Strategies for Responsibly Reporting Back Environmental Health and Non-Genomic Research Results (R01 Clinical Trial Optional) | RFA ES 23 006

Opportunity Information: Apply for RFA ES 23 006

The NIH, led by the National Institute of Environmental Health Sciences (NIEHS) and working with the NIH Office of Science Policy (OSP), the All of Us Research Program, and the National Human Genome Research Institute (NHGRI), is funding R01 research projects that focus on one central challenge: how to responsibly return environmental health, non-genomic research, and gene-by-environment (GxE) findings to people who participate in studies and to other important decision-makers who may use those results. The opportunity is aimed at supporting projects that do more than discuss return-of-results in theory. Applicants are expected to identify, develop, adapt, and then actually test practical strategies for communicating these types of research findings in ways that are ethical, understandable, useful, and appropriate for the audiences receiving them.

A major theme of the announcement is that environmental health and other non-genomic results often raise complicated questions that are different from traditional clinical lab reporting. Environmental exposure data, biomarkers, or GxE findings can be uncertain, context-dependent, and hard to translate into clear personal action steps. This grant opportunity is therefore designed to advance real-world methods for reporting back results that balance potential benefits (transparency, participant empowerment, trust, possible health-protective actions) with potential risks (confusion, anxiety, misunderstanding of uncertainty, stigma, or misuse of information). It explicitly allows projects to focus on returning results directly to study participants and/or to key partners such as health care professionals, Institutional Review Boards (IRBs), and policy makers, reflecting the reality that responsible return-of-results often involves multiple audiences, each with different needs, responsibilities, and levels of technical background.

The mechanism is an R01 (Clinical Trial Optional), meaning applicants can propose studies that include a clinical trial component if it fits the aims, but a clinical trial is not required. In practice, that flexibility supports a wide range of research designs, such as randomized evaluations of different communication approaches, pragmatic trials embedded in cohort studies, implementation studies that test how return-of-results workflows function in real research settings, and mixed-methods projects that combine qualitative feedback with quantitative outcomes. The funding activity is categorized under environment and health, and it is associated with CFDA numbers 93.113 and 93.172. The funding opportunity number is RFA-ES-23-006, and it was created on 2023-04-03 with an original closing date of 2023-06-15. The listing does not provide an award ceiling or the expected number of awards in the source data provided.

Eligibility is broad across U.S.-based organizations and includes many common NIH applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Overall, this opportunity is about building and testing evidence-based ways to communicate environmental and other non-genomic findings back to participants and stakeholders, with careful attention to ethics, comprehension, uncertainty, and real-world use. The intended impact is to improve how research programs handle return-of-results in environmental health and related fields, strengthening participant-centered research practices while also supporting consistent, responsible decision-making among clinicians, oversight bodies, and policy leaders who may be influenced by these findings.

• The National Institutes of Health in the environment, health sector is offering a public funding opportunity titled "Strategies for Responsibly Reporting Back Environmental Health and Non-Genomic Research Results (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172.
• This funding opportunity was created on 2023-04-03.
• Applicants must submit their applications by 2023-06-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA ES 23 006

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