Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

NIAMS Clinical Trial Planning Cooperative Agreement (U34)

Activity Code

U34 Clinical Planning Grant Cooperative Agreement

Announcement Type

New

Related Notices

  • May 1, 2014 - This PAR has been reissued as PAR-14-199.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • July 12, 2013 - See Notice NOT-AA-13-004. Notice of NIAAA's Participation.
  • July 14, 2011 - See Notice NOT-AR-11-020 Notice of Updated NIAMS Policy for Investigator-Initiated Clinical Trials.
  • May 27, 2011 - See Companion PAR-11-219 NIAMS Clinical Trial Implementation Cooperative Agreement (U01).
  • March 18, 2011 - See Notice NOT-AR-11-014 Notice of New NIAMS Policy for Investigator-Initiated Clinical Trials.

Funding Opportunity Announcement (FOA) Number

PAR-11-169

Companion FOA

PAR-11-168, UM1 Clinical Trial Implementation Cooperative Agreement

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic
Assistance (CFDA) Number(s)

93.846, 93.273

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will support planning cooperative agreements (U34) (hereafter called “planning grant”) for investigator-initiated clinical interventional trials. The U34 planning grant is designed to permit the necessary planning, design, and preparation of documentation prior to implementation of investigator-initiated clinical trials. Completion of the agreed upon milestones of a U34 planning grant is recommended prior to submission of a clinical trial through a cooperative agreement (UM1) application that will support the actual implementation and conduct of the study.  Consultation with NIAMS staff is strongly encouraged prior to the submission of the U34 application. The trials must be hypothesis-driven, milestone-defined, related to the research mission of the NIAMS and considered high priority by the Institute.

Key Dates
Posted Date

March 18, 2011

Open Date (Earliest Submission Date)

June 1, 2011

Letter of Intent Due Date

30 days after publication date, 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)

July 1, 2011, November 1, 2011, March 1, 2012, July 1, 2012, November 1, 2012, March 1, 2013, July 1, 2013, , November 1, 2013, March 1, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

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

January 2012, May 2012, October 2012, January 2013, May 2013, October 2013, January 2014, May 2014, October 2014 

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

Expiration Date

March 2, 2014

Due Dates for E.O. 12372

Not Applicable

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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, published concurrently with this announcement,

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 greater complexity or risk, investigators should apply for funding through a NIAMS Clinical Trial Implementation Cooperative Agreement (UM1). These larger and more complex trials require substantial planning and preparation prior to opening for recruitment, and investigators are expected to apply for a NIAMS Clinical Trial Planning Grant (U34) prior to submitting an application for the UM1 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; applicants for a Clinical Trial Implementation Cooperative Agreement are expected to be able to begin the trial without further planning activities when the UM1 is awarded.   Investigators who have already completed planning activities either by a previously awarded NIAMS U34, R34, or other means may also submit a UM1 implementation grant, 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.

Investigators are strongly encouraged to contact their Program Officer prior to submitting applications for a U34 clinical trial planning grant or UM1 clinical trial implementation grant. Applicants are also strongly encouraged to submit a Letter of Intent (LOI) to the NIAMS before submission of an application for either a U34 or a UM1, including new and resubmission applications.  Applicants are encouraged to allow enough time before the planned receipt date, particularly if there has been no prior consultation with the NIAMS about the application. LOI should be submitted to the Scientific/Research contacts listed in the FOA who will share the request with the appropriate Program Official. This program announcement, NIAMS CLINICAL TRIAL PLANNING COOPERATIVE AGREEMENT (U34) , addresses the  planning phase; a companion FOA addressing the second part of the process for implementing a clinical trial cooperative agreement (UM1) is also available (PAR-11-168).

Overview of the NIAMS policy for investigator-initiated, clinical trials

Background

Clinical research is a significant NIAMS investment aimed at answering critical questions about a particular disease or disease process. It is essential to support intervention 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 has determined that investigator-initiated, interventional clinical trials requesting NIAMS support should undergo a rigorous planning, design, and documentation phase before a decision is made to implement a study with a substantial fiscal and human investment. The implementation of a clinical trial requires extensive administrative planning (e.g., protocol finalization, manual of operations development, establishing collaborations and estimating recruitment potential) before participant recruitment can occur.  The NIAMS is offering this two-part process that separates planning from subject recruitment and study implementation to provide adequate support and facilitate the timely implementation of the studies important to the mission of the institute. In addition, use of the cooperative agreement mechanism will allow NIAMS programmatic input during the early planning stages and throughout the conduct of the actual clinical trial.

