1. What is the Common Fund?
The NIH Common Fund, managed by the Office of Strategic Coordination in the Office of the Director, supports cross-cutting, trans-NIH programs that require participation by multiple Institutes and Centers. Common Fund programs are intended to be transformative, catalytic, synergistic, cross-cutting, and unique. This program is a short-term, goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. More information can be found at https://commonfund.nih.gov/about. 

2. What makes a good application for a Common Fund program?
Common Fund programs are designed to support actively managed, milestone-driven projects that are different from mainstream studies such as R01 or P01. These projects are expected to work together to address key roadblocks in emerging fields that will transform the way biomedical research is conducted. Reviewers will evaluate whether a project proposes an incremental improvement or a significant advancement which will transform the field.

3. Why was the NIH Common Fund's Bridge to Artificial Intelligence (Bridge2AI) program created?
Rapid advancements in Artificial Intelligence and Machine Learning (AI/ML) analysis in recent years show promise in discovering new biomedical and behavioral research insights (that are often surprising). In 2018, members of the AI/ML and computational biomedicine research communities, and in 2019, the AI Working Group of the Advisory Committee to the NIH Director, presented visions to propel progress of AI/ML methods in biomedical and behavioral research. These groups encouraged NIH to stimulate widespread adoption of AI/ML models that can tackle cross-cutting biomedical and behavioral research grand challenges. The NIH Common Fund’s Bridge2AI program was created in response to these recommendations and aims to harness the emerging power of AI/ML models for human health, beginning with an ‘analysis-first’ approach that values the machine-understandability of data and incorporates ethical principles surrounding data collection and use.  

4. What is the goal of the Bridge2AI program?
The goal of the Bridge2AI program is to generate flagship data sets and best practices for the collection and preparation of AI/ML-ready data to address biomedical and behavioral research grand challenges. This goal will be accomplished by:

• Generating new flagship biomedical and behavioral data sets that are ethically sourced, trustworthy, well-defined, and accessible 
• Developing software and standards to unify data attributes across multiple data sources and across data types 
• Creating automated tools to accelerate the creation of FAIR (Findable, Accessible, Interoperable, and Reusable) and ethically sourced data sets 
• Providing resources to disseminate data, ethical principles, tools, and best practices 
• Creating training materials and activities for workforce development that bridges the AI, biomedical, and behavioral research communities 

5. How is the Bridge2AI program structured?
The Bridge2AI program will use biomedical and behavioral research grand challenges to drive the development of ethics, standards, tools, data sets, and skills and workforce development strategies for linking scientific workflows, protocols, and other information about the data collection process into computable knowledge. The Bridge2AI program plans to support interdisciplinary Data Generation Projects (OTA-21-008) and a complementary cross-cutting Integration, Dissemination, and Evaluation (BRIDGE) Center (RFA-RM-21-023). Teams funded through these two planned opportunities will be expected to interact and collaborate regularly to complete cross-cutting Bridge2AI program goals.

6. Will Bridge2AI help make existing data AI-ready?
No, the Bridge2AI program is focused on generating new AI/ML-ready data that can be used to address biomedical and behavioral research grand challenges. In a separate effort, the Office of Data Science Strategy has an initiative to improve the AI-readiness of existing, IC-supported data that aligns with the NIH Strategic Plan for Data Science.

7. What other NIH initiatives are supporting the use of AI for biomedical research and how are they different from each other?
The NIH has a number of initiatives to advance AI for biomedical research, each focused on a unique aspect or challenge, including generating new flagship data and developing best practices (Bridge2AI), addressing workforce gaps and improving AI-readiness of existing data (ODSS), and advancing health equity and researcher diversity (AIM-AHEAD). An overview of these efforts is included below, and you can learn more about them on the ODSS Artificial Intelligence at NIH webpage:

• NIH Common Fund’s Bridge2AI program: working to facilitate widespread adoption of AI by generating new flagship data sets and best practices through the collection and preparation of ethically-sourced AI/ML-ready data to address biomedical and behavioral research grand challenges. The generation of ethically-sourced data will require diverse teams and expertise.
• Office of Data Science Strategy (ODSS) initiatives: (1) Addressing the Workforce Gap in Data Governance for AI in Biomedicine, (2) Ethics, Bias, and Transparency for People and Machines, and (3) Improving the AI-readiness of Existing, IC-supported Data
• AIM-AHEAD (Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity): establishing mutually beneficial and coordinated partnerships to increase the participation and representation of researchers and communities currently underrepresented in the development of AI/ML models
• Institute- and Center-Funded Initiatives: a number of NIH institutes and centers are developing AI/ML technologies and strategies

8. What is the Common Fund Data Ecosystem (CFDE) and will the Bridge2AI program participate?
The Common Fund Data Ecosystem (CFDE) is intended to make Common Fund data sets more impactful by enabling data discovery, access, interoperability, and reuse. Common Fund data sets include large data sets and associated digital tools needed to mine and analyze the data. To help maximize their impact, CFDE is creating a portal or central access point for Common Fund data sets, tools, and other digital objects, through which users can access and compute on data in a cloud environment. This CFDE portal is not designed as a data repository or platform but will instead link multiple data platforms that have been established through Common Fund programs and create cloud workspaces for users to access and compute on data across the different platforms. While users may continue to access an individual data set via the platform created for that data set, the CFDE will foster new discoveries and support different types of analyses by enabling queries of multiple data sets simultaneously. The CFDE will provide user support through automated help tools, online courses, webinars, and in-person training events. By providing infrastructure, advice, resources, best practices, common components, and services to fit the needs of Common Fund programs, the CFDE will increase the utility of Common Fund digital objects by making them more findable, accessible, interoperable, and reusable, also known as FAIR. The CFDE will require a collaborative effort, involving Common Fund Data Coordinating Centers who represent the data generators for each program, and a central coordinating component known as the CFDE Coordinating Center (CFDE-CC). 

The Bridge2AI program will be structured to facilitate engagement in the CFDE. Bridge2AI projects are expected to interact with the CFDE to ensure the interoperability and compatibility of common software standards and tools with the CFDE and other Common Fund datasets and resources. Interoperability and compatibility with the CFDE includes, but is not limited to: sharing persistent identifiers of publicly available data sets, submitting metadata harmonized to a CFDE data model, and ensuring access to Bridge2AI data assets in a cloud environment.

For more information, please visit https://commonfund.nih.gov/dataecosystem/faqs

9. What is the Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative?
As the scale of data-related research grows, NIH continues to explore opportunities to support NIH researchers’ use of the cloud for data storage and compute. The STRIDES Initiative enables NIH and NIH-funded investigators to more easily take advantage of cloud services. The STRIDES Initiative has negotiated agreements with commercial cloud service providers (CSPs) for 1) discounted rates on cloud services, 2) access to professional services to provide support on how to use the cloud effectively, 3) access to training to help learn more about the cloud and its capabilities, and 4) the potential for collaborative engagements to explore topics of special interest to NIH.

For more information, please visit https://commonfund.nih.gov/dataecosystem/faqs

10. Where can I find more information about Bridge2AI?
Stay tuned for updates on funding announcements and the latest news from the Bridge2AI program by visiting the program website: www.commonfund.nih.gov/bridge2ai regularly and subscribing to the Bridge2AI listserv.

11. Who should I contact with questions?
Questions about the Bridge2AI program can be sent to bridge2ai@od.nih.gov.

12. What is Artificial Intelligence (AI) and is it different than Machine Learning (ML)?
Artificial Intelligence (AI) is a broad concept that encompasses the idea of machines being able to perform tasks that normally require human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages. Machine Learning (ML) is an application (or subset) of Artificial Intelligence (AI) that provides machines (like computers) the ability to automatically learn and improve from experience, without being explicitly programmed. The intention of ML is to enable machines to learn by themselves using provided information (data) to make accurate predictions.

13. Why is AI/ML being used for research? How will AI/ML help improve human health?
There are a number of biomedical and behavioral research applications that would benefit from AI/ML approaches. For example, using AI/ML to decode the functional genome in order to understand how genomic variations affect outcomes in health, or to develop digital twins—a virtual representation of a living system used to monitor health, predict adverse events, assist clinical decision making, and/or personalize treatments. Using AI/ML approaches to help computers “understand” the conditions in which data are collected and the questions that data are intended to answer will unlock the potential of this information to transform science and human health.

14. How will you make sure the AI/ML developed by the Bridge2AI program is safe and ethical?
Ensuring the development of ethical and trustworthy AI/ML is a critical component of the Bridge2AI program. The unique ethical, legal, and social implications (ELSI) of biomedical and behavioral AI/ML research in addition to principles of trustworthy AI/ML will be a key component of the Bridge2AI program.

General FAQs

15. What will the Bridge2AI Integration, Dissemination, and Evaluation (BRIDGE) Center do?
The BRIDGE Center will be responsible for integrating activities and knowledge across Data Generation Projects, disseminating products, best-practices, and workforce development materials/activities, and evaluating all aspects of the Bridge2AI program with input from external stakeholder communities. The BRIDGE Center will combine cores of expertise in team science, ethics, standards, tools optimization, and skills and workforce development. Please see RFA-RM-21-023 for additional information.

16. How many BRIDGE Centers will the Bridge2AI program support?
The Bridge2AI program plans to support one BRIDGE Center that will include multiple cores:

• Administrative Core
• Teaming Core
• Ethics Core
• Standards Core
• Tool Optimization and Dissemination Core
• Skills and Workforce Development Core

17. When will BRIDGE Center Team Building Activities take place?
A series of Bridge2AI Team Building Activities for potential applicants took place in June 2021. Visit the Bridge2AI Team Building Platform (registration required) for access to resources for building diverse and cross-disciplinary teams. Applicants may submit proposals to RFA-RM-21-023 if they did not participate in the Team Building activities.

Guidance on building diverse teams and creating a Plan for Enhancing Diverse Perspectives (PEDP) can be found on the Building Diverse Teams webpage. For additional information visit the Scientific Meetings webpage.

Application FAQs

18. Should a potential BRIDGE Center application include multiple cores?
Yes, each potential BRIDGE Center application should include an Administrative Core and one or more of the following optional cores: Teaming, Ethics, Standards, Tool Optimization, Skills and Workforce Development. Cores will be individually reviewed and individual cores from different applications may be selected and funded to work collaboratively as a single BRIDGE Center. Please see RFA-RM-21-023 for additional information.

19. How should infrastructure activities be included in BRIDGE Center proposals?
The proposal for the U54 (RFA-RM-21-023) is a means to share with us your strategy, knowledge and experience - what you can bring to fulfill the spirit and goals of the Bridge2AI program. Please note the responsiveness criteria in the FOA guidelines: RFA-RM-21-023. The final determination of actual infrastructural needs will be determined by the Bridge2AI Consortium.

BRIDGE Center (RFA-RM-21-023) Questions BRIDGE Center (RFA-RM-21-023) Questions   General Questions  

General FAQs

20. What is a Data Generation Project "grand challenge" and how do I know if my idea fits the criteria?
Bridge2AI Data Generation Projects will be centered around biomedical and/or behavioral research "grand challenges" that promote broad uses for modern AI/ML models. Grand challenges should tackle complex biomedical questions that cannot be answered without the use of AI/ML approaches. When evaluating a Bridge2AI grand challenge idea, consider these three questions (1) have the AI/ML-ready data that could allow the primary question to be answered already been created? (2) can this question be answered effectively using existing analytical tools that do not use AI/ML? and (3) would the project fit within the general scale of a large R01 project? Bridge2AI grand challenges will likely have "no" as the answer to all three of these questions. Examples of grand challenges are provided in OTA-21-008, additional information about grand challenges can be found on the Bridge2AI IMAG Wiki page. 

