Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)

Title: Parkinson’s Disease Data Organizing Center [PD-DOC] (U24)

Announcement Type
This is a modified reissue of RFA NS-05-001 (RFA-NS-05-001)

Request For Applications (RFA) Number:  RFA-NS-11-001

Catalog of Federal Domestic Assistance Number(s)
93.853, 93.113

Key Dates
Release Date: January 21, 2010
Letters of Intent Receipt Date(s): March 30, 2010
Application Receipt Dates(s): April 30, 2010
Peer Review Date(s): July 2010
Council Review Date(s): October 2010
Earliest Anticipated Start Date: January 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: May 1, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Environmental Health Sciences (NIEHS) invite Cooperative Agreement applications for developing a re-designed and enhanced Parkinson’s Disease Data Organizing Center (PD-DOC).  This is a one-time solicitation to support a PD-DOC for a maximum of five years.

In 2003, an FOA was issued to establish a Parkinson’s Disease Data Organizing Center for collecting and sharing data in PD research.  This FOA is a modified reissue of the prior FOA, and the objectives are to expand and enhance the scope of this resource and its efforts to further facilitate data sharing by establishing an accessible approach for data deposition, access, and linkage with an emphasis on usability and harmonization. Applicants with expertise in developing interoperable, user-friendly, expandable, flexible databases are encouraged to apply.  Prior experience in Parkinson’s disease databases is not necessarily required.    

While significant advances have been made in Parkinson’s disease (PD) research, the etiology and pathogenesis of this disease remain poorly understood, and no disease modifying therapy has been identified.  It is expected that the correlation of clinical, imaging, genetic, pathology, and biomarker findings will enhance our understanding of PD and facilitate identification of novel therapeutic approaches. Such correlations may allow for an improved understanding of the natural history of PD, the characterization of phenotypic subtypes at the genetic and pathology levels, as well as the identification of environmental or genetic risk factors for the disease and its heterogeneous clinical manifestations.  In addition, the examination of clinical data in relation to biospecimens may enhance the discovery of markers of disease state and progression as well as identify novel targets for drug development.  The active development of a centralized repository of clinical data, from both observational studies and clinical trials, should strengthen data sharing efforts and synergize research in the PD research community and establish important links between research efforts which could not otherwise be achieved.

To this end, the participating institutes seek to redesign and enhance the scope of a PD-DOC to serve as a shared community resource for PD investigators.  As outlined further below and in the review criteria, the main objectives for this resource and implementation plan include:

The participating institutes seek applicants with the expertise and resources to design and maintain a resource capable of achieving these aims.

Clinical data repository

PD-DOC will serve as a centralized repository for primary data from large clinical studies, including clinical trials, epidemiology studies, and genetic studies in PD.  Data from academia, non-profit disease organizations, and industry studies may be deposited in PD-DOC.  The successful applicant must have the capability to accept data, including analyzed imaging data, in various formats as well as provide secure storage and back-up of these data.  In addition, the center should have the capability to track use of the website and the data accessed.

PD-DOC and its Steering Committee will be responsible for reviewing the suitability of datasets for incorporation into PD-DOC.  Data from NIH-funded studies, studies funded by other sources such as non-profit disease organizations, industry studies, and foreign studies may be deposited into PD-DOC.  As such, the successful applicant must be able to develop agreements with academia or industry as necessary to allow data transfer.

These data must be easily accessible and searchable by investigators who access the PD-DOC database.  Specifically, there must be the capability to search for common features/terms within and across datasets (e.g., subjects with MMSE scores less than 26 at baseline).   Data dictionaries must be included to facilitate understanding and use of the deposited data. 

It is expected that the PD-DOC will work with investigators to facilitate data transmission to this central repository.  Subcontracts to the data management centers for individual studies may be necessary to cover costs associated with such data preparation and transfer to PD-DOC.  In addition, guidance would be provided to those investigators accessing and using the deposited data, and staff should be available to address questions regarding the data as needed.  It is expected such assistance may include support designing data search queries to facilitate data access and mining, including assembly of complex datasets.

It is expected that new datasets deposited into the repository will be harmonized to facilitate comparisons across studies.  (It is not expected that data currently housed in PD-DOC need be harmonized.) 

As the PD-DOC matures, the scope may be expanded to include efforts aimed at other parkinsonian disorders including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, and dementia with Lewy bodies. 

Linked data

There is significant interest in collecting biospecimens, genetic samples, imaging, and pathology on subjects with associated clinical phenotypic data. An important function of the PD-DOC will be to link the accrued clinical data with other available subject information. It will be necessary for the PD-DOC to interface with other repositories/data systems and link the associated clinical data with genetic, imaging, biospecimen, and pathology materials, as available.  Examples of such resources include the NINDS Human Genetics Resource Center at Coriell, the NIH database of Genotypes and Phenotypes (dbGaP), and NINDS funded brain banks.

A mechanism to ensure complete and accurate linkage across multiple databases will need to be developed, such as designating unique subject identification numbers.  Systems will need to be in place to ensure all data are de-identified, all policies regarding human subject protections are maintained, and HIPAA policies regarding confidentiality are followed.  

