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 Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
National Cancer Institute (NCI)(http://www.cancer.gov/)
National Institute on Aging (NIA)(http://www.nia.nih.gov/)
National Institute of Child Health and Human Development (NICHD)(http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)(http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)(http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)(http://www.niehs.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)(http://www.ninds.nih.gov/)

Title: ELSI Regular Research Program (R01)

Announcement Type
This is a reissue of PA-04-050, which was previously released January 15, 2004.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PA-08-012

Catalog of Federal Domestic Assistance Number(s)
93.172, 93.399, 93.866, 93.209, 93.361, 93.865, 93.279, 93.173, 93.113, 93.853

Key Dates
Release/Posted Date: October 22, 2007
Opening Date: January 5, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: New Date May 8, 2011 (per issuance of NOT-HG-11-006), Original Date: January 8, 2011

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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
3. Reporting

Section VII. Agency Contacts
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

This FOA is designed to encourage research projects that anticipate, analyze and address the ethical, legal, and social implications (ELSI) of the discovery and use of new information and technologies resulting from human genomic research. Of particular interest are studies that examine issues and, where appropriate, develop policy options in the following areas: 1) the translation of genomic information to improved human health; 2) the conduct of genomic research; 3) intellectual property issues surrounding access to and use of genomic information; 4) non-medical applications of genomic technologies and information; 5) the impact of genomics on concepts of race, ethnicity, kinship and individual and group identity; 6) the implications of uncovering genetic contributions to not only disease, but also 'normal' human traits and behaviors; and 7) the ethical boundaries for the uses of genomics.

Significance

The publication of an accurate, comprehensive sequence of the human genome in April 2003 marked the completion of the international Human Genome Project (HGP). The attention of the biomedical research community has now turned to the understanding and interpretation of this fundamental source of knowledge about human biology, health and illness and to the development of new approaches for applying genomic technologies and information to improving human health.

Proactive and sustained efforts are needed to ensure that the potential benefits of genomic research are maximized and potential harms minimized. To achieve this goal, research that anticipates and addresses the ethical, legal and social implications (ELSI) of the availability and use of large amounts of personal genetic and genomic information continues to be critical.

Research Scope

New genetic tests and detailed personal genomic information are becoming widely available and are being used in a variety of settings. New ethical, legal and social questions are being raised by the availability and use of such information, and the need for coherent and effective policies to address them has never been more acute. Without reliable data, provided by sound theoretical models and rigorous research, on which to base such policies and guide decision-making, there is a danger that such policies may be ill-informed and consequently ineffective, inappropriate, or even counter-productive. To facilitate the continued development of this body of knowledge, the participating institutes will support research in the ELSI area, including: 'basic' investigations directed at developing conceptual frameworks, transdisciplinary research methods and shared vocabularies; 'applied' projects that produce empirical data in clinical and non-clinical settings; and 'translational' projects that use such tools and data to develop effective public-policy options. It is critical that this research takes into consideration the perspectives of individuals from diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities.

High priority will be given to those projects that examine issues and, where appropriate, develop policy options in the areas identified as "Grand Challenges" during the NHGRI/NIH planning process focused on the future of genomic research. These Grand Challenges are described in greater detail in "A Vision for the Future of Genomics Research," (Nature (2003) 422:835-847) (http://www.genome.gov/Pages/About/vision.pdf). They are listed below, along with some examples of research questions and areas of interest. The examples should be understood as illustrative only, and not as limiting. In addition, given the rapidly changing nature of genomic and ELSI research, applicants are encouraged to visit the ELSI Research website to view current and emerging high priority research areas. http://www.genome.gov/page.cfm?pageID=10001618#Priorities.

1. Ethical, Legal and Social Factors that Influence the Translation of Genomic Information to Improved Human Health. (Grand Challenges II-5, II-6 and III-1) Research in this area is critical given the increasing availability and use of large amounts of individually identifiable genomic information and the movement towards personalized genetic medicine. Examples of research questions include: What are the optimal models for provider/patient communication about the meaning and implications of genomic information? How do individuals understand genomic information and incorporate that knowledge into their decision making? What happens if people get more information than they expected (so-called unanticipated or incidental findings)? What impact does receiving personalized genomic information have on an individuals adherence to surveillance and management interventions? What impact does receiving personalized genomic information have on an individuals health and quality of life? How will the ability to generate this information affect the fair distribution of health care resources? How will genomic information on individuals be used by health and life insurers?