The U34 planning grants will give investigators the time and funds necessary to complete detailed clinical trial planning to meet NIAMS and NIH standards and regulatory requirements. A structured planning process will allow studies to determine the optimal design strategy and to complete the administrative activities as expeditiously as possible so that the implementation phase (UM1) can start and finish the required activities within a five-year grant period.  

Part 1: Clinical Trial Planning Phase (U34)

The U34 planning grant is expected to precede the submission of a clinical trial cooperative agreement (UM1) application.  The U34 will provide support to complete the administrative and planning activities that are required prior to subject recruitment.  These activities may include, but are not limited to:  establishing the research team, identifying collaborators and clinical sites, defining recruitment strategies and collecting data on a potential pool of interested and eligible subjects that could be recruited into the study (e.g., through conducting “model recruitment” using focus groups, questionnaires, etc), developing the protocol and clinical investigators brochure, writing of the manual of operating procedures (MOP), establishing a data and safety monitoring plan, developing tools for data collection and data management, and initiating the IRB approval process and submitting an application to the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application, IND exemption, or Investigational Device Exemption (IDE), etc.  Guidelines to help investigators develop a MOP and data and safety monitoring plan can be found on the NIAMS clinical research page.

The study design and protocol for the proposed trial should be presented in the U34 application in sufficient detail so that a review group can judge the feasibility of the proposed approach and the potential significance of the trial. In instances where basic protocol development can best be completed with U34 funding, the application should indicate why this is the case and indicate how the funding will be used to complete the design of the study.

The U34 is not designed for the conduct of pilot studies to support the rationale for a clinical trial or the collection of preliminary data. Please refer to (PAR-10-282), Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21), to submit an application for initiating exploratory/developmental research related to the prevention or treatment of arthritis and musculoskeletal and skin diseases.

Prior consultation with NIAMS staff prior to submitting the U34 application is strongly encouraged.  Please refer to (NIAMS website) for details on what should be included in the Letter of Intent (LOI) to NIAMS.  Letters of Intent should be submitted to the Scientific /Research contacts listed in the FOA who will direct your request to the appropriate Program Official.  Applicants may want to allow enough time before the planned receipt date to give the Institute at least 10-weeks.  Applications for the U34 will be peer reviewed by a standing clinical trials review committee managed by the NIAMS Scientific Review Branch.

Prospective applicants should note that funding of a U34 planning grant does not guarantee or imply funding for a subsequent application for a UM1 clinical trial. The U34 cooperative agreement will provide up to two years of support, although it is expected most will only need one year of support.

Part 2: Clinical Trial Implementation Phase  (UM1)

The product of an awarded U34 planning grant that has met its milestones, as submitted in the application and as approved by the Principal Investigator and the NIH Program Official, will be an application (UM1) to conduct the clinical trial. It is expected that a U34 planning grant will lead to the timely submission of an application for support of the full-scale study which incorporates the elements developed under the planning grant. If the planning phase is not successful, an investigator may decide not to proceed to an application for the UM1 clinical trial.

It is expected that all investigators who are considering submitting applications for clinical trials (any phase) will begin by submitting a U34 application.  However, an applicant may not need a U34 planning grant if all of the administrative activities relating to the start-up of the study (e.g., the U34 milestones) are complete.  If a clinical trial is ready for implementation without a planning phase, and readiness is adequately supported by documentation, a UM1 application may be submitted without a preceding U34. The investigators must be ready to implement the proposed trial by the time the UM1 is to be awarded.  Note that for UM1 applications which have direct costs of $500,000 or greater in any year, prior approval for submission must be obtained from the NIAMS per the NIH large grant policy.   Please refer to (NIAMS website) for details on what should be included in the request to NIAMS.

All UM1 clinical trial cooperative agreement applications will be peer-reviewed, and the NIAMS will consider the results of the peer-review process when deciding whether to support the UM1 clinical trial implementation cooperative agreement.

