Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Alzheimer's Disease Research Centers (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-AG-13-019

Related Notices

  • February 5, 2014 - See Notice NOT-AG-14-007. Notice of Correction to the Resource Sharing Plan Instructions.

Funding Opportunity Announcement (FOA) Number

RFA-AG-15-002

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications from qualified institutions for support of Alzheimer's Disease Research Centers (ADRCs).  These centers are designed to support and conduct research on Alzheimer's disease (AD), to serve as shared research resources that will facilitate research in AD and related disorders, distinguish them from the processes of normal brain aging and mild cognitive impairment (MCI), provide a platform for training, collect biospecimens useful for clinical research, develop novel techniques and methodologies, and translate these research findings into better diagnostic, prevention, treatment and care strategies.

Key Dates
Posted Date

January 16, 2014

Open Date (Earliest Submission Date)

April 14, 2014

Letter of Intent Due Date(s)

April 14, 2014

Application Due Date(s)

May 14, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2014

Advisory Council Review

January 2015

Earliest Start Date

March 2015

Expiration Date

May 15, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Alzheimer's disease (AD) is estimated to affect millions of older people in the United States.  Although it is occasionally identified in patients in their forties and fifties, it is most frequently associated with advancing age.  AD is the most frequent cause of institutionalization for long-term care.  It destroys the active, productive life of its victims and devastates their families financially and emotionally. It has been estimated that the United States spends well over 100 billion dollars/year for the direct and indirect costs of care for people with AD.  The risk of AD increases greatly with age, and projections suggest that the numbers of people with AD will increase with the aging of the population unless effective interventions are found.

In the United States, the Executive and Legislative Branches of the Federal Government have both expressed concern about the enormity of the problem posed by AD, and in 2011, Congress passed the National Alzheimer’s Project Act (NAPA).  Congressional concern has focused on funding for research on the causes, diagnosis, treatment, and prevention of the disease, as well as on disparities and on the cost and coordination of care. In 1984, Congress directed the National Institutes of Health (NIH), and in particular the National Institute on Aging (NIA), to foster further research related to AD.  The NIA Alzheimer's Disease Centers (ADCs) program is authorized by the Public Health Service Act, Section 445, and currently includes fifteen Alzheimer's Disease Research Centers (ADRCs) and twelve Alzheimer's Disease Core Centers (ADCCs).

The ADC program had moved into a new era, capitalizing on the extraordinary opportunities presented by leveraging the strengths of the network of centers to provide large numbers of samples and standardized clinical data collection from well-characterized participants as well as a large pool of potential participants for future AD-related research. At the same time, strong emphasis is placed on the unique contributions and new directions of each individual center. Additionally, renewed emphasis is placed on possibilities for utilizing the resources within and across the ADCs to advance and augment the fields of drug discovery and drug development for novel therapeutics for AD.

The principal aim of the ADRCs should be to enhance the performance of innovative research on AD and related topics, including research that may lead to potential disease-modifying therapy or behavioral or other symptom treatments.  Centers are requested to concentrate their attention on better defining normal aging and the transition from normal aging to mild cognitive impairment (MCI) to the earliest stages of dementia, whether AD itself or other related dementias associated with aging.  Clinical and pathological information about the earliest cognitive changes is now beginning to make it possible to develop strategies to prevent the disease from developing or slow its progression.  Attention should also be paid to mixed dementias and overlapping neurodegenerative syndromes that often occur with AD, such as vascular dementia, Lewy Body disease, Frontotemporal degeneration and Parkinson’s dementia, in order to better differentiate among them and to recognize commonalities. In addition, co-occurring conditions in other organ systems that may contribute to clinical dementia could be studied.

Centers are expected to provide an environment and core resources which will enhance cutting-edge research by bringing together biomedical, behavioral, and clinical investigators to study the etiology, pathogenesis, diagnosis, treatment, and prevention of AD, and to improve health care delivery.  Centers should also foster the development of new lines of research and provide a rich training environment for fellows and junior faculty to acquire research skills and experience in interdisciplinary AD research.  The Centers provide investigators and research groups with well-characterized patients and control subjects, family information, and brain tissue and biological specimens.  Centers should incorporate contemporary biochemical/molecular techniques and pursue research, when feasible, in genomics, epigenomics, proteomics and metabolomics.  Centers are encouraged to develop in accordance with local talents, interests, and resources, but should also be responsive to national needs related to AD.

The ADCs provide a mechanism for fostering and coordinating the interdisciplinary cooperation of a group of established investigators conducting programs of research on AD and related dementing disorders of older people.  The central focus may be translational research, clinical – pathological research, basic research or a combination. Applicants are strongly encouraged to include efforts to address the needs of, and research on, ethnically and racially diverse people as well as other underserved populations.