21. What is an Other Transactions (OT) Award?
The Other Transactions Authority is governed by 42 U.S. Code § 282 (n)(1)(b). Other Transactions (OT) are not grants, cooperative agreements, or contracts. They are used by the NIH to provide considerable flexibility in establishing policies for the awards; policies and terms for individual OT awards may vary between awards, each negotiated with a specific agreement, which may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape and or availability of funds.

22. Who is eligible to apply for an Other Transaction (OT) Award?
Prospective applicants may or may not have received NIH funding in the past. All entities public and private, small or large, for-profit or not-for-profit, eligible Agencies of the Federal Government (including NIH Intramural Research Program) are eligible to apply. Unaffiliated individuals who are U.S. citizens are also eligible to apply. For a list of anticipated eligible organizations please see the Other Transaction Opportunity Announcement (OTA-21-008).

23. How do I form a team around my Grand Challenge Team Building Idea?
Visit the Bridge2AI Team Building Platform (registration required) for access to resources for building diverse and cross-disciplinary teams. Applicants may submit proposals to OTA-21-008 if they did not participate in the Team Building activities.

Guidance on building diverse teams and creating a Plan for Enhancing Diverse Perspectives (PEDP) can be found on the Building Diverse Teams webpage. For additional information visit the Scientific Meetings webpage.

24. When will Data Generation Projects Team Building Activities take place?
A series of Bridge2AI Team Building Activities for potential applicants took place in June 2021. Visit the Bridge2AI Team Building Platform (registration required) for access to resources for building diverse and cross-disciplinary teams. Applicants may submit proposals to OTA-21-008 if they did not participate in the Team Building activities. For additional information visit the Scientific Meetings webpage.

Application FAQs

25. For Data Generation Project OT applications, are the same documents that typically go in a traditional grant application required?
No. Other Transactions (OT) do not require the same documentation as traditional NIH Grants. Only the documents listed in OTA-21-008 are required to be submitted with the application. These include a Cover Page and a separate Research Plan and Budget for each Data Generation Project Module, a Resource Sharing Plan, a Plan for Enhancing Diverse Perspectives (PEDP), a letter of support from the proposer’s organization indicating institutional commitment to the project, and letters of support from proposed collaborators who are not included as Key Personnel.

26. What should be included in the 2-page biosketch?
The 2-page biosketch should include pertinent information about the individual that would aid the reviewer in understanding that person’s qualifications and expertise pertaining to the project. The Bridge2AI Research Opportunity Announcement (OTA-21-008) indicates that, at a minimum, the information in the biosketch should include the name and position title, education/training (including institution, degree, date (or expected date), and field; list of positions and employment in chronological order (including dates); Other Research Support; and a personal statement that briefly describes the individual’s role in the project and why they are well-suited for this role. The NIH biosketch format used for grant applications is acceptable, but not required, as OT awards are not grants.

27. How do I submit a budget with my Data Generation Project OT application?
Applicants must complete a SF424 budget. Do not complete the budget form in the ASSIST module, instead download and complete the relevant form(s) found on the Bridge2AI Data Generation Projects Budget Forms and Instructions webpage. The completed SF424 budget PDF form(s) will then need to be included in the application as an “other attachment” in ASSIST. Budget information and any related administrative documentation shall not count toward the total proposal page limit.

28. Is one institution the prime (submitting institution) for all modules?
Yes. The Bridge2AI program requires each Data Generation Project to identify a Principal Investigator/Project Director (PI/PD) team with at least one biomedical/behavioral domain expert and one data science/data management expert, who are responsible for the overall leadership of the Data Generation Project. This team may be drawn from the leadership of any of the six modules. The application may be submitted by any member of this team. That member's institution will then be the prime for all modules.

Applicants should prepare editable budget spreadsheets using the form(s) available on the Bridge2AI Data Generation Projects Budget Forms and Instructions webpage. Please note that post-review, NIH will conduct negotiations with proposers to determine optimal scientific, technical, and logistical arrangement of each Data Generation Project award and their modules.

