, and/or society):

• Ethical considerations and best practices for research with NIH-designated populations that experience health disparities, including:
  • Fair participant selection and representativeness of research participants
  • Community-engaged research (including bidirectional communication and input)
  • Potential neurological health and healthcare disparities or inequities created by artificial intelligence/machine learning
  • Designing and evaluating culturally appropriate tools or approaches to aid individual, family, and community decision-making and education about use of digital health technologies and/or real-world data
  • Issues related to the inclusion of individuals from groups historically underrepresented in biomedical research
• Ethical considerations and best practices for research related to vulnerable populations, including:
  • Research with populations, including pediatric, geriatric, palliative care, and individuals with cognitive impairment
  • Research on stigmatized conditions
• Predictive/diagnostic research related to brain and nervous system disorders
• Use of algorithms and/or artificial intelligence as tools in clinical care
• Issues related to expanded access/right to try
• Concerns related to genetic testing and insurance coverage
• Differential effects of neuroscience advances on different groups in society and supporting equitable dissemination of the products of neuroscience research
• The identification of biomarkers or neural correlates (e.g., for stigmatized diseases, or to predict the development of disease) and their effects on patients
• Use of new and emerging technology in the treatment of nervous system-based diseases/disorders, such as: gene editing; organoids; artificial intelligence; machine learning; neural implants and invasive or non-invasive modulation; digital health; consumer-generated data; synthetic biology

NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy).

Application and Submission Information

This notice applies to due dates on or after October 5, 2024 and subsequent receipt dates through October 16, 2027. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcements through the expiration date of this notice.

• PA-20-183 Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184 Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-200 NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-21-219 Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-NS-24-073” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Nina Hsu, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Division of Extramural Activities
Email: nina.hsu@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov