1. Eligible Applicants

2. Cost Sharing

3. Additional Information on Eligibility

Number of Applications  

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

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

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

Need and uniqueness:  A resource must meet a demonstrable and timely community need, so the potential impact on the scientific community should be described.  Factors also could include known work that has used the Registry, its database or website, or other evidence for community usage or community interest for basic and clinical scientists.  (Do not provide letters of support here; see below.)  Include information about how further development of the Registry and its database will provide a complementary resource that does not duplicate other efforts to enhance research.

Access:  Indicate how broad access to the Registry will be made available to all investigators, for clear purposes that are understood by the providers and the users.  As a resource, the Registry must include cost-effective mechanisms for dissemination and advertisement of resources and services to the community of basic and clinical investigators, as well as to the general public.

Appropriate attention is needed to regulations on human subject protections and confidentiality of data collected.  Plans must describe how the registry will coordinate donor recruitment and tissue procurement; how and where donated tissues and related data will be handled, evaluated, archived and protected; fair distribution of the donated tissues, and how to access the information will be allocated and protected.

Quality control:  Measures must be described to monitor, control,document, and increase the quality of specimens and data, including such aspects as donor data, tissue harvesting and handling protocols, and database upgrades for the resource.

Outreach:  Describe plans to maximize effective use of the Registry for outreach to research scientists and to the public. Describe in detail how donor recruitment will be enhanced to increase donations and to include the targeting of underrepresented populations or clinically informative populations.

Efficiency: Describe appropriate staffing plans and discuss measures for improving efficiency or offsetting some costs. Consider appropriate technology that will not become obsolete rapidly. 

Overall, enhancements to consider must include features for increasing donor participation, imaging and informatics in the design and content of the database, and optimizing the scale and efficient use of existing resources for research.

Administration:  Details must be provided for the role of any personnel receiving support from this award. The resource must be integrated with broad strategic interests of potential users on a national and international scale.  Accordingly, a framework for a Steering Committee for the Registry must be proposed to provide technical and scientific expertise for guidance. Accordingly, a framework for a Steering Committee for the registry must be proposed to provide technical and scientific expertise for guidance. If a Steering Committee is already in place, please list the names, affiliations, and dates of service for current and former members.  Do not name individuals who may be considered in the future for Steering Committee membership.

Milestones:  Objective milestone indicators are needed to help guide the project, and to ensure that the resource is meeting the community's needs, is of high quality, and is accessible.  Applications must include quantifiable metrics for ongoing improvement, and to gauge the impact of usage on the scientific field.  Examples could include tracking growth of the collection information (new donors, new tissues, etc.), requests for services, successful use of the resource data, the number of users, publications citing uses, etc.  The milestones must include realistic quantitative goals for resource usage to be reported at the end of each annual funding period. 

Letters of Support: Limit letters of support to only those who are named in the application (e.g., collaborators, senior/key personnel and other significant contributors) and are expected to contribute in a substantive way to the execution of the proposed resource.   Do NOT provide letters from potential or previous users (individuals, groups, or consortia) .

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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.

Significance  

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

How well does the proposed resource meet a significant community need by contributing substantially to the quality of research on human temporal bones and the ear (otology, audiology, and other clinical and basic sciences involving the inner and middle ear, etc.)? Will the proposed services and outreach convincingly add major value to the research community? Is the resource likely to improve the public awareness of human ear disorders and the need for research and for temporal bone donors?

Does the proposed Resource address the needs of the research projects that it will serve? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

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?

Does the PD(s)/PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Registry? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing archival research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Registry? Does the applicant have experience overseeing selection and management of subawards, if needed?

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 PD(s) PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?

Does the application propose novel organizational concepts, management strategies, or instrumentation] in coordinating the research resource the Registry will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach  

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

How is quality control addressed and is it adequate? Evaluate the plans for how accessible the resources are to the scientific community. Will the resources be broadly accessible? Are the plans for resource sharing satisfactory, including protections for data? Are the plans for the administrative framework and Steering Committee appropriate for the resource? Are the personnel well justified?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Registry will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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 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?

Milestones

Does the application have a plan in place for evaluation of the resource activity? Are the proposed milestone metrics appropriate for assessing the ongoing value of the proposed resources?

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 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  

Renewals  

Revisions  

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