Notice of Change to NHGRI-specific language in RFA-HG-23-017, Investigator-Initiated Research in Genomics and Health Equity (R01 Clinical Trial Optional)
Notice Number:
NOT-HG-24-031

Key Dates

Release Date:

April 12, 2024 

Related Announcements

  • June 5, 2023 - Investigator-Initiated Research in Genomics and Health Equity (R01 Clinical Trial Optional). See NOFO RFA-HG-23-017

Issued by

National Human Genome Research Institute (NHGRI)

Purpose

The purpose of this Notice is to inform potential applicants of changes to NHGRI-specific language and non-responsive criteria in RFA-HG-23-017

The following sections of RFA-HG-23-017 have been modified (changes in bold italics). 

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Currently Reads:

Background

Although advances in genomic discovery and technology have fueled the application of genomics to improve understanding of human health and disease, not all groups have benefitted equitably. Without equity in research, resource allocation, and clinical practice, disparities in the benefits of genomic research and its applications will persist. The 2020 NHGRI Strategic Vision includes a bold prediction that within the next 10 years, individuals from ancestrally diverse and underrepresented backgrounds will benefit equitably from advances in human genomics. In April 2022, NHGRI held a virtual public workshop to understand the gaps and opportunities in genomic health equity research and identify research directions that will help to alleviate health disparities and advance health equity. The workshop report, which includes recommendations from attendees, inform the scope and objectives of this RFA.

Program Description

Scope and objectives

This NOFO, together with RFA-HG-23-018, will support investigator-initiated research in genomics and health equity. NIH recognizes the importance of innovative, nimble, and focused approaches that originate from independent researchers and their teams. By supporting both R01 and R21 applications, independent research based on either mature scientific ideas with preliminary data (R01) or at the exploratory or developmental level (R21) is encouraged. All supported investigators are expected to actively participate in one annual meeting in which substantial information sharing is anticipated. This approach will allow for independent but synergistic efforts among supported investigators and promote rapid sharing of successful approaches and resulting data.

Health equity is relevant across all aspects of genomic research. This initiative will solicit applications to conduct research that addresses health equity in the areas in genomics that are related to the research missions of NHGRI, NIA, NCI and ORWH. The research supported by this initiative will address broader implications of health equity beyond demonstrated health outcomes in individuals. Applicants are encouraged to include populations or communities that experience health disparities, such as racial or ethnic minority groups, people with lower socioeconomic status (SES), socioeconomically disadvantaged populations, underserved rural communities, and sexual and gender minority groups. The research supported by this initiative also includes women and individuals with disabilities, as relevant to the scientific question to be investigated. Efforts related to rigorous community engagement preceding or as part of the research are encouraged. However, the application must go beyond simple inclusion of women or an health disparity or disability population and show evidence that the research will address health equity in genomics.

Addressing health disparities and health equity through a genomic lens relates to a number of research areas, including but not limited to the following examples.

National Human Genome Research Institute (NHGRI)

  • Access to high-quality and comprehensive genomic information
    • Improving prediction of molecular variation from genetic variation in admixed populations, in conjunction with biological and social determinants of health
    • Maximizing the utility of genomic, social, and environmental data to address health disparities in women or health disparity or disability populations
    • Addressing challenges to genomic data sharing or data science that impact health equity
    • Integrating genomic data with fine-scale data across multiple dimensions (other -omics, precision environmental health) to better characterize health disparities
  • Development of accessible technology and methods
    • Developing and implementing genomic technology for under-resourced laboratories and clinics
  • Access to genomic technology or testing; quality or management of genomic testing results
    • Distinguishing the utility of race and other socially defined descriptors from genomic information in determining laboratory reference values and clinical algorithms
    • Identifying the gaps between the prognostic and diagnostic properties that genomic tests need to have to impact health disparities, and the current properties of genomic tests; designing strategies to address those gaps
    • Conducting decision science, economic or healthcare utilization studies around new genomic technologies or genomic testing that impacts equitable allocation of clinical resources
    • Conducting ethical, legal and social implication studies around equitable integration of genomics into clinical care and society for underserved and health disparity populations
  • Acceptability of genomic approaches and interventions to the public.
    • Developing and applying metrics of health equity in genomic research that are acceptable and useful to communities, participants, and researchers
    • Identifying and overcoming barriers that limit participation in and benefit from genomic research, particularly barriers stemming from structural and social inequities
    • Developing and evaluating models of engagement and inclusion of communities, particularly women or health disparity or disability populations, in genomics research studies of health equity

Applicants are encouraged to utilize Social Determinants of Health (SDOH) measures in the PhenX Toolkit, as relevant.

