Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Simulation applications for gastrointestinal endoscopy and laparoscopic surgery were introduced in the early 1990s and followed the development of simulation-based methods for anesthesia care, team training, and crisis management. With the development of simple "box trainers" surgical skill acquisition for basic laparoscopic procedures was possible on a wide-spread and economical basis, and the development of virtual reality trainers for advanced laparoscopic and catheter-based procedures prompted an expanded role of simulation in the graduate medical education domain. The impact of simulation adoption on the quality of healthcare delivered by practicing clinicians has received little attention, however, and this deficiency was recently explored in a workshop jointly sponsored by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

The acquisition of "expert" levels of proficiency for academic trainees through the use of simulation-based methods has been shown to reduce intraoperative errors, reduce intra- and post-operative complications, and reduce patient length-of-stay when applied to resident learning experiences , but similar studies that examine the role of simulation on reducing errors or improving outcomes for practicing clinicians are lacking. Similarly, a pre-operative warm up with a simulator has been shown to result in a significant improvement in resident performance , but no similar study has examined the possible benefit of a pre-operative simulation-based skill rehearsal on the performance of practicing clinicians. Simulation applications have been developed for specific procedure-related skill acquisition with on-site mentorship of trainees, but the benefit of simulation-based skills training for the recognition and management of rare adverse events by practicing clinicians has been largely unexplored. More fundamentally, it is unknown whether the same schedule and frequency of simulation training used by trainees are associated with maximum or best skill acquisition and maintenance by experienced clinicians.

It is assumed that maximum safety and outcomes achievable in the procedure-related specialties correlates with the degree of procedural mastery possessed by the clinicians. Procedural mastery is a combination of technical mastery and expert judgment, and methods to improve the performance of experienced clinicians toward the goal of procedural mastery may benefit from simulated scenarios which support the acquisition and maintenance of both technical skills and judgmental skills. The development, evaluation and validation of simulation applications which support judgmental skill acquisition have largely been unexplored.

The importance of simulation-based training and the role of simulation in the enhancement of clinical safety and outcomes have been recognized increasingly over the past few years. There are now 96 accredited advanced education centers which provide access to simulation models and methods, and this follows the ubiquitous development of simulation centers and laboratories at virtually all teaching hospitals in this country.

With the awareness that medical error contributes significantly to the morbidity, mortality and costs of healthcare, and the demonstration that some practicing clinicians demonstrate below-average levels of clinical skills, there is increased interest to explore simulation-based training as a means of improving the quality of healthcare.

Research Objectives

The purpose of the Funding Opportunity Announcement (FOA) is to develop, evaluate and validate methods by which simulation technologies can be used by practicing clinicians for the purpose of acquiring, maintaining, and improving skills which are critical for optimal safety, outcomes and benefits of care delivered to patients.
The three focus areas of this FOA are:

1. Skill Acquisition - Applications which address the processes of skill acquisition, skill maintenance, and skill enhancement for practicing clinicians and healthcare providers. Applications to evaluate simulation-based approaches to procedural error analysis and error prevention are sought, as are applications to establish the most effective methods for the acquisition and maintenance of skills by experienced clinicians. Studies which assess the method and time course of skill acquisition and maintenance by experienced clinicians through the use of simulation devices and/or applications are appropriate for this FOA. Before-and-after trials of simulation-based training on measurable effects of healthcare delivery are considered clinical trials and are not accepted by this FOA . Applications which propose clinical trials of interest to NIDDK must be directed to PA-18-330: Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required), as described under the NIDDK Interest Statement below.

2. Outcomes Assessment - Applications which assess the skills of experienced clinicians and correlate the simulation-based assessment of skill levels with the quality of care experienced by patients treated by these care-givers, including factors such as safety (e.g., morbidity and mortality), outcomes (e.g., being free of disease/condition, recovery and rehabilitation from interventions) and costs (e.g., length of hospital stay, cost of treatment). Studies which compare clinical skill measurement by simulation methods with the outcomes of patients treated by those practitioners whose skills have been assessed are appropriate for this FOA. Randomized controlled trials on measurable effects of healthcare delivery are considered clinical trials and are not accepted by this FOA. Applications which propose clinical trials of interest to NIDDK must be directed to PA-18-330, as described under the NIDDK Interest Statement below.