Web-based data entry system

In order to facilitate the design and implementation of new clinical research studies in PD, the PD-DOC will develop a web-based data entry system.  This system could be utilized by a variety of PD investigators including epidemiologists, geneticists, and clinical trialists.  The system should be flexible so that an investigator can easily select the components relevant to his/her particular study.  In addition, as new instruments are developed, the PD-DOC data entry system should have the capability of being modified and updated as necessary.

It is expected that the PD-DOC will also interface with the NINDS Common Data Elements Project (http://www.nindscommondataelements.org/default.aspx) and utilize the data elements developed by this effort to optimize data harmonization across studies.  It is anticipated that the common data elements for PD will be complete by the Fall of 2010, and thus these recommended assessments should be incorporated in the PD-DOC data entry system.  Utilization of common data elements across studies will allow for more standardized data collection, enabling comparisons of data between studies and meta-analyses. 

Centralized resource listing

NINDS is committed to facilitating clinical and translational research in PD, and there are numerous PD resources available to the research community.  In addition to NINDS-funded clinical and basic research, NINDS supports the Morris K. Udall Centers of Excellence for PD Research which are multidisciplinary research centers with basic, translational, and clinical expertise aimed at furthering our understanding of the etiology, pathogenesis, and treatment of PD (http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/).

The PD-DOC will serve to provide a centralized listing of PD resources for the research community.  NIH, as well as non-NIH, resources should be included. Components would include such information as availability of antibodies and animal models as well as standard operating procedures for various assays or biospecimen preparation.  It is anticipated that the PD-DOC PI will work in collaboration with the Udall Center Coordinating Committee to maximize the utility of this component of the PD-DOC. 

Outreach and oversight

There are a variety of data from sources other than NINDS-funded studies which currently may not be easily accessible to researchers.  Such data include large data sets from other government agencies such as the CDC and the VA as well as epidemiologic, genetic, and interventional studies within and outside the US.  In addition, the data from industry sponsored trials currently are not readily accessible. 

The PI should develop an outreach plan to access additional datasets and to interface with and/or link to other PD related databases.  Institute staff may assist with such efforts. 

In addition, the PI should develop an outreach plan to enhance use of the PD-DOC resource by the PD research community.  Such efforts could include data user conferences and collaboration with appropriate professional societies and non-profit organizations as well as academic and industry investigators.

The intent of the PD-DOC is for data to be publicly available; yet, the various complexities regarding data sharing and access are recognized.  Other non-federally funded data sets from industry or non-profit organizations would be of interest to the PD research community.  As such, it is expected that a variety of data transfer agreements may need to be negotiated so that data may be made available via PD-DOC.  In addition, the PD-DOC PI, with institute staff and the Steering Committee, will work toward developing a process to further enhance and incentivize data sharing, facilitating collaboration between those who collect the data and those interested in analyzing the data.

Implementation

This program is implemented with the U24 Cooperative Agreement mechanism; specific milestones of progress established at the time of award must be met prior to funding of each subsequent budget period.  NIH program staff will have a significant, although not dominant, role in the planning and execution of the supported activities.  In addition, institute staff will work toward further promoting data sharing with PD-DOC and have a significant role in the assessment of annual milestone performance.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U24 Cooperative Agreement award mechanism.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  Plans beyond the current funding opportunity are indefinite.

2. Funds Available

The following information must be included (paragraph or bulleted form):

The estimated amount of funds available for support of one project awarded as a result of this announcement is $1.2 to $2 million for fiscal year 2011.  Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply. However, investigators from Foreign institutions may participate (under subcontractual arrangements) on an application submitted by a PI from an eligible institution within the U.S.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

The PD-DOC PD/PI and associated staff must have expertise in web technology as well as database development and management.  Other qualifying considerations include demonstrated ability to provide leadership of a project with diverse aims and to perform outreach to a diverse community to promote data usage and sharing via the PD-DOC resource to further enhance PD research.  While it is not necessary for the PI to have expertise in the field of Parkinson’s disease, the ability to work across disciplines should be demonstrated.  It is expected the PI will work with a team to achieve the goals as outlined in this FOA.  The PI has the option to identify consultants and/or subcontract with other organizations for such activities as web base development.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit only one application in response to this FOA.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: March 30, 2010
Application Receipt Date(s): April 30, 2010
Peer Review Date(s): July 2010
Council Review Date(s): October 2010
Earliest Anticipated Start Date(s): January 1, 2011

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

The letter of intent should be sent to:

Wendy R. Galpern, MD, PhD
Office of Clinical Research
NINDS / NIH
6001 Executive Blvd., #2225
Bethesda, MD 20892
Telephone: (301) 496-9135
Email: galpernw@ninds.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

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

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., #3201
Bethesda, MD 20892
Telephone: (301) 496-9223
Email:  nindsreview.nih.gov@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

The awardee of this grant must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

For all applications, the following special requirements and performance requirements should be addressed within the 12 page Research Strategy, unless otherwise noted below:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

The PD-DOC will serve as a central location for data from clinical studies from a variety of sources including academia, non-profit disease organizations, and industry.  In collaboration with the participating institutes, the PD-DOC will oversee data sharing plans, in accordance with NIH policy.  In addition, there will be oversight regarding data access to ensure appropriate use of the data as well as recognition and involvement of the data donor as appropriate. 