29. Should applications to each module have a separate budget and/or multiple subcontract sites?
Yes, each module must have a separate budget. Multiple subcontract sites are not required, but may be included as long as a justification is provided. The Data Generation Project personnel and budget structure should be set up based on the needs of the project. Applicants should prepare editable budget spreadsheets using the form(s) available on the Bridge2AI Data Generation Projects Budget Forms and Instructions webpage. Please note that post-review, NIH will conduct negotiations with proposers to determine optimal scientific, technical, and logistical arrangement of each Data Generation Project award and their modules.

30. Can participants in an ongoing project (outside of Bridge2AI) collect new multimodal data that do not fall within the original data collection/sharing plans as new data for Bridge2AI?
Yes, this could be new data for Bridge2AI, but with the caveat that the existing participants (and researchers) are already diverse and represent a variety of perspectives. The Bridge2AI application should include a Plan for Enhancing Diverse Perspectives that justifies the existing participants and researchers and the roles they are contributing, especially in addressing the ethical issues at each stage of the data preparation process. Please see the Building Diverse Teams page for additional information.

31. Can Bridge2AI Data Generation Projects include the development of AI/ML models?
No, Bridge2AI Data Generation Projects will not support the development of AI/ML models, they are intended to generate new biomedical and behavioral datasets that are ethically sourced, trustworthy, well-defined, and accessible. The purpose of the program is to create a bridge to AI by making the data AI/ML-ready, not by developing AI/ML models. Existing AI/ML models can be used throughout the data generation process in preparing the data, and mechanistic modeling frameworks can be used to determine what data need to be collected within the landscape of knowledge. Mathematical, statistical, computational (ML) models can be used as tools to incorporate ethical principles and standards into the data acquisition protocols, from diverse perspectives. After the Bridge2AI Consortium is formed, modelers will be encouraged to join in community activities (such as jamborees and codeathons) to mine and assess the Bridge2AI data for quality and ability to address grand challenges for future scientific discovery.

32. Should a budget for cloud compute and storage be included in a Bridge2AI application?
Yes, applicants should include any required cloud compute and storage costs in their application. If recommended for funding, NIH will consider these cloud costs and the possibility of leveraging the NIH STRIDES initiative for those costs. See FAQ #7 (above) for additional information about the STRIDES Initiative.

33. Should infrastructure needs, shared Institutional Review Boards (IRBs), and/or data sharing agreements be included in Data Generation Project module proposals?
A proposal for the Data Generation Projects (OTA-21-008) is a means to share with us your strategy, knowledge, and experience - what each applicant can bring to the table to help fulfill the spirit and goals of the Bridge2AI program. If including infrastructure needs, such as the amount of cloud resources needed to store a certain type of data or data sharing agreements needed to share and assess data, depicts your understanding of the challenges based on past experience, then propose it! The final determination of actual infrastructural needs will be determined by the Bridge2AI Consortium.

34. Does the bibliography count towards the Research Plan 10-page limit for each module?
No, the bibliography does not count towards the 10-page limit for each module's Research Plan.

35. In the Module Cover Page instructions for OTA-21-008, who should be listed as the "Awardee"?
In the Module Cover Page instructions on page 19 of OTA-21-008, the term “Awardee” refers to the Institution of the Contact Principal Investigator for that module (i.e., the Module Lead). The Module Cover Page should include the following information about the Module Lead and their Institution:

• Part C should provide the legal entity name, address, and contact information of the Module Lead’s Institution
• Part D should provide the name and contact information for the Module Lead
• Part E should provide the name and contact information for the Authorized Business Official of the Module Lead’s institution.

General FAQs

36. What is a PEDP?
A PEDP or “Plan for Enhancing Diverse Perspectives” is a summary of strategies to advance the scientific and technical merit of the proposed project through inclusivity. This plan should be applied throughout all of the proposed Bridge2AI research plans.

37. What does "diverse perspectives" mean for a research project?
Broadly, diverse perspectives refer to the people WHO* do the research and the places WHERE** research is done, as well as WHO PARTICIPATES*** in the research as part of the study population.

