Required Application Instructions

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

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

The Biomedical/Biobehavioral Research Development (BRAD) program encompasses the long-standing Extramural Associate Research Development Award (EARDA) program and the newer International Extramural Associate Research Development Award (IEARDA) program. The BRAD program continues to encourage the development of leaders in research administration who can develop and implement strategies for strengthening the administrative research support infrastructures at non-research intensive institutions that play prominent roles in educating and diversifying the next generation of biomedical and biobehavioral scientists. Additionally since 1997, the National Institutes of Health (NIH) has dramatically increased its funding of research and training in developing countries. The BRAD program continues to extend support to institutions in select developing countries to build capacity in regulatory compliance and research administration related functions.

NIH on Workforce Diversity: Diversity in science matters. Social scientists have long observed the ability of heterogeneous groups to derive a greater number of alternatives and perspectives that lead to more complete and inventive solutions, which are critical for scientific innovation and problem solving (http://www.ncbi.nlm.nih.gov/pubmed/15534225. In support of this interest, the NIH makes significant contributions to the development of a highly skilled and diverse scientific workforce. Moreover, the Advisory Committee to the NIH Director on Diversity has recommended that the NIH expand opportunities that accelerate progress toward the development of a more diverse scientific workforce. (http://acd.od.nih.gov/dbr.htm).

NICHD Workforce Diversity Objectives: Diversifying the scientific workforce is also a priority for the NICHD. The BRAD program encourages applications from institutions with racially and ethnically diverse student enrollment in the science, technology, engineering and mathematics (STEM) disciplines and that are committed to engaging students in research, with the intent of stimulating their interest in pursuing research careers. Studies show that the provision of early intensive research experiences can attract students into academic research careers. Components of the BRAD program provide opportunities for grantees to plan and implement faculty development activities that explore current topics in NICHD supported research, with the intent of encouraging faculty and student participation in the institute’s other research capacity building programs. These programs include the:

• Cooperative Research Partnerships to Promote Workforce Diversity in the Reproductive Sciences Program (Fertility and Infertility Branch);
• Academic/Community Partnership Conference Series (R13) (Office of Health Equity);
• Biomedical and Biobehavioral Research Innovations to Ensure Equity (BRITE) in Maternal and Child Health (R15) (Office of Health Equity); and
• Research Supplements to Promote Diversity in Health-Related Research Program (All NICHD Branches)

The phrase "diverse student enrollment" encompasses individuals from racial and ethnic minority groups that are underrepresented in the domestic scientific workforce, individuals with disabilities, and individuals from disadvantaged backgrounds (i.e., family annual incomes below established low-income thresholds, rural and urban environments that lack basic resources and conditions, etc.).

Scope

The Biomedical/Biobehavioral Research Administration Development (BRAD) program is an infrastructure development initiative; its areas of emphasis include increasing institutional competency in research administration and organizational development with a focus on addressing and eliminating barriers to faculty participation in externally supported research. The program scope encompasses pre- and post-award service delivery, process development, development of competency in regulatory compliance, leadership development in research administration, certification-guided training, limited Office of Sponsored Program (OSP) staffing and training, facilitating the development of a culture of research, and faculty professional development in targeted areas such as enhancing grant-writing skills, expanding faculty competencies in state-of-the-art research methodologies.

Objectives

The objectives of the BRAD program are to:

• Facilitate the development of leadership in research administration. In support of this objective BRAD supports:
  • Training that culminates with a certification in Research Administration for the Extramural Associate (EA) and other OSPR staff;
  • Limited OSP staffing and the development of staff training modules
• Develop or enhance institutional administrative research support infrastructures with a focus on providing efficient, consistent, and responsive service to faculty engaged in research. In support of this objective BRAD supports:
  • Pre-Award related service and process development
  • Post-Award related service and process development
  • Regulatory Compliance training and program development (i.e., Institutional Review Board and Institutional Care and Animal Use review process development, etc.)
• Promote research program development and sustainability. In support of this objective the BRAD program supports ORSP (or similar entity) sponsorship of activities aimed at increasing faculty competitiveness for external research support, for example:
  • Needs assessments that identify and guide policy development to eliminate barriers to research;
  • Selected faculty development activities, including short courses/workshops that focus on enhancing research related competencies and/or research productivity (i.e., research design, state-of-the-art-methodologies and techniques, granting-writing, balancing teaching and research roles, laboratory management, scientific writing, etc.).

Structure and Governance

The emphasis on program structure and governance is intended to ensure that all allowable activities supported by BRAD are in alignment with the strategic direction applicant institutions. Accordingly, program governance focuses on people, roles, structures and policies.

• Extramural Associate (PD/PI): The Extramural Associate (EA) serves as PD/PI or contact PD/PI of the G11 award. The EA has full project authority to manage and direct BRAD program resources and to make decisions regarding program direction. The EA must have the support of the applicant institution and be empowered with the authority to oversee and execute the IDP for research administration. The EA must also have the flexibility to dedicate the allowable level of effort to carry out the expectations described in this FOA.
• Senior Administrator (SA): The role of the SA is to provide scientific leadership for planning, developing, and evaluating the outcomes of the Institutional Development Plan for research administration. The SA is envisioned as a senior-level administrator such as a dean, provost or vice-president for research (or his/her designee) whose scope of authority may include three key decision-making areas faculty time commitment, scope of research administration related services provided, and integration of evidence-based best practices into any pre-existing research administration infrastructure. The SA is also expected to serve as an effective advocate or champion for faculty research and for the development of capacity in research administration as an enabling component of the institution s research enterprise.
• Mentor: Office-to-office mentoring is a best practice for building capacity in Offices of Research and Sponsored Programs. Within this context, the EA is expected to identify a mentor. The mentor must have demonstrated expertise in research administration based on past training and experience at an institution with a sizable research portfolio.
• Steering Committee: The steering committee is responsible for ensuring that the proposed elements of the Institutional Development Plan (IDP) for research administration support the applicant institution's strategic vision for research. In such a role, it is anticipated that the steering committee will be comprised of senior level stakeholders in the applicant institution’s research enterprise and provide advice on key issues such as resource allocation for research administration, existing institutional policies and capabilities, and opportunities for growth.

Program Activities

• Training: Participation in the following training activities is a requirement of the program.

NIH Residency Training takes place at the NIH and is scheduled for a 3-week period, usually during the late May/June timeframe during budget year 1 of the grant award. NIH Residency Training focuses on NIH processes and procedures, knowledge and skills needed to administer NIH and other grant awards, and leadership in research administration at BRAD-eligible institutions. Residency training also includes a broad participation by NICHD staff and from other NIH Institutes and Centers, other components of the U.S. Public Health Service, and selected public or private grantee institutions. The EA's participation in NIH Residency Training is a condition of the grant award. The Grantee Institution Webinar will be scheduled to take place during NIH Residency Training. The webinar is a requirement for the SA. Additionally, a designated representative of the grantee institution s administrative and/or scientific leadership, including but not limited to the VP for Academic Affairs, VP for Finance and Administration, Provost, Dean, or VP for research, as appropriate, are also strongly encouraged to participate. The purpose of the webinar is to familiarize the grantee institution s leadership with the strategic mission of the program, provide an overview of NIH Residency Training, as well as to ensure concurrence of the grantee institution's priorities with the BRAD program goal.

NIH Training Part 2: The second part of training will be scheduled in year 3 (at a time to be determined) and will consist of up to five web-based sessions. The theme is "Innovations in Enhancing a Culture of Research." The sessions will focus on issues such as institutional research funding strategies, sustainability, and facilitating research productivity from the pre-award context.

• Institutional Development Plan (IDP) for Research Administration: The Institutional Development Plan (IDP) for Research Administration is intended to serve as a roadmap for enhancing the research administration infrastructure at the applicant institution..

Sustainability Initiatives: BRAD Sustainability Projects are intended to support the implementation of innovations that enhance faculty effectiveness in competing for external research, address key barriers to faculty participation in research, and promote the development of an enabling research environment.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

The applicant must offer baccalaureate or advanced degrees in the sciences and meet the requirement of having received NIH research support totaling not more than $6 million per year (in both direct and F&A/indirect costs) in each of 4 or more of the last 7 years. Note that the following activity codes are excluded: C06, S10, and all activity codes starting with a G.

Domestic applicants must also have a diverse student enrollment with a significant representation of individuals from groups underrepresented in careers in the biomedical, clinical, behavioral, and social sciences. Specific groups underrepresented in such careers include:

• Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
• Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
• Individuals from disadvantaged backgrounds who are defined as:
• - Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
• - Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career

Typically institutions that have significant enrollments of individuals from groups underrepresented in the scientific workforce are also known as minority serving institutions (MSIs). These institutions have historically educated and graduated students from racial and ethnic minority and other underrepresented groups (i.e., persons with disabilities and women).

Previous domestic EARDA awardees that meet the eligibility criteria described in NOT-HD-11-026 may submit renewal applications for project periods of up to three (3) years.

Former domestic BRAD and EARDA awardees may submit new applications following a break in support of a minimum of 5 years after the termination of their previous BRAD awards. Such institutions may contact the Office of Health Equity at NICHD to confirm their eligibility to submit new applications.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Foreign organizations must be institutions of higher education public or private in India; sub-Saharan Africa; or low, lower middle and/or upper middle income countries in Latin America and the Caribbean as defined by the World Bank classification (http://data.worldbank.org/about/country-classifications/country-and-lending-groups) that meet the criteria below:

• Applicant Institutions with at least three NIH awards (e.g., R01, R03, R21, U01, D43, etc.), through a direct grant or as a subcontract to a U.S. domestic award. Each of these awards should be currently active and/or reflect collaboration on an NIH-funded project within the past 3 years. Applicants must have an existing research administrative infrastructure (Office of Sponsored Projects, Office of Research and Sponsored Projects, etc.) in place.
• Applicant Institutions with the required electronic connectivity and Internet access for NIH electronic grant submission and post-award administration.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

PD(s)/PI(s) may have doctorate or masters level training; must have a regular, full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) at the applicant institution; have an interest in promoting biomedical and behavioral science education among students from underrepresented groups; and be capable of providing administrative and scientific leadership for proposed program. The EA will be expected to monitor and assess the program and submit all documents and reports as required.

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

BRAD Program Option:

Applicants are encouraged to consider the multiple PI option. In such cases, administrative and scientific leadership may be provided by the contact PD/PI (i.e., the designated EA) and SA, respectively.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH-IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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.

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Regina Smith James, MD
Director, Office of Health Equity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03A
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: 301-435-2692
Email: rjames@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Project Summary/Abstract: The Project Summary/Abstract should provide an overview of the proposed BRAD program, including the following elements: a succinct description of the institution's vision for research, the objectives of the Institutional Development Plan (IDP) for research administration, and the methods (i.e., specific aims) for accomplishing the objectives. The abstract should also highlight innovations and succinctly describe how the stated objectives support the applicant institution’s research vision.

The project/ summary should not exceed 30 lines of text.

Project Narrative: The project narrative is a requirement for all applications. Succinctly describe the intended impact of the BRAD award in the areas of service delivery, promoting faculty participation in research, and/or integrating research into the institutional culture. Progress toward integrating research into an institutional culture is reflected by the development of three specific behaviors: administrative and financial commitment to research, implementation of enabling reward systems, and hiring practices and promotion of continuing faculty development. Use no more than two to three sentences.

Facilities & Other Resources: Succinctly describe the types of research facilities available to faculty, the potential for increasing the level of externally- sponsored research projects, and the institution s approach to and potential for increasing student exposure to biomedical and behavioral research.

Additionally, briefly describe the following:

• Type of service provided by the existing Office of Sponsored Programs (OSP) (or similar entity), as relevant;
• Faculty participation in research and level of external research support;
• The diversity of student enrollment in the biomedical, behavioral, social, and clinical sciences or STEM areas (i.e., enrollment of students from groups underrepresented in the scientific workforce) and level of student participation in research

Overall Environment: Briefly describe the institution’s strategic vision for research and discuss how engagement in research will enable the institution to better accomplish the teaching and community service aspects of its mission. Discuss the current status of research at the institution, including how institutional policies and faculty incentive structures may either stimulate or act as barriers to the development of robust faculty research programs.

Support for the BRAD Program: It is also essential to document how the applicant institution will support the BRAD program, financial or otherwise. This could include, for example, space, creative ways to enable faculty to achieve a workable balance of teaching and research and to improve the research culture at the institution.

All instructions in the SF424 (R&R) Application Guide must be followed.

Designate the Extramural Associate (contact PD/PI), the Senior Administrator (SA), and the mentor as well as any other Senior/Key personnel.

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

International Applicants: In year 1, applicants may increase the base award by up to $10,000 for travel related to NIH Residency Training, for a maximum budget request of $55,000 (direct cost).

Domestic Applicants: In year 1, applicants may increase the base award by up to $5,500 for travel related to NIH Residency Training for a maximum budget request of $90,500 (direct cost).

All Applicants (as appropriate):

In budget years 4 and 5, a portion of the budget may be re-programmed up to $10,000 for international applicants and up to $20,000 for domestic applicants to support prototype sustainability initiatives.

For the purposes of the BRAD program, the mentor will not typically commit any specific measurable level of effort and therefore no associated salary or fringe benefits should be requested. Planned expenditures should be included in consultant services section of the budget.

Budgeted costs may include a minimum of 3 person-months (25 percent) effort up to a maximum of 6 person-months (50 percent) effort for the contact PD/PI; up to 0.36 person-months (3 percent) effort for the SA; and up to 6 person-months (50 percent) effort for a research administrator. The institution can increase the level of effort for the contact PD/PI, the SA and research administrator through "in kind" contributions. In the Other Personnel section, list any additional personnel, including research administration staff, coordinators, grants managers, etc.

Itemize costs for competency-based training at professional society conferences (i.e., the Society of Research Administrators International, National Council of Research Administrators) or similar venues under travel.

Budget Justification: In the Budget Justification, briefly describe the venue, purpose, and area of emphasis for training.

Itemize costs for consultants, including names and organizational affiliations for invited facilitators who assist in the conduct of workshops, short courses, and similar activities. Include anticipated number of days for consultation, expected rate of compensation, travel, per diem and other related costs.

Allowable costs for the BRAD program include support for the following types of activities:

• Development and implementation of pre-award processes and services (e.g., stimulating new grant proposals, disseminating funding information, and managing the development and submission of proposals);
• Development and implementation of post grant award processes and services (e.g., monitoring spending, billing, effort reporting, providing financial reports, performing closeout activities);
• Development of systems that enable grantee institutions to better comply with research-related Federal and state statutes and regulations;
• Communication (including website development) and information systems (administrative systems and database development);
• Recruitment/support of research administrators in the ORSP to assist in developing and managing pre-award services support may be requested for up to 6 person months (0.5 FTE), and justification must be provided;
• Regulatory compliance (use of human subjects and animals in research, biosafety, training in OMB circulars, technology transfer issues, etc.);
• Continuing professional development that enhances faculty competitiveness for accessing external research support (i.e., institutional and/or regional workshops on grantsmanship, research process and design, statistical tools, research ethics, consortium research arrangements, and laboratory management).
• Competency-based training for research administrators/grant managers to ensure that support staff has the requisite knowledge and skills to provide efficient pre- and post-award services throughout the life cycle of the research award. Professional development in research administration and grants management may include participation at local workshops (seminars, learning communities, or the train-the-trainer models) or at national meetings on research administration, e.g., the Society of Research Administrators International (SRA) or the National Council of Research Administrators (NCURA). The training budget may include travel, membership and registration fees, and courses;
• E-learning some institutions sponsor online training opportunities that might be extended to others outside of their home institution; and
• Mentorship for the EA. Support may be requested for the mentor to travel to the grantee institution, or for the EA to travel to the mentor's institution. No salary may be requested for the mentor.

