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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 Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)

Title: National NeuroAIDS Tissue Consortium (NNTC) Limited Competition (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-MH-08-021

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.853

Key Dates
Release Date: May 18, 2007
Letters of Intent Receipt Date(s): August 4, 2007
Application Receipt Date(s): September 4, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 5, 2007

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
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 purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to continue support for the patient characterizations and associated collections of brain, tissue, and fluid samples for research uses that are currently being accomplished at the NNTC sites as well as to foster the development of an NNTC-based scientific agenda. The aim is that the future NNTC awards will directly and indirectly support ongoing neuroAIDS research projects and the initiation of new projects concerning the long term effects of HIV infection and treatments on brain function. The future collection of well characterized brains and fluids from HIV+ populations will continue to be an important resource for the community. While much has been learned about the neuropathogenesis associated with neuroAIDS, brain-related changes in response to current and future treatments are unknown. The NNTC will continue to be able to provide researchers with brain and fluid samples as the disease evolves and becomes a chronic condition treated by new therapies. The restructuring of the resource from serving as a research resource for the scientific community to being a cooperative research project reflects a changed emphasis; from primarily serving as clinical and brain bank collection sites to a resource that also provides a scientific research agenda for the community. This scientific research agenda will be based upon the current collections in hand and upon the associated data in the NNTC database. The database harboring the NNTC common data set is an increasingly valuable resource for epidemiology studies due to the uniqueness of the NNTC cohort. In this renewal period, the aim for this database is that it be able to provide descriptive statistics on demographics and epidemiology-related information that is increasingly valuable as diagnosable end-stage patients are surviving and living longer lives (see RFA-MH-08-020 for further description of the Database Coordinating Center (DCC) initiative). To ensure that the maximal scientific benefit is derived from this significant public investment and is consistent with the goals of proposed NIH policy on data and resource sharing, this funding opportunity aims to support rapid sharing of data and research resources with the broad scientific community for research use.

Background

HIV-associated dementia (HAD) consists of a clinical phenotype including severe cognitive impairment, behavioral abnormalities, and motor dysfunction. The disorder was particularly detrimental in the pre-highly active antiretroviral therapy (HAART) era when estimates indicated that approximately 20% of individuals infected with HIV developed dementia and the related complex of abnormalities. While HAART reduced the incidence of HAD, the lifetime prevalence of HAD in conjunction with its milder presentation known as Mild Cognitive and Motor Disorders (MCMD) is thought to be increasing due in part to the increased longevity of individuals who are surviving on current treatments. Additional factors potentially accounting for the increased prevalence include the cumulative insults of multiple pharmacological treatments, normal brain-related aging process, challenges to physical and emotional stress response systems, substance abuse, and complicating coinfections (i.e., HCV) or opportunistic infections. The relationship between HIV neurocognitive impairment (HNCI) and viral load or peripheral immune status is unclear in that discordance often occurs between systemic HIV/AIDS disease progression and CNS manifestations. Only a resource like the NNTC will be able to provide researchers with brain and fluid samples as the disease evolves and becomes a chronic condition treated by new therapies such that researchers can address mechanisms of neuropathogenesis and treatment-related effects.

The NNTC was established in 1998 with the purpose of providing neuroAIDS researchers with high-quality brain and fluids samples from well-characterized HIV-infected patients in terms of their neuromedical and neuropsychiatric antemortem status. NNTC participants have been evaluated at 6-month intervals and researchers can now request tissues from persons who have been characterized by: degree of neurobehavioral impairment, neurological and other clinical diagnoses, history of drug use, antiretroviral treatments, blood and CSF viral load, and neuropathological diagnosis. Currently, more than 2000 subjects are enrolled and the NNTC banks contain approximately 641 brains, thousands of plasma samples, over 600 CSF samples, and additional organs and nerves of interest. More than 200 publications have credited the resource as being instrumental in their research findings. The four clinical and brain banking sites are located at Mt. Sinai, New York; University of Texas, Galveston; University of California, San Diego; and University of California, Los Angeles.

Data Management: A common set of patient-related data variables including laboratory and clinical diagnoses has been uploaded by the NNTC database coordinating center (DCC) since the inception of the NNTC. The unexpected number of end stage disease (an enrollment criteria) survivors offers unique opportunities for basic science and database-related epidemiology research. The DCC generates descriptive statistics based on the NNTC patients. In the future, it is anticipated that they will also help drive the scientific agenda by providing the appropriate HIV, biostatistical, and genetic epidemiology expertise to guide the NNTC PIs through the capabilities of the database in terms of its public scientific agenda.

Research Objectives

The NNTC has a unique mission, cohort, and subpopulation of enrollees who have survived several years after being diagnosed as having end-stage disease. The consortium will be poised to serve as a resource by providing human tissue for other scientists to initiate or replicate research projects such as the identification/validation of potential biomarkers for HIV (or other e.g., HCV, PML, JCV) disease progression in brain (or potentially liver, heart, etc.) tissue. Additionally, the resource may be able to rapidly respond to new findings in the field by validating potential biomarkers or other findings via its consortium related scientific agenda and priorities. The consortium will provide important, novel information regarding the epidemiology of neuroAIDS and make additional inroads, through its resource and internal scientific agenda functions, into the pathogenesis of brain disease in the context of HIV infection. The value of the NNTC clinical and brain banking operations will continue to be important to researchers in the future as the disease evolves and new treatments are brought to patients.

In light of the unique cohort and associated data, the objectives for the future include restructuring current operations such that the consortium can incorporate a scientific agenda into its operations by integrating scientific collaborators with expertise in all disciplines necessary to address a NNTC scientific agenda (i.e., neuropathology, virology, immunology, neuroscience (molecular, cellular and integrative), genetics, genetic epidemiology, biostatistical) into the consortium. The NNTC will be managed by an Executive Committee (EC) (see Section VI.2.A.3) whose voting membership will consist of the NNTC clinical site Principal Investigators (PIs) and the scientific PI of the DCC (DCCsPI). In addition, a Scientific Leadership Group (SLG) will be formed, consisting of the EC, a NIMH Project Collaborator and a NINDS Project Collaborator, as well as lead scientific discipline experts in the areas identified by the EC as important to the development of the scientific agenda. The SLG will be charged with identifying best practices regarding optimal recruitment (practices, numbers at sites, demographics, and scientific value in the context of the NNTC mission, etc), and methodologies (clinical and laboratory), as well as explicitly defining and promulgating a NNTC-based scientific agenda and research resource for the larger neuroAIDS scientific community.

In general, applications to continue the NNTC operations should formulate and address key questions related to the current and future recruitment strategy (specifically, how many subjects will be maintained at each site; on average, how long do sites anticipate following a subject; how will between-site differences in recruitment number and length of patient enrollment be handled; what is the rationale for between-site variability regarding recruitment, length of follow up, and procedural differences; how will future NNTC recruitment occur such that subject demographics and the scientific value/utilization of tissues is taken into account before additional recruitment and collections continue, such that the scientific value is maximized and cost is minimized). In addition, other scientific agenda areas of interest to the NIH Institutes sponsoring the NNTC include, in part:

HIV CNS disease diagnoses research that addresses which nervous system abnormalities are HIV-related, and which are due to other conditions prevalent in the under-served and under-studied populations that now constitute the majority of the epidemic’s victims; what tools are best to diagnose, quantify, and follow HIV-associated cognitive impairment in non-literate/low-education/non-English-speaking/poorly acculturated populations. Are there unique biomarkers (blood, CSF, neuropsychological tests, neuroimaging) that predict the onset of HAD and follow the response to treatment?

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Cooperative Agreement (U01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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". The NIMH intends to reissue the funding opportunity near the end of the projects awarded term.

2. Funds Available

The NIMH intends to commit approximately $4.95 million in total costs and NINDS intends to commit approximately $2.5 million in total costs in FY 2008 to fund 4 NNTC sites in response to this FOA. Each applicant may request a project period of up to 5 years. Although the financial plans of NIMH and NINDS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. Funding beyond the first year of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. The expected amount for individual awards will vary between $750,000 and $1.6 million per year in direct costs; first year site budgets should not exceed those budgeted for the current FY 2007 year.

The anticipated start date is April 1, 2008. The periods of performance for new awards will continue for 5 years after the start date.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Applications may only be submitted by the 4 institutions that represent the current 4 NNTC clinical and banking sites. The 4 sites that constitute the NNTC are:

1.B. Eligible Individuals

Only the current Principal Investigator or an appropriate designee at the corresponding NNTC site is eligible to apply. The Principal Investigator must be able to commit at least 10% effort to the NNTC.

If an appropriate designee is proposed as PI, this person must possess the skills, knowledge, resources, and professional experience needed to carry out the proposed clinical and brain banking procedures and the capacity and willingness to share in the goals and objectives established by the consortium and steering committee. In addition, the proposed PI should have established a demonstrably productive working relationship as a scientific collaborator.

2. Cost Sharing or Matching

Not applicable

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application 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 on line 2 of the face page of the application form and the YES box must be checked.

SUPPLEMENTAL INSTRUCTIONS

Part A and Part B sections should take the place of Sections A-D of the Research Plan.

Part A: NNTC Collaborative Description: Organizational Structure, Functions, Progress, Achievements, Inter-site Communications, and Proposed Scientific Agenda (30 pages total; resubmissions are allowed an additional 5-page introduction to be used across Sections 1 and 2): Section 1: Description of the current organizational structure, progress, and achievements on providing a research resource (approximately 10-15 pages). Section 2: Description of the proposed organizational structure of the NNTC and delineation of the proposed scientific agenda. (approximately 15-20 pages). (Part A is identical across all sites)

Part B: NNTC Individual Site Description: Progress, Achievements, Site Activities, and Ability to Contribute to Scientific Agenda Building (15 pages total; resubmissions are allowed an additional 2 page introduction to be used across Sections 1 and 2): Section 1: Description of progress and achievements at the specific NNTC site. Section 2: Description of how the specific site is poised to contribute to developing a scientific agenda. (Part B is specific to each site.)

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(s): August 4, 2007
Application Receipt Date(s): September 4, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Kathy L. Kopnisky, Ph.D.
Division of AIDS, Health and Behavior Research
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7726
FAX: (301) 443-9719
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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 five copies of the appendix material must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6156, MSC 9606
Bethesda, MD 20892-9606
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5160
FAX: 301-594-0702
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Mental Health and the National Institute Neurological Disorders and Stroke. Incomplete and 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 Request for Applications (RFA) 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 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html).

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 http://grants.nih.gov/grants/policy/policy.htm.

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 or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation 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 FOA requests that applications be submitted with two sections, Part A and Part B. Part A will be the same in each application and will describe and discuss the collective NNTC operations, structure, and progress during the most recent award period. The discussion should be followed by the proposed future NNTC operations, structure, and scientific agenda. There should also be a description of the group’s collective scientific and operational agenda and an outline of the work that will be carried out at each of the 4 clinical sites and at the Data Coordinating Center. Because the NNTC functions (clinical, banking and future agenda setting) will be implemented at each individual site, Part A should not include a budget. Part B is a description that is specific to the submitting site. The site-specific operations are presented in this Part (one from each of the 4 clinical center sites) to describe each site’s capability to move the NNTC operations and agenda forward. Part B will include a budget to cover each site’s contribution to the management of the cohort and tissue collection, and the implementation of the scientific agenda as set forth in Part A.

PART A: NNTC Collaborative Description: Organizational Structure, Functions, Progress, Achievements, Inter-site Communications, and Proposed Scientific Agenda (30 pages total; resubmissions allowed an additional 5 page introduction)

In general, Part A should address the ways in which the NNTC investigators will continue clinical and banking operations that are responsive to a newly formed Scientific Leadership Group (SLG) which will be charged with overseeing operations and facilitating the development of an NNTC based scientific agenda. The application should primarily focus on past and future practices and the key scientific agenda building process (with timelines) as determined by the NNTC Principal Investigators. Note that all activities of the NNTC will be reviewed, discussed, and shaped by a Scientific Leadership Group (SLG) (see Section I Research Objectives). However, Part A should address how the NNTC PIs will actively assume the responsibility and take the lead on all EC and SLG activities and issues. The Scientific Leadership Group will be charged with assuring that overall operations and direction are in keeping with high standards of scientific and programmatic achievement and that adequate mechanisms for systematic assessment of clinical procedures, banking/tissue quality, and scientific agenda building processes are in place. The NNTC PIs should detail in their application how the (non-voting) Scientific Leadership Group members input will be solicited and addressed on a regular basis. The NNTC PIs should include SLG members who are not directly associated with the NNTC institutions and who, to the best of their knowledge, have no conflict of interest with the NNTC PIs.

