The National Institutes of Health (NIH), pharmaceutical companies and nonprofit organizations have together created the Accelerating Medicines Partnership® (AMP®) program to develop new ways of identifying and validating promising biological targets for diagnostics and drug development.

These FAQs apply to the following Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases (AMP AIM) Program funding opportunity announcements (FOAs):

General

Where can I get answers to additional questions?

You can email the scientific contacts of the AMP AIM program at: AMP_AIM@mail.nih.gov

Please check back on this webpage. The FAQs will be updated periodically.

Participation

Is there any limit on the number of applications from a single institution?

Multiple applications from an eligible organization may be submitted if the proposed science in each application is distinct.

Can I apply for my own grant if I am going to be a co-investigator on a colleague’s application for the same RFA?

This may be allowable as long as there are sufficient levels of effort committed to each project and there is no scientific, budgetary, or commitment overlaps.

Can I apply for both RFA-AR-21-015 and RFA-AR-21-016?

Yes. Institutions/PIs may apply for Disease Teams (DTs), Technology and Analytic Cores (TACs) and Research Management Unit (RMU) through separate applications.

Investigators may submit more than one application in response to RFA-AR-21-015 and RFA-AR-21-016.

Each application submitted to RFA-AR-21-016 should focus on only one of the following: Technology Core (TC) or Systems Biology Core (SBC) or Tissue Repository Core (TRC) or Research Management Unit (RMU). Applicants may submit more than one application.

Can multi-PI applications be submitted?

Yes. Applications in response to RFA-AR-21-015 and RFA-AR-21-016 may propose multiple PIs.

Can I collaborate with investigators in the NIH Intramural programs?

Yes. Collaborations with investigators in the NIH Intramural programs are strongly encouraged.

Can non-US organizations participate in the AMP AIM?

Foreign organizations/institutions/companies are not eligible to apply but may participate as components/collaborators of a domestic-led application.

What is the role of the industry partners?

The industry partners are members of the AMP AIM Steering Committee (SC), convened by FNIH and including representatives from sponsoring organizations including NIH, industry and not-for-profit organizations. The AMP AIM SC will provide scientific guidance and oversight to the AMP AIM Research Program.

Given the need to demonstrate flexibility and collaboration, how should we think about writing specific aims?

Applicants should follow the instructions in Section IV. Application and Submission Information to construct the specific aims, aligned with the Objectives for each component described in the RFAs.

Logistics

Do I have to submit a letter of intent? What should be in it? How should I send it?

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH to estimate the potential review workload and plan the review. 
 
Please include as much of the following information as possible:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

Information regarding disease focus, technologies to be used, and specific aims is welcomed.
 
Letters of intent should be sent to:
Justine Buschman
Telephone: 301-496-4811
Email: buschmanj@mail.nih.gov

What is the page limit for the RFAs (RFA-AR-21-015 and RFA-AR-21-016)?

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed. The research Strategy section should not exceed 12 pages.

Network

How will the Network projects be developed?

NIH expects that studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken to achieve the AMP AIM program objectives. It is unlikely that any study proposed in the application will be undertaken exactly as planned, or at an individual site. Prioritized projects will be developed collaboratively by the AMP AIM Network following a short planning period.

Can you provide details about the Knowledge Portal?

The Knowledge Portal is to be established separately by the NIH. Its purpose will be the acquisition, storage, and display of all AMP AIM data.  The KP will enable sharing of data generated by AMP AIM with all stakeholders.

Budget

Is the estimated $5M commitment stated in the Disease Teams (DTs) FOA (AR-21-015) for per annum or for the 5-year duration of the grant?

A total of $5M is estimated for four awards, one each for rheumatoid arthritis, lupus, Sjögren’s syndrome and psoriatic spectrum diseases, during the initial budget period (first year of award). Funding levels for subsequent years may be adjusted based on available funds and the needs of the project (planning, pilot or scale-up activities) as determined by the Network.

What should the budget be for clinical sites, especially when disease teams involve multiple participating sites?

Application budgets are not limited but should reflect the actual needs of the proposed studies. In addition to personnel costs, the budget should include patient costs for pilot and scale-up activities (calculated based on per patient costs) as outlined in the FOA (AR-21-015). The planned enrollments may include 50 patients for the pilot studies and 200 patients for the scale-up studies. More details can be found under R&R Budget in Section IV. Application and Submission Information.

What if we need to add capacity later?

Applicants are expected to assemble teams with sufficient capacities to provide required patient samples (for DT applications) or analytic pipelines (for TACs applications) for the proposed studies. If, however, increased needs are identified by the network and are deemed essential for the pipeline projects, additional sites may be brought into the network to add capacity later.

What is the purpose of Opportunities Fund (OF)?

OF is intended to capitalize on emerging opportunities and sharing of resources for activities such as pilot/feasibility projects, new technologies /analytics, collaborations and scale up studies. OF projects must be within the scope of the AMP AIM Research Program.

How the Opportunities Fund (OF) should be budgeted and managed?

The maximum budget allowed is $2M / year in years 2-5 to support four to six subcontracts per year. The budget must include a separate item to establish future subcontracts with AMP AIM recipient and other institutions. Applicants should NOT include or propose specific projects to be funded from the OF; these decisions will be made in conjunction with the AMP AIM NIC and AMP AIM SC after award. One institution will be chosen by NIH after award from the successful applicants to manage the OF for the entire AMP AIM Network. This institution must agree to take responsibility for managing the OF, including establishing an administrative structure for disbursement and tracking funds.

For the Opportunities fund (OF) section, we are expected to list this in the budget as a single line item under subaward/consortium. Since we are not proposing specific subawards, how do we ensure that eRA Commons will not generate an error? Are we expected to list the total amount exclusive of indirect cost, or should we split direct and indirect costs?

The Opportunities Fund budget should be a discreet line item placed in the “Other” line. The F&A base should properly exclude the OF cost; a note about the exclusion should be stated in the Budget Justification page.

Is $5M for each of the RFAs direct or total costs? Is $2M for Opportunities Fund direct or total costs?

The $5M for each of the RFAs is total costs (direct plus indirect). The $2M for Opportunities Fund also refers to total costs.

Is there a budget limit for the DTs or TACs?

The $5M is the total cost estimate but the actual budgets for individual DTs and TACs are not capped. The number of TAC awards will be determined by the review outcomes and available funds.

Disease Teams (DTs)

If our site is interested in studying multiple diseases or combining as a Disease Team (RFA-AR-21-015) and technology or research coordination (RFA-AR-21-016) site, does that require multiple applications?

Each Disease Team application can focus only on one of the AMP AIM diseases. If your site is interested in studying multiple diseases, you need to submit separate applications for each disease of interest in response to RFA-AR-21-015.

Applications for the Technology and Analytic Cores (TACs) or Research Management Unit (RMU) should be submitted as separate applications in response to RFA-AR-21-016.

Will the disease teams be based on the aggregation of several different applications or are the teams expected to submit as a unit?

The disease teams are expected to self-assemble prior to applying as a unit. Multiple PIs may be proposed, with one being the contact (coordinating) PI.

Can you provide clarification on clinical trials in the application?

The FOA is “clinical trial optional” that allows flexibility for future studies that meet the NIH definition of a clinical trial. Applicants may include a discussion of the use of clinical trials as a potential approach, but clinical trial details are not expected to be described in the application. For this FOA, these studies are considered "Delayed Onset Study”.

Do I need to have tissues at hand in order to apply for the DTs or the TACs FOA?

While having tissue samples at hand is not a requirement, evidence demonstrating i) previous experience, or ii) the ability to obtain and process such samples must be included in the application. Any existing data or samples discussed in the application must be made available to the AMP AIM upon award.

Can DTs cross recruit for other DTs teams to help meet recruitment goals?

Each Disease Team application is expected to focus on only one of the AMP AIM diseases, although you can mention any capacity for other disease cohorts without including detailed information on research strategies. If your site is interested in studying or recruiting patients for multiple diseases, you need to submit separate applications for each disease of interest in response to RFA-AR-21-015.

Should the DT have language in IRB submission to allow for sharing of data and samples across the Network?