Funds may not be used for:

• Research infrastructure (such as laboratories)
• Research projects
• Alterations and Renovations

Recipients of other NIH research capacity building awards, if successful in applying for this award, may have their budgets reduced in areas where there is significant overlap in capacity development for research administration related activities and processes.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Specific Aims: The specific aims page should provide a master plan for the application. As such, it reflects the steps that the applicant will take to accomplish the proposed objectives for the project period. A clear measurable goal and objectives will lead into the specific aims; accordingly, the goal of the specific aims is to provide solutions to identified problems or challenges (i.e., objectives).

Research Strategy: The BRAD program does not provide direct support for research projects. The purpose of the BRAD Award is to provide support for strengthening institutional research administration infrastructures. Accordingly, the Research Strategy section must provide an Institutional Development Plan (IDP) for research administration that outlines the objectives and approaches for developing capacity in research administration.

Significance

• Explain the importance of the problem or barrier to research that the proposed research administration capacity building plan will address.
• Identify which aspects of research administration related services the Plan will address (i.e., pre-award services, post-award services, ethical compliance, etc.) and explain how the proposed plan will improve those services.
• Describe how the research enterprise at the applicant institution will benefit if the proposed aims are achieved.
• Describe how the enhanced research capacity will provide new opportunities for underrepresented students to participate in behavioral or biomedical research.

Investigators

• The Extramural Associate (EA) is the contact PD/PI. Briefly discuss how the EA’s knowledge and skills prepare him/her to provide leadership for the BRAD program. The discussion should also address the EA s:
  • Rapport with faculty and students, ability to motivate and advise others, and commitment to serve the institution;
  • Commitment to research administration;
  • Ability to oversee the development and management of a research administrative infrastructure, such an Office of Research or Office of Sponsored Projects (as applicable); and
  • Commitment to increasing and strengthening biomedical and behavioral research capacity at the institution.
• Briefly discuss how the SA’s knowledge and skills prepares him/her to provide scientific leadership for the BRAD program’s proposed Institutional Development Plan for research administration.
• Briefly describe the mentor's role in assuring the success of the Institutional Development Plan and in facilitating the development of an enabling environment for research. The mentor should have demonstrated expertise in research administration at an institution with a productive research program. As appropriate, a mentor may serve as a resource for planning faculty development activities with an emphasis on stimulating research and enhancing faculty grant-writing skills.

Innovation

• Describe any novel concepts or approaches that will be used to build capacity in research administration, to increase faculty interest in research, or to increase faculty competiveness in obtaining external research support. For the purpose of the BRAD program, innovation is considered the use of existing products or processes in different and more effective ways or the creation of more effective processes or products.

