Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional) | RFA EB 23 005

Opportunity Information: Apply for RFA EB 23 005

Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity that supports exploratory, early-stage research focused on the ethical questions that come up when bionic and robotic technologies are created and moved into real-world use. The central idea is that ethics is not an afterthought in this field; it is built into every step of the process. Projects are expected to examine bioethical issues that can arise across the full lifecycle of these technologies, including device design decisions, laboratory and preclinical work, first-in-human and later-stage testing (if applicable), and broader implementation in clinical care or community settings. Because this is an R21 mechanism, it is generally aimed at innovative, proof-of-concept work that can generate foundational evidence, frameworks, or methods that later efforts can build on. The listing notes that clinical trials are optional, meaning applicants can propose studies that do not involve clinical trials as well as projects that may include them, as long as the work fits the ethical research focus.

The scope is deliberately broad: it covers both bionic devices (such as prosthetics, neural interfaces, sensory restoration systems, or implantable assistive technologies) and robotic devices (including rehabilitation robotics, assistive robots, or other human-interactive robotic systems). The ethical research may address questions that emerge during development and translation, such as how researchers and developers should weigh benefits and risks, how informed consent should be handled when devices are complex or rapidly evolving, how to manage uncertainty about long-term effects, and how to ensure that user perspectives and lived experience meaningfully shape design and evaluation. It also naturally includes issues tied to autonomy, agency, identity, privacy and data governance (especially where sensors or neural data are involved), accountability when systems fail or behave unpredictably, fairness and access, appropriate participant selection, and responsible communication about capabilities and limitations to avoid hype or therapeutic misconception. The emphasis is not on building the devices themselves, but on producing rigorous research that clarifies ethical challenges and proposes practical, evidence-informed approaches to address them.

The opportunity is identified as RFA-EB-23-005 and falls under a discretionary grant category, with a funding activity category of health and CFDA number 93.286. The original closing date listed is 2025-01-22, and the opportunity was created on 2023-04-28. While the provided source text does not specify an award ceiling or expected number of awards, it clearly frames the program’s purpose: to stimulate bioethics research that keeps pace with fast-moving bionic and robotic innovation and helps guide responsible translation into practice.

Eligibility is broad and includes many types of U.S.-based applicants: 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The NOFO also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions, as well as Indian/Native American tribal governments that are not federally recognized.

For international participation, the rules are specific: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components, as defined by the NIH Grants Policy Statement, are allowed. In practice, that means a U.S. applicant can include certain foreign collaborations or project components when justified and compliant with NIH policy, but a foreign institution cannot serve as the primary applicant.

Overall, this NOFO is aimed at building the ethical evidence base and practical guidance needed to develop and translate bionic and robotic devices responsibly. It supports projects that can meaningfully influence how these technologies are designed, tested, evaluated, and implemented, with careful attention to human subjects, users, communities, and the broader societal impact of increasingly intimate human-machine systems.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286.
• This funding opportunity was created on 2023-04-28.
• Applicants must submit their applications by 2025-01-22. (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.

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