3. Technology development - Projects to develop virtual coaches by incorporating intelligent methods into existing simulators to provide adaptive, cognitive assistance to coach experienced practitioners in retaining, retraining and improving performance levels in the context of the user environment. Technological solutions that incorporate artificial intelligence with theory-driven, physics-based, physiologically realistic models are strongly encouraged. Simulators should replicate real life work flows, including planning, warm-up exercises, and rehearsal leading up to the actual procedure. The resulting technology outcome is a virtual coach based on physiologically realistic models that operate in real-time, capable of seamless integration in a variety of provider environments; including rural and low-resource settings. Applications should incorporate end users as part of the technology development team.

Existing simulation methods may include mannequins, standardized patients, task trainers, and procedure-specific trainers of either the virtual (computer assisted) or actual type (cadavers). Applications which propose to use endoscopic, videoscopic (laparoscopic), and robotic simulation techniques are welcome, as are standardized patients, and the depiction or portrayal of rare adverse events or specific procedures. NIH encourages a variety of simulation projects from across the healthcare spectrum which impact diverse patient populations, including priority populations, provider groups and clinical settings. Priority populations include: low income groups, minority groups, women and children, the elderly, and individuals with special healthcare needs. Diverse settings of care might include but are not limited to hospitals, ambulatory surgical and endoscopy centers, primary care clinics, medical centers, healthcare provider organizations, healthcare systems, professional health organizations and societies, as well as quality and safety improvement organizations.

Applications which are directed at team training, crisis management, or communication skills are not considered appropriate for this funding announcement. Improvement of technical skills, and the application of procedure-related simulation, are the primary focus of this FOA.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in applications targeted to focus areas 1 and 2, concentrating on abdominal, gastroenterological, and urological diseases and conditions. Studies which quantify or otherwise assess skills of practicing clinicians by the use of a task simulator and compare those skill assessments to the measured outcomes (e.g., morbidity, mortality or cost) of those patients treated by the clinicians are of interest. These studies constitute an observational study (and not constitute a clinical trial) and would be of interest to NIDDK for this FOA.

NIDDK Clinical Trial Guidance

Applications which propose clinical trials related to the diagnosis and treatment of diseases or conditions of interest to NIDDK (abdominal, gastrointestinal, and urologic diseases and conditions) and which are related to this announcement must be directed to PA-18-330 (Investigator-initiated Clinical Trials Targeting Diseases Within the Mission of NIDDK). A guideline for defining a clinical trial is available at https://grants.nih.gov/policy/clinical-trials/case-studies.htm. The study elements which qualify for designation as a clinical trial include the following:

1. An intervention is employed in human subjects (which might include patients or healthcare providers)
2. The subjects are prospectively assigned to the intervention(s)
3. The study is designed to assess the effects of the intervention on the subjects
4. The effects of the intervention are assessed as health-related outcomes.

Therefore, applications which propose to develop, evaluate and validate simulation-based methods for the acquisition, improvement and maintenance of skills by practicing clinicians may be considered clinical trials if an intervention is employed, and the effects of that intervention on health-related outcomes are assessed.

Applications which seek to improve the acquisition, or maintenance of clinically relevant skills of practicing clinicians through a comparison of methods (interventions) or before-and-after assessments of clinical outcomes after instituting a proficiency-based program of skill attainment on a task simulator would be designated as clinical trials, by the guidelines for clinical trials referred to above, and must be directed to PA-18-330 for applications of interest to NIDDK.

Applications which are directed to PA-18-330 should reference this funding announcement in the rationale and significance portions of the application
Applications which seek support for pilot studies for clinical trials according to the definition above should be directed to Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional).

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in supporting applications targeted to focus area 3, enhancing medical simulation technologies using multiple disease or conditions as testbeds for the technology development. Complicated or rare procedures, relevant to skilled practitioners in rural and low-resource settings are especially encouraged.

The NIBIB is interested in promoting the development of medical simulation technologies that have broad diagnostic, therapeutic and interventional applications in diseases or health conditions. Areas of interest include medical simulation technologies to complement technology development in all other program areas of the NIBIB, https://www.nibib.nih.gov/research-funding.

