General Programs FAQs
Below you will find a wide range of answers to common questions about ARPA-H programs and funding. If your question is not addressed below, please refer to the program’s page, specific solicitation, and additional information found on SAM.gov. You can also learn more about ARPA-H from our Agency FAQs. Thank you for your interest in ARPA-H’s programs.
General Questions
An ISO is ARPA-H’s unique solicitation instrument, which can either be in the form of a Program-Specific or Mission Office ISO. A Program-Specific ISO is used to solicit potential solutions for a specific ARPA-H program, while a Mission Office ISO is intended for potential solutions that fall within a mission office area of research interest but may not be addressed by any specific ARPA-H program. Please note that depending on when ARPA-H receives submissions to MO ISOs, funding may be limited and ARPA-H’s submission reviews may take longer compared to submissions to Program-Specific ISOs.
Solution summaries are concept documents that potential researcher performers may submit at the request of ARPA-H in response to Innovative Solutions Openings (ISOs). Solution summaries are generally limited to a few pages and are intended to save the proposer time and money by allowing ARPA-H to provide feedback on the relevance and acceptability of a technical idea before proposers invest the resources needed for a full proposal submission. Full proposals are detailed applications for a new or innovative solution/idea that ARPA-H will use to make their final funding decision. Please refer to the information in the Program-Specific ISO, Mission Office ISO, or other ARPA-H solicitation to identify the requirements for solution summaries and full proposals.
No. Proposers should typically expect to receive “encourage” or “discourage” feedback from ARPA-H when solution summaries are requested. However, proposers should view each ISO or other ARPA-H solicitation to obtain details on solution summary review criteria and process.
IP rights will be part of award negotiations between the proposer and ARPA-H. Note, there are more flexibilities regarding IP under “other transactions” than under “financial assistance regulations.”
Proposers are responsible for clearly identifying proprietary information. Proposers must have the cover page and each page containing proprietary information marked with a label, such as “Proprietary,” for each submission when applicable.
No. The timeline is aggressive and set at the same benchmark for all proposers. The full proposals will be evaluated based on the criteria stated in each solicitation.
The ARPA-H model is inherently fast-paced and fuels innovation at an accelerated rate. While ARPA-H may collaborate with clinical sites, we expect performers to move at the pace of the program in order to succeed. More information will be provided to performers once each program begins.
Program teams are unable to discuss concepts that a potential applicant is considering submitting to a solicitation. We will evaluate and provide feedback on technical concepts once they have been officially submitted.
Please be sure to review a specific program’s solicitation in its entirety, including all the attachments at the bottom of the page. The submission process and other questions should all be answered by reviewing these materials.
New programs are announced frequently, so we recommend interested parties first review the current Program-Specific ISOs on ARPA-H’s website or SAM.gov. If you still cannot find a good fit based on your research idea, consider a submission to one of ARPA-H’s Mission Office ISOs: https://arpa-h.gov/research-and-funding/mission-office-iso.
Participation in Proposers’ Day is generally not required for proposers to submit a solution summary or full proposal. However, proposers should view each ISO or other ARPA-H solicitation to obtain information and associated requirements.
Letters of support are typically not required for solution summary submissions. However, some ISOs require identification of key team members (including planned sub-awardees and consultants) and estimated sub-awardee costs that will form the Basis of Estimate. Proposers should view each ISO or other ARPA-H solicitation to obtain solution summary information and associated requirements.
You can and should show preliminary data in your solution summary as applicable. Refer to the specific ISO to view the description of what is expected in a solution summary and the evaluation criteria.
ARPA-H supports, but does not conduct, research. Instead, the agency funds research organizations such as universities and medical centers to conduct such work. If you have an interest in volunteering for a health research study, consider exploring opportunities at www.ClinicalTrials.gov. This registry, maintained by the National Institutes of Health, includes a wide array of health research, funded by both public and private entities, and includes a page on volunteering for clinical studies. Thank you again for your interest, and we encourage you to stay up to date on the current state of ARPA-H programs at https://arpa-h.gov/research-and-funding/programs/.
Teaming Questions
No. Teaming is at the discretion of proposers.
Teaming changes may be allowed at ARPA-H’s discretion and in response to new or different needs arising from the program’s progress. However, requests will be dealt with on a case-by-case basis.
No. If you believe you and/or your team can accomplish all program metrics, there is no requirement to team with other entities. While we believe teaming will be generally important to succeed, teaming is at your discretion.
No. ARPA-H recognized that cutting edge research can happen in both academic and industry labs, and we will provide commercialization and transition assistance regardless of team makeup.
There is no maximum, but be aware that an increasing number of teams/people creates an increasing administrative, management, and communication burden.
Contract and Funding Questions
Generally, ISOs do not include a funding limit for individual awards. Solution summaries and proposals will be evaluated based on the criteria outlined in the ISO.
Please provide realistic, justifiable, comprehensive, and reasonable budgets that demonstrate how you will accomplish the metrics of your selected program structure (e.g., Option A, Option B, Option C).