• *WHO: The inclusion and empowerment of investigators and trainees from a variety of backgrounds, including those traditionally underrepresented in the biomedical research workforce (see NOT-OD-20-031), and investigators from different scientific disciplines, at varying career stages, and with varied skills, experience, and expertise.
• **WHERE: Participation of researchers from all relevant sectors, including diverse organizations and institutions (e.g.  research intensive and research-active, undergraduate, minority-serving, community-based etc.). Historically, largely well-resourced academic and research institutions have competed successfully for NIH funding. The goal is to broaden the Bridge2AI program's reach by supporting projects, partnerships, and collaborations at institutions and organizations that, to date, have not often been part of NIH-funded work.
• ***WHO PARTICIPATES: To realize the broadest benefits to human health impacting all segments of the population, the Bridge2AI program is committed to promoting equity in research participation. To that end, maximum effort is encouraged to engage and recruit diverse participants for human studies. To make findings broadly relevant, it is expected that projects involving human participants or samples derived from humans should be collected in an ethically sound manner and consented appropriately.

38. Why is the PEDP included in Bridge2AI program applications?
It is widely accepted that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Accordingly, the NIH’s commitment to diversity is well documented (NOT-OD-20-031). The inclusion of a PEDP represents explicit alignment of research activities, peer review, and research funding considerations with the Bridge2AI Programs commitment to advance the scientific and technical merit of projects through expanded inclusivity.

39. What should be included in a PEDP?
Within the 2-page PEDP summary, applicant(s) are expected to show how enhancing diverse perspectives is supported throughout the application and how this strengthens the scientific and technical merit of the project (in terms of significance, investigator(s), innovation, approach, and environment), as appropriate. The PEDP will depend on the content and structure of the scientific aims, the expertise required, the environment, and the performance site(s). The PEDP should include a timeline and milestones for relevant components that will be evaluated as part of the review. Within the research strategy, applicant(s) are expected to align their description with the strategies summarized in the PEDP. Please see the Bridge2AI Building Diverse Teams and Plan for Enhancing Diverse Perspectives.

40. What guidance on the PEDP is available for applicants?
For guidance and other materials please see the Bridge2AI Building Diverse Teams, Plan for Enhancing Diverse Perspectives, and Program FAQs. Questions not covered by these resources can be directed to bridge2ai@od.nih.gov. Additional guidance and FAQs will be updated as needed.

Applications

41. Where in applications should the PEDP information be addressed?
The PEDP information should be included in the "Plan for Enhancing Diverse Perspectives" under “Other attachments” (2-page limit) and where appropriate, within the research strategy section. The 2-page PEDP attachment should:

• Include a summary of strategies of expanded inclusivity to advance the scientific and technical merit of the proposed project
• Outline how enhancing diverse perspectives is viewed and supported throughout the application
• Incorporate strategies relevant to each of the review criteria (significance, investigator(s), innovation, approach, and environment), as appropriate
• Include a timeline and milestones for relevant components that will be considered as part of the review

Within the Research Strategy, applicant(s) should align their description with the PEDP strategies and milestones, and are encouraged to refer to information included in the PEDP attachment. The content of the PEDP will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Please see the Bridge2AI Plan for Enhancing Diverse Perspectives for key elements and examples.

42. Are there examples of the types of strategies that might be part of a PEDP?
The Bridge2AI program anticipates that every PEDP will be unique and will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Examples of strategies that advance inclusivity in research and may be part of a PEDP can include, but are not limited to the list provided in the Bridge2AI Plan for Enhancing Diverse Perspectives.

43. Is there a PEDP template or example available?
No. A PEDP template or example is not available because the PEDP will depend on the content and structure of the scientific aims, required expertise, the environment, and performance site(s). Please see the Bridge2AI Plan for Enhancing Diverse Perspectives.

44. Does a grant application need to include every strategy listed in the PEDP Key Elements and Examples?
No. The details of the PEDP will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Applicants are asked to explain how the proposed research project will benefit from the diverse perspectives described in the application. They are expected to provide a rationale for the inclusion of different PEDP strategies and how these strategies strengthen the research project.

