Key Dates

Related Announcements

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to promote and support innovative methods in Big Data Science (BDS) to identify unappreciated biomedical, behavioral, social patterns and other social determinants that shed light on HIV acquisition, transmission, the development of comorbidities, and long-term viral control as in the HIV treatment continuum. BDS approaches can bring together data to evaluate the complex interplay between individual, contextual, and structural factors influencing the epidemiology of risk and care. Further, because this field can reveal unexpected associations through analysis of diverse data, BDS approaches may reveal events that are unseen or transient in traditional analysis of datasets. Discovery of these events will considerably advance research on HIV networks of transmission and the care continuum. This NOSI will support the establishment of BDS standards, bioinformatics data tools, machine-learning algorithms, mathematical modeling, advanced epidemiology and statistical analytic methods, and consideration and application of privacy and ethical issues in the use of public and personal data in the context of HIV research.

Background

The NIH established the NIH Strategic Plan for Data Science to promote research and to develop biomedical computing and informatics focused on important biomedical and behavioral problems. BDS specifically refers to research that capitalizes on the increased analytical speed, data storage capacity and liquidity of diverse data from health, genomics, community characteristics, environment, social media, and commercial activities. Thus, data in BDS are characterized by their high volume and variety, and the field is evolving to capture, manage, organize, integrate, harmonize, and analyze data to extract new knowledge.

The NIH is interested in promoting and applying BDS technologies, computing, informatics, and analytics to address gaps in our understanding of HIV transmission risks, social networks, and the HIV treatment continuum, including comorbidities such as mental health and substance use disorders. The NIH seeks to expand actionable approaches to improve HIV prevention and treatment. While BDS methods can provide insight into health behaviors, there are also ethical considerations. Examples include issues of anonymity and the use of data, collected under conditions thought to be private or combined in ways unanticipated by the community. Yet, because of the ability to elucidate associations not seen in less diverse data sets and the inherent scalability, these methods may yield transformative approaches in HIV prevention, treatment, and long-term outcomes. BDS research may also be able to shed light on behaviors that occur outside of venues surveyed by health professionals, or behaviors that are significantly modified by the presence of others, and thus are difficult to document. Research that seeks to identify rare, unseen, and perhaps transient events, networks, risk and health seeking behaviors as they pertain to HIV will fundamentally improve the quality of the inferences but may risk a loss of privacy or confidentiality. Accompanying this work, the NIH expects the involvement of a bioethicist and development of an ethical framework where appropriate.

Research Objectives

This NOSI seeks to promote multidisciplinary collaborations across epidemiology, bioinformatics, mathematical modeling, statistics, social and behavioral sciences, HIV prevention and care, and bioethics, among others, to address the following:

• Improve our understanding of HIV risk, health seeking behaviors, mental health, social determinants of health and the complex contextual environment in which they occur.
• Develop and advance the ethical framework to evaluate Big Data methods and explore ethical challenges in conducting big data research, including privacy concerns, access to specific types of data, communication among users of data and the research community.

Specific areas of research interest include but are not limited to:

• Using heterogeneous data types and sources to explore, identify, classify, and characterize social, behavioral, and contextual factors that put individual people at risk for HIV acquisition
• Simulation modeling to explore patterns of social networks, risk, and health seeking behaviors, in time and in transitions in HIV prevention and treatment
• Explore machine learning to process and visualize data, learn patterns iteratively, and predict the unknown based on what is known about HIV and the context in which it occurs with attention to potential biases from source data or algorithms
• Differentiation of sex, race/ethnicity, sexual preference, geographic as well as economic factors to explain disparities in HIV disease acquisition, retention in care, and long-term outcomes, including comorbidities
• Insight into HIV test-seeking behaviors using the linkage, modelling, and iterative processing of social media, or other effluent data, geospatial, pharmaceutical or commercial data, or sources of de-identified laboratory test results
• Using viral phylogenetics and data characterizing human phenotypes to define HIV transmission networks that can inform the development of approaches to disrupt them
• Analyzing ethical, legal, and policy issues raised by BDS in HIV research and developing appropriate working guidance documents or policy frameworks to guide research
• Studies that use BDS and/or existing big data sources to gain insights on HIV-associated malignancies, including but not limited to, insights on their epidemiology, pathogenesis, screening, and optimal treatment

NIDA is interested in research proposing novel ways to integrate data of different types and scales to allow new types of analysis through big data science approaches to:

• Address research gaps in the implementation of HIV prevention and care continuum for people who use drugs (PWUD)
• Address research gaps in the roll out and uptake of evidence-based service strategies e.g. SSP at all levels of government and community-based healthcare systems to eliminate HIV transmission in networks of people who inject drugs (PWID)
• Identify factors contributing to socioeconomic, ethnic and gender-based disparities in HIV prevention and care among PWUD
• Develop risk prediction models that inform HIV interventions for PWUD

It is critical to enhance data-sharing and access to ensure that funded data be Findable, Accessible, Interoperable, and Reusable (FAIR).All NIAID-funded researchers are encouraged to share research data, tools, software, or resources to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guidelinesat: https://www.niaid.nih.gov/research/data-sharing-guidelines, as appropriate.

The NIH recognizes that certain factors (e.g.,legal, ethical, technical) may limit the ability to preserve and share data. Any data or resource sharing plans must ensure data security and compliance with privacy protections for human data. Plans should include consideration of these factors, when applicable, in describing the approach to data management and data sharing. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html

The areas below will NOT be supported through this NOSI:

• Establishment of new cohorts requiring primary data collection or generation
• Clinical trials requiring an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application or assessing the safety of the intervention
• Clinical trial planning activities for protocol development.

Application and Submission Information

This notice applies to due dates on or after September 7, 2021 and subsequent receipt dates through May 7, 2024.

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guideand the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-AI-21-054 (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

Scientific/Research Contact(s)

Rosemary McKaig, M.P.H, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3214
Email: rm434n@nih.gov

Susan Wright, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6683
Email: susan.wright@nih.gov

Lori A.J. Scott-Sheldon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-792-2309
Email: lori.scott-sheldon@nih.gov

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2899
Email: adevine@niaid.nih.gov

Pam Flemming
National Institute on Drug Abuse (NIDA)
Telephone: 301- 480-1159
Email: pfleming@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov