Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov/)
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)
National Eye Institute (NEI) (http://www.nei.nih.gov)  
National Institute on Aging (NIA) (http://www.nia.nih.gov)  
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)  
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) 
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)  
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)  
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)  
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)  
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)  

Title:  Short-Term Interdisciplinary CareerEnhancement Awardsfor NeurodegenerationResearch (K18)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DC-07-005

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.389, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.894, 93.859, 93.242, 93.853, 93.361

Key Dates

Release/Posted Date: October 2, 2006
Letters of Intent Receipt Date(s): November 8, 2006
Application Receipt Date(s): December 8, 2006
Peer Review Date(s): February-March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 1, 2007
Expiration Date: December 9, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

A concise description of the funding opportunity

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

      A. Eligible Institutions
      B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives .

Background

Diseases of the nervous system pose a significant public health and economic challenge, affecting nearly one in three Americans at some point in life, with a cost exceeding $500 billion per year. The National Institutes of Health (NIH) Blueprint for Neuroscience Research is a collaborative effort among the NIH Office of the Director and 15 Institutes and Centers to accelerate the pace of discovery and understanding in neuroscience research.  By pooling resources and expertise, the Blueprint takes advantage of economies of scale, confronts challenges too large for any single Institute or Center, and develops tools and infrastructure that serve the entire neuroscience community. (for details see the following: http://neuroscienceblueprint.nih.gov/blueprint_basics/about_blueprint.htm)).

The Blueprint was inspired by the recognition that unifying themes in neuroscience research are fundamental to understanding the normal and disordered nervous system and to developing better prevention and treatment strategies.  The Blueprint has identified three broad themes that bear on the missions of all participating Institutes and Centers: (1) neurodegeneration from disease and aging; (2) development of the nervous system throughout the lifespan, and (3) plasticity of the nervous system in response to the environment, experience, injury and disease.  These themes will be foci of Blueprint initiatives for FY 2007, FY 2008 and FY 2009, respectively.  On March 6-8, 2006, the NIH Blueprint for Neuroscience Research hosted a workshop focused on the first of these themes, neurodegeneration.  This RFA is based on recommendations made at this workshop (for report, see http://neuroscienceblueprint.nih.gov/blueprint_basics/200603_workshop_report.htm ).  This is one of a group of four announcements focused on neurodegeneration that resulted from this initiative.  The other three initiatives are: Therapeutics Delivery for Neurodegenerative Diseases (R21) (RFA-EY-07-001), Biomarkers for Neurodegeneration (R21) (RFA-NS-07-004), and Interdisciplinary Individual Postdoctoral Fellowships for Training in Neurodegeneration Research (F32) (RFA-AG-07-004). 

Neurodegeneration, the progressive loss of nerve cells, occurs in aging and in classical neurodegenerative disorders, such as Alzheimer’s, Parkinson’s, ALS, and Huntington’s disease, in retinal degeneration, and other damage to sensory systems (e.g., visual, auditory, somatosensory), in stroke, head and spinal trauma, in drug and alcohol abuse, in exposure to industrial and environmental toxicants, and, perhaps, in mental disorders and chronic pain.  Primarily, these diseases are characterized by chronic and progressive loss of neurons in discrete areas of the brain, causing debilitating symptoms such as dementia, loss of memory, loss of sensory or motor capability, decreased overall quality of life and well-being, disability, and eventually, premature death. For most neurodegenerative diseases, there is little or no treatment; at best, treatments are symptomatic in nature and do not prevent or slow the progression of disease.  Clearly, an understanding of pathological progression can help to identify points of intervention and lead to promising therapeutic approaches.  A fundamental approach for reducing the burden of neurodegenerative diseases is thus to slow or halt progression, and ultimately, to prevent the onset of the disease process. Strategies for neurorescue, neurorepair, or neuroprotection are being actively pursued by the basic, translational, and clinical research communities.  As our population ages, the already enormous impact of neurodegeneration on society will become even larger without better prevention and treatment.  Developing strategies to prevent degeneration of neurons and to promote a health nervous system is, thus, critical to the missions of all Blueprint members.

Participants at the Blueprint Neurodegeneration Workshop underscored the importance of catalyzing new interdisciplinary research communities and approaches to investigate neurodegeneration through cross-training established scientists in scientific and technical disciplines different than their own.  This would stimulate the crossfertilization of ideas and data to accelerate progress in research on neurodegenerative disease. 