2. Issues Surrounding the Conduct of Genomic Research (Grand Challenge III-1). Genomic approaches are increasingly being applied to research involving human subjects. Research is needed to evaluate the effectiveness and appropriateness of existing research policies and guidelines for the conduct of a wide range of genomic studies. Examples of research questions include: What is the impact on individuals, families and society of the current proliferation of large studies that collect whole genome data that is linked to potentially identifiable health and demographic information and placed in widely accessible research databases? How can researchers most effectively protect the privacy of participants, their families and their communities, without creating unnecessary roadblocks to the conduct of important research that benefits society? What are the most effective procedures for ensuring that participants are fully informed of the potential risks and benefits of these studies? How can researchers best protect research participants privacy when the data obtained in analyzing their samples are placed in public and or controlled access databases? Are the research regulations guiding the use of anonymized biologic specimens appropriate when whole genome studies may result in the identification of participants? Are there special issues that need to be considered with respect to the participation of children in large-scale genomic research? What are the interests of family members when it would be scientifically useful to study a deceased persons samples in a large-scale genomic research project? What models of community consultation are most effective for various types of large-scale genomic research projects?

3. Intellectual Property Issues Surrounding Access to and Use of Genomic Information (Grand Challenge I-3). There are a number of important issues in this area, including the impact that laws, regulations, and practices in the area of intellectual property have on both the development and commercialization of genomic technologies and derived products, and on access to and use of such technologies and information by both researchers and the public. To maximize the positive impact of genomics on human health, it is necessary to achieve a balance between the commercial incentives for development of useful products that are provided by the patent system, versus the research and public health benefits of free and open access. Research to explore the way in which these competing priorities can be balanced to achieve maximal public benefit is critical. Because genomic research is global, it is also important to examine the impact of international treaties, laws, regulations, practices, belief systems and other social and cultural factors on these and related questions.

4. Non-medical Applications of Genomic Technologies and Information (Grand Challenge III-1 and III-3). Another important area of research is the exploration of the implications of using genetic information and technologies in non-health care settings, such as employment, insurance, education, adoption, criminal justice, or civil litigation. Examples of questions that might be addressed include: What are the ethical and social implications of the possible use in educational settings of genetic information on predisposition to attention deficit and hyperactivity disorders, to learning disabilities or to substance abuse and addiction? What would be the legal implications if genetic information about behavioral traits, including susceptibility to drug abuse and addiction, were determined to be admissible in criminal or civil proceedings? What are the issues associated with the possible use of racial or ethnic genetic profiling (i.e. associating individual or population-base genotypes with behavioral phenotypes, such as intelligence or violent behavior or physical characteristics such as skin or hair color)? How would this information be interpreted and used? What are the public attitudes and values that could influence how this information may be used? How would the use of this information interact with individual and societal concepts of privacy and responsibility? Are existing legal protections against discrimination adequate to ensure against the misuse of genetic information in non-health care settings, or is there a role for additional, genetic-specific legal protections?

5. The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and Individual and Group Identity (Grand Challenge III-2, III-3, III-4). As the number of genetic association studies increases, studies of differences in allele frequencies among populations for various diseases and behavioral traits will also proliferate. Some such studies, if interpreted or reported irresponsibly, have the potential to stigmatize entire racial or ethnic groups. Recent research on the role of natural selection in the human lineage and potential geographic differences in the distribution of selective genetic adaptations further highlights the need for continued attention to the implications of research in this area. Additional research is particularly needed in the following areas: (1) how study populations are and should be defined and identified by genetics researchers; (2) how researchers and the press do and should interpret and report the findings of genetic studies that reveal allele frequency differences among different populations; and 3) ethical, legal and social issues related to the use of genomics to determine the geographic ancestry of individuals and populations.

6. The Implications of Uncovering Genomic Contributions to 'Normal' Human Traits and Behaviors (Grand Challenge III-3 and III-2) . Biological research is increasingly exploring the genetic contributions to non-disease-related biological attributes such as handedness, cognition, diurnal rhythms, aging and various behavioral and personality characteristics. The findings from such studies may have profound and complex implications for how individuals, families and society understand human variation, health and illness. In particular, there is a growing need for ELSI research in the area of behavioral genetics and neurogenetics. The number of studies purporting to establish associations between particular genetic variants and psychiatric disorders or less well-defined behavioral phenotypes (e.g., addiction, obesity, impulsivity) is growing rapidly. In some such studies, the phenotypes are poorly defined, as are the study populations in which the trait is found to have a higher or lower frequency. As these types of studies multiply, it will be important to address their implications, particularly in three areas: (1) problems associated with the tendency among both researchers and the press to interpret and report the findings of such studies in a manner that reinforces the fallacy of genetic determinism or genetic reductionism; (2) the risk of group stigmatization, if genetic variants found to be associated with particular characteristics or traits (particularly those with negative connotations, such as a predisposition to violent or aggressive behavior, or low intelligence) are found to have a higher or lower frequency in some racial or ethnic groups; (3) the use of the findings of behavioral genetics studies in non-medical contexts, such as in the criminal justice and educational systems.

