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Frequently Asked Questions about the Genomic Medicine Pilot Demonstration Projects - Study Investigators (U01) RFA-HG-12-006

Is this RFA limited to human genetic variation?

Yes. For example, sequencing of tumors and genotyping and/or sequencing of germline DNA is allowed, but genotyping and/or sequencing of the microbiome is not allowed.

Is there a companion RFA?

Yes, RFA-HG-12-007 will support one application for the Genomic Medicine Pilot Demonstration Projects Coordinating Center (U01). The Coordinating Center will serve as a centralized resource to facilitate and support a consortium of collaborative investigators funded through RFA-HG-12-006 (Genomic Medicine Pilot Demonstration Projects).

Is the RFA targeted for the groups that convened for the Genomic Medicine Meetings referenced in the announcement?

The RFA is open to everyone. The groups that formed within the Genomic Medicine Workshop and the external working groups are also eligible to apply.

How is this RFA different from the Clinical Sequencing Exploratory Research Program, RFA-HG-12-009?

The Genomic Medicine Pilot Demonstration Projects (U01 (RFA-HG-12-006) are primarily intended to expand and link existing genomic medicine efforts in diverse settings and populations, contribute to the evidence base regarding genomic medicine outcomes, and elucidate the processes involved in genomic medicine implementation, diffusion, and sustainability in diverse settings. This program will support projects that develop institution- or system-wide methods for incorporating an individual patient's genomic information into his or her clinical care. Applications that focus on expanding the reach of existing, already-implemented genomic medicine interventions from early adopter sites to less experienced sites, especially in defining institution-or systems-wide factors necessary for successful implementation of a specific genomic intervention across multiple sites, are well suited for this RFA.

The Clinical Sequencing Exploratory Research Program will support multi-disciplinary research on the implementation of genome-scale sequence data to clinical care. Its emphasis is on the generation and integration of sequence data into the clinical encounter, and defining the relevant technical requirements to applying genomic sequencing in a clinical workflow. Applicants must integrate research in three areas: 1) study design and clinical rationale; 2) analysis and interpretation of sequence data and 3) research on the ethical and psychosocial implications of returning results. Applicants interested in a multi-disciplinary approach to exploring the incorporation of genomic sequence data into the clinical workflow and the important ethical and psychosocial issues associated with return of such data to patients are well suited for this RFA.

The RFA mentions an "early adopter site" and "less experienced groups", how do these differ?

"Early adopter sites" are those with at least one ongoing program that is incorporating an individual patient's genomic information into his or her clinical care. "Less experienced groups" are those without such programs, or with programs in related areas that would benefit from collaboration. The goal is for the "early adopter sites" to share its experience and preliminary efforts with less experienced groups to speed the implementation and expand the diversity of settings, populations, and hospital systems in which genomic medicine efforts are conducted.

Do I have to collaborate with another institution?

No, you do not have to propose to collaborate with another institution in your application but it's important to remember that inclusion of diverse settings and populations is particularly encouraged, as is expansion beyond a single hospital system. Note that diversity of settings and populations will be considered in making funding decisions. All applications funded under RFA-HG-12-006, will be expected to collaborate with each other and operate as a consortium.

If I decide to collaborate with another institution, do I submit one application?

If partnering with another institution, the PI from the lead institution should submit one application and the partner site(s) should be listed as a subcontract(s).

Can there be more than one PI (for one application) represented on the Genomic Medicine Pilot Demonstration Projects Consortium Steering Committee?

No, only one PI from each study (even with multiple sites) can serve on the Steering Committee.

Do I need to include a travel budget for the thrice yearly Steering Committee meetings in the Washington, DC metropolitan area?

Yes, each funded PI will be responsible for budgeted travel expenses for themselves and key personnel to attend the thrice yearly Steering Committee meetings.

Note that the requested budget should not exceed $750K in the first year (FY13) and $1M total costs per year in fiscal years 201-2016.

Would a project proposing to use family history without genomic information be considered responsive?

Yes, though also incorporating available genomic data, such as whole exome, whole genome or targeted sequencing, might be perceived by peer reviewers as more significant or innovative.

This RFA is operating under a U01 mechanism, what does this entail?

The U01 activity code is a research project cooperative agreement mechanism that is similar to an R01 activity code (single project), as it supports discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interest and competencies. The U01 mechanism is used when substantial programmatic involvement is anticipated. The role of NIH staff will be to facilitate and not to direct the activities. A U01 can cover single investigator, multi-centered and multi-investigator consortia.

What is the page limit for this RFA?

There is a 12-page limit. Please reference the SF424 Application guide for more information on page limits, Table of Page Limits.

For more information, please contact:

Ebony Bookman, Ph.D.
Phone: (919) 541-0367

Heather A. Junkins, M.S..
Phone: (301) 402-0343

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Posted: June 14, 2012