RFA GM-10-001 Pharmacogenomics Research Network (PGRN) (U01/U19)
RFA GM-10-002 Pharmacogenomics Knowledge Base, PharmGKB (R24)
Announcements
- It is voluntary but highly encouraged to identify whether you plan to apply for a U01 (research group only) or U19 (research group + network resource/s) in a letter of intent, due May 2, 2009.
- Please be sure to include a bookmarked copy of your application on the CD submitted that contains your appendix items.
- Consider including a cover letter along with your application with suggestions of review expertise (do NOT name names) needed for your application.
- If anyone wishes to share with others their intent to organize any network-wide resource/s in an area, you may disseminate this information by contacting Rochelle M. Long, Ph.D.
- If an external advisory committee is proposed in an application, do not ask those individuals to serve and do not list those individuals’ names in your application, because then they would not be eligible to serve as reviewers.
- If anyone wishes to join an information dissemination e-mail group, please contact Rochelle M. Long, Ph.D.
FAQs Regarding RFA-GM-10-001
(This listing will be updated periodically.)
Budgetary Instructions
Supplemental Instructions
FAQs Regarding RFA-GM-10-002
(This listing will be updated periodically.)
If you have questions, please contact Rochelle M. Long, Ph.D. at rochelle_long@nih.gov and reference "PGRN 2010 RFA" in the subject line.
RFA-GM-10-001
Questions and answers as of May 26, 2009
Q. Where should mention of hosting the PGRN meeting (described under Supplemental Instructions in the RFA) be placed in the application?
A. There is no specified location, but we suggest in the Management section of the Research Plan.
Q. How should the application be assembled? What about when there is a research group and one or two network resources planned?
A. Follow the instructions in RFA GM-10-001 for the Research Plan Limitations, which are intended to replace the content of the Research Plan (sections 2. - 5.) as described in the Instructions for the PHS398 grant application (see page I-42). An additional 10 pages are allowed for each network resource planned. Every other instruction for the PHS398 should be followed. Please group budgets together, biosketches together, resources together, etc. This should appear as one integrated application, and not as separate applications "welded" together.
Q. Should the recommendation for division of the 40 pages for the Research Plan be strictly adhered to?
A. It is simply a recommendation for division of the sections, and of course some may require partial pages. All sections should be present and the 40 page limit overall for the Research Plan should not be exceeded. Other parts (sections 6. - 17., for example Bibliography and References Cited) do not count against the page limits.
Q. What other general instructions can you provide?
A. Have a very clear table of contents and useful page headings to aid the reviewers and NIH staff.
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RFA-GM-10-001
Questions and answers as of May 22, 2009
Q. Will applicants be able to provide scientific updates just prior to review?
A. This will be determined at the discretion of the Scientific Review Officer (SRO); it is likely this will be allowed with some limitations, for example:
- up to 2 pages of material
- submitted as a pdf
- e-mailed to the SRO (please cc: to Rochelle Long)
- not later than 30 days in advance of the review date
Q. When will the review take place?
A. Probably in late Fall 2009 (November-December time frame). It takes quite a bit of lead time to assemble and schedule a high quality review panel with the appropriate expertise.
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RFA-GM-10-001
Questions and answers as of May 15, 2009
Q. For existing PGRN members, are these new or renewal applications?
A. For existing PGRN members, these are renewal applications even in cases where there is a mechanism change from U01 to U19.
Q. For existing PGRN members, what should the start date be?
A. For existing PGRN members or for new applicants, the earliest date that these programs will be funded is July 1, 2010. Ignore the date of April 1, 2010 specified in the RFA, as it was automatically generated. NIGMS intends to renew in Summer 2010; the applications are going to January 2010 Council so that there is plenty of time to plan for the network.
Q. Do the PHS398 instructions, part 1, pg 1-42, content of research plan still apply?
A. Yes, they still apply. Additionally, please see the recommended Research Page Limitations specified in RFA GM-10-001. A few topics are listed both places (e.g., data sharing, multiple PIs) because these topics are of high importance to this initiative and should be included prominently in the research plan. Details could be provided in the later sections of the application if necessary.