Yes, the DT applications should have language in the IRB submission that allows for sharing across the Network. All AMP investigators are expected to share protocols, samples and data across the Network, consistent with achieving the goals of the AMP, as outlined in RFA-AR-021-015 in Section IV. under “Resource Sharing Plan”.

For Disease Team applications with MPIs, is the expectation that each PI devote 2.4 person-months?

Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person months. The level of commitment can be increased to be commensurate with the needs of the project (planning, pilot or scale up activities).

I am submitting a new multi-site research study under this RFA (RFA-AR-21-015)? for one of the disease teams. Is a single IRB required for my multisite research project?

Yes. Under the Revised Common Rule (45 CFR 46.114), any protocol initially approved by an IRB on or after January 20, 2020 is required to have a single IRB for all participating domestic sites.

For questions about whether the single IRB policy applies to your study, please contact your Program Officer. Additional information about the Single IRB Policy for Multi-site research can be found here: https://grants.nih.gov/faqs#/hs-single-IRB-policy-for-multi-site-research.htm?anchor=question55255

 

For my multi-site research project for AMP AIM, I am using a protocol from AMP RA/SLE that was initially approved prior to January 20, 2020. I was not required to have single IRB for my AMP RA/SLE protocol because the grant was submitted prior to the issuance of the NIH single IRB policy. Is a single IRB now required for this new submission under RFA-AR-21-015 if using my previous protocol?

Yes. Please note, because the protocol was initially approved prior to January 20, 2020, your study does not fall under the Revised Common Rule. But, you are required to comply with the NIH single IRB policy since you are coming in on a new competing submission, which requires all domestic sites using the same research protocol to use a single IRB.
For questions about whether the single IRB policy applies to your study, please contact your Program Officer. Additional information about the Single IRB Policy for Multi-site research can be found here: https://grants.nih.gov/faqs#/hs-single-IRB-policy-for-multi-site-research.htm?anchor=question55255

Technology and Analytic Cores (TACs)

If there are multiple technologies from the same group, can these be addressed within the same application?

For Technology Cores, applicants may propose to carry out more than one technology provided those are complementary or carried out as part of a single analytic pipeline. The application should identify the technology/approach that represents the major focus and strongest area of expertise of the applicant team.

Is it required for the Technology Core applications to propose analyses for multiple AMP AIM diseases/tissues?

The AMP AIM program expects to establish a robust analytical pipeline to analyze more than one type of tissue in more than one disease. If an analytic has a very narrow focus for one type of tissue and/or one disease, applicants needs to provide strong justification for its feasibility to be applied to other diseases and/or tissues.

Will at least one technology core, one system biology core and one tissue repository core be funded for each disease of AMP AIM program?

No. The TACs are expected to work collaboratively with multiple disease teams depending on the scientific questions and network priorities.

Are only single cell technologies considered responsive for the Tech Cores (RFA-AR-21-016)?

No. All analytics, not limited to single cell technologies, that can be applied to human tissue biopsies and biospecimens would be responsive to this RFA to obtain high dimensional data to understand the molecular and cellular processes that drive the diseases.

Is the SBC the only entity responsible for data analyses?

No. While the SBC will conduct systems-level analyses of all data generated from the Network, the TCs are expected to conduct primary analysis of the datasets they generate.

Research Management Unit (RMU)

Who can/should apply for the Research Management Unit?

Any institutions/organizations/companies who have past experiences and capabilities in providing clinical monitoring/oversight and operational support for multi-sites clinical studies/clinical trials or large network and consortia are encouraged to apply.

What is the role of the Research Management Unit (RMU)?

The RMU is a central hub expected to provide operational management, clinical monitoring for the entire AMP AIM program, and coordination of network-wide activities such as establishment of necessary working groups, development of study timelines.

Will the RMU be responsible for ensuring that clinical data are complete and optimally collected?

The RMU will provide capacity for clinical monitoring for the entire AMP AIM program and be responsible for ensuring that clinical data are complete and optimally collected. The RMU can subcontract the clinical monitoring function to a third-party organization.

 

 

Accelerating Medicines Partnership and AMP are registered service marks of the U.S. Department of Health and Human Services.

Last Updated: August 2021