As part of a network, centers should be poised to participate in cooperative efforts on a massive scale within a relatively short time frame. Applicants must agree to collect a standard clinical data set (the Uniform Data Set, or UDS) that is common to all Centers and will be transmitted to the National Alzheimer’s Coordinating Center (NACC). To support the unique research needs of the center, most centers collect additional data to supplement those required by the UDS.  Centers should demonstrate a readiness to provide biological samples and data, with proper consent from well characterized populations, to enable participation in large scale collaborative national or international research projects.

Centers should work together with other AD research groups in collaborative research activities and cooperate with other Federal, State, and Local agency-supported AD programs (such as the Alzheimer's Disease Cooperative Study (ADCS) and the Alzheimer's Disease Neuroimaging Initiative (ADNI)), as well as community organizations such as the Alzheimer’s Association in furthering mutual goals.  Centers should also, whenever possible, cooperate with other NIA Centers such as Pepper, Shock, and RCMAR Centers (Resource Centers for Minority Aging Research), and Udall Centers sponsored by the National Institute of Neurological Disorders and Stroke (NINDS).

The use of NIH resources, such as those available from the chemical genomics center (http://www.ncats.nih.gov/research/reengineering/ncgc/ncgc.html) or the Biomedical Informatics Research Network (BIRN, http://www.nbirn.net/) is also encouraged. In addition, AD Centers should consider, where there are research questions in common that are consistent with the scientific goals of the center, collaboration with Centers for Drug Discovery or Clinical and Translational Science Award recipients (see http://www.ncats.nih.gov/research/cts/ctsa/ctsa.html).

Alzheimer’s Centers are required to include the following five cores:

Other cores can be proposed if they contribute to the overall mission of the Center, are scientifically justified, support projects affiliated with the Center, and fit within the budget guidelines.

ADRC applications will include, in addition, two or three research projects with a duration of up to five years (equivalent to small R01 grants) at least one of which should depend on Clinical or Neuropathology Core resources at the home Center or another Center. The number of research projects funded and their duration will depend upon scientific quality. Funding for one to three smaller one year pilot grants should also be requested. Centers should show plans of career progression for junior investigators including leadership of projects and cores within the center and successful pursuit of independent funding.

The Center Grant may incorporate ancillary activities such as longitudinal studies and limited patient care necessary to support the primary research effort.  The spectrum of activities should comprise a multi-disciplinary approach to the problem of AD and other neurodegenerative diseases, including distinguishing early stages from normal aging, investigating mixed dementias, as well as studying unique aspects and subtypes of these very complex and heterogeneous disease processes.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission (RFA-AG-13-019 applications only)

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The NIA intends to commit approximately $24 million in FY 2015 to fund 12 grants in response to this FOA.

Award Budget

New applications may request a budget for direct costs of up to $1 million per year.

Renewal applications may request direct costs for all cores (both required and optional), and the other listed functions, i.e., projects, satellites, and pilot grants at a level not exceeding the combined direct costs of all funded activities awarded during the final year of the present funding period plus a 3% increase, or $1 million per year, whichever is larger.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Eligible institutions should support an ongoing base of high-quality AD research or research in other neurodegenerative diseases, or in aging of the nervous system.  To be eligible, an institution must support:

The work proposed in the ADC should be different from the ongoing supported research. NIA will review overlap of existing support through P01s or other award mechanisms and adjust support of the center appropriately prior to any award.  Institutions can have only one active Alzheimer’s Center receiving NIA support.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be a scientific leader experienced in the field of AD and/or other neurodegenerative disease research and must be able to coordinate, integrate, and provide guidance in the establishment of programs in AD research and allied areas. 

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number is allowed for either RFA-AG-15-002 Alzheimer's Disease Research Center (P50) or RFA-AG-15-001 Alzheimer's Disease Core Center (P30), but not both grant mechanisms.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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. New applicants are strongly encouraged to contact the program officer listed under "Scientific/Research Contact".

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Creighton Phelps, Ph.D. 
Alzheimer’s Disease Centers Program
Dementias of Aging Branch
Division of Neuroscience
National Institute on Aging
7201 Wisconsin Ave., Suite 350
Bethesda, MD, 20892-9205 (20814 for express shipping
Telephone: 301-496-9350
Fax: 301-496-1494
Email: phelpsc@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core (Use this component for the Administrative Core)

12

Core (Use this component for the Clinical Core, Data Management and Statistical Core, Neuropathology Core, Outreach, Recruitment and Education Core, Satellite Diagnostic and Treatment Clinic Core, and Additional Cores)

6

Project (Use this component for each Research Project)

12


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Please enter in ASSIST using the order listed above.

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities and Other Resources: Shared resources across cores should be described in the Facilities and Other Resources attachment. 

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Program Director/Principal Investigator: The PD/PI should be a scientific leader experienced in the field of AD and/or other neurodegenerative disease research and must be able to coordinate, integrate, and provide guidance in the establishment of programs in AD research and allied areas.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the aims of the overall center and outline how the different cores will contribute to these aims.  

Research Strategy: Significance: Focusing on the center as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed center is focused on, (ii) how the resources of the proposed center will improve scientific knowledge, technical capability, and/or clinical practice, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Additionally, show how the center will:

Renewal Applications: Describe any changes in research emphasis.

Innovation: Considering the center as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

Approach: Include the major approaches and studies in the application showing how the approaches of cores complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the center and maintain a multidisciplinary focus.

Renewal Applications: Provide an overall summary that addresses the major scientific achievements in research on AD, normal aging and related topics carried out by Center personnel as well as by research utilizing Center resources in the last funding period. Identify the most significant findings that were facilitated or supported directly through Center resources. Include summaries of progress in achieving the major aims of the Center and highlight major publications. Provide examples of how the presence of the ADC has brought new investigators into the field and has stimulated non-ADC funded research in the last funding period. Explain the Center’s role in generating new funding from grants as well as leveraging funds from donors and other private sources.   Discuss the interrelationship of the center to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation (charts and tables may be included). In addition, describe the administrative relationships of the proposed ADC to the institution. Include relevant issues relating to institutional commitment and settings. May also present summary tables such as those provided in the annual Non-Competing Continuation Grant Progress Report detailing: Federally and non-federally funded grants that utilized resources from the Center, funding for therapeutic trials and other grants from industry, collaborations (including NACC, Alzheimer’s Association and others), and minority related grants.

In lieu of an overall summary, new applications will be evaluated based on preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Protection of Human Subjects: In addition to the required content of the Protection of Human Subjects section, describe the procedures for obtaining informed consent for 1) research on cognitively impaired human subjects who may not have the capacity to consent, specifically how proxy or surrogate consent will be obtained in the context of local and state law; 2) future participation in research studies if the patient becomes unable to consent (advanced directive for research); 3) placing data in the National Alzheimer’s Coordinating Center’s Uniform Data Set and sharing data and specimens with other qualified scientists consistent with achieving the goals of this program; and 4) autopsy, specifying how and by whom and with whom the topic will be discussed, when and how often. Attention should be paid to obtaining advanced directives for research, and obtaining autopsy permission from patients and families and informed consent for current and future use of biological samples by qualified investigators. Permission should be obtained for sharing of cells, DNA, and genetic and phenotypic information as well as for storage in repositories. See the Biospecimen Task Force guidelines on the NACC web site (https://www.alz.washington.edu/BiospecimenTaskForce.html) for further guidance on consent forms, as well as http://www.nia.nih.gov/research/dn/sharing-policy-and-guidance-research-genetics-alzheimers-disease for sample language regarding genetics that may be used in consent forms. Also, if genome wide association studies (GWAS) are planned, applicants are expected to follow the NIH policy on GWAS, available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

Inclusion of Women and Minorities:

Inclusion of Children:

Vertebrate Animals:

Consortium/Contractual Arrangements: For consortium arrangements, the application must include the following information:

An explanation of the programmatic, fiscal, and administrative arrangements made between the grantee institution and the collaborating institutions. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of the program, applicants should commit to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for all proposed cores and projects in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

A significant time commitment (2.4 person months) must be made by the PD/PI.

If large items of equipment are requested, the application must document what is already available and provide clear justification in terms of use by core staff and how it relates to research projects dependent on the core.  General-purpose equipment needs should be included and justified only after surveying the availability of such items within the institution.

Research patient care costs (both inpatient and outpatient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities.  Costs relating to the clinical efforts of the ADRC may be funded through the ADRC, provided there is no overlap of funding. Only those research patient costs directly related to ADRC activities may be charged to the ADRC.

Domestic and foreign travel of project personnel directly related to the core and scientific activities of the ADRC is allowable.  Budgeting should include travel and lodging 1) for the PD/PI and other key personnel to attend the semi-annual meetings of the Center Directors, 2) for annual meetings of administrators, clinical core leaders, education core leaders, data managers, and neuropathology core leaders 3) for representatives of the Center to attend at least 2 ad hoc meetings called by the ADCs or the NIA to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures among the ADCs, 4) for Center investigators to visit other ADCs for the exchange of scientific ideas, planning of multi Center research projects and to receive training in specialized techniques, 5) for the Administrator to attend the Administrators’ meeting and 6) for core leaders to attend meetings with core leaders from other ADCs.

Requests for pilots in competing applications (new and renewal) will be budgeted in the Administrative Core budget.  A brief description of the first year pilot research and detailed pilot budgets for the first year of Center funding will be requested as Just-in-Time information through eRA Commons shortly before the award of successful applications, and future year pilots should be submitted with the annual non-competing renewal applications.  Facilities & Administrative costs will be provided in accordance with these budgets.

Pilot costs should be in the range of $25,000-$35,000 direct costs per year. Pilot projects may be awarded to investigators outside of the home institution. Funds for the pilot projects should be included under the other expenses within the administrative core budgets.  These funds should not be listed as a separate line in the composite budget.  Pilot grants are allowed for consortium arrangements. 

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores and projects of the center. Provide an overview of how the core will set the overall direction of the Center and ensure optimal utilization of Center resources.  

