Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional) | RFA EB 23 001

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity titled "Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional)." The Funding Opportunity Number is RFA-EB-23-001 and the CFDA number listed is 93.286.

What is the main purpose of the program?

The opportunity supports exploratory, early-stage research that directly studies bioethical issues that arise when bionic and robotic devices are designed, tested, translated into practice, and used in real-world settings. The focus is on generating evidence and guidance about ethical challenges that are built into these technologies across their lifecycle.

What kinds of projects are a good fit?

Projects are expected to focus on bioethical questions tied to bionic and robotic devices, rather than primarily proposing technical device development with a small ethics component. The program is positioned to support conceptually innovative, hypothesis-generating, or methods-developing bioethics work that can open up new lines of inquiry.

Does the scope only cover clinical testing or later-stage deployment?

No. The scope is intentionally broad and covers all stages of design, testing, and/or implementation. Ethical questions can be studied at the earliest design stage, during data collection and prototyping, in human testing, during clinical integration, and through broader implementation and long-term use.

What bioethical topics does NIH indicate are in scope?

Examples of in-scope topics mentioned include responsible device design; user autonomy and agency; privacy and data governance (especially for sensor-rich or networked devices); informed consent and participant understanding in device trials; equitable access and fairness in who benefits; safety and risk tradeoffs; long-term support obligations after a device is deployed; and effects on identity, stigma, or social participation.

Are applicants required to include a clinical trial?

No. The opportunity is labeled "Clinical Trial Optional," which means applicants may propose a study that meets NIH's definition of a clinical trial if it is appropriate for the ethical research question, but a clinical trial is not required.

If clinical trials are optional, what kinds of research approaches are possible under this announcement?

Based on the description provided, the opportunity can support conceptual and empirical bioethics research approaches such as qualitative interviews, surveys, stakeholder deliberation methods, and policy analysis. It can also support studies involving interventions or prospective evaluation when those designs are justified by the ethics aims.

What funding mechanism is used?

The announcement uses the NIH R21 mechanism, which typically supports exploratory and early-stage research. The emphasis is generally on innovation, hypothesis generation, and the development of methods or frameworks rather than large, definitive studies.

What is the award type and general subject area?

The award is described as a discretionary grant under NIH. The activity category is health.

What is the maximum funding amount mentioned?

An award ceiling of $275,000 is listed in the provided information.

Who is eligible to apply?

Eligibility is described as broad for U.S.-based organizations and includes: state, county, and local governments; special districts; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities.

Are specific institution types and community organizations highlighted as eligible?

Yes. The announcement explicitly highlights additional eligible categories including Alaska Native and Native Hawaiian 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.

Can foreign institutions apply as the primary applicant?

No. Foreign institutions (non-U.S. entities applying as the primary applicant organization) are not eligible to apply under the description provided.

Can international collaborators or foreign activities be included in the project?

Yes, with limits. The information states that non-U.S. components of U.S. organizations may participate, and that foreign components are allowed as defined in the NIH Grants Policy Statement. This generally means international collaborators or activities can be included when needed and well-justified, even though a non-U.S. entity cannot be the primary applicant.

What does NIH mean by saying ethics issues are "not an add-on" for these technologies?

It means the ethical questions are treated as integral to how bionic and robotic devices are conceived, built, tested, and adopted. Projects should examine how ethical concerns show up in concrete decisions and practices across the technology lifecycle, not just as a general discussion appended to a technical proposal.

What makes this opportunity different from proposing a robotics or bionics engineering grant?

The expectation described is that funded projects will directly study bioethical challenges related to bionic and robotic devices. A proposal that is primarily about building or improving a device, with only a small ethics section, would not match the stated intent as closely as a proposal designed to generate bioethics evidence, methods, or guidance related to these technologies.

What is the funding opportunity number and CFDA identifier?

The Funding Opportunity Number is RFA-EB-23-001, and the CFDA number listed is 93.286.

What are the key dates provided?

The provided source lists a creation date of 2023-02-01 and an original closing date of 2023-04-28.

What is the overall outcome NIH appears to be seeking?

Based on the description, the opportunity aims to strengthen the evidence base and practical guidance for developing and translating bionic and robotic devices in ways that protect participants and users, respect autonomy, address social and equity impacts, and responsibly manage the unique risks and benefits these technologies can create.