Purpose and Objectives

The purpose of this Neuroscience Blueprint initiative is to provide established investigators short-term mentored career development and enhancement training experiences over a period of six- to twelve-months, typically undertaken during an academic sabbatical year, to acquire new interdisciplinary perspectives and capabilities in neurodegeneration research.  This research training experience shall take place in a host laboratory, whether within the applicant’s own institution or elsewhere, under the mentorship of a well-qualified expert in a research or technical/tool area different than the applicant’s neuroscience/scientific or technical discipline.  During this period, applicants shall devote between half-time (50%) and full-time (100%) effort to the research career development program.  The allowance for a part-time commitment of professional effort will allow awardees to hold their ongoing NIH/Federal research grants and meet their academic responsibilities, in a limited capacity and in accordance with NIH grants policy, as they retool in a new area.  However, the total effort cannot exceed 100%.  The goal of this initiative is to accelerate progress in neurodegeneration research by stimulating new ideas, fostering new approaches and catalyzing new interdisciplinary research collaborations in cellular, molecular, systems, multisystems, and/or behavioral levels neuroscience that will lead to new research programs competitive for NIH research funding.

Areas of particular scientific need in neurodegeneration research encouraged for this RFA include, but are not limited to:

The program, tailored to the individual needs and experience of the applicant, would generally incorporate two components: 1) didactic (e.g., directed study/tutorials, short courses, seminar series, journal clubs) and/or laboratory-based training in the new discipline, techniques or technologies; and 2) a small-scale research project in the host laboratory.

This award is not renewable and may not be transferred to another individual.  Due to the short duration of the award, it may not be transferred to another institution/organization.

The desired outcome of the Short-Term Interdisciplinary Career Enhancement Awards for Neurodegeneration Research initiative is to provide established researchers with new scientific knowledge and research capabilities to forge substantive, multidisciplinary collaborative research programs focusing on neurodegeneration.    In addition to this series of four Blueprint initiatives there are many other programs at NIH that support research and training in neurodegeneration.  Prospective applicants should review the NIH Guide and the websites of the NIH Institutes for other opportunities for funding and access to resources in their area of interest.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1.   Mechanism of Support

This FOA uses the NIH K18 grant award mechanism.  As an applicant, the candidate and his/her mentor will be responsible for planning, directing and executing the proposed project and career development and enhancement activities.

This FOA uses the just-in-time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).  A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2.    Funds Available

The total project period for an application submitted in response to this funding opportunity shall be between six and twelve months.  The salary amount provided by this K18 program shall be prorated based on the candidate’s full-time, 12-month salary and the support period requested, up to the maximum legislated salary level (currently set at $183,500).  This program will also provide up to $40,000 Direct Costs for research development support to cover career enhancement training expenses, such as tuition and fees for short-courses, consultant fees, travel to scientific meetings, and research-related costs, primarily supplies and technical services.  Facilities and Administrative (F&A) Costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

The candidate’s institution may supplement the salary received from the K18 award to a level consistent with the institution’s salary scale.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the conduct of the K18 program.  No PHS funds may be used for supplementation.

The participating organizations intend to commit approximately $1,250,000 dollars in FY2007 to fund up to twelve applications.

NIH grants policies as described in the NOT-OD-05-004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) are invited to work with their organizations to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

This award is intended for midcareer and senior investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor, or the equivalent in nonacademic settings, who have established records of independent, peer-reviewed Federal or private research grant funding and scientific/technical accomplishment in neuroscience, or in other domains or disciplines of science or engineering, who seek mentored research experience in neurodegeneration.  This could include: (1) basic and clinical science researchers and clinician-researchers focused on different neurodegenerative conditions; and, (2) researchers in different scientific domains, such as cellular neuroscience, systems neuroscience, behavioral biology, genetics, epidemiology, medicinal chemistry, pharmacology and informatics.  Applicants must identify one or more mentors with extensive research experience and an active, funded research program in the desired domain or discipline, who is well-qualified and willing to sponsor the short-term research career development experience.

At the time of award, applicants must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status.  Noncitizen nationals are generally persons born in outlying territories of the United States (e.g., American Samoa and Swain’s Island).  Individuals on temporary or student visas are not eligible.  Individuals may apply for this award in advance of admission to United States as a Permanent Resident, recognizing that no award will be made until legal verification of Permanent Resident status is provided.

2. Cost Sharing or Matching

Not applicable. This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants for this program may not concurrently apply for any other PHS award that duplicates the provisions of this award.

Applicants may submit only one application in response to this FOA.  In addition, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Each short-term career enhancement program must be tailored to meet the individual needs of the candidate.  The candidate and mentor are jointly responsible for the preparation of the career enhancement plan.  The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career enhancement program that maximize the use of relevant research and educational resources and propose qualified investigators as mentors.

If the host laboratory is not within the applicant institution, a Resources Format page (PHS 398) must be included in the application.

Section IV. Application and Submission Information


1. Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  Applicants must use the currently approved version of the PHS 398.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application grant application instructions and forms.