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Administrative core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases. 

Approach:

Describe how the center's administrative structure will facilitate the following:

Present plans to establish and operate Center advisory panels including:

Pilot Projects: A plan to support one to three pilot projects for basic or clinical biomedical, translational, and epidemiological, caregiving, educational or behavioral research should be included in the application. The announcement for pilot funding should include a description of data available through NACC, including their website. Use of this resource should be strongly encouraged. This funding mechanism is intended to allow an investigator the opportunity to develop preliminary data sufficient to provide the basis for an application for independent research support. They are designed for postdoctoral or junior faculty level investigators, but may be awarded to a more senior investigator who has experience in areas other than AD research, and who wants to work in the AD research field or who wants to try a new hypothesis, method, or approach that is not an extension of ongoing AD research. Any one investigator is eligible only once for pilot support, unless the additional proposed pilot project constitutes a real departure from his or her ongoing research.  Pilot projects are typically limited to a nonrenewable single year of support.  If described and well justified, two years of support may be requested.

Examples of possible pilot projects are:

No pilot project applications should be submitted with the Center application. Funds designated for pilots are restricted until the pilots receive NIA approval. Successful Center applicants should conduct a competition and submit the successful applications to NIA for the first year of pilot funding after receiving notice of grant award; in subsequent years competition for pilot awards should be timed so successful applications can be submitted with the non-competing renewal application for NIA review.

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Provide evidence of successful overall integration of cores to promote the theme(s) of the center as well as interaction within the academic and local and national communities. Provide evidence of productivity of funded pilot grants. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Consortium/Contractual Arrangements:

For consortium arrangements, the application must include the following information:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable

Clinical Core

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources:  Provide a description of all resources for this core in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Clinical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Clinical cores of ADCs are usually based in university medical center neurology or psychiatry department memory disorders clinics, but they may also, or instead, include special populations that might be available to some applicants such as an ethnic or minority population, a religious community or a community population living in elderly housing where the likelihood of being able to study the full spectrum from normal aging to mild cognitive impairment to AD would be possible.

Research & Related Senior/Key Person Profile (Clinical Core)

Budget (Clinical Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Clinical Core)

A core is a shared central laboratory or clinical research facility, service, or resource whose function is essential to the scientific purpose of the ADC. Each core is directed by an investigator with substantial expertise related to the core. Facilities may be proposed that will enhance productivity or in other ways benefit a group of investigators to accomplish stated goals. Several important and related considerations are (1) the degree to which currently funded investigators within or outside the Center will use and will benefit from core resources, (2) the degree to which the cores coordinate with each other to further the overall Center mission and (3) the degree to which the resources will promote new and/or expanded AD research efforts locally, regionally or nationally. Applicants should document and describe briefly the research, both existing and planned, whether funded by the Center or not, that has, or will depend upon, resources provided by the requested cores.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.

Describe the target population for which the core will provide well-characterized, longitudinally followed patients and control subjects for cutting edge research projects involving e.g., clinicopathological correlations, comparison of disease states to normal aging (including those using biological samples or imaging), and drug/intervention studies.

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Significance: The clinical core has the responsibility of establishing and maintaining a clinical enterprise that provides valuable, well-documented resources for cutting edge clinical research for both center personnel and the wider scientific community. Explain the role of the clinical core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases.  If the clinical core will include special populations, the applicant must describe the characteristics of the population and justify the added scientific value to research at the Center resulting from the inclusion of this group, so that peer reviewers can evaluate the comparative strengths and weaknesses of the proposed clinical core. If the application includes a satellite clinic as part of the clinical core, explain its significance.

Approach: The clinical core, in addition to patient and control subject recruitment, provides evaluation, and diagnosis, maintains a patient registry that tracks number and reasons for subjects lost to follow-up, and conducts longitudinal follow up of patients and control subjects.  Procedures should be described related to collection, storage, and distribution of biological samples, that may include, but are not limited to, cell lines, cerebrospinal fluid (CSF), blood and plasma; particular attention should be paid to an ability to share these samples both within and outside the Center as well as to best practices for collection and use of biospecimens, as detailed in documents available on the NACC website at https://www.alz.washington.edu/BiospecimenTaskForce.html and at http://www.nia.nih.gov/research/dn/alzheimers-disease-genetics-sharing-plan (for sample language regarding genetics that may be used in consent forms.)  Also, if genome wide association studies (GWAS) are planned, applicants must follow the NIH policy on GWAS, available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

Applicants should follow agreed upon protocols for multi-center projects involving specimen collection.