No, we will be providing that to awardees. However, you will still need to budget for a contract research organization to perform investigational new drug (IND) or investigational device exemption (IDE) work. Visit the PATIO page for more information on transition support.
ARPA-H strongly prefers that clinical trials be performed in the United States. However, trials in other countries will be considered on a case-by-case basis at ARPA-H's discretion (as will foreign sub-awardees). Please see the International section below and each program solicitation for specific requirements regarding foreign entity participation on ARPA-H awards.
NDAs may be used at the proposer’s/performer's discretion.
We recommend you work within your institution/entity to establish the best funding pathway for proposer-agnostic necessities. ARPA-H will not provide guidance on which funding pathway to select; it is up to the proposer to select and make that decision. However, award type will be negotiable and will ultimately be ARPA-H's decision.
No, performers will not be reimbursed for previous work.
The principal investigator’s institution receives the funds and distributes them to the co-investigators.
Terms and conditions are provided during negotiations, depending on award type.
ARPA-H’s statutory authority does not require cost-sharing. However, ARPA-H will consider or encourage cost-sharing in proposals where appropriate. Refer to the specific ISO for details.
Eligibility Questions
We welcome submissions from researchers and organizations across all areas of the health ecosystem. Most programs anticipate that teaming will be necessary to accomplish our program goals and metrics. You can find more information about teaming on each program’s page.
Yes, but only one PI may be the prime awardee. Similarly, an individual can only be a prime awardee once, but can be a sub-awardee on multiple proposals. PIs should consider their level of effort across numerous projects and expect an ARPA-H program to take a significant level of effort.
An entity may only submit a single proposal as the prime awardee. An entity may propose in multiple proposers’ teams as a sub-awardee/subcontractor. If an entity, proposed as a sub-awardee, is part of multiple successful teams (i.e., award recipients), the Government may establish Associate Contractor Agreements (ACAs) with the applicable prime awardees. The requirement for an ACA will be dependent on the types of services/supplies provided by the sub-awardee, and the specific terms and conditions will be negotiated for each award.
Receiving funding from another entity does not necessarily disqualify you. Majority ownership through a private enterprise is acceptable, but all situations will be assessed by ARPA-H at the proposal review stage, with a determination made on a case-by-case basis.
International Questions
Yes. In our interconnected world, where diseases and health issues transcend borders, and where the most challenging health problems cannot be solved by any one country, it is essential for nations to work together to improve healthcare and promote global well-being. ARPA-H recognizes the importance of international cooperation and coordination, and will continue to explore opportunities to do so.
While ARPA-H will prioritize awards to entities (organization or individuals) that will conduct funded work in the United States, it is not a requirement. For clinical trials, ARPA-H strongly prefers that they be performed in the United States. However, trials in other countries will be considered on a case-by-case basis at ARPA-H's discretion.
ARPA-H follows HHS financial assistance regulations and policies. For financial assistance awards, the methodology would need to be otherwise in accordance with HHS requirements, which places an 8% cap for indirect costs reimbursed to foreign entities awarded HHS cooperative agreements. For other transactions (OTs), there is greater latitude for negotiating costing methodologies. Proposers would need to provide their methodology to the ARPA-H Program Manager for approval, to ensure it meets the nature and needs of the project.
They will vary depending on the award type as well as the project and will not be unique to international participants. Financial assistance awards will follow regulatory requirements for reporting. However, additional reporting will be negotiated for all award types. ARPA-H Program Managers are significantly involved with performer progress; therefore, ARPA-H Programs typically follow a monthly reporting structure.
This will depend on the nature and needs of the project and is not a unique consideration for international participants. Project manager costs are not forbidden nor discouraged on ARPA-H awards, but the type, amount, and mix of labor is subject to negotiation.
No, at this time only U.S. citizens are eligible to become Program Managers.
IP rights will be part of award negotiations between the ARPA-H and the proposer, regardless of country of origin.
Note that, for both domestic and international performers, there are more flexibilities regarding IP under Other Transactions than under Financial Assistance Regulations. For example, the Bayh-Dole Act, as implemented in 47 CFR part 401, applies to Cooperative Agreements, but does not apply to Other Transactions.
Non-U.S. citizens are eligible to apply. Proposals must be led by one PI under a single organization, and the composition and roles of additional team members or co-PIs are the responsibility of the proposing team. Co-PIs from other institutions are allowed. Non-U.S. companies can register for a unique entity identifier (UEI), which is required to submit a proposal. A non-U.S. company does not need to be represented by a U.S.-based organization, but they do need to make sure they are addressing how their solution will be of benefit to the U.S. taxpayers.
There is no preference for an international entity performing as a prime contractor or subcontractor. It is dependent on the merits of the proposal and the qualifications of the proposer.
Please contact the Division of International Affairs at international@arpa-h.gov.
Still have questions?
Additional FAQs specific to individual programs are found on program pages and on the opportunity’s SAM.gov page. You can also review the agency FAQs.
If you have a question not answered here or on the above pages, please reach out directly to the program or fill out our Contact Form with the specific question. Please include the specific opportunity you are referencing.