Centers of Excellence in ELSI FAQ

National Human Genome Research Institute

National Institutes of Health
U.S. Department of Health and Human Services


Centers of Excellence in ELSI Research (CEER)

Frequently Asked Questions about the CEER RFA

Can an institution submit more than one application?
Will you allow applications from groups proposing a center in which research activities are dispersed to investigators from more than one institution?
What format should be used to present the overall aims of the center and the research aims of individual elements? Should they be presented in separate sections of the application?
What are the page limits for P50 center grant applications and P20 exploratory grant applications?
Even though the results of our proposed research will potentially be generalizable, we need to conduct the research in a selected clinical setting (or with a specifically identified disease). Will identifying a specific clinical setting/disease (e.g. diabetes research, predispositional testing) be viewed as too narrow?
Must the PI (center director) of the application be the most experienced member (or the one with the longest track record) of the research team?
What percent effort is required of the PI for an exploratory grant (P20)?
Are there limits to the number of investigators that can be included in a center application?
Can community members who are not formally affiliated with a participating university be co-investigators in CEER applications?
Does the training component "encourage" or "require" the support of post-doctoral students? What about pre-doctoral students?
Can these students be individuals with disabilities rather than underserved minorities?
Should a single budget be included in the application, or should each component have a separate budget?
Can funds be budgeted for the support of meetings, including food?
Can we include support of "patient costs" (e.g. genotyping) if it is necessary for the conduct of the proposed research project to examine its effects/impact?
Which "study section" will be reviewing these applications?
Will the review be an "integrated review," that is, will reviewers be assigned to review the full application, or will they be asked to review only one or two sections of each application (e.g. two reviewers for all training components and two reviewers for all administrative management plans)?
Are there limitations to the number of appendices or articles to be included in the appendices?


Can an institution submit more than one application?

Yes. However, if an institution is considering submission of more than one application, each should be fully justified. The existence of the other application should be acknowledged and the rationale for the need for two centers at a single institution should be addressed. Potential applicants are advised to consider carefully whether two centers are actually needed or whether combining efforts might strengthen the overall ELSI environment at the institution. If there is overlap in personnel efforts, the effects of this must be described.

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Will you allow applications from groups proposing a center in which research activities are dispersed to investigators from more than one institution?

We expect that centers will be tightly focused around a theme and that administration as well as research and training activities will be coordinated from a single site. However, we realize that it may be necessary (and in some cases encouraged) to include experts and collaboration from other sites to fill specific gaps. For example, a center site may have access to limited diversity among researchers and communities. In such a case, the center may propose to collaborate with a minority serving institution. A second example might be a center that chose to focus on economic issues related to increasing use of genetic technologies, the center may propose to enlist the participation of health economists and other experts from several sites. If multiple sites are included in a center application, a strong management plan will be important to assure reviewers that there will be close coordination among investigators at all sites.

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What format should be used to present the overall aims of the center and the research aims of individual elements? Should they be presented in separate sections of the application?

There is some flexibility in the format to be used. For P50s, the center's theme and overall aims, and the role of each individual component, should be described in detail. They may be presented in separate sections or discussed together at the applicant's discretion. Whichever approach is chosen, the issues of integration between the center's theme and overarching aims, and the aims of each individual component must be clear and strongly justified.

For P20s, there is more flexibility, as the overall aim of the P20 should be to position your institution to develop the needed resources to submit a P50 grant application after two years. The purpose of the P20 is to plan a research center rather than actually complete a research plan.

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What are the page limits for P50 center grant applications and P20 exploratory grant applications?

For P50 applications, an expanded page limit of up to 40 pages will be allowed for a description of the research plan (sections a-d of the PHS 398 application form). The description should include the overall theme and aims of the center, the elements that will comprise the center and how they will be integrated, as well as specific research aims, design and methodologies, data analysis and dissemination plans. Up to 15 additional pages will be allowed to describe the organizational structure of the center, management plans and plans for training activities. Additional pages can be used for the other required sections (e.g. the inclusion of women, minorities and children, and human subjects protections). Each individual section should be clearly labeled.

For the P20 applications, the regular PHS 398 instructions should be followed (with a page limit of 25 pages total for sections a-d of the research plan).

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Even though the results of our proposed research will potentially be generalizable, we need to conduct the research in a selected clinical setting (or with a specifically identified disease). Will identifying a specific clinical setting/disease (e.g. diabetes research, predispositional testing) be viewed as too narrow?

Applicants may need to select a "clinical laboratory" (e.g. a specific disease or clinical setting) in which to conduct their research. Should this be the case, the proposal should include a full description justifying the selection of the specific disease or setting and why it was not appropriate to use a more general setting or multiple diseases. The potential for generalizing the results to address other diseases or settings, as well as the limitations of the selection must be fully discussed in the application.