Scope of the U34 Planning Grant

The U34 planning grant process is designed to permit early peer review of the rationale for the proposed clinical trial and to provide support for the applicant to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, develop and finalize the clinical protocol and all essential elements of the study required for the clinical trial including all the appropriate documents.

The activities proposed in the U34 planning grant will depend on the type and complexity of the study (e.g., drug trial, surgical, or behavioral intervention). Activities supported by the U34 planning grant include, but are not limited to, the following examples:

In the event of an award, the NIAMS and the PD/PI will agree on a list of milestones to be completed during the U34 project period. They are derived from the specific activities that need to be completed before an implementation trial can be initiated. The submission of the application for the UM1 may be one of the milestones and may precede the end of the U34. The milestones will be incorporated into the notice of grant award (NoA). 

Section II. Award Information
Funding Instrument

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

New
Resubmission

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.

Award Budget

Budgets for direct costs of up to $250,000 per year and a project duration of up to two years may be requested for a maximum of $500,000 direct costs over a two-year project period.

Award Project Period

Scope of the proposed project should determine the project period.  The maximum period is 2 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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

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

Governments

Other

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.

Required Registrations

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 registrations.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.   

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.

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.

While not required, the NIAMS strongly encourages applicants to consult with Program staff prior to resubmission.   

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

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.

Applicants are strongly encouraged to submit a letter of intent (LOI) to the NIAMS before submission of the NIAMS Clinical Trial Planning Cooperative Agreement (U34) application, including new and resubmission applications.  Applicants are encouraged to allow enough time before the planned receipt date to give the Institute at least 10-weeks, 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
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Anna Nicholson
Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 818, MSC 4872
Bethesda, MD 20892 (use 20817 for overnight courier delivery)
Telephone: 301-594-2463
Email: nicholsona@mail.nih.gov

Required and Optional Components

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.

Page Limitations

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

PHS 398 Research Plan Component

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

Minimum Application Requirements for U34 Planning Grant are as follows and the following items should be included in the Research Strategy:

Rationale/Significance - Provide the rationale for the proposed clinical trial, documenting the significance and need to perform the study, detailing potential risks and benefits.  Describe the potential of the clinical trial to affect health care, policy or practice.  Include sufficient background information to enable reviewers to assess appropriateness of design, selection of experimental and comparator arms, and appropriateness of proposed study population.

Study Design- Sufficient details of the clinical trial (such as overall study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s), sample size, study end points and duration of recruitment and follow-up) should be included to permit assessment of the scientific importance and validity of the design, as well as  feasibility of the trial.  In instances where basic protocol development can only be completed with U34 funding, the application should indicate why this is the case and indicate how the support will be used to complete the design of the study. The application must describe and address the availability of the requisite patient/subject population and plans for recruitment outreach and follow-up.  In addition, plans for addressing issues and challenges regarding adherence to the proposed intervention protocol should be included.

Planning Activities - Specify how the planning period will be used.  The application should include the specific aims and rationale for the planning period, and descriptions of the activities to be carried out and a clear explanation as to how each one will be completed during the planning period. Enough information should be provided to allow reviewers to evaluate how the clinical trial documents will be developed.  Clear milestones and a timeline for completion of each should be provided.

Investigators - The application must include a description of the leadership and proposed organization of the clinical trial, including proposed clinical sites (letters of commitment are not required at this stage).  This includes the ability of the PD/PIto bring together the necessary study network.  Describe the mechanism for identification and selection of additional collaborators.  Describe the research team members participating in the planning process, their roles in the development of the plan, and their experience in related studies.

If the products of the planning phase are complete and the clinical trial is ready to begin, a U34 may not be necessary; applicants are strongly encouraged to consult with NIAMS staff if they believe they are ready to proceed to the implementation phase without a U34.

Requirements for the Human Subjects Section

Although human subject enrollment will not occur during the planning period, the application must address availability of the study population(s), provide a description of the requisite study population and describe plans for recruitment, outreach and follow-up. If there will be any “modeling recruitment” (as described in Section I) conducted to determine eligibility and interest in the proposed study, this should also be described in this section. The “model recruitment” plan may involve activities that would meet the definition for human subjects research.  If so , the application should address the required human subjects points in this section (Risk, Protections, Benefits and Importance of Knowledge to be Gained.  In addition, plans for addressing ethical and safety issues, if any, and challenges regarding adherence to the proposed intervention protocol should be included. This section cannot be used to circumvent page limits of the Research Strategy. 