7. Ethical Boundaries for the Uses of Genomics (Grand Challenge III-4 and III-2). To help ensure the safe and effective use of genomic information and technology, it is important to explore how society views the ethical boundaries for the uses of genomics. For instance, which sets of values determine attitudes towards the appropriateness of applying genomics to such areas as reproductive genetic testing, 'genetic enhancement' and germline gene transfer? Examples of research questions include: How are these areas defined and understood? How does this conceptualization shape values and attitudes? Are there aspects of these concepts and values that are common to all cultures and religious traditions? How are these issues viewed by individuals with disabilities? How are potential ethical boundaries for the application of genomics viewed by the research community? What might be the impact on society and the future of genomic research of the development of public policies that define and apply boundaries to the research enterprise?

In addition, a number of participating institutes have identified the following high priority issues of particular interest.

NIA is particularly interested in specific issues (ethical, legal, social, and economic) that researchers face and the unique safeguards that are needed to protect participant privacy when genetic data is linked with a rich array of data that may include longitudinal information, behavioral, social and health measures and/or information derived from linked administrative records. These issues may include those faced by researchers, those posed by data sharing and access committees to protect privacy, and those related to concerns of individual study participants and their families.

The NCI is interested in assessing the impact of heritable cancer syndromes on individuals, their families, and extended families. Study of the psycho-social, behavioral, and health behaviors of affected individuals and their families would be of particular interest. The ultimate goal of this research will be to improve all outcomes related to the diagnosis of a heritable cancer syndrome.

The NICHD has specific interests in research with implications for children, adults, and families in the following areas: assisted reproductive technologies; race, ethnicity, and kinship; child development; obesity; developmental disabilities; and medical rehabilitation. For example, the NICHD supports studies of the genetics of learning disabilities (reading, math, comorbidities of these such as ADHD), and the need to consider the social and ethical implications of how this information will be used to inform parents and to guide educational interventions is extremely important to the continuation of such research.

The NIDCD is interested in addressing social, ethical and legal issues related to deafness and other communication disorders (hearing, balance, smell, taste, voice, speech and language). The NIDCD is especially interested in the impact of genetic testing on the behaviors and attitudes of individuals with hearing impairment and their families.

The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, and genetic susceptibility to environmental exposures. In particular, NIEHS has an interest in supporting an ongoing dialogue between scientists and the public for accurate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of educational interventions used.

The NINDS is particularly interested in applications which address subjects relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH, see http://www.ninds.nih.gov/about_ninds/mission.htm".

The research areas and possible research questions described above should be seen as a guide to areas of particular interest, but should not be understood as an exhaustive listing of all possible research topics. As genomic research evolves and the interpretation and use of this information continues to emerge, applicants are encouraged to identify additional research topics and issues.

The research design of all applications should be appropriate to the nature of the project(s) proposed and the discipline(s) involved. Interdisciplinary, collaborative projects among bioethicists, genome scientists, social scientists, clinical researchers, public health researchers, behavioral researchers, health economists, legal scholars, historians, theologians and/or other scholars in the humanities are particularly encouraged.

Researchers interested in submitting applications that focus primarily on genomic technology and methods development, new approaches to bioinformatics, new strategies to apply genomics to analysis of genome structure and function, genetic variation, and population genetics should contact the appropriate NHGRI program staff about other NHGRI funding opportunities .

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 Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.

The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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

Competing renewal applications are allowed.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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 SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:January 5, 2008 (Earliest date an application may be submitted to Grants.gov):
Letters of Intent Receipt Date(s): N/A
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing


3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than
5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly 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 renewal award.

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

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Item 3 of the PHS398 Research Plan is limited to 12 pages.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component.See Section 3.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly competing continuation) applications, resubmission (formerly revised/amended) applications, and revision (formerly competing supplemental) applications. See NOT-OD-02-004, October 16, 2001.