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Must the PI (center director) of the application be the most experienced member (or the one with the longest track record) of the research team?

No. One of the review criteria on which the application will be evaluated is the strength of the center director (PI), in terms of scientific or academic achievement (track record), management ability and leadership qualities. Convincing evidence should be provided that the PI has outstanding abilities to lead, coordinate, and manage all of the activities of the CEER.

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What percent effort is required of the PI for an exploratory grant (P20)?

There is no specific requirement. However, the PI should devote sufficient time to demonstrate that he/she will be able to draw the group together to develop a P50 center proposal.

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Are there limits to the number of investigators that can be included in a center application?

There are no limits to the number of investigators who can be included in a center grant application. However, each investigator included on the list of personnel should have a well-defined role in the center.

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Can community members who are not formally affiliated with a participating university be co-investigators in CEER applications?

Yes, though as a co-investigator they would need to be supported under a sub-contract to the center rather than as a consultant. NHGRI is committed to supporting meaningful and genuine involvement by community members in ELSI research.

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Does the training component "encourage" or "require" the support of post-doctoral students? What about pre-doctoral students?

It is expected that each center will support up to two post-doctoral students each year. One of the responsibilities of a center is to contribute to NHGRI's efforts to increase the number of ELSI researchers in the future. centers will provide a unique opportunity as the training will occur across disciplines. Within the training component, centers have a responsibility to assist in increasing the number of ELSI researchers from underrepresented minority communities (African Americans, Alaskan Natives, Hispanic Americans, Native Americans, Pacific Islanders). As such, the training component of the application must provide a credible plan that will assure recruitment of potential trainees from minority populations. Tuition and other training costs can be requested as a part of the proposal.

While pre-doctoral students can be supported as research assistants through center activities, tuition and other associated training costs will not be supported.

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Can these students be individuals with disabilities rather than underserved minorities?

Students supported by the center can be individuals with disabilities. Recruitment of such individuals is encouraged. However, such recruitment does not replace the requirement of laying out a plan for the recruitment and involvement of people from underrepresented minority communities.

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Should a single budget be included in the application, or should each component have a separate budget?

A single budget for the overall center application is required. However, there is flexibility in the way an applicant may justify the costs for components of the center and the applicant should use the approach that he/she judges to be most informative for the review group. For example, an application may be composed of identifiable components that are presented together in an overall budget but in the budget justification it may be most appropriate to provide separate justifications for each component.

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Can funds be budgeted for the support of meetings, including food?

You may request funds for the support of meetings, travel, lodging, etc. Food may be included in the request if it is part of a working meeting. You should not budget funds for such travel, food, and lodging support for federal employees, nor should you request food support for individuals who will be paid a per diem.

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Can we include support of "patient costs" (e.g. genotyping) if it is necessary for the conduct of the proposed research project to examine its effects/impact?

Yes. Costs of "testing" and participant "incentives" can be included in budget requests.

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Which "study section" will be reviewing these applications?

Applications that are received in response to the CEER RFA will be reviewed by a Special Emphasis Panel (SEP) that is assembled by the NHGRI Office of Scientific Review (OSR). The specific make up of the Panel to be convened will be based on the nature of the research questions that are proposed in the CEER applications.

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Will the review be an "integrated review," that is, will reviewers be assigned to review the full application, or will they be asked to review only one or two sections of each application (e.g. two reviewers for all training components and two reviewers for all administrative management plans)?

We expect to have an integrated review with three or four reviewers assigned to evaluate the entire application. Additional reviewers with specialized expertise may be assigned to evaluate specific components of the research plan.

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Are there limitations to the number of appendices or articles to be included in the appendices?

While the number of appendices is not limited, it is critical that information important to the application be included in the application and not the appendices. Do not use the appendix to circumvent the allowed page limitations. Photocopies, questionnaires, or other things that do not copy well should be included in the appendices. PHS398 states that a total of no more than ten publications should be included in the appendices. For this RFA, if there are more than 10 key personnel for whom applicants would like to submit publications, no more than one publication per key personnel member identified will be allowed. DO NOT include more publications than necessary and DO include only those that will strengthen your application.

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Additions to this FAQ may be added as they arise.

Further inquiries regarding CEER applications or this FAQ should be addressed to:

Program Director, ELSI Research
National Human Genome Research Institute
National Institutes of Health
31 Center Drive, Room B2B07
Bethesda, MD 20892-2033

Phone: (301) 402-4997
Fax: (301) 402-1950
E-mail: et22s@nih.gov
www.genome.gov

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Last Updated: July 11, 2012