Approach

• Institutional Development Plan (IDP): Describe the overall strategy and methodology to be used to accomplish the objectives of the program and outline the processes and work tools that will be developed and/or acquired to address gaps in research support services (i.e., pre-award services, post-award services and regulatory and ethical compliance, etc.). Briefly describe the theoretical framework for organizational change that will inform the IDP for research administration. Overall, the Plan should be goal focused and each identified goal should be followed by a description of the strategy or strategies and action items for accomplishing that goal. Also describe the existing infrastructure that will be improved upon and/or where the infrastructure will be enhanced by adding new components or by addressing identified needs or weaknesses. Discuss potential challenges to implementing the IDP plan for research administration and how such challenges will be addressed.
• Prioritize the elements of the plan and indicate the time frame for implementing each of the elements during the project period. Also describe the process for developing the plan and the stakeholders who will contribute. EAs are strongly encouraged to use the program logic model concept for IDP planning purposes and for program implementation.
• Mentoring Plan: Briefly describe the proposed mentoring plan. Discuss how the proposed mentor is is ideally suited to fulfill the mentoring role.
• Steering Committee: Describe the plan for appointing members of the Steering Committee, including its composition, desired expertise of its members, and its function. Also include the frequency of its meetings and any other relevant information. New applicants should not name or contact potential steering committee members until the review of the BRAD application has been completed.
• Sustainability Initiatives: Briefly describe the types of activities, within the scope of the BRAD program, that can potentially facilitate or promote financial sustainability for the applicant institution's research programs. Barriers to sustainable extramural research support may include difficulty in balancing teaching responsibilities and research, lack of expertise in state-of-the-art research methodologies and/or lack of support for retooling, and the limited access to experienced researchers with funded programs who can serve as mentors. Sustainability projects will be further addressed during NIH Residency Training.
• Evaluation Plan: An Evaluation Plan is a requirement under this FOA. Keep in mind that organizational change and individual behavior change occurs incrementally over time and therefore the evaluation process should reflect this reailty. Applicants are encouraged to consider using the logic model process for planning and evaluation.

New Applications from Previous EARDA/BRAD Awardees:

In the Preliminary Studies/Progress Report section of the application, briefly describe the overall impact of five years of BRAD funding on the applicant institution. Address the following areas:

• Incremental changes in the status of the research administration infrastructure, including the type services provided to faculty, pre- and post-award processes, competency in regulatory compliance, communication strategies for informing faculty of the services provided;
• Organization development within the context of the elimination of barriers to research, development of reward/incentive programs, etc.
• Competency in research administration, within the context of the certifications received by OSP staff;
• Faculty professional development, with a focus faculty competency in competing for externally supported research. In tabular format address the papers published in scientific journals, the applications for external research support submitted (include funding agency) and the grant awards received.
• Progress Report for Renewal Applications: For applicants who originally responded to PA-11-270 and received support, provide a summary of the accomplishments of the previous EARDA program in the Preliminary Studies/Progress Report section of the application. The summary must describe the outcomes of an evaluation of the previous program, including a short description of the indicators and measures and lessons learned. It is expected that the program evaluation covered a number of the areas described above under new applications from previous EARDA/BRAD awardees.

Multiple PD/PI Leadership Plan: For BRAD applications designating multiple PD/PIs, a leadership plan must be included. Describe the governance and organizational structure of the leadership team for the research administration capacity building project, 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 program should be delineated for the PDs/PIs.

Letters of Support: Provide letters of support for the proposed BRAD program following instructions in the SF424 Application Guide.

• Institutional Commitment Letter: Provide an institutional Letter of Commitment from the President or designated high-ranking official such as the Provost, Vice President for Research or Dean. For illustrative purposes, examples of institutional commitment include but are not limited to: the provision of adequate staff, facilities, and support processes and resources that can contribute to the planned capacity building efforts. Institutional commitment is also reflected by the institution's willingness to develop long-term strategies for providing an enabling environment for faculty participation in externally supported research post BRAD funding.
• Other Letters of Support: Applicants must provide three letters of support from colleagues who have worked with the PD/PI and/or have knowledge of his/her effectiveness in working with a team and ability to successfully communicate and coordinate across organizational boundaries. Each letter should include the referee’s name, title, institutional affiliation, address, telephone and fax numbers, and email address. To comply with this requirement, it is recommended that all letters of support be obtained as far in advance of the application deadline as possible.
• Renewal applications: If the previous Extramural Associate will not be serving as the PD/PI on a renewal application, the institution must provide a letter of nomination for the new PD/PI, to be included in the Letters of Support section of the grant application. The new PD/PI may participate in (i) NIH Residency Training, Part I at the institution's expense, or (ii) in NIH Training Part II, which will be given via web conferencing.

