Request For Information: ARPA-H Seeks Ideas for ELSI Initiative

CLOSED: Request for Information: Design and Development of ARPA-H Ethical, Legal, and Social Implications (ELSI) Initiative

The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas to help the agency develop a well-informed, comprehensive, and actionable Ethical, Legal, and Social Implications (ELSI) of research framework. This framework will help to guide, clarify, justify, and evaluate ARPA-H investments as the agency seeks to support the development of high-impact health solutions. Given that ARPA-H will invest in tools and technologies that push the boundaries of currently available solutions and capabilities, the agency must consider the secondary impacts – both positive and negative – that these advancements may have on individuals and on society. ARPA-H understands that the pace of technological innovation can exceed the pace of regulatory, policy, or framework development, and as such is also seeking revolutionary ideas, technologies, and capabilities for the implementation and incentivization of ELSI activities within the agency’s programs, projects, or as stand-alone efforts. A proactive approach will enable and enhance responsible biomedical and health research innovation and will promote a future that upholds ethical principles, adheres to legal requirements, ensures broad accessibility to all who may benefit, and is cognizant of the potential societal implications.

Submission Criteria

This Request for Information (RFI) seeks novel ideas, approaches, and models concerning – but not limited to – any of the following:

Design frameworks that consider ELSI – including accessibility –related to ARPA-H’s research and development (R&D) program research methods, technologies, tools, and capabilities:

  • Alternative ELSI initiative structures, strategies, or approaches relative to traditional ELSI activities implemented in other Federal agencies
  • Case studies highlighting specific opportunities for ARPA-H to design and implement an ELSI model or other programs focused specifically on the ARPA-H mission and potential R&D programs
  • Proposed models for how ARPA-H could best support its performers’ needs for consultation and guidance on ELSI
  • Effective models for engaging experts throughout the research and development (R&D) lifecycle to capture potential positive or negative ethical, legal, and social impacts of the solutions
  • Definitions of and strategies to address equitable access in terms of geographic location, socio-economic status, disabilities (physical, sensory, and cognitive), infrastructure, and culture
  • Design futures, speculative design, and strategic foresight approaches
  • Methods to support and maintain transparency at all stages of program lifecycle, from design to transition.

Assessment methods:

  • Methods for assessments of proposed R&D program investments in technology, tools, and capabilities that evaluate potential ethical, legal, accessibility, and societal implications risks and/or benefits (specific proposed risk assessment strategy on AI/ML risks and biases in health R&D is encouraged)
  • Models for leveraging AI/ML capabilities for ELSI assessments
  • Proposed methods to assess equitable access of technology and products

Investment models:

  • Effective models to invest in emerging technologies and navigate potential concerns about societal effects of those developments
  • Novel approaches to leverage the incentives available as a funding agency to promote ELSI priorities
  • Concepts for ELSI-relevant prize challenges in health
  • Development of innovative technologies that enhance ELSI priorities

Equitable access strategies and considerations:

  • Case studies that consider cost, accessibility, and/or user experience, with a focus on cultural and indigenous perspectives
  • Equitable access framework considerations, including best practices, values, risk, and practical and policy implications that address federal efforts around affordability and accessibility
  • Intellectual property (IP) rights considerations, including the current state of Bayh-Dole
  • Engagement strategies with potential performers and transition partners about potential impact and implications of our ELSI approach
  • Best practices to increase engagement with underrepresented populations
  • To ensure population representation in research, building trust and transparency with the community, and incorporating equity-centered design methodology

Technology innovations:

  • Hardware, wetware, and software technological innovations that support integration of ELSI principles into emerging technologies at their inception
  • Technological innovations that address concerns that extend beyond “traditional” ELSI focus areas, including but not limited to environmental impact, responsible innovation, and dual use concerns.
  • Exploration of opportunities at the interface of AI and biomedical research (and other related fields) to promote and incentivize ELSI initiatives.

Dates

Interested respondents are invited to submit comments on or before 5 p.m. ET on October 30, 2023. Early submissions are encouraged as materials will be reviewed on a rolling basis.

Addresses

Please submit comments electronically to ARPA-H-ELSI@arpa-h.gov and include “Design and Development of the ARPA-H ELSI Initiative” in the subject line of the email. Questions on the RFI can also be sent to this address and should include “RFI Question” in the subject line of the email. Due to time constraints, mailed paper submissions will not be accepted, and electronic submissions received after the deadline may not be taken into consideration.

Instructions

Responses to this RFI are voluntary and the government will not provide reimbursement for any costs incurred in responding. Respondents may address as many or as few topics as they wish but only one submission is allowed per respondent. ARPA-H will review responses on a non-attribution basis for market research and planning purposes only and does not intend to provide a response to submissions. ARPA-H is not seeking proposals or applications for financial assistance in response to this RFI, and submissions do not constitute a binding legal agreement of any type. Comments submitted in response to this notice are subject to the Freedom of Information Act (FOIA). Any proprietary information shall be clearly marked in the document.

Electronic responses must be provided as attachments to an email rather than a link. Comments of five pages or fewer (no more than 2,500 words) are requested. Responses should include the name of the person(s) or organization(s) filing the response. Responses containing references, studies, research, and other empirical data that are not widely published should include electronic links to the referenced materials.

Definitions

Ethical: Ethical considerations explore both the personal and societal moral implications – including risks and benefits – that may result from scientific and technological advancements. Ethical considerations may involve questions related to individual rights, privacy, autonomy, consent, fairness, and justice.

Legal: Legal considerations focus on the effects of existing laws, regulations, and policies that govern scientific research and its applications. Other considerations include the development of new policies and regulatory approaches to ensure that there is no potential unexpected discrimination from scientific and technological advancements. Legal considerations may involve questions related to intellectual property, patents, data protection, privacy laws, continued content, and regulations regarding the use of emerging technologies.

Social Implications: Social implications encompass the broader societal impact, positive and negative, of scientific advancements. They explore the social, cultural, economic, and psychological dimensions that arise from the use of new technologies. Social considerations may involve questions of equity, diversity and inclusivity, social justice, and discrimination. Finally, social implications include consideration of the range of accessibility needs to ensure that the results of technological advancements are available and affordable to all populations in need, when they are needed. Accessibility considerations include geographic location, socio-economic status, disabilities (physical, sensory, and cognitive), infrastructure, and culture.