National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Funding Opportunity Title
NIAMS Clinical Trial Implementation Cooperative Agreement (U01)
U01 Research Project – Cooperative Agreements
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
This Funding Opportunity Announcement (FOA) issued by the NIAMS invites cooperative agreement (U01) applications for implementation of investigator -initiated interventional clinical trials (all phases). This U01 FOA, which allows for the electronic submission of applications for single-site projects, compliments the previously released UM1 FOA, which permits submission of paper applications for multi-site projects. Applications for clinical trials submitted to the NIAMS are normally expected to go through a two-part process, which begins with a U34 planning phase (Part 1) followed by an application for the U01. Investigators who have completed all necessary pre-trial planning and preparation through other means may also apply for a NIAMS U01. Consultation with NIAMS staff is strongly encouraged prior to the submission of the clinical trial implementation U01 application. The NIAMS expects such trials to be hypothesis driven, milestone-defined, related to the research mission of the NIAMS, and considered high-priority by the institute.
May 27, 2011
Open Date (Earliest Submission Date)
July 1, 2011
Letter of Intent Due Date
July 1,2011, August 15, 2011, December 15, 2011, April 15, 2012, August 15, 2012, December 15, 2012, April 15, 2013, August 15, 2013, December 15, 2013
Application Due Date(s)
August 1, 2011, November 1, 2011, March 1, 2012, July 2, 2012, November 1, 2012, March 1, 2013, July 1, 2013, November 1, 2013, March 3, 2014 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
October/November 2011, February/March 2012, June/July 2012, October/November 2012, February/March 2013, June/July 2013, October/November 2013, February/March 2014, June/July 2014
Advisory Council Review
Earliest Start Date(s)
April 1, 2012, July 1, 2012, December 1, 2012, April 1, 2013, July 1, 2013, December 1, 2013, April 1, 2014, July 1, 2014, December 1, 2014
March 4, 2014
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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
Clinical research is a significant NIAMS investment aimed at answering critical questions about a particular disease or disease process. It is essential to support clinical studies to test promising new interventions with the potential to improve health practices and clinical care. Special attention must be paid to enabling these important studies to get through the administrative processes at a reasonable pace so that the conduct of the study, analysis of data, and dissemination of results are not delayed.
The NIAMS is committed to identifying effective approaches to address the burden of arthritis and musculoskeletal and skin diseases and disorders. Improving health through the generation of high quality data from well-designed and executed clinical trials is a high priority for the NIAMS.
A clinical trial is defined by NIH as “a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g., imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects (SF424).”
As announced in NOT-AR-11-014, the NIAMS has redesigned its clinical trials program in order to support the spectrum of such studies with funding mechanisms tailored to different levels of complexity. For trials involving greater numbers of subjects or of greater complexity or risk, investigators should apply for funding through a NIAMS Clinical Trial Implementation Cooperative Agreement (UM1) for multi-site trials, or through the NIAMS Clinical Trial Implementation Cooperative Agreement (U01) for single-site trials. These larger and more complex trials require substantial planning and preparation prior to opening for recruitment, and investigators are expected to be able to begin the trial without further planning activities when the UM1/U01 is awarded. In order to accomplish necessary planning with NIAMS support, investigators may apply for a NIAMS Clinical Trial Planning Grant (U34) prior to submitting an application for the UM1/U01 to implement the trial. The planning grant will allow an investigator to accomplish the planning activities (manual of operating procedures, FDA approvals, etc) which are often necessary for actually implementing a clinical trial. Investigators who have already completed planning activities either by a previously awarded NIAMS U34, R34, or other means may also submit a UM1/U01 implementation grant application, but are strongly encouraged to consult with NIAMS staff in advance. Investigators considering applying to the NIAMS for a clinical trial grant should refer to the NIAMS Clinical Trials policy web site.
Clinical Trial Planning Phase (U34)
The first phase of the NIAMS clinical trials grant process is the Clinical Trial Planning Cooperative Agreement (U34) which will provide the support for planning activities necessary for implementation of a clinical trial. The U34 is generally expected to precede the submission of a Clinical Trial Implementation Cooperative Agreement (UM1/U01) application. Note that an application for the UM1/U01 may be submitted while other activities continue in the U34-funded planning phase. However, the materials to be developed in the U34 planning phase should have been completed by the time the UM1/U01 is to be awarded, and investigators are expected to be ready to implement the proposed trial at the time of the UM1/U01 award.