Recent developments in biomarker research and improvements in evaluation of cognitive change in normal aging, and preclinical stages of mild cognitive impairment (MCI) and AD, present new opportunities for research on early stages of disease and diminish the necessity to enroll only symptomatic subjects. In those Centers with research interests related to the earliest stages of disease, Clinical Cores have the option to recruit cognitively normal but higher risk subjects for natural history and biomarker studies. This cohort would be distinct from the primary clinical cohort. Retention and follow-up are of critical importance for this group of subjects just as for the regular Clinical Core subjects. Such subjects may be selected for age, ApoE status, family history or any other criteria that may predict higher risk of developing Alzheimer or neurodegenerative pathology. These subjects would be very valuable for primary and secondary prevention trials supported by other grants.  Cognitively normal higher risk subjects would receive the baseline clinical and psychometric evaluation for the UDS that all subjects enrolled in the Clinical Core receive, and biospecimens would be collected, but these subjects would not necessarily be seen for an in-person UDS visit annually.  Instead these cognitively normal subjects could be given a brief UDS compatible telephone-based cognitive test(s) at their first and second annual follow-up scheduled approximately one and two years after initial enrollment.  However, if a clinically important decline in cognition is noted at one of the telephone follow-up calls, the subject would be scheduled for a full, in-person clinical evaluation (including UDS) as soon as would be feasible. From that point forward the subject would be seen annually for an in-person evaluation and would become part of the regular clinical core cohort.  If cognitive or functional decline does not trigger an in-person visit earlier, all subjects would be brought back to the ADRC for a full evaluation in the third year after enrollment.   In the cognitively normal subjects it would be critically important to obtain serial biological fluid biomarker measurements and, when possible, serial imaging following the baseline enrollment visit.  If the natural history of biomarker change and correlation with clinical disease can become well established, such biomarkers may eventually serve as intermediate endpoints for clinical trials or intervention.  

Longitudinal data on preclinical stages of AD, MCI, possible and probable AD, other neurodegenerative disorders and normal aging should be collected and transmitted in a timely manner to the Data Management and Statistics core.  Cooperation, concurrence and collaboration with the Data Management and Statistics core should continue from the initial specification of data content through data collection to database management and data analysis. A clear linkage between clinical and neuropathological data should be described. There should be a commitment to working across the center to increase the number of participants who agree to autopsy, especially of controls and persons with MCI or early in the course of AD.  Applicants must state in this section of the application that they agree to collect and provide the Uniform Data Set (UDS) to NACC where it will be combined with data from other Centers and made available to scientists for collaborative studies. Participants should be enrolled in the clinical core with the intent of longitudinal follow-up. Information on the UDS is available from NACC (https://www.alz.washington.edu/).

The clinical core may perform a limited amount of developmental work, but should not directly support research per se.  The developmental work allowable in a clinical core must be related to the function of the core.  It may be directed toward improving and expanding the core functions, e.g., improving existing diagnostic strategies, or developing additional methodologies, techniques or services.  Proposed developmental work should be described in the application.

Include a description of the types (with specific examples) of research projects and clinical trials that use or will use the core and what benefits will obtain to other research activities from the existence of the clinical core. While supporting clinical drug trials may be one function of a clinical core, it should not be the only major effort of the core.

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Clearly summarize resource use in affiliated research projects (both funded by the center and externally funded) and the new insights obtained from these studies. Describe demographic information including numbers and kinds of participants recruited, diagnosis, percentage follow up and dropout rate and reasons for drop out, and diagnostic accuracy confirmation by autopsy. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented. Publications resulting from resources or developmental work carried out by the core should be listed. 

Inclusion of Women and Minorities: Summarize strategies, with reference to the education core, to recruit and retain participants from diverse backgrounds including a description of how the plan fits with all of the proposed research that will make use of the core. The plan should demonstrate sensitivity to research design and biostatistical analysis. Procedures for communicating recruitment needs to the Education Core and for evaluating success should be outlined.

The inclusion of participants with different characteristics will assist investigators in providing answers to questions about AD diagnosis, treatment, and management strategies that are likely to be applicable to the broad U.S. population. Additionally, a more diverse participant pool will facilitate investigations of the neuropathology and genetics of AD as well as studies of care giving and family burden in diverse groups. Diversity of participants may be achieved in multiple ways. One option is to have a Satellite Clinic in locations that have higher populations of underserved individuals.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Planned Enrollment Report  (Clinical Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Data Management and Statistical Core

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Data Management and Statistical Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Data Management and Statistical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Statistical Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Application guide states that Project Narrative is required.  However it is only required for the Overall component. 

Facilities and Other Resources: Provide a description of all resources for this core in the Facilities and Other Resources attachment.  

Project /Performance Site Location(s) (Data Management and Statistical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Management and Statistical Core)

Budget (Data Management and Statistical Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Data Management and Statistical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.

Describe both database and statistical services that will be provided to the cores and pilots. Outline the process for contributing data to NACC and for making data available both within and outside of the center, consistent with achieving the goals of the program.

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Significance: The Data Management and Statistics core both performs data management and provides statistical consultation and liaison with other cores and projects. Data cores are important to facilitate not only local analyses but also collaborations between and among Centers and with NACC.  Explain the role of the Data Management and Statistics core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases. 

