U01 program announcement

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Cooperative Agreements. Investigator-Initiated Research. Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators e.

The I-Corps at NIH mission is to empower entrepreneurs in developing and validating a strategic business model through diverse customer discovery in order to meet unmet clinical needs. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies.

Orlando Lopez, PhD Tamara McNealy, PhD The National Institutes of Health NIH intends to support the development of innovative quantitative imaging and other relevant biomarkers of myofascial tissues for pain management involving research participants using a two-phase grant funding mechanism. Candidates for the quantitative imaging biomarkers may include objective measures based on minimally invasive imaging technologies, electrophysiological recordings, integration of multiparametric imaging and electrophysiology approaches, or their integration with other markers e.

In addition, the R61 phase should include team building and planning activities for the R33 phase. This funding opportunity announcement FOA invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing.

Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions i. NIH considers such studies as prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials see, e. Applications proposing studies that include but not limited to model animal research or observational studies involving humans should submit under the companion Clinical Trials Not Allowed version of this FOA.

Elise Rice, PhD This funding opportunity announcement FOA invites research projects that seek to model the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in health, illness, recovery, and overall wellbeing. Both animal and human subjects research projects are welcome.

For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA PAR-. This intensive, mentored research career development experience is expected to lead to an independently funded research career at the LMIC institution or in another LMIC.

This Funding Opportunity Announcement FOA invites applications from LMIC scientists from any health-related discipline who propose career development activities and a research project that is relevant to the health priorities of their country under the mentorship of LMIC and U.

Melissa Riddle, PhD The purpose of this Funding Opportunity Announcement FOA is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption IDE for a Significant Risk SR study or Institutional Review Board IRB approval for a Non-Significant Risk NSR study, as well as a subsequent clinical feasibility study.

The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments e. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships.

Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see BP MedTech website.

The over-arching goal of the MOSAIC UE5 program is to support educational activities that encourage individuals from diverse backgrounds, for example those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development and Mentoring Activities. Applications are encouraged from organizations of biomedical researchers e.

More detailed instructions regarding the U01 application process are contained in PAR no clinical trials and PAR clinical trials. All applicants, regardless of whether you hold a U34, are strongly encouraged to contact NIDDK program staff at least 12 weeks before submitting a U01 application. Program staff will help the investigator understand whether the proposed clinical study addresses a high priority research area and meets programmatic needs including balance across research areas , whether it is appropriate to conduct using this mechanism, and whether funds might be available for the full clinical study.

Since this is a cooperative agreement, NIDDK will have substantive scientific involvement with the proposed project. NIDDK will need sufficient time to thoroughly consider the proposed study. Allowing as much time as possible for the consultation process will allow time for revisions, should they need to be made. This preapproval process is distinct from prior consultation.

Your written request for prior consultation should be as succinct as possible. The details included in your letter may vary depending on the type of study planned e.

Generally, the letter should include all of the following items:. U01 Frequently Asked Questions. The NIDDK supports investigator-initiated, multi-center high-risk clinical studies through a two-part process: Implementation planning phase U34 Cooperative agreement U01 to conduct the study This guidance applies to all high-risk clinical studies, interventional trials as well as observational studies, conducted at more than one center.