Clinical Trial Implementation Phase (UM1/U01)
Once appropriate planning and milestones have been completed, either through a U34 or some other means such that the clinical trial would be ready to implement by the time the UM1/U01 is awarded, investigators may apply for the Clinical Trial Implementation Cooperative Agreement (UM1/U01).
Each clinical trial implementation (UM1/U01) application will include the clinical protocol, Clinical Investigator's Brochure where appropriate, or other equivalent document(s) that contain(s) relevant non-clinical and preclinical data on study products, a Manual of Procedures, and meet all applicable NIAMS, NIH, Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) policy requirements. Planning grant awardees must prepare their protocols, Clinical Investigators' Brochures, and Manuals of Procedures to meet this guidance (see http://www.niams.nih.gov/Funding/Clinical_Research/NIAMS_guidelines.asp for the NIAMS’s Clinical Protocol and Manual of Procedures guidelines). Information about Institutional Review Board and Independent Ethics Committee (IRB/IEC) registration and assurances can be found at http://www.hhs.gov/ohrp/.
A Clinical Trial Implementation Cooperative Agreement (UM1/U01) application should describe all necessary components to successfully conduct a clinical trial. Implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:
Resources that may be available to support clinical trials during clinical trial implementation can be obtained from the NIAMS program staff. NIAMS clinical research policy and guidance information as well as NIAMS templates are available at the following website: http://www.niams.nih.gov/Funding/Clinical_Research/NIAMS_guidelines.asp
Examples of studies that might be supported by this FOA include, but are not limited to:
Each NIAMS Clinical Trial Implementation Cooperative Agreement (U01) award will support the implementation of a single clinical trial. Applications for a U01 that include more than one clinical trial will not be reviewed.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period
The maximum amount of time requested for a clinical trial implementation cooperative agreement may not exceed five years.
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:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
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 SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. It is expected that each application will be for a clinical trial for which investigators will have completed all necessary pre-trial planning and preparation either through a NIAMS clinical trial planning cooperative agreement (U34) or by other means such that the trial will be ready to be implemented when the U01 is awarded.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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, 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.
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.
Applicants are strongly encouraged to submit a Letter of Intent to the NIAMS before submission of the NIAMS Clinical Trial Implementation Cooperative Agreement (U01) application, including new and resubmission applications. Applicants are encouraged to allow at least 10 weeks before the planned receipt date, particularly if there has been no prior consultation with the NIAMS about the application.
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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Shahnaz Khan, MPH
Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 810, MSC 4872
Bethesda, MD 20892 (use 20817 for overnight courier delivery)
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The goals of the trial and the expected outcome(s) should be concisely stated in the Specific Aims section. The specific objectives of the trial must be clearly and concisely presented, including a specification of the primary and major secondary endpoints to be measured. There should be a clear explanation of the importance of various endpoints.
The Research Strategy must include:
A Milestone Plan must be included in the Research Strategy. Applications that lack the Milestone Plan will be considered incomplete and will not be reviewed.
Applicants are required to provide detailed project performance and timeline objectives in a section entitled “Milestone Plan” and must include:
Protection of Human Subjects
Instructions in the PHS398 “Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan” should be closely followed.
Clinical Protocol Synopsis
The clinical protocol synopsis should be included at the end of the Human Subjects section. Applications that lack the Clinical Protocol Synopsis will not be peer reviewed. The clinical protocol synopsis must include the following information:
Data and Safety Monitoring (DSM) Plan
A Data and Safety Monitoring (DSM) Plan that is commensurate with the risk level of the proposed clinical research must be included for all clinical trials (see http://grants.nih.gov/grants/guide/notice-files/not98-084.html ). This DSM Plan is part of the Human Subjects section. Note that if an application is awarded, the NIAMS will organize an independent Data Safety and Monitoring Board or appoint a Safety Officer based on the risk and complexity of the trial. All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB), the NIAMS/NIH, the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used). The DSM Plan must address the following areas:
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, with the following modification:
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:
The following additional documents should be included in the Appendix material:
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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 SF 424 (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.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.
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 Central Contractor Registration (CCR). 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.
