Frquently Asked Questions NIAMS Core Centers for Clinical Research (CCCR) (P30)

October 31, 2016

The NIAMS held two informational webinars for prospective applicants.

Are multi-PI applications accepted?
Would extending/expanding an existing longitudinal cohort fall into the type of core resource the CCCR budget could support?
Is it a requirement for the Methodology Core to charge for core services? Do I need to charge user fees for the services and resources offered by the Resource Cores?
Can I include large equipment in my application budget?
Will there be an attempt to split the review based on diseases?
When were the last CCCRs funded?
Is it permissible to apply for this if you already have a P30?
What is envisioned for interactions of the Core Research Centers within and external to the institution?
Can I include Resource Cores and core users outside the grantee organization?
Does the research community need to be funded by NIAMS?
How do I handle Human Subjects and Vertebrate Animals in my application?
If I choose to have a Pilot and Feasibility Program, can I include specific projects within the application?
Should I include names of proposed Advisory Committee members?
Can a foreign investigator be the PI of a research project or core within a CCCR application?
What is the purpose of the required $2,500 yearly travel expense in the Administrative Core?
What is allowable for the optional Pilot and Feasibility projects if providing this opportunity is part of the Administrative Core?
Can genetic or biochemical biomarkers be generated as an activity of a CCCR?

Are multi-PI applications accepted?

Yes, but NIAMS strongly discourages multiple PI applications for the P30. However, if there are multi PIs, one should be listed as Director and one as Associate Director and the decision-making process should be well described.

Would extending/expanding an existing longitudinal cohort fall into the type of core resource the CCCR budget could support?

That should be fine. Keep in mind the goal of the CCCR is to leverage existing resources to stimulate clinical research for clinical care.

Is it a requirement for the Methodology Core to charge for core services? Do I need to charge user fees for the services and resources offered by the Resource Cores?

Typically P30s do charge fees for core services both within and outside the institution. It is expected that the Methodologic and/or Resource Core(s) will recover at least a portion of the cost of providing services or other resources in the form of user fees that are charged to the funds of the users. The Administrative Core component, with the assistance of the External Advisory Committee, should “describe how these Core(s) will set user fees, taking into account applicable Federal cost principles as discussed in NOT-OD-13-053.” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-053.html).

Can I include large equipment in my application budget?

This grant mechanism is not intended for acquisition of high-cost equipment. Equipment purchases in excess of $25,000 for any year of the grant would require special justification. Under unusual circumstances, where costly items of equipment are requested, the application must document available equipment within the institution and provide clear justification in terms of core service to be provided by the CCCR. Costly items of equipment should be funded through other sources.

Will there be an attempt to split the review based on diseases?

All of the applications are reviewed in one meeting. The meeting will cover all research areas within the NIAMS mission and relevant to the applications received. The results from the peer review will be assessed and evaluated by the NIAMS leadership.

When were the last CCCRs funded?

This is a new Centers program that focuses on providing resources to the broader NIAMS communities for clinical research.

Is it permissible to apply for this if you already have a P30?

Yes, it is permissible to apply to this funding opportunity even if you already have an existing P30. Keep in mind this FOA encourages leveraging existing resources. There should be no overlap between the two applications, but synergy is encouraged.

What is envisioned for interactions of the Core Research Centers within and external to the institution?

While research within the mission of NIAMS may be carried out in separate departments and even schools, the goals of Core Resource Centers is to provide services and resources to serve institutional, local and national clinical research efforts.

Can I include Resource Cores and core users outside the grantee organization?

Yes.

Does the research community need to be funded by NIAMS?

Not necessarily. However, the proposed Center should be serving a research community that will use Center resources for research within the NIAMS mission.

How do I handle Human Subjects and Vertebrate Animals in my application?

If no work is done in the Core that goes beyond approved protocols of other projects in the research community OR there is no human or animal activity involved, answer NO to human and animal involvement.

If a Core involves stand-alone human and/or animal activity, you must answer YES to human and/or animal involvement and the required sections must be completed.

Any Pilot and Feasibility project that includes human subjects or vertebrate animals will need to be addressed by the NIAMS prior to funding.

If I choose to have a Pilot and Feasibility Program, can I include specific projects within the application?

No. Descriptions of projects or individuals named for support should NOT be included in the application. However, plans for soliciting, reviewing, selecting, managing and reporting on the results of projects during the tenure of the Center should be included in the application.

Should I include names of proposed Advisory Committee members?

No. Describe the expected composition of the Advisory Committee (number of members, types of expertise, etc.), but do NOT name the members of the committee who are not from the Center Institution in the application so as not to limit the pool of potential reviewers.

Can a foreign investigator be the PI of a research project or core within a CCCR application?

Yes, but the need for the foreign component must be well justified.

What is the purpose of the required $2,500 yearly travel expense in the Administrative Core?

Travel funds from the Administrative Core are intended for two individuals per year from the Methodology and/or Resource Cores to attend in-person meetings with other CCCR investigators. This would be in addition to routine meetings that will occur within each Center. These two-day, in-person meetings of NIAMS CCCR investigators are intended to create synergies and to leverage emerging resources within the community of NIAMS-funded CCCR’s. These interactions should seek to drive synergy, creativity, innovation, and technical advancement toward improving health in all NIAMS mission areas. Fostering training of future clinical researchers will be an important key to guide such educational opportunities.

What is allowable for the optional Pilot and Feasibility projects if providing this opportunity is part of the Administrative Core?

The Administrative Core can offer opportunities for CCCR funded Pilot and Feasibility projects in years 2, 3, and 4 of the funded grant as a component of the CCCR enrichment program. A CCCR can fund up to 2 P&F projects/year with budgets no more than $50,000/year/project. If P&F projects are included as part of the enrichment plan, funds up to $100,000/year can be designated in the budget of the Administrative Core. The P&F projects may be funded for 1, 2, or 3 years in length, depending on the year funded and the nature of the research. The process for solicitation, review, and funding of these projects should be described within the Administrative Core section of the application. If opportunities for very short term P&F’s will be offered more than once in a timeline then details of this process should be provided.

Can genetic or biochemical biomarkers be generated as an activity of a CCCR?

This FOA does not allow support of core centers focused only on generation of biological or genetic data. However, identification, curation and validation of genetic and biochemical biomarker data are allowed as part of efforts of patient/subject phenotypic characterization.