Section1: Current Structure, Progress, and Achievements on Providing a Research Resource (10-15 pages)

The progress and achievements section should address, in part, the total current NNTC structure and inter-site practices (communications, decision-making, etc.), current holdings in the repository, the collective inventory, the number of publications and possibly grants funded utilizing the resource, the total requests for tissue on an annual basis, the historical distribution of tissue/fluids on an annual basis, between site QA/QC measures (lab and clinical), regular NNTC activities/ meetings, promotion of the resource during the year, NNTC publications. The application should include a table(s) clearly showing the historical annual active NNTC cohort by site and sub-site, annual autopsies collected by site and sub-site, and autopsies collected in study (as part of the NNTC protocol having pre-mortem data) versus those enrolled at death for HIV+ and HIV- individuals.

Section 2: Proposed Structure and Scientific Agenda (15-20 pages)

The section should include a description of the proposed (future) organizational and functional structure for the consortium. The NNTC investigators should address how they will identify the highest priority NNTC-related research questions in neuroAIDS based upon their data and specimens and how internal analyses will guide future clinical procedures (regarding recruitment, targeted demographics, number of annual visits, etc.) and laboratory procedures (such as aliquot methodologies or DNA collection or storage practices). The scientific agenda section will include a description of the internal and external scientific agenda.

The internal agenda will include an agenda that the 4 brain banks, the DCCsPI and the DCC actively foster and are in a unique position to develop due to their familiarity with the data in the database, the clinical population, and their collective access to tissue for multi-site studies. The internal scientific agenda should address issues related to clinical and laboratory protocol changes. For instance, how will the sites handle between-site variations in recruitment and retention numbers if, for instance, one site has 3 times the number of patients enrolled for a given number of yearly collections; if >50% of a site’s cohort has been followed for more than 3 years and are healthy. How or will the internal committee determine if/when to alter the clinical methodologies or protocol schedules from bi-annual to annual visits; how will the PIs respond to advice from the SLG regarding changing laboratory methodologies for storing samples such that, for instance, cell activation studies would be possible, or DNA/genetic analyses are optimal, etc. Applications to continue the NNTC operations should formulate and address key questions related to the current and future recruitment strategy (how many subjects will be maintained at each site; on average, how long do sites anticipate following a subject; how will between-site differences in recruitment number and length of patient enrollment be handled; what is the reason for between-site variability regarding recruitment, length of follow up, and procedural differences; how will future NNTC recruitment occur such that subject demographics and the scientific value/utilization of tissues is taken into account before additional recruitment and collections continue such that the scientific value is maximized and cost is minimized). Are there areas where the PIs anticipate alterations in current practice? The internal scientific agenda should also identify consortium-wide research projects which do not require additional funding but are possible via actively analyzing and publishing (regularly collected) data to date (histological/neuropathological/clinical) on the NNTC cohort.

The external agenda should provide the research community with a better understanding of the limitations and possibilities associated with research projects based upon NNTC collections. The external agenda should speak to the issue of the feasibility of the resource for certain types of scientific projects, such as host genetics and biomarkers-related research, taking into consideration the numbers of individuals in the cohort who have specific diagnoses (i.e., HAD, MCMD, HCV/HIV coinfections, depression or other psychiatric illness, drug/alcohol abuse etc.). The PIs should address current thoughts regarding the external scientific agenda and future plans for the development of a more thorough agenda under the new structure. The PIs should: provide timelines for the development of the internal and external agendas and for the posting of the external NNTC agenda to their website among other places; include approximate dates for EC meetings and other proposed activities; identify all scientific areas of expertise needed to fully develop an internal and external scientific agenda based upon the NNTC collections; add consultants (funded through the individual site budgets) who agree to fill expertise niches and serve on the SLG as formal members.

PART B: NNTC Individual Site Description: Progress, Achievements, Site Activities, and Unique Site Attributes, Scientific Agenda Building (15 pages total)

Section 1 Progress and Achievements at Site:

Detail the site’s organizational structure, management and methods of communication within the site and in relation to the current NCO and other PIs. Describe the progress and achievements of the NNTC site during the current funding cycle, including issues such as how the site recruits, retains, and follows up on its subjects. Describe outreach efforts to community advocates or a community advisory board or group.

Describe how many volunteers are currently enrolled in the donation program; how long individuals have been enrolled in the program; the relationship between the length of time individuals have been enrolled in the NNTC protocol, the number of individuals enrolled, and the collection of tissues.

Each site application should include standardized tables describing the cohort recruitment, retention, missed visits and missing data and specimens.

Describe intra-site QA/QC measures for data, histology and other key measurable variables.