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

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

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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

For this particular announcement, note the following:

Investments in research administration, which encompass pre-award processes as well as post-award research management processes, have a synergistic impact in regard to increasing faculty participation in research, increasing competitiveness for external research support, improving research project management, and ultimately increasing the diversity of the scientific workforce. Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the project will lead to a more supportive research environment and an effective and productive Office of Sponsored Programs (OSP) that will have a synergistic impact on overall institutional research capacity and incremental increases in the ability of faculty to successfully competing for external research support.

In consideration of the scored review criteria and non-scored additional review criteria, reviewers should provide an overall impact score. The impact score reflects reviewer assessment of the likelihood that the Institutional Development Plan (IDP), when implemented, will have a sustained, positive impact on the applicant institution s research administration infrastructure and thereby increase the likelihood of incremental improvements in faculty participation in externally funded research. Additionally the overall impact score should reflect reviewer assessment of the likelihood that the strategies introduced in the IDP for research administration will be institutionalized, through their integration into the operations of the OSP/ORSP or similar entity and/or through institutional policies, as appropriate. The applicant institution's potential for contributing to a diverse scientific workforce based on the diversity of their student body enrollment and graduation of those students should also be reflected in the impact score.

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

Significance

Does the 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?

Is the proposed project well justified in terms of addressing deficiencies or gaps in the existing research administration infrastructure? Are processes and/or work tools identified that need to be developed, facilitated, or acquired to address current gaps in the infrastructure? Does the application target one or more areas of emphasis for improving faculty support within the context of the research award cycle? How will completion of the aims change the research environment and the operation of the OSP (or an Office of Research Development, as applicable) in a way that promotes faculty effectiveness in developing competitive research proposals?

Investigator(s)

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

Does the Extramural Associate (PD/PI) have the qualifications and experiences to provide scientific and/or administrative leadership and direction? Has he/she demonstrated the ability to perform in a team environment to accomplish objectives that require coordination across multiple organizational entities? Does the PD/PI have the requisite authority to implement the proposed Institutional Development Plan (IDP) for Research Administration?

Does the Senior Administrator (SA) have the qualifications and experiences, position and commitment to provide scientific leadership and oversight for the contact PD/PI, in regard to implementing the Institutional Development plan?

Does the proposed mentor have the experience in research administration as well as experience in mentoring to facilitate the continuing professional development of the EA as well as advise the EA regarding best practices in research administration?

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?

Does the application identify critical research administration infrastructure needs (i.e., effective information dissemination; staffing the OSP and grants management function, training OSP and grants management staff, stimulating interest in research, institutional-based professional development for faculty in research project development and management, etc.), and seek creative ways, within the context of a non-research institution, to address those needs?

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?

Does the Institutional Development Plan (IDP) for research administration adequately identify specific needs/weaknesses within the applicant’s existing research administration infrastructure, establish reasonable specific aims, as well as identify best practices (i.e., interventions, work tools, and processes) that can effectively address and eliminate targeted deficiencies and gaps? Are the plans for providing competency based training in research administration and grants management for support staff adequate? What is the likelihood that accomplishing the specific aims would increase both the level and quality of research at the applicant institution?

Are the roles and responsibilities of the Steering Committee appropriate? Is the composition of the committee appropriate for its identified roles and responsibilities? Has the applicant adequately described the member selection criteria?

Does the evaluation plan adequately assess the effectiveness of program implementation and its impact on the research administration infrastructure? Does the applicant identify the capacities that will be assessed as well as the indicators and measures that will be used to assess the anticipated outcomes?

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

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?

Does the institutional leadership exhibit solid support for strengthening the institution’s research administration infrastructure as a pre-requisite to increasing the level and quality of research? Which comments in the Official’s letter best demonstrate the strength of his/her resolve to support efforts to make the changes necessary to begin to change the trajectory of the institution in terms of increasing the level and quality of research in a sustainable fashion?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

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.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Della Brown White, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 435-2712
E-mail: whitede@mail.nih.gov

Kathleen Michels, Ph.D
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: Michelsk@nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: duperes@mail.nih.gov

Jill Rogers
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-7008
Email: rogersj@mail.nih.gov

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: bruce.butrum@nih.gov

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

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.