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements.  The D&B number may be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.  The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this FOA, “Short-Term Interdisciplinary Career Enhancement Awards for Neurodegeneration Research (K18), RFA-DC-07-005,” must be typed on line 2 of the face page of the application form and YES box must be checked.

See also Section VI.2 for additional information.

SUPPLEMENTAL INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III, starting on page 44.

Note that applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application, attached to the face page of the original application.  Applications submitted without the requisite number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times

See Section IV.3.A for details.  Applications must be received on or before the receipt date noted below.

3.A. Submission, Review, and Anticipated Start Dates

Letter of Intent Receipt Date(s): November 8, 2006
Application Submission Date(s): December 8, 2006
Peer Review Date(s): February-March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s):  July 1, 2007  

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC 7180
Executive Plaza South, Room 400C
Bethesda, MD 20892-7180 (20852 for express/courier service)
Telephone: (301) 496-8683
Fax: (301) 402-6250
Email: melissa_stick@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 instructions for preparing a career development grant application, as described above.  Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service, non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC 7180
Executive Plaza South, Room 400C
Bethesda, MD 20892 (20852 for express/courier service)
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: melissa_stick@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application.  Type the RFA number on the label.  Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review.  In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked.  The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above by (See Section IV.3.A. ). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and for responsiveness by the NIDCD. Incomplete and nonresponsive applications will not be reviewed. 

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the sponsoring institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the applicant department.  The candidate is required to devote between 50% and 100% effort to this career enhancement program for a period of six-to-twelve months.

Research Development Support: The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time spent in research and career enhancement activities.  Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

The K18 is not renewable and may not be transferred to another individual.  Due to the short-term nature of the award, it may not be transferred to another institution.

6. Other Submission Requirements

Using the Supplemental Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application.

CANDIDATE

CAREER ENHANCEMENT PLAN

RESEARCH PLAN

A small-scale/pilot research project that is consistent with the candidate’s level and research development and the objectives of his/her career enhancement award shall be provided, if it is formulated in advance.  If it is to be developed during the didactic phase of the K18 program, the steps to be taken to formulate the project must be described.

Organize the research plan as indicated in the Form 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods, to the extent possible and appropriate.  The candidate should consult with the mentor regarding the development of this section.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Describe a plan for training in the responsible conduct of research or describe the training that has already been completed with the last three years that is relevant to the proposed career enhancement experience.  The candidate must have completed this training by the time the K18 award begins.  No award will be issued until confirmation is provided that this requirement has been completed.

STATEMENT(S) BY MENTOR(S)/CONSULTANTS(S)/COLLABORATOR(S)

Consultant(s)/Collaboator(s): Signed statements must be provided by each consultant/collaborator confirming his/her participation in the project and describing specific roles.  Collaborators and consultants generally do not need to provide their biographical sketches.  However, information should be provided clearly documenting the appropriate areas of expertise of the consulting/collaboration.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

The sponsoring institution must define and document a strong, well-established research program related to the candidate’s area of interest, including a research environment with staff capable of productive collaboration with the candidate.  The sponsoring institution must provide a statement of commitment to meeting conditions of the award.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientist addressing the above areas and any other evidence that the candidate has a high potential for successfully augmenting his/her research program.  The mentor(s) may also submit a letter(s) of reference, but these letters will be considered independently of the three required reference letters.  All sealed reference letters should be attached to the face page of the application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT

Within the direct cost limitations for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are listed in logical order and not in order of priority.

CANDIDATE

CAREER ENHANCEMENT/DEVELOPMENT PLAN

Likelihood that the plan will contribute substantively to the scientific development of the candidate in redirecting their research program in a new trajectory, based on:

RESEARCH PLAN

Some candidates may have a fairly well-developed research plan at the time of application, while others will need the initial period of the K18 program to develop their research plan.  Candidates in the former group shall provide a fundamentally sound and feasible research plan, while those in the latter group shall provide a plan for developing this.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

STATEMENTS BY MENTOR/CO-MENTOR(S), CONSULTANT(S) AND COLLABORATOR(S)

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development and enhancement plan.  The appropriateness of the percent effort listed by the candidate for the work proposed.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
 
3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”       
 
2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

Evaluation:

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

3. Reporting

The Final Progress Report for this short-term interdisciplinary career enhancement award for neurodegeneration research should include the following information:

A final progress report, invention statement and Financial Status Report are required when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Daniel A. Sklare, Ph.D.
Research Training Officer
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251                                                                                      
Email: sklared@nidcd.nih.gov


2. Peer Review Contacts:

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250                                                                                     
Email: melissa_stick@nih.gov


3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758                                                                                     
Email: myersc@mail.nih.gov


Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations.  For publications listed in the appendix and/or Progress Report, Internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites.  Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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