Information should be provided regarding the number of specimens stored, the numbers sent out by the site in response to requests each calendar year (to internal and external researchers with internal researchers being investigators listed on the site s Key Personnel list), and the amount of time spent shaping requests.

Section 2: Scientific Agenda:

The PI has the option of continuing clinical and brain banking procedures without contributing substantively to the development of a NNTC scientific agenda. If the PI chooses to opt out of the NNTC scientific agenda development role, the PI (as are all PIs) is bound to implement protocol related changes that are decided upon by the EC and the site is limited to a $750,000 award. All site PIs will be expected to participate in regular monthly calls and discuss all NNTC related matters and implications regarding changing clinical or laboratory protocols or procedures however, if the PI opts out of the active scientific agenda building efforts, they are not responsible for participating in detailed scientific agenda building discussions and efforts that occur outside of the annual EC meeting and monthly calls.

If the PI chooses to contribute to the scientific agenda, the PI should describe how their site is primed to contribute to certain aspects of the internal and external scientific agenda (i.e., unique patient cohort/demographics, partnerships, and/or collaborations, etc). The PIs should incorporate (and budget for) the SLG experts; each PI may want to budget for the expertise needed in a particular aspect of the scientific agenda in which that site plans to lead or specialize (i.e., genetics, virology, comorbidities, disease diagnoses, etc).

Detail in paragraph form how the site plans to reduce (or more efficiently operate within) historical levels of awarded costs such that they can incorporate the expertise and new functions of the NNTC, which includes the development of an internal and external scientific agenda, and continue clinical and brain banking operations.

Human Subjects Research (as part of item E in the application)

All sites should detail methods used to insure the protection of human subjects (in the Human Subjects Research section of the application, which immediately follows Part A and Part B), including how the site handles requests for: the commercial use of specimens and utilization of samples; genetics studies to allow for optimal subject protections and maximal research capacity.

Appendix

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html for further guidance. This FOA follows the guidance of this notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The sharing of biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the analysis of human diseases. To address the joint interests of the government in the availability of, and access to, the results of publicly funded research and in the opportunity for economic development based on these results, NIH expects applicants who respond to this FOA to develop and propose detailed plans for data sharing.

All applicants are expected to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection 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 NIMH and NINDS in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Additionally, the review criteria listed below address the synergy that is possible in a multi-site project such as the NNTC where the whole is aiming to be greater than the sum of the parts. Criteria are listed for each Part of the application. The overall scoring of the application should reflect a summary score based on the strengths and weaknesses of the individual Parts and as well as the synergy between those Parts.

PART A: NNTC Collaborative Description: Organizational Structure, Functions, Progress, Achievements, Inter-site Communications, and Proposed Scientific Agenda

Significance. Has the NNTC successfully met a need for the scientific community during the current funding cycle? Do the current and future clinical and laboratory practices appear to be appropriate such that the scientific value of patient-related information and samples are maximized? Did the NNTC articulate an internal scientific agenda building plan that will be able to answer unique and important questions regarding neuroAIDS? Does the NNTC appear poised develop areas of research unlikely to be answered through other resources? Did the NNTC articulate an external scientific agenda building plan that will be helpful to the research community at large by conveying the broad possibilities and limitations of the resource in terms of research projects?

Approach. Are the conceptual framework, design, methods, and analysis plan adequately developed, well-integrated, and appropriate for this cohort of men and women with, or at risk for, HIV infection? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation. Is the scientific agenda building plan, presented by the investigators, innovative in its approach? Are consortium clinical, laboratory and banking practices innovative?

Investigators. Are the investigators and key personnel appropriately trained and experienced to manage and direct NNTC-wide research? Are they well-suited to engage in highly collaborative interactions with each other and with investigators external to the NNTC who wish to utilize NNTC data and specimens, in collaboration with the NNTC? How well do the NNTC investigators foster collaborations with other investigators? Is the proposed scientific agenda appropriate to the experience level of the Principal Investigators and their proposed EC members?

Environment. Does the environment in which the work will be done contribute to the probability of the success of the Clinical/Banking operations and the NNTC-wide scientific agenda? Do the proposed analyses take advantage of unique features of the NNTC scientific environment or optimize useful collaborative arrangements NNTC?