Approach: The data core should have the capacity to prepare the Uniform Data Set (UDS) for transmission to the National Alzheimer's Disease Coordinating Center (NACC) which in turn will make appropriate data sets available to qualified investigators for further research.  The funding organization will be responsible for monitoring the data sharing policy. The data core should be adequately funded and staffed to allow required tasks to be carried out. (New applicants may contact NACC to learn more about NACC procedures, the structure of the uniform data set, and the regular updates to the datasets required from all Centers; http://www.alz.washington.edu/).

The data management plan should include at least:

The staff of the data core should work with clinical and research personnel to transfer their data into computer usable form, as well as with statisticians to insure that the data are represented in a fashion that will allow the analyses to be accomplished. Data core staff should have a working relationship with core data collectors and have their cooperation to reconcile errors and missing or incomplete data elements as discovered through error check programs or through ‘hands-on’ inspection procedures. In addition the core staff should work cooperatively with the NACC staff and respond appropriately to data calls issued by NACC.

Biostatistics consultation and liaison should:

Other possible functions of the core might include:

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Summarize progress and activities related to data collection, data management and statistical consulting activities.  Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Include progress and interactions with NACC as well as descriptions of any novel data analysis or study design strategies that have been developed. Present evidence for meeting timetables for data transfer in the proper format to NACC.  Any developmental work carried out by the core should also be presented.

Progress Report Publication List:  Publications resulting from resources or developmental work carried out by the core should be listed. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Planned Enrollment Report  (Data Management and Statistical Core)

Not Applicable 

PHS 398 Cumulative Inclusion Enrollment Report (Data Management and Statistical Core)

Not Applicable

Neuropathology Core

When preparing your application in ASSIST, use Component Type 'Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Neuropathology Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Neuropathology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Neuropathology Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for this core in the Facilities and Other Resources attachment.

Facilities and equipment for use in carrying out the activities of the core should be described in this section.

Project /Performance Site Location(s) (Neuropathology Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Neuropathology Core)

Budget (Neuropathology Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Neuropathology Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.

Describe the state of the art diagnostic services, strategy for collecting well-prepared brain material, and distribution of samples for cutting edge research, locally as well as in cooperative research across Centers and with other researchers outside of Centers.

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Significance: The neuropathology core has the responsibility for providing post mortem diagnosis on cases and normal control subjects enrolled in the clinical core and on other well documented AD cases and controls. Explain the role of the Neuropathology core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases. 

Approach: Procedures should be described related to criteria for diagnosis, and the collection, storage, and distribution of brain tissue and other biological samples, including, but not limited to, cell lines, cerebrospinal fluid (CSF) and plasma.  Specimen collection, data gathering and storage activities should be coordinated with those of the Clinical Core and the Data Management Core. Procedures and processes to prevent catastrophic loss of stored specimens should be described. Describe how the core will provide a resource for research studies that include clinical-pathological correlations across Centers.  To do so, ADCs should agree to follow standardized procedures whenever possible, so that cross-Center correlations are possible. (New applicants may go to the NACC to get the most recent best practice guidelines for biospecimens: https://www.alz.washington.edu/BiospecimenTaskForce.html). Unless specific research questions require brains from late stage AD patients, emphasis should be placed on collection of normal, MCI and early AD brains, in order to support specific research efforts of investigators affiliated with the local center and other scientists. If collection of special material is proposed (e.g., tissues from patients with other dementias) justification should be included. If proposing developmental work, describe the role of this work and its significance to the core, the center and other research activities.

The procedure for prioritizing the use of tissues and other biological samples stored at the Center should be discussed along with a brief description of potential research projects that will use the samples.  Procedures to provide coded samples to investigators that protect the identity of the patients should be described. Neuropathology cores should provide the infrastructure necessary for applying novel technologies, techniques and/or information to increase the value of stored tissues and fluids, especially those that have longitudinal data available.

To facilitate data sharing and cross-Center comparisons of diagnosis, all Centers should use the neuropathological criteria for AD developed by the NIA-Alzheimer's Association Working Group (Acta Neuropathol (2012) 123:1-11).  If tissue from other diseases is collected, list the clinical diagnostic criteria used. More detailed criteria for local research purposes should also be described.  Pathology data should be included in the data set transmitted to NACC as defined by the UDS.  (New applicants may get information from NACC about the pathology data set).  Neuropathologists from the ADCs meet yearly to share ideas and discuss technical aspects of tissue sampling, development of standardized tissue processing for diverse research protocols, cataloging and data management, and banking and distribution of tissues and biological samples.  The applicant should commit to sending a representative to this meeting.

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program. All applicants, but particularly new applications or centers with primarily younger cognitive normal cohorts, where few autopsies might be expected, may wish to focus the neuropathology core on biological sample collections, storage, and distribution.