National Cancer Institute (NCI)

Of specific interest to NCI will be applications aimed at improving the discovery, utilization, and translation of genetic information in the prevention, detection and treatment of cancer across diverse populations, including through:

National Institute on Aging

The mission of the National Institute on Aging (NIA) is to support and conduct biological, clinical, behavioral, social, and economic research on Aging; foster the development of research and clinician scientists in Aging; provide research resources to facilitate innovative aging research; and disseminate information about Aging and related advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA will support meritorious applications that focus on aging research as well as Alzheimer’s Disease and related dementia (AD/ADRD). Studies that draw data from across the lifespan are especially encouraged and applicants are expected to factor sex as a biological variable into research designs, analyses and reporting in vertebrate animal and human studies. Applicants interesting in submitting applications on aging and AD/ADRD should review the NIA Strategic Directions for Research, 2020 2025 and the AD/ADRD Research milestones for more information on NIA’s research priorities.

NIH Office of Research on Women's Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director, and works in partnership with the NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations.

For the purpose of this NOFO, ORWH will support research that focuses on health disparities in genomic research to eliminate health disparities among women, including populations of women who are understudied, underrepresented, and underreported (U3) in research. The evolving conceptualization of factors relevant to the understanding and reduction of health disparities is illustrated in the NIMHD Minority Health and Health Disparities Research Framework. Applying such a framework to genomic research will help to advance community engagement in biomedical research, and acceptability of genomic approaches, and increase access to genomic technology and interventions needed to advance the equitable use of genomic data to improve health in US populations.

There is also a crucial need to address sex and gender influences in genomic research relevant to women's health, and, as appropriate, address the influence of sex as a biological variable (SABV) in the context of genomic research on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for everyone. For additional guidance, please review the 2019-2023 Trans-NIH Strategic Plan for the Health of Women.

Data sharing

Recipients must comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports the broadest appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

  • Transdisciplinary research projects and collaborations among researchers from different disciplines.
  • Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Individual applications and partnerships that enhance geographic and regional heterogeneity.
  • Investigators and teams composed of researchers at different career stages.
  • Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
  • Opportunities to enhance the research environment to benefit early- and mid-career investigators.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from minority and other health disparity populations into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. For more information, see Notice of NIH's Interest in Diversity, NOT-OD-20-031 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further the NIH mission.

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. Despite tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program.

Applications from New or Early Stage Investigators

This initiative will champion a diverse genomics research workforce by supporting New or Early Stage Investigators from diverse backgrounds, including those from underrepresented groups. For the purpose of this RFA, a New Investigator (NI) is an investigator who has not worked with their institution to compete successfully for substantial, independent funding from NIH. An Early Stage Investigator (ESI) is an investigator who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously worked with their institution to compete successfully as PD/PI for a substantial NIH independent research award. Additional information on NI/ESI status can be found at https://grants.nih.gov/policy/early-stage/index.htm.

The R01 and R21 applications supported by this initiative will be distinguished by their emphasis on genomics and health equity. NHGRI offers other NOFOs for R01 or R21 applications from New and/or Early Stage Investigators (https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-21-041.html, https://grants.nih.gov/grants/guide/pa-files/PAR-19-222.html, https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-22-001.html). NI or ESI proposing research that addresses other areas of NHGRI’s mission, but without a specific focus on health equity, are encouraged to contact the Scientific Contacts for those NOFOs.

Non-responsive applications

Applications with the following properties will be considered non-responsive, and will not be reviewed:

  • Applications without a focus on health equity, even if the research is conducted in an understudied or underrepresented population.
  • Applications that do not have a primary focus on genomics research.
  • Applications that do not include a Plan for Enhancing Diverse Perspectives (PEDP).