Special Review Criterion:

Feasibility and Logistics. Are the scientific goals set forth in this application feasible considering the size and make-up of the cohort? Are the core laboratory procedures well coordinated, with adequate and appropriate quality control? Has the NNTC demonstrated flexibility and strength in its structure and data collection system so that it will remain well suited to address new questions which are not yet anticipated? Does the scientific and organizational structure of the NNTC facilitate the conduct of the NNTC scientific agenda? Does this structure foster collaborations with investigators outside the NNTC? Is the structure of the NNTC flexible enough to address new questions related to neuroAIDS as they arise?

PART B: NNTC Individual Site Description: Progress, Achievements, Site Activities, and Ability to Contribute to Scientific Agenda Building

Significance. Have the NNTC clinical/banking sites successfully served as the source for NNTC data and specimens? Is the functioning of the NNTC clinical site critical to the success of NNTC-wide scientific studies? Have the NNTC clinical sites successfully recruited and retained sufficient numbers of participants?

Approach. Are the design and methods for cohort maintenance, data and specimen collection, adequately developed, well-integrated, and appropriate to the aims of the NNTC? Does the applicant acknowledge potential problem areas and consider alternative approaches?

Innovation. Is the site clinical, laboratory and banking practice innovative or state of the art?

Investigators. Are the investigators appropriately trained and well suited to carry out the work specific to the NNTC clinical sites, such as data and specimen collection and the performance of site-specific data analyses? Are there key personnel in place to conduct NNTC operations ranging from clinical exams and tissue banking to computer management and general study design and analyses? Have the Principal Investigators budgeted sufficient time to ensure appropriate oversight of their clinical site and the NNTC-wide scientific agenda?

Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support?

Special Review Criterion:

Feasibility and Logistics. Are the plans for maintaining the cohort, obtaining data and sending data to the DCC, and for obtaining and storing biological specimens feasible and adequate? Are the plans for establishing and maintaining relations with community advocates/groups relevant to the NNTC adequate? Are the plans for working with the NCO/DCC in future to ensure appropriate standardization and quality control of data collected at each site adequate? Are the site-specific plans for participation in the NNTC-wide scientific agenda adequate?

2.A. Additional Review Criteria

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

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

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

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and

http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the 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.

Note that special terms and conditions will be developed to accommodate changes deemed necessary by the NIH Institutes.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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 (U01), 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.

Annual NNTC SLG meetings are required. The meeting will always be held in the Washington, DC area, unless NIH Project Collaborators approve otherwise. A substantial portion of each meeting should be devoted to assessing scientific progress and establishing scientific priorities and timelines. The Data Coordinating Center should ensure the availability of updated summary data for these meetings.

2.A.1. Project Director/Principal Investigator Rights and Responsibilities

The Project Director/Principal Investigator will have the primary responsibility for: Defining the research objectives, approaches and details of the projects within the guidelines of the FOA.

The quality of the internal (and partially external) NNTC-based research and resource will largely depend on the degree of collaboration among the five site PIs and key personnel of the DCC. Due to the multi-Center settings and continuous feedback between sites, the responsiveness of the sites in providing information to the DCC will be the responsibility of the NNTC Principal Investigators. In particular, NNTC PIs will be responsible for:

The NNTC clinical site PIs will also be responsible for

The PD/PI will retain custody of, and have primary rights to the data information and software developed under the cooperative agreement, subject to Government rights of access consistent with the current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement:

2.A.2. NIH Responsibilities

An NIH Project Collaborators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

It is planned that the NIMH Project Officer will also serve as the NIMH Project Collaborator. Similarly, the NINDS Project Officer will also serve as the NINDS Project Scientist. The NIH Project Scientists will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below.

In addition to the standard program stewardship, NIH Project Collaborators will:

In the event that an NIH Project Collaborator is not available, an alternate Project Collaborator will be named and have the same rights and responsibilities.

2.A.3. Collaborative Responsibilities

EXECUTIVE COMMITTEE: All activities of the NNTC are coordinated and supervised by the Executive Committee (EC) whose voting membership will consist of Principal Investigators (NNTC clinical site PIs, each with one vote) and the DCC Principal Investigator (one vote). The EC collaboratively decides all scientific policy and organizational issues concerning development and implementation of research agendas, structure, working group memberships, publications, access to data and interim data monitoring, and access to biological specimens.