Q. What is meant by the section on "Commitment to Diversity"?
A. NIGMS has as part of its mission the goal of training underrepresented minority scientists. (NIH does as well, which includes other institutes participating in this initiative.) Underrepresented minority scientists typically includes African-American, Hispanic, Native and Pacific Islanders. The objective of this language is to encourage applicants to make their research teams as "diverse" as possible - we want to challenge applicants to think proactively about this in the research problems approached and in the team put together to approach them.
Q. Do indirect costs of the subcontracts count toward the overall cap?
A. They do not, nor do one-time equipment costs.
Q. Are the full details of the Other Support needed at the time of submission?
A. No, they may be submitted "Just-in-time" in 2010, closer to the time of actually making funding decisions.
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RFA-GM-10-001
Questions and answers as of April 24, 2009
Q. Should a network resource application include research funding?
A. It is expected that some research activities might be part of a network resource responsible for advancing an area (e.g., ethics, economics, statistics), but only for projects that can be well-described and are essential to achieving network goals. There are other opportunities to apply to NIH for stand-alone research projects in pharmacogenomics in the ethical, legal, economic, and social areas; NIGMS and NHGRI will accept R01 applications.
Q. Should research that is fundamental to a research group (e.g., Next-Gen sequencing that is central to completing a research project) be included in a network resource application?
A. If the activity is absolutely required to complete a research group’s project, then funds for that activity should be requested as part of the research group portion of the application. That said, there can be adjustments made after review and prior to funding the PGRN awards through negotiation with NIH, as these will be cooperative agreements.
Q. Should a network resource include an undesignated pot of funds available for future projects?
A. Most likely it would not be wise to ask for funds for projects that are not yet known, and in most instances reviewers would probably delete. There will be separate set-asides for new pilot and developmental partnerships in the PGRN (see New Administrative Features).
Q. Can administrative support be requested in U01 or U19 applications?
A. Yes, see RFA GM-10-001, under Supplementary Instructions.
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RFA-GM-10-001
Questions and answers as of April 10, 2009
Q. What are the page limits for the application and how do they differ from the standard PHS 398 form?
A. 40 pages for sections 1-5 and the additional items listed in the directions in RFA GM-10-001 (Management, Data, Diversity, Resources, IP, etc.) and no limit for sections 6-17 (but they still are required) from the PHS398 instructions. For this RFA, the Leadership plan is part of Management and does count against the page limits.
Q. Where can samples be shared efficiently?
A. The NIGMS-funded portion of the Coriell Repository can accept high value samples and develop and maintain immortalized cells, as well as DNA, to sell to the scientific community at reasonable cost.
Q. Can CIDR be used as a genotyping facility? How would that be conveyed in an application?
A. Go ahead and contact CIDR preliminarily, and describe the plans in the application and indicate when a decision will be made. This arrangement would of course need to be verified prior to funding, or alternative plans would have to be made.
Q. Can specimens be included from overseas studies?
A. Yes, provided that consents are appropriate and human use assurances from the institutions are on file with NIH. Additional clearances will be needed (obtained by NIH through the US State Department and the host country, which may have specific rules about sharing) prior to the release of any funds to support the work.
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RFA-GM-10-001
Questions and answers as of March 27, 2009
Q. What is intended by the “Commitment to Diversity” section?
A. That there should be inclusion of underrepresented minorities (and women) in the research teams themselves, ideally at all levels of responsibility.
Q. Is a U19 application designed to support a “network resource” and should it be submitted separately?
A. No, a U19 application is a request to support a research group + a network resource. They are combined into one PHS398 submission.
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RFA-GM-10-001
Questions and answers as of February 27, 2009
Q. What should a data-sharing plan look like?
A. That depends upon the type of data to be shared. Any genome-scale or GWAS data should be shared with dbGAP, the database of genotypes and phenotypes. Any knowledge and shared datasets such as those developed by the IWPC and ITPC should be shared with PharmGKB. Data obtained with model organisms, or cell lines, might go other places. Please use the most established archival sources and explain plans to deliver data in a timely manner, no later than concurrent with publication. Data sharing plans will vary among institutions, but all should be progressive and proactive as possible for this initiative.