Renewal Applications only: Clearly summarize resource use in affiliated research projects and the new insights obtained from these studies, as well as type and quantity of tissue provided to investigators both funded by the Center and by other means. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Neuropathology Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Neuropathology Core)

Not Applicable

Outreach, Recruitment and Education Core

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Outreach, Recruitment and Education Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Outreach, Recruitment and Education Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach, Recruitment and Education Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for this core in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Outreach, Recruitment and Education Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Outreach, Recruitment and Education Core)

Budget (Outreach, Recruitment and Education Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Outreach, Recruitment and Education Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.

Summarize the outreach and education needs of the center as well as local academic and community settings. Outline recruitment plans in light of the needs of the research that will rely on the center. Provide an overview of any professional development activities.  

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Significance: The Outreach core has the responsibility for providing important liaison and outreach between the ADC and patients, their caregivers and the professional community so that information may be communicated bidirectionally. Explain the role of the education core in the center as a whole and as a community resource on Alzheimer’s Disease.

Approach: Provide an assessment of the outreach and educational needs that are unique to the center as well as to the geographical area in the vicinity of the ADC, including identifying underserved groups. The assessment might include information about census data, community organizations, and an evaluation of the educational, outreach and recruitment activities and needs of each research function of the center. Depending on the local needs as identified in the analysis of local needs, the education core may focus either on A) coordination with the clinical core for recruitment and retention of subjects for particular research protocols and clinical trials, with a special emphasis on underserved/underrepresented populations and/or B) innovative development of professional staff (including nurses, social workers, physicians, researchers, medical students, other professional careers, etc.) for clinical and research skills related to AD and other dementias. An outreach plan should address the needs identified, including both strengths and barriers (e.g., parking/transportation).

The methods and techniques to be employed to disseminate information and the audience targeted to receive information should be defined including 1) approaches to training of professionals including possible reciprocal exchange programs between Centers to provide access to different research environments and technologies; 2) descriptions of seminar or lecture series, workshops and continuing education programs; 3) outreach to specific communities to publicize research; 4) collaboration with other organizations such as state and local agencies, the Alzheimer’s Association, other community/service groups, sports teams, hospitals, religious organizations, business groups, local medical societies, etc.) and 5) descriptions of materials (e.g., videos and printed matter) to be developed by the Center.

Attention should be directed to issues of cultural sensitivity and, where appropriate, the information should be structured so that it can effectively reach diverse populations, including non-English-speaking people.  Procedures by which the education and outreach activities are closely coordinated with the clinical core and satellite(s) (if appropriate) should be described, especially in recruitment of diverse populations. The education and outreach activities should also be prepared to support activities of the Centers group as a whole as well as recruitment for special NIA initiatives, such as subjects for genetic studies. Collaboration with other ADCs and the NIA Alzheimer’s Disease Education and Referral Center (ADEAR) in subject recruitment, education and coordinated dissemination of educational materials is expected. Collaboration and/or consultation with RCMARs regarding recruitment and retention of diverse elder populations are encouraged (http://www.rcmar.ucla.edu/).

Other major activities of the Outreach Core might include:

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Describe efforts to assist the clinical core and NIA special initiatives, such as the genetics initiative, in subject recruitment, especially any efforts directed to recruitment of minority and ethnically diverse subjects. Provide information about training activities that effectively impart knowledge to professionals and the lay public. Describe other outreach activities. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report  (Outreach, Recruitment and Education Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Outreach, Recruitment and Education Core)

Not Applicable

Satellite Diagnostic and Treatment Clinic Core

When preparing your application in ASSIST, use Component Type 'Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Satellite Diagnostic and Treatment Clinics (SDTCs) are designed to increase the heterogeneity of the research patient pool and to enhance the research capabilities of the ADC by extending the activities of the clinical core.  Existing Centers should retain any satellites or any special recruitment activities within the clinical and education cores previously designated as a satellite and should describe these activities in a separate section of the application labeled as a separate core.  New satellite clinics may be proposed if they fit within the overall budget requirements.  Satellite clinics are not required to conduct research but should serve as vehicles for the recruitment, diagnosis and management of AD patients and control subjects from rural and minority communities, who are then offered the opportunity to participate in research protocols, clinical drug trials and autopsy.  Effective satellites usually include multicultural staff members who have links to the community being involved.  In addition, the satellite should have clearly delineated interactions with all of the other cores of the center. 

SF424 (R&R) Cover (Satellite Diagnostic and Treatment Clinic Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Satellite Diagnostic and Treatment Clinic Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Satellite Diagnostic and Treatment Clinic Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for this core in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Satellite Diagnostic and Treatment Clinic Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Satellite Diagnostic and Treatment Clinic Core)

Budget (Satellite Diagnostic and Treatment Clinic Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Satellite Diagnostic and Treatment Clinic Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.  

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

For Renewal Applications: Place overall summaries in the approach section of each core. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Planned Enrollment Report  (Satellite Diagnostic and Treatment Clinic Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Satellite Diagnostic and Treatment Clinic Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Additional Cores

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

The NIA will support additional cores that provide opportunities for scientific research beyond those attainable solely through support of the mandatory cores and other functions. However, any optional cores must support one or more research projects and fit within the budget restrictions outlined in the budget guidelines for the application. Support should not be requested for cores that only replace or centralize resources supported on individual project grants. In a Center grant application, it is not sufficient for the PD/PI merely to identify such centralized resources.  Rather, it must be demonstrated exactly how each core would augment or enhance the present capabilities of investigators using center resources to make possible new activities at the home Center as well as other Centers. 