NIBIB will support applications that develop novel medical simulation technology solutions that can broadly apply to multiple disease and conditions. NIBIB will support an application focused on a single disease or condition if it is clear that the single disease or condition is an initial test bed for a medical simulation technology that could be applied to other diseases or conditions. NIBIB will not support any applications that are solely using and not developing enhanced medical simulation technologies. NIBIB will not support any applications targeted for focus areas 1 and 2.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

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

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.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.

Letter of Intent

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

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:

Jose Serrano, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8871
Fax: 301-480-8300
Email:serranoj@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.

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

R&R or Modular Budget

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.

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

Research Strategy:

For Focus Areas 1 and 2 Outcomes Assessment and Skill Acquisition:

Methods and Resources: Applicants are encouraged to specify the simulation methods, equipment and resources that will be utilized, the end users that will be recruited to participate in the proposed studies, and how the simulation method proposed is expected to impact patient safety outcomes.
Project Design: Applicants are encouraged to provide a project design and methodology plan that covers development, evaluation and validation activities for the assessment of skill acquisition and maintenance of practicing health care providers.
Projected Implementation Timeline: Applicants are encouraged to outline how the simulation will be implemented in the proposed healthcare setting and include appropriate milestones and timelines for assessing skill acquisition and maintenance. The milestones should describe quantitative metrics to be used to indicate acceptable performance.

For Focus Area 3 Technology Development:

End users and evaluation: Applicants are encouraged to incorporate end users as part of the technology development team. These end users should sufficiently represent the needs and challenges of the larger community to be served by the proposed new simulation technology. Applicants should describe how the technology will be evaluated by the end user community.
Context of use, scope and timeline: Applicants should clearly describe the context of use and the scope of the technology being proposed. The scope should be described in technology milestones, in which each should include the criteria for success and a go-no-go assessment. Applicants should propose a timeline for the scope of the project and are encouraged to present a longer timeline describing the overall scope and timeline for the final technology outcome.
VV&UQ: Applicants should describe how verification, validation and uncertainty quantification will be addressed

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

All technology development applications, regardless of the amount of direct costs requested for any one year, should address a plan for sharing the computational models and data produced from the proposed project. The plans may include policies for access and sharing; including provisions for appropriate protection of privacy, confidentiality, security, intellectual property, or other rights or requirements. In the body of the text, the section should begin with a heading indicating "Resource Sharing Plan". Resource Sharing Plans should provide details for the model components or modules, data parameters and associated datasets. The plan should include the minimum requirements for model and data documentation, development and collection, validation and reproducibility. Applicants are also expected to include plans to link proposed technology outcome ? with other relevant resources. Any software associated with proposed technology outcome ? are expected to also be addressed in the Software Sharing Plan (below). Applicants are strongly encouraged to make their technology and data electronically available in synchrony with paper publication.

• Applications that develop software to instantiate the proposed mathematical or statistical models and algorithms should address a plan for sharing software. In the body of the text, the section should begin with a heading indicating "Software Sharing Plan". There is no prescribed single license for software produced through grants responding to this announcement. This FOA, however, includes goals for software dissemination, and reviewers will be instructed to evaluate dissemination plans relative to these goals:
  
  The software should be freely available to biomedical, biological, behavioral, environmental, and clinical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  To preserve utility to the community, the software should be transferable such that another individual or team can reproduce the analytical tool and continue development in the event that the original investigators are unwilling or unable to do so.
  The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

NOTE: Applicants are welcome to consider editing this example data sharing plan, https://grants.nih.gov/grants/sharing_example_data_sharing_plan.doc to include the sharing of all the research outcomes from this FOA (e.g. models, data, software, etc.).

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

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? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), 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?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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
Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Revisions, 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.

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

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, 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 appropriate national Advisory Council or Board. 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to 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.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Jose Serrano, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8871
Email: serranoj@mail.nih.gov

Dana K. Andersen, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 410-868-0638
Email: dana.andersen@nih.gov

Grace C.Y. Peng, PhD.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: grace.peng@nih.gov

Merav Sabri, Ph.D.,
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: merav.sabri@nih.gov

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: robert.tamburro@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Charmaine Parsad
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-3451
Email: parsadc@niddk.nih.gov

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: kellis@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-594-3788
Email: carows@mail.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

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

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 Part 75.