45. Are there specific type(s) of diversity that are preferred?
No. The Bridge2AI program encourages innovative approaches that support scientific excellence by fostering inclusivity and promoting culture change. The Bridge2AI program places strong emphasis on the inclusion of investigators representing diverse disciplines of science. The PEDP seeks to broaden this approach beyond scientific disciplines to include career stage, investigator background, partnerships, collaborations, etc. that advance the goals of the project (see the Bridge2AI Building Diverse Teams and Plan for Enhancing Diverse Perspectives).

46. What makes a strong PEDP?
Reviewers will evaluate the PEDP based on the criteria specified in the Funding Opportunity Announcement (FOA) or Research Opportunity Announcement (ROA). Briefly, the PEDP should reflect careful consideration of how to maximize diverse perspectives within the research project and outline the benefits. It should also provide rationale for the selected types of PEDP strategies and include a timeline and milestones for relevant PEDP components.

47. Are foreign collaborations considered to enhance diverse perspectives?
While an emphasis on U.S.-based geographic diversity is encouraged, foreign collaborations may be considered to enhance geographic and regional diversity, if justified as described in III.5. Consistent with NIH policy, foreign components will be subject to additional review requirements (see NIH Grants Policy Statement section 16).

48. If costs increase as a result of the PEDP, can funds be requested to support the PEDP?
Applicants may include a request for allowable costs associated with PEDP implementation (see NIH Grants Policy Statement section 7).

Review

49. How will reviewers be instructed to evaluate the PEDP?
PEDP considerations will be included in each of the scored review criteria (Significance, Innovation, Investigators, Approach, and Environment). Reviewers are asked to consider the strengths and weaknesses associated with each of the review criteria and weigh them appropriately. Thus, the PEDP evaluation will contribute to the criterion scores and overall impact score of each application. It is expected that a PEDP judged by reviewers as insufficient, would result in poorer criterion score(s) and overall impact score.

50. What will happen to an application with its PEDP judged by reviewers as insufficient?
A PEDP judged by reviewers as insufficient may result in poorer criterion scores and overall impact score. The reviewers are instructed to evaluate all components of the application as reflected in the FOA. As such, peer reviewers will evaluate the PEDP as part of each of the scored review criteria, and in the overall impact score.

51. Is training on the PEDP available for reviewers?
Reviewers will be directed to the guidance materials available to applicants. In addition, review panels will be provided with opportunities to learn more about the PEDP ahead of any scheduled review meetings.

52. Is a PEDP “Other Attachment” required?
Yes. Applications that fail to include the required PEDP “Other Attachment” will be considered incomplete and will be withdrawn prior to review.

53. Will the PEDP be considered in programmatic funding decisions?
Yes. As a whole, the following will be considered in making programmatic funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review
• Availability of funds
• Relevance of the proposed project to program priorities, including the PEDP

54. What post-award oversight of the PEDP will be expected?
As part of their required progress report, investigators will be asked for updates on the implementation of the PEDP in their annual NIH Research Performance Progress Report (RPPR). Investigators should describe progress in the PEDP based on the goals, timelines, and milestones outlined in the application and/or in response to the reviewers’ comments as well as on any additional elements recommended by the study section and/or program staff. If sufficient information is not provided in the progress report, program officials may request the additional information needed to assess satisfactory progress.

55. What administrative actions can be taken if a research project does not meet its PEDP objectives?
In cases where an investigator encounters challenges in meeting their PEDP objectives, Program Officers (POs) can request an interim progress report with clear explanation of the difficulties, as well as the actions taken to overcome them. In response, POs may suggest alternative approaches, request an interim progress report, or issue a no-cost extension, to delay the noncompeting renewal until the difficulties are resolved. Broadly speaking, failure to meet expectations agreed upon by the Recipient and the NIH/IC may result in Enforcement Actions as described in the NIH Grants Policy Statement section 8.5.2.