SCIENTIFIC LEADERSHIP GROUP: The NNTC Scientific Leadership Group SLG is charged with assuring that the overall NNTC operations are in keeping with high standards of scientific and programmatic achievement and that adequate mechanisms for systematic assessment of clinical and banking quality and scientific agenda building processes are in place. While the scientific discipline experts (e.g. host genetics, immunology, HIV epidemiology, behavioral genomics, etc) of the SLG, who are retained by the site PIs, do not have voting rights on the EC, their participation at annual EC meetings and subsequent written recommendations are required in order to help shape the resource and scientific agenda setting such that it is maximally valuable to the scientific and patient community.

NNTC site PIs will be required to accept and implement policies approved by the EC and by NIMH and NINDS Project Collaborators.

INTERACTION WITH THE COMMUNITY: An optimal interaction between the NNTC sites and the communities from which the participants are drawn will be critical for the long-term success of the study. The NNTC PIs will be responsible for ensuring that individual NNTC sites maintain ties to their patient communities and interact in a spirit of collaboration that is mutually responsive. Each NNTC site will be responsible for budgeting appropriate expenses for the support of these interactions.

2.A.4. Arbitration Process

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. An Arbitration Panel composed of three members will be convened. The three members will be: a designee of the Executive Committee, chosen without the NIH Project Collaborators input; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two designees. In the case of an individual site disagreement, the first member of the arbitration panel may be chosen by the individual awardee with the disagreement. This special arbitration procedure in no way affects 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.

2.A.5. Access to Data

The EC members will be responsible for optimizing the mechanism for rapid access to data for exploratory work or manuscript preparation. Requests by investigators for raw and summary data will be managed by the DCC after clearance and prioritization by the EC. The combined NNTC data will be kept at the DCC, with copies of the dataset being sent to each NNTC site and to the NIH Project Collaborators at each NIH institute funding the NNTC. Prior to approval and release of data, research plans submitted to the EC will be evaluated to determine if it is in accordance with the informed consent signed by the NNTC participants. A NNTC public-use data set will be created by the DCC and will be updated within 90 days of each monthly upload.

2.A.6. Access to Biological Specimens

In view of the importance of biological specimens for current and future studies, their number and volume should be regularly monitored by the DCC and reported to the EC and to the NIMH and NINDS Project Collaborators. Each site's annual report to NIMH/NINDS and any other NIH co-funding institutes should include a DCC summary report on biological specimens and a detailed status report of any local repository. Problems with specimen collection at individual sites should be brought to the attention of the EC, through the DCC and the working groups, for appropriate remedial measures. Requests for specimens by NNTC (internal) investigators or independent (external) investigators should describe in detail the study for which specimens are sought, their number and volume, in accordance with a standardized NNTC Data and Specimen request form. The NNTC PIs especially, as well as the other EC members, will actively promote wider and optimal utilization of NNTC specimens by outside investigators. Prior to approval and release of specimens, research plans submitted to the EC will be evaluated to determine if the research is in accordance with the informed consent and that necessary approvals have been obtained. EC approval is not necessarily applicable to specimens in local repositories; however, EC notification about studies being conducted on local repository specimens is expected, and compliance with human subjects regulations is required.

2.A.7. Dissemination of Study Results

The existing NNTC publication policy should be followed. The policy will be reviewed in the first 6 months of the next competitive renewal funding cycle, and amended by the EC if necessary, to achieve overall fairness and timeliness in the formal reporting of research results. The timely dissemination of study results to the communities involved is strongly emphasized. The support of the NIH Institutes in funding the NNTC should be acknowledged and the NIH grant numbers included in all publications.

3. Reporting

The NNTC PIs will submit, in electronic format, an annual progress report to the NIH Project Collaborators that will include the following:

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. Special Terms and Conditions will be added to the notice of grant award regarding templates for reporting subject demographics, recruitment, retention and autopsy numbers by NNTC site and sub-site.

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:

Kathy L. Kopnisky, Ph.D.
Division of AIDS, Health and Behavior Research
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7726
FAX: (301) 443-9719
Email: [email protected]

Michael Nunn, Ph.D.
Neural Environment Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2115, MSC 9521
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
FAX: (301) 402-2060
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9609
Telephone: (301) 443-3534
FAX: 301-443-4720
Email: [email protected]

3. Financial or Grants Management Contacts:

Rita V. Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: [email protected]

Ms. Tijuanna Decoster
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3254, MSC 9537
Bethesda, MD 20892-9537
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-9231
Fax: (301) 402-0219
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the 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.

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

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

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

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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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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