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the NOFO scientific/research contact prior to submission to discuss whether their application is responsive.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Modified to read (changes shown in bold italics):

Background

Although advances in genomic discovery and technology have fueled the application of genomics to improve understanding of human health and disease, not all groups have benefitted equitably. Without equity in research, resource allocation, and clinical practice, disparities in the benefits of genomic research and its applications will persist. The 2020 NHGRI Strategic Vision includes a bold prediction that within the next 10 years, individuals from ancestrally diverse and underrepresented backgrounds will benefit equitably from advances in human genomics. In April 2022, NHGRI held a virtual public workshop to understand the gaps and opportunities in genomic health equity research and identify research directions that will help to alleviate health disparities and advance health equity. The workshop report, which includes recommendations from attendees, inform the scope and objectives of this RFA.

Program Description

Scope and objectives

This NOFO, together with RFA-HG-23-018, will support investigator-initiated research in genomics and health equity. NIH recognizes the importance of innovative, nimble, and focused approaches that originate from independent researchers and their teams. By supporting both R01 and R21 applications, independent research based on either mature scientific ideas with preliminary data (R01) or at the exploratory or developmental level (R21) is encouraged. All supported investigators are expected to actively participate in one annual meeting in which substantial information sharing is anticipated. This approach will allow for independent but synergistic efforts among supported investigators and promote rapid sharing of successful approaches and resulting data.

Health equity is relevant across all aspects of genomic research. This initiative will solicit applications to conduct research that addresses health equity in the areas in genomics that are related to the research missions of NHGRI, NIA, NCI and ORWH. The research supported by this initiative will address broader implications of health equity beyond demonstrated health outcomes in individuals. Applicants are encouraged to include populations or communities that experience health disparities, such as racial or ethnic minority groups, people with lower socioeconomic status (SES), socioeconomically disadvantaged populations, underserved rural communities, and sexual and gender minority groups. The research supported by this initiative also includes women and individuals with disabilities, as relevant to the scientific question to be investigated. Efforts related to rigorous community engagement preceding or as part of the research are encouraged. However, the application must go beyond simple inclusion of women or an health disparity or disability population and show evidence that the research will address health equity in genomics.

Addressing health disparities and health equity through a genomic lens relates to a number of research areas, including but not limited to the following examples.

National Human Genome Research Institute (NHGRI)

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics research cannot be fully achieved.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate NIH Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

Examples of genomic and health equity research to be supported by this RFA include, but are not limited to:

  • Access to high-quality and comprehensive genomic information
    • Improving prediction of molecular variation from genetic variation in admixed populations, in conjunction with biological and social determinants of health
    • Maximizing the utility of genomic, social, and environmental data to address health disparities in women or health disparity or disability populations
    • Addressing challenges to genomic data sharing or data science that impact health equity
    • Integrating genomic data with fine-scale data across multiple dimensions (other -omics, precision environmental health) to better characterize health disparities
  • Development of accessible technology and methods
    • Developing and implementing genomic technology for under-resourced laboratories and clinics
  • Access to genomic technology or testing; quality or management of genomic testing results
    • Distinguishing the utility of race and other socially defined descriptors from genomic information in determining laboratory reference values and clinical algorithms
    • Identifying the gaps between the prognostic and diagnostic properties that genomic tests need to have to impact health disparities, and the current properties of genomic tests; designing strategies to address those gaps
    • Conducting decision science, economic or healthcare utilization studies around new genomic technologies or genomic testing that impacts equitable allocation of clinical resources
    • Conducting ethical, legal and social implication studies around equitable integration of genomics into clinical care and society for underserved and health disparity populations
  • Acceptability of genomic approaches and interventions to the public.
    • Developing and applying metrics of health equity in genomic research that are acceptable and useful to communities, participants, and researchers
    • Identifying and overcoming barriers that limit participation in and benefit from genomic research, particularly barriers stemming from structural and social inequities
    • Developing and evaluating models of engagement and inclusion of communities, particularly women or health disparity or disability populations, in genomics research studies of health equity

Applicants are encouraged to utilize Social Determinants of Health (SDOH) measures in the PhenX Toolkit, as relevant.