Q. Is the listing of network resources in the RFA exactly what the NIH want to see?
A. No, that list is intended to provide examples only. It is up to the investigators to develop and thoroughly justify all requests.
Q. Can groups work together for network resources?
A. Yes, this is encouraged! An ideal network resource incorporates expertise and skills from multiple sites, is well-focused, offers efficiency and coordination that cannot easily be achieved with individual R01 grants, and ideally impacts the entire field in a positive manner.
Q. Can an R01 application be associated with this funding opportunity announcement?
A. No, this initiative is not intended to fund regular R01-scale work. The supporting institutes are still interested in R01 applications in their topic areas, but the Pharmacogenomics Research Network is intended to fund larger-scale, multidisciplinary groups of researchers who are willing to commit substantial time and effort to group and leadership activities, which is beyond the expectations of a typical R01 award.
Q. Can Pilot and Developmental Projects be included in applications?
A. As for any grant application, discussions of future plans are encouraged. But the funds for Pilot and Developmental Partnerships are intended to be held in reserve for internal competitions for opportunities that were not known at the time that these applications are due.
Q. Should other agencies be informed of applications being planned? For example, AHRQ?
A. Yes, please inform all interested government staff so that they can potentially work together.
Q. How can an applicant learn what kinds of costs are allowable under "applicable NIH cost principles"?
A. Please make a list of proposed expenses and plan to discuss these with the Financial/Grants Management Contact listed in the RFA. It would be wise to include a representative from your institution's grants and contracts office in the discussion.
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RFA-GM-10-001
Questions and answers as of February 13, 2009
Q. How does one learn more about the pre-existing PGRN?
A. Go to the NIGMS Pharmacogenetics Research Network Web page, and click on Research Network where you will find a listing of all funded groups and summaries of their research activities.
Q. Is a U19 a network resource, and can it be applied for alone?
A. No, a U01 application is for a research group only, and a U19 application is for a research group and a network resource or two. Also, groups can band together to prepare network resource application sections. A network resource should be available to serve all groups in the PGRN, and should be a core or focus of activity. It cannot be disease or drug-specific.
Q. Can animal or model organism studies be included in an application for this initiative?
A. Yes, as long as that work is in support of uncovering the genetic contributions to understanding and predicting drug actions in humans and is part of a comprehensive research program. For example, model organisms could be used for "discovery" studies or in studies to understand a drug’s mechanism of action.
Q. Can an application be submitted in an area that does not match with the described interests of one of the institutes sponsoring this RFA?
A. Maybe, it depends upon the NIH’s determination of your subject area of research. Contact one of the listed staff people for a discussion of your proposed topic(s) of research.
Q. Can a hot new area of research or a method or technique be proposed?
A. Yes of course, keeping in mind the goals for the network as a whole (see below, reproduced from the RFA). In general, an application should be sufficiently tightly focused to have a theme area of interest and well-justified as one that would contribute substantially to the network. This initiative is not intended for traditional R01-scale work, and all institutes of the NIH still welcome pharmacogenetics applications in their respective areas.
The scientific objectives expected of the PGRN as a whole include:
- definition of the critical problems for the safe and effective use of medications;
- establishment of truly cross-disciplinary research groups and teams;
- application of the most cutting edge genetic and genomic methods to investigations with important specimen collections;
- discovery (and replication) of the critical genes and biological pathways, and important variation in those systems;
- identification of the mechanisms of action and modes of clearance of the drugs being studied;
- definition of the clinical implications of genetic variant detection.
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RFA-GM-10-002
Questions and answers as of March 6, 2009
Q. How can one gain access to the existing data in PharmGKB in order to prepare a new competing application for the knowledge base?
A. PharmGKB has prepared XML files that have the entire contents of the knowledge base in a relatively structured format. This includes all of the controlled terminologies, gene information, drug information, disease information, gene variation information (including annotations), VIP gene information, the non-graphical part of the pathways (the graphics are downloadable), and the curated and non-curated literature references. It also contains the full contents of all primary genotype and phenotype datasets hosted at PharmGKB. This is available to users who are registered with PharmGKB, since it includes individual-level genotype and phenotype data. Those who download must agree to the PharmGKB usage terms, as do all users who view this granularity of data. The data are provided "as is" and without technical support. Contact feedback@pharmgkb.org.