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NINDS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

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

Scored Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 project address an important problem or a critical barrier to progress in the field?  If the aims of the project 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?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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? Do the PD-DOC PD/PI and associated staff have adequate expertise in database development and management?  Is there a demonstrated ability to provide leadership of a resource with diverse aims and to provide outreach to a broad community to promote data sharing via such a resource?   (While it is not necessary for the PI to have expertise in the field of Parkinson’s disease, the ability to work across disciplines should be demonstrated.)  Does the applicant demonstrate the ability to manage a team including experts in PD, medical databases, data management, bioinformatics, web technology, etc?  (In order to incorporate the expertise to achieve the stated objectives of the PD-DOC, various mechanisms, such as subcontracts and consultants, may be included.)

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?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  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 project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application demonstrate the ability to:

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? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations 

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

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for planning, organizing, and administering activities of the Parkinson’s Disease Data Organizing Center.  These activities will include database design and maintenance, quality control of data, interaction with donor investigators regarding data transfer, interaction with data accessors regarding queries, development of web-based data entry system, as well as the development and maintenance of an up-to-date catalogue of PD resources.  In collaboration with the NINDS Project Scientist, the PI will be responsible for outreach to researchers and organizations to promote and enhance broad data sharing and usage across the PD research community via the PD-DOC resource. 

In addition, the PI will work with the NINDS Project Scientist to develop a Steering Committee which together will define and plan objectives and approaches; plan, conduct, analyze, and publish results, interpretations, and conclusions, as appropriate; and organize and implement administrative and research activities. The Steering Committee will be responsible for overseeing direction of the PD-DOC including review of clinical studies for deposition of data into PD-DOC; review of databases and datasets for linkage with PD-DOC; determination of content of web-based data entry system; development of procedures regarding data sharing and access, in compliance with NIH policy, including development of a publication policy; and oversight regarding general direction and scope of the project.  This Committee will approve operating procedures and any changes in operating procedures.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.   It is expected that the awardee will facilitate access to data and system infrastructure for running and maintaining an ongoing repository to achieve the programmatic goals for this project.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.  This individual will work with the Principal Investigator and the Steering Committee to oversee the PD-DOC and its activities.  The Project Scientist will be a full participant and voting member of the Steering Committee and, if applicable, any subcommittees.  The dominant role and prime responsibility for the project resides with the awardee, although specific tasks and activities will be shared among the awardee and the NINDS Project Scientist. 

NINDS will establish an Oversight Board which will assess progress on an annual basis.  The membership of this committee will be selected by the NINDS.  It is expected that this Board will include representatives from academia, industry, other government agencies, and non-profit organizations. 

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  This individual will be responsible for coordinating the assessment of the progress toward achieving specified milestones and for recommending if further funds should be released to the project.  

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the governing board for the PD-DOC.  NINDS will be represented by the Project Scientist.  The Chair will be the Principal Investigator of the PD-DOC. The Steering Committee members will be selected by the PI in consultation with the Project Scientist after the time of the award and must be approved by NINDS.  It is expected that the Steering Committee will include representation from academia (including a Udall Center representative), industry, and non-profit PD organizations.    Each Steering Committee member, including the Project Scientist, will have one vote. 

As outlined in detail above, the role of the Steering Committee is to define and plan objectives and approaches; plan, conduct, analyze, and publish results, interpretations, and conclusions, as appropriate; and organize and implement administrative and research activitiesThe Steering Committee will also participate in decisions regarding project direction, scope, and progress as well as aid in review of data sets for sharing and procedures regarding data access. 

The PI will be responsible for organizing regular conference calls to occur at least monthly and one annual in-person meeting of the Steering Committee. 

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Wendy R. Galpern, MD, PhD
Office of Clinical Research
NINDS / NIH
6001 Executive Blvd., #2225
Bethesda, MD 20892
Telephone: (301) 496-9135
Email: galpernw@ninds.nih.gov

Cindy P. Lawler, PhD
Program Director
Cellular Organs and Systems Pathobiology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
530 Davis Drive, Keystone Building, Mail Drop K3-15
Research Triangle Park, NC 27709
Telephone: 919 316-4671
Email: lawler@niehs.nih.gov

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., #3201
Bethesda, MD 20892
Telephone: (301) 496-9223
Email:  nindsreview.nih.gov@mail.nih.gov

3. Financial or Grants Management Contacts:

Tijuanna DeCoster, MPA
Grants Management Officer, Grants Management Branch
National Institutes of Neurological Disorders and Stroke
6001 Executive Blvd
Room 3258, MSC 9537
Bethesda MD 20892-9537
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9231
E-mail: decostert@ninds.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women. Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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