National Cancer Institute (NCI)

Of specific interest to NCI will be applications aimed at improving the discovery, utilization, and translation of genetic information in the prevention, detection and treatment of cancer across diverse populations, including through:

National Institute on Aging

The mission of the National Institute on Aging (NIA) is to support and conduct biological, clinical, behavioral, social, and economic research on Aging; foster the development of research and clinician scientists in Aging; provide research resources to facilitate innovative aging research; and disseminate information about Aging and related advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA will support meritorious applications that focus on aging research as well as Alzheimer’s Disease and related dementia (AD/ADRD). Studies that draw data from across the lifespan are especially encouraged and applicants are expected to factor sex as a biological variable into research designs, analyses and reporting in vertebrate animal and human studies. Applicants interesting in submitting applications on aging and AD/ADRD should review the NIA Strategic Directions for Research, 2020 2025 and the AD/ADRD Research milestones for more information on NIA’s research priorities.

NIH Office of Research on Women's Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director, and works in partnership with the NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations.

For the purpose of this NOFO, ORWH will support research that focuses on health disparities in genomic research to eliminate health disparities among women, including populations of women who are understudied, underrepresented, and underreported (U3) in research. The evolving conceptualization of factors relevant to the understanding and reduction of health disparities is illustrated in the NIMHD Minority Health and Health Disparities Research Framework. Applying such a framework to genomic research will help to advance community engagement in biomedical research, and acceptability of genomic approaches, and increase access to genomic technology and interventions needed to advance the equitable use of genomic data to improve health in US populations.

There is also a crucial need to address sex and gender influences in genomic research relevant to women's health, and, as appropriate, address the influence of sex as a biological variable (SABV) in the context of genomic research on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for everyone. For additional guidance, please review the 2019-2023 Trans-NIH Strategic Plan for the Health of Women.

Data sharing

Recipients must comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports the broadest appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

  • Transdisciplinary research projects and collaborations among researchers from different disciplines.
  • Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Individual applications and partnerships that enhance geographic and regional heterogeneity.
  • Investigators and teams composed of researchers at different career stages.
  • Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
  • Opportunities to enhance the research environment to benefit early- and mid-career investigators.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from minority and other health disparity populations into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. For more information, see Notice of NIH's Interest in Diversity, NOT-OD-20-031 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further the NIH mission.

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. Despite tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program.

Applications from New or Early Stage Investigators

This initiative will champion a diverse genomics research workforce by supporting New or Early Stage Investigators from diverse backgrounds, including those from underrepresented groups. For the purpose of this RFA, a New Investigator (NI) is an investigator who has not worked with their institution to compete successfully for substantial, independent funding from NIH. An Early Stage Investigator (ESI) is an investigator who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously worked with their institution to compete successfully as PD/PI for a substantial NIH independent research award. Additional information on NI/ESI status can be found at https://grants.nih.gov/policy/early-stage/index.htm.

The R01 and R21 applications supported by this initiative will be distinguished by their emphasis on genomics and health equity. NHGRI offers other NOFOs for R01 or R21 applications from New and/or Early Stage Investigators (https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-21-041.html, https://grants.nih.gov/grants/guide/pa-files/PAR-19-222.html, https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-22-001.html). NI or ESI proposing research that addresses other areas of NHGRI’s mission, but without a specific focus on health equity, are encouraged to contact the Scientific Contacts for those NOFOs.

Non-responsive applications

Applications with the following properties will be considered non-responsive, and will not be reviewed:

  • Applications without a focus on health equity, even if the research is conducted in an understudied or underrepresented population.
  • Applications that do not have a primary focus on genomics research.
  • Applications that do not include a Plan for Enhancing Diverse Perspectives (PEDP).
  • Applications not aligned to any participating NIH Institute/Center/Office mission and area of interest, as described above

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the NOFO scientific/research contact prior to submission to discuss whether their application is responsive.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Inquiries

Please direct all inquiries to:

Lucia Hindorff, Ph.D.

National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: [email protected]