Q. Can the URL for PharmGKB be included in an application?
A. An applicant may include the URLs for web sites and databases that are products of
research. These can be treated like publications and reviewers may access these sites to assess their quality and impact. Sufficient description of the content should also be included in the application text for a summary evaluation. Applicants are cautioned that all hyperlinks in paper applications will lose their functionality when scanned by CSR (which means reviewers will have to cut and paste URLs if they want to view them). Applicants may provide an appendix submitted as PDF to the SRO that contains the active hyperlinks and include it on CD for the reviewers.
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Budgetary Instructions
Overall composite budgets should be provided for the entire program, and individual budgets provided for each component part (project, core, or network resource, etc.). Place these budgets at the front of the application in sequence, so that they do not interrupt the pagination and limits described above. Use roman numerals and titles to identify each component of the program and its associated budget, and make them match the entries in the Table of Contents. Place the composite budgets before the associated detailed budgets. All costs should be reflected in the composite budgets, but Facilities and Administrative costs required to set up and maintain subcontracts will not count against the upper budgetary limits for this announcement, nor will one-time equipment requests.
Composite budgets - There should be a composite budget for the initial budget period (to cover all components for the first year of the program) on form page 4, and there should be a composite budget for the entire proposed period of support (typically 5 years) on form page 5. For each composite, prepare and total the amounts by each major budget category such as Personnel, Equipment, Supplies, etc. (list the amounts by component in the space allowed on the form to itemize, and place category totals in the blocks on the forms).
Individual component budgets - For each project, core, or network resource, there should be a detailed, itemized budget for the initial budget period (to cover all aspects for the first year of the program) on form page 4, and a budget for the entire proposed period of support (typically 5 years) on form page 5. Complete justifications and explanations should be provided, including the rationale for continuing any component for the entire project period. Inflationary increases will be limited to the NIH-approved amounts, and in some cases individual institutes will limit increases for awards that received funding in prior years (details to be provided by the institute staff contacts listed in this announcement).
Subcontracts - Where there are subcontracting organizations, each entity will need to submit separate budget pages, if they are not already presented separately according to the instructions above. They should both be included in the itemized listing described for a project, core, or network resource, and their requests must be prepared separately as a detailed, itemized budget for the initial budget period and as a budget for the entire proposed period of support.
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Supplementary Instructions for all applications
Every research group should plan for and may request funds to support the travel of the principal investigator(s) and at a minimum one co-investigator to at least two PGRN meetings per year of two days duration, to be held in a rotating location around the US. The purpose of the meetings will be to assess scientific opportunities in the field and for dissemination of technical information, as well as to hold the internal Steering Committee meetings to discuss PGRN planning and administration.
Each group should be prepared to co-organize and provide local assistance for at least one meeting during the entire five year funding period. Activities in support of a meeting should be described and charges estimated, in accord with applicable NIH cost principles. Plans should be presented for this purpose in each application, but funds should NOT be specifically requested at this time. NIH will likely choose to award funds only when it is decided that a meeting will occur, by mutual agreement with the principal investigator. NIH may also decide in the future how the funds will be awarded, or possibly coordinated with a logistical network resource (if such an award is made). Any future requests for supplements will always include a review of unobligated balances on an award, in order to consider rebudgeting funds from other categories.
Every research group should plan to support a program coordinator for adequate effort to assist with communication and coordination of PGRN activities within a research group. This person's duties will exceed secretarial tasks and should require a background commensurate with the responsibilities. Funds to support this role may be requested in a U01 application.
Any group that applies for a network resource (as described in New Program Features) should also specifically plan to support a network resource liaison for adequate effort to assist with communication and coordination of activities between research groups in the PGRN. Funds may be requested for the role in a U19 application, and this may be the same person as the program coordinator for a research group, mentioned above, for a greater amount of effort.
Any group that applies for a network resource (as described in New Program Features) should describe any specialized activities proposed, if they are an essential part of the service proposed for the network. For example, periodic workshops could be proposed, or publication of reports. These activities must be explicitly described, estimated, and justified in the network resource plans, and the funds to support activities may be requested in accord with applicable NIH cost principles.
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