Some examples of research support that core components could provide are:

SF424 (R&R) Cover (Additional Cores)

Complete only the following fields:

PHS 398 Cover Page Supplement (Additional Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional Cores)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for this core in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Additional Cores)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Additional Cores)

Budget (Additional Cores)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Additional Cores)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

Specific Aims:  Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores (and projects, if relevant) of the center.

Demonstrate the augmentation or enhancement of capabilities of center resources to make possible new activities at the applicant center as well as other centers. Provide a description of research project(s) that will use resources of the additional core(s).

Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach. There should be a detailed discussion of the project(s) that will use resources of additional cores.

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications: Place overall summaries in the approach section of each core. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources.  Reports should include Core objectives and progress in meeting them.  Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Planned Enrollment Report  (Additional Cores)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Additional Cores)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Projects

When preparing your application in ASSIST, use Component Type ‘Project.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide a description of all resources for each proposed project in the Facilities and Other Resources attachment. 

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Research Projects)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Applications should request funding for two or three research projects (similar to small R01s).  The research projects should request up to five years of funding and propose studies that will advance our understanding of the basic and clinical underpinnings of AD and related disorders. Projects may focus on areas such as preclinical etiology, genetics, pathogenesis, epidemiology, diagnosis, therapeutic interventions including small scale clinical trials, patient management, and caregiver issues.  Projects that are translational, focusing on drug discovery or preclinical drug development for AD or other neurodegenerative diseases are also encouraged. These may focus on: validation of new therapeutic targets, development of new assays or animal models, screening of candidate compounds or acquisition of preliminary preclinical efficacy data. The projects should be similar in quality to small R01 grants and subprojects of program project grants. It is required that at least one of the projects predominantly utilizes patients or patient samples from the clinical core or neuropathology resources.  A part of the mission of the Centers program is to train and encourage new researchers in the field of AD, at least one of the projects should be led or co-led by a junior investigator (to include post doctoral fellows and junior faculty who have not yet had NIH R01 grant support) or someone new to the field (whose primary publications and grants focus on an area other than AD) or include plans for development of a junior investigator.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies.  Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD.  Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants’ confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct research on patients and control subjects collected by the individual Center while also sharing common data sets with NACC.

Applicants should follow NIA and NIH policies on data and sample sharing (please see the following web pages for further information, including example language that may be used in consent forms:

Planned Enrollment Report  (Research Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at Vemuri@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Participation in ADC Meetings

In order to assure active collaboration with other Centers, the ADRC PD/PI and other staff should attend semi-annual meetings of the ADC PD/PIs and other ad hoc meetings arranged by the ADCs or the NIA to share research findings, participate in planning for cooperative research or help to refine and standardize operating procedures among the Centers.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the projects proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

How strong is the base of ongoing high quality research in AD and other related neurodegenerative disorders? Do the stated goals and plans demonstrate potential for contributing to cutting edge research on normal aging, MCI, early AD and related disorders? How well is the center able to participate in coordinated national efforts for collaborative research (including establishing network of investigators, sharing data and resources within the network, and holding jointly organized meetings)? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

How well do the investigators and staff provide creative scientific and administrative leadership of the Center and demonstrate a commitment to devote adequate time to the management of the ADRC program? Is there evidence of collaboration and interdisciplinary research among the investigators who will be associated with the ADRC? Does the group have stability? Are plans for recruitment of new personnel addressed? Are transition plans clearly described and feasible? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

How well do the proposed center and each component demonstrate the capacity to develop critical new knowledge and unique and innovative contributions to AD research locally and nationally?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?   

How well does the proposed Center demonstrate appropriate organization and core management? Are the organizational plan and management structure adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

How adequate are the relevant facilities for the proposed work? Does the geographic relationship between facilities seem reasonable to carry out the proposed work? How strong are the environment and core resources to enhance cutting-edge research by bringing together multidisciplinary investigators? 

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

The adequacy of plans to share brain tissue and biological specimens with other research scientists both within and outside the AD Centers network will be assessed. Any specimens that could be used for genetics research (e.g., blood, tissue) by the Center should be made available to the National Cell Repository for Alzheimer's Disease (NCRAD) in accordance with agreed upon protocols and policies http://www.nia.nih.gov/research/dn/alzheimers-disease-genetics-sharing-plan .

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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 eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Creighton H. Phelps, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: phelpsc@nia.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone:  301-496-9666
Email: Vemuri@nia.nih.gov

Financial/Grants Management Contact(s)

Deborah Stauffer
National Institute on Aging (NIA)
Telephone:  301-496-1472
Email: stauffed@nia.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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