Resource Sharing Plan

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

Appendix

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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.

Important reminders:
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 Planning (U34) 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the significance of the future clinical trial clearly delineated?  Would the proposed trial make a difference in practice that would lead to improved outcomes in disease prevention or treatment? If appropriate, will the trial lead to a better understanding of mechanisms of health and/or disease? 

Investigator(s)    

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? Are the investigators involved in the planning period and are their roles in the future clinical trial clearly specified? Are the expertise and ability of the investigator (and the clinical trial team) adequate to develop, organize, manage, and execute the proposed trial?  

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence for adequate resources, such as a data coordinating center or study personnel that would allow for adequate trial performance, including safety monitoring, compliance with human subjects protection, and monitoring of data integrity?       

Additional Review Criteria

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.

Justification of Planning Activities.

Are the proposed planning activities well justified? Do the specific aims of the planning grant identify areas that are needed for the future clinical trial? Do the proposed planning activities address all major barriers to the future clinical trial and poise the project for timely recruitment of subjects and implementation of the future clinical trial? Has a clear rationale been presented to justify the development of each study document? For projects where basic trial design is not complete yet, is justification provided as to why funds are needed to complete its development?

Approach to Planning Activities.

Are the aims and activities of the planning period clearly and adequately described, such as the specification of the study documents, data and safety monitoring plans, subject recruitment plans, identification of collaborators and sites, staff training, and protocol/study development? Is there an appropriate and feasible timeline for these activities and are clear milestones presented? For projects where basic trial design is not yet complete, is there an adequate plan to do so?.

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not applicable

Revisions

Not Applicable

Additional Review Considerations

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

Not applicable

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.

2. Review and Selection Process

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 NAMS Advisory Council. The following will be considered in making funding decisions:

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

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 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.

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.

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:

All aspects of the study, including any modification of study design, conduct of the study quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The awardee agrees to accept close coordination, cooperation, and participation of NIAMS staff in those aspects of scientific and technical management of the study as stated in these terms and conditions:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAMS staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies;

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 PD/PI(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:

1. Steering Committee

For multi-center trials, a Steering Committee organized by the NIAMS Program Director will be the main oversight body of the study. The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols, approve the common protocols, facilitate the conduct of participant follow-up, monitor completeness of data collection and timely transmission of data to the DCC, and report various study results. It will also be responsible for establishing study policies in such areas as access to patient data, publications and presentations, and performance standards. Major scientific decisions regarding the core data will be determined by the Steering Committee.

The Steering Committee will be composed of all Principal Investigators (data coordinating center and clinical centers), the NIAMS Project Scientist and others from the DCC, the clinical sites and the NIAMS as deemed necessary; however, only the principal investigators and the NIAMS Project Scientist or designee will be voting members.

A Chairperson for the steering committee will be selected by the NIAMS Program Director from among the principal investigators. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2. Data Safety and Monitoring Board

An independent Data and Safety Monitoring Board will be established by the NIAMS. The Data and Safety Monitoring Board will review interim results periodically as established in the data and safety monitoring plan and report to the NIAMS Program Director. The NIAMS Program Director will report in writing to the Steering Committee on the recommendations of the DSMB and the NIAMS concurrence/non-concurrence of the DSMB recommendations. The principal investigators will assume responsibility for reporting of the DSMB and the NIAMS recommendations to their respective Institutional Review Boards.

Dispute Resolution:

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 Steering Committee 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.

3. Reporting

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Shahnaz Khan, MPH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS))
Telephone: 301-594-2463
Email: Khanshah@mail.nih.gov

Anna Nicholson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-2463
Email: nicholsona@mail.nih.gov

Peer Review Contact(s)

Charles Rafferty, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5019
Email: Raffertycn@mail.nih.gov

Financial/Grants Management Contact(s)

Mark Langer
National Institute of Arthritis and Musculoskeletal and Skin Diseases  (NIAMS)
Telephone: 301-451-8216
Email: langerM@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.

Authority and Regulations

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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