Prior Consultation. Prior consultation with the NIAMS is strongly encouraged for submission of the NIAMS Clinical Trial Implementation (U01) Grant application, including new and resubmission applications. NIAMS staff will consider whether the proposed clinical trial meets the goals and mission of the Institute and whether it is appropriate to conduct it as an investigator-initiated clinical trial, but will not evaluate the technical and scientific merit of the proposed trial. Technical and scientific merit will be determined during peer review. In the presubmission consultation phase, if the proposed trial does not meet the goals and mission of the NIAMS, applicants will be so informed. If the NIAMS ascertains that substantial additional planning may be necessary, submission of the application may be considered under the Clinical Trial Planning Grant (U34) Cooperative Agreement FOA, PAR-11-169 . The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff 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 SF 424 (R&R) Application Guide. Applicants should go to the NIAMS website for information about what to include in their Letter of Request.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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.
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 there preliminary data or literature or biological mechanisms supporting the need for a clinical trial to test the proposed hypothesis or intervention? Is there potential of the outcome to change clinical practice, community behaviors, or health care policy? If a Phase III trial, are the potential findings likely to be generalizable? Are there ethical issues surrounding the trial and the disease/condition under study?
Are the PD/PIs, 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? What are the qualifications of the trial statistician and data center staff to implement and monitor the study, analyze and report study results? What plans are there to address the possibility of adding or dropping enrollment centers? If a multicenter trial, is the proposed organizational structure, particularly the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate?
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?
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
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the required study population available? Is the experimental design adequate and does it address the translation of the clinical question into a statistical hypothesis? Are the sample size and duration of the trial appropriate? Are the primary and secondary outcome variable(s) and data to be collected clear, and are they relevant to the clinical and statistical hypothesis being tested? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed?
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? Is the required study population available?
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/priority score, but will not give separate scores for these items.
Data Management. Have the methods for standardization of procedure for data management to assess the effect of the intervention and quality control been addressed? Are the general statistical approach and specific analytic techniques and plans for handling dropouts, missed visits, and losses to follow-up appropriate?
Clinical Trial Documentation (Clinical protocol synopsis, Clinical Investigator’s Brochure or equivalent, and MOP or equivalent). Are the materials complete, appropriate, and adequate to allow training of study staff and recruitment of study subjects if a cooperative agreement award is made? Are all of the clinical trial documents compliant with Good Clinical Practice (GCP) guidelines?
Plans for Patient Recruitment/Retention. Does the application document the availability of the requisite eligible subject pool in the proposed clinical centers? Is the status of evidence showing whether or not clinically important sex/gender and race/ethnicity differences in the intervention effect are to be expected (see Inclusion of Women and Minorities in Clinical Research below) addressed? Are plans for recruitment outreach, and as appropriate, follow-up procedures to ensure collection of data at stated intervals adequate? Are the plans for retention and criteria for withdrawal clear?
Adequacy of Data and Safety Monitoring Plan: Is the safety monitoring plan adequate? Does it address the risks involved and ethical aspects of expected risks? Does it discuss risk-benefit balance? Does it address informed consent procedures, a safety monitoring plan, and provisions for early termination? Are there plans for a Data and Safety Monitoring Board (required if a study is multi-site, blinded, and using a high risk intervention or population)?
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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
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.
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.
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.
For Renewals, the committee will consider the progress made in the last funding period.
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/priority 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
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 the NIAMS , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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 NIAMS Advisory Council. The following will be considered in making funding decisions:
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
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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Studies in which recruitment milestones are not met as per criteria established pre-award, or for which regulatory approval has not been met within one year, and are deemed unlikely to improve sufficiently to bring the study to completion within an acceptable budget or time frame, may be closed for lack of progress following review and consideration by NIAMS staff.
If a study is finally determined to lack feasibility and will no longer accrue subjects, awardees are required to submit a close-out plan to NIAMS staff within three months of a decision either by NIAMS staff or the grantee that an awarded study is no longer feasible. The plan must be approved and signed by the Institutional Official and the PI/PD(s) listed on the award prior to submission.
The NIAMS may terminate or curtail the study (or an
individual award) in the event of (a) failure to implement the study protocol,
(b) a substantial shortfall in participant recruitment, follow-up, data
reporting and dissemination, quality control, or other major breach of the
protocol, (c) substantive changes in the agreed-upon protocol with which the
NIAMS does not concur, (d) reaching a major study objective substantially
before schedule with persuasive statistical evidence, or (e) human subject
ethical issues that may dictate a premature termination.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the PD/PIs, chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Shahnaz Khan, MPH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Charles Rafferty, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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.
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