APPENDIX MATERIALS

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.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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.

Foreign Applications (Non-domestic (non-U.S.) Entity)

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 Web site, 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.

All applicants must 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 impact/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 (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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

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

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high impact/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.

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 core review criteria, and additional review criteria (as applicable for the project proposed).

Core 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?

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?

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?

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?

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?

2.A. 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.

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.

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.

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.

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.

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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).


3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

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 Contact(s):

ELSI Research Program
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892

Telephone: (301) 402-4997
FAX: (301) 402-1950

Dr. Jean E. McEwen
Program Director, Genetic Variation, Law and Social Policy
Email: jean.mcewen@nih.hhs.gov

Dr. Elizabeth J. Thomson
Program Director, Clinical Genetics and Research Ethics
Email: et22s@nih.gov

Ms. Joy T. Boyer
Senior Program Analyst, Genetics and the Humanities
Email: jb40m@nih.gov

Dr. Carol Kasten
Project Officer
Cancer Genetics Network Epidemiology and Genetics Research Program
National Cancer Institute
5136 EPN, 6130 Executive Blvd
Bethesda, MD 20892-7393
Office: 301.402.8212
Blackberry: (301) 326-8978
Fax: 301.435.5477
Email: kastenca@mail.nih.gov

Dr. Erica L. Spotts
Health Scientist Administrator
Behavioral and Social Research Program
National Institute on Aging/National Institutes of Health
7201 Wisconsin Avenue, #533
Bethesda, MD 20892-9205
Phone: 301.451.4503
Fax: 301.402.0051
Email: spottse@mail.nih.gov

Dr. Rosalind Berkowitz King
Health Scientist Administrator
Demographic and Behavioral Sciences Branch Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B07, MSC 7510
Bethesda, MD 20892-7510 [Express mail: Rockville, MD 20852]
Phone: (301) 435-6986
Fax: (301) 496-0962
Email: kingros@mail.nih.gov

Dr. Amy Donahue
Chief, Hearing and Balance/Vestibular Sciences Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: donahuea@nicdc.nih.gov

Dr. Jonathan D. Pollock
Chief, Genetics and Molecular Neurobiology Research Branch
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd
Bethesda, MD 20892
Tel. 301-435-1309
Fax. 301-594-6043
Email: jpollock@mail.nih.gov

Dr. Kimberly A. McAllister
Scientific Program Administrator
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
P.O. Box 12233 (MD EC-21)
Research Triangle Park, NC 27709
Phone: (919) 541-4528
Fax: (919) 316-4606
Email: mcallis2@niehs.nih.gov

Dr. Katrina A. Gwinn
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd Room 2143
Bethesda, MD, 20817
Tel 301-496-5745
Fax 301-402-1501
Email: gwinnk@ninds.nih.gov

2. Peer Review Contact(s):

Not Applicable

3. Financial/Grants Management Contact(s):

Ms. Cheryl Chick
Chief, Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305
Telephone: (301) 402-0733
Fax: (301) 402-1951
Email: cc149o@nih.gov

Ms. Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard
EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-8634
Fax: (301) 496-8601
Email: crystal.wolfrey@nih.gov

Ms. Linda Whipp
Grants and Contract Management Office
National Institute on Aging
Gateway Building, 2N212
Bethesda, MD 20892-9205
Phone: 301-496-1472
Fax: 301-402-3672
Email: whippl@gw.nia.nih.gov

Mr. Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01A, MSC 7510
Bethesda, MD 20892-7510 [Express mail: Rockville, MD 20852]
Phone: 301/435-6975
Fax: 301/402-0915
Email: clarkb1@mail.nih.gov

Mr. Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, EPS 400C MSC 7180
Bethesda, MD 20892-7180
Phone: (301) 402-0909
Fax: 301 402-1758
Email: Myersc@mail.nih.gov

Ms. Pamela Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse
6101 Executive Blvd, 260
Rockville, MD 20852
Tel. 301-435-1369
Fax. 301-594-6849
Email: pfleming@nida.nih.gov

Mr. Dwight Dolby
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, EC-22
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7824
FAX: (919) 541-2860
Email: dolby@niehs.nih.gov

Ms. Tijuana Decoster
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd, Room 3258
MSC 9537 NSC NINDS/NIH
Rockville, MD 20892
Phone: 301-496-4231
Fax 301.402.0219
Email: 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 (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing 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 impact/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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women, 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 SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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