Current Limited Submissions

Slots: 1

Deadlines

Internal Deadline: Friday, January 6, 2023, 5pm PT

LOI: January 28, 2023

External Deadline:  February 28, 2023, 5pm PT

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $1.5M 

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-022.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.

Materials to submit include:

• (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
• (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

Key Terms for this FOA

• The terms “Clinical Research” and “Clinical Trials” in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch.)
• ACCESS Hub: An organization or group of organizations which consists of institutions that may be individual institutions with affiliate members, healthcare systems, successful practice-based research networks, other relevant institutions, or any combination thereof, that includes a single scientific leadership team that is responsible for study procedures and participant recruitment into CSRN trials and studies.
• Affiliate Organization (AO): An Affiliate Organization refers to a hospital, clinic, primary care practice, or other institution where participants are enrolled on a regular and ongoing basis to CSRN-approved clinical trials.
• NCI Central Institutional Review Board (CIRB): A centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Overall Goals of CSRN and Scope of this FOA

Overall Goals of CSRN: The overall goal of the CSRN is to evaluate technologies and strategies for the purpose of cancer screening in asymptomatic individuals.

To successfully achieve this goal, the CSRN must:

• Establish the organizational and administrative infrastructure of all necessary components needed to implement cancer screening clinical studies and trials, especially a large, randomized control trial for cancer screening.
• Develop cancer screening trials to evaluate emerging cancer detection modalities for clinical utility.
• Assess the clinical utility of cancer screening programs or biomarkers of detection including downstream interventions and health outcomes.
• Apply precision medicine approaches to screening using novel risk assessment tools to individualize screening protocols.
• Evaluate the effectiveness, feasibility, and scalability of screening strategies in real-world settings.
• Identify and address technical, process, and/or cultural challenges to adapt the implementation of screening strategies for diverse practice settings.
• Conduct surveillance of cancer screening in diverse populations to track progress and characterize reach and health outcomes across populations.
• Develop cancer screening studies to evaluate clinical workflow and coordination of care.

This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to a wide variety of established and emerging screening methods, technologies, and strategies.

Scope of this FOA: The scope of research conducted by the CSRN will include the evaluation of technologies for early detection of cancer, but not for the purpose of detection of recurrence of a previously treated cancer.

To support the CSRN goals, the CCC will be expected to have the expertise and capacity to contribute the following:

• Provide scientific leadership in the overall development, conduct, and coordination of cancer screening clinical trials and observational studies within the CSRN.
• Work collaboratively with the NCI program staff in the creation and management of study operations including the development and implementation of communication activities for trials and studies.
• Develop and implement trial-specific participant recruitment and retention strategies. This includes devising specific recruitment approaches for underrepresented populations including racial, ethnic, and religious minorities, rural populations, and others.
• Develop participant-facing materials in plain language and sensitive to specific populations as necessary for trial recruitment and retention.
• Develop and update the trial information website.
• Produce and distribute messages and graphics appropriate for use by ACCESS Hubs on a variety of social media platforms with translations to languages other than English.
• Coordinate protocol development and management for the CSRN including the Vanguard pilot study. Trial design activities will be undertaken in collaboration with the NCI program staff, SDMC, and ACCESS Hubs. NCI will review and have final approval for the trial protocol and all subsequent amendments.
• Ensure compliance with NIH, FDA, OHRP, and other federal requirements.
• Conduct audits and site visits of ACCESS Hubs and Affiliate Organizations.
• Coordinate specimen collection for biobanking.
• Work collaboratively and in an integrated manner with the SDMC and ACCESS Hubs.
• Facilitate the development and management of a Participant Advisory Committee.
• Develop affiliation agreements with each ACCESS Hub, its affiliate organizations, and the SDMC.
• Provide education, training, and support to ACCESS Hubs and monitor and evaluate the performance of the individual ACCESS institutions. Together with the SDMC, the CCC will monitor and evaluate the diversity of the participant population and tailor strategies for recruitment and retention to improve the diversity of the participant pool.
• Provide support for ACCESS Hubs to integrate new investigators and institutions into the NCI rostering system.
• Plan and facilitate meetings for the Network Steering Committee and any subcommittees or working groups under the Steering Committee. The Steering Committee will include members from all components of the Network and the NCI program staff.
• Facilitate the development of the Data Safety Monitoring Board for trials and other Network activities for CSRN studies.
• Interact with companies providing materials to CSRN trials, and, in consultation and collaboration with NCI program staff, participate in the technology assessment and selection process. For example, the CCC may participate in the MCD assay evaluation and selection process for participation in a CSRN study.
• Collaborate with the SDMC and ACCESS Hubs to develop and implement the Vanguard pilot study. This protocol will be developed with the close involvement of NCI staff and its results will inform the design of future large-scale clinical trials.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

Slots: 1

Deadlines

Internal Deadline: Friday, January 6, 2023, 5pm PT

LOI: January 28, 2023

External Deadline:  February 28, 2023, 5pm PT

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $1M 

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-021.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.

Materials to submit include:

• (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
• (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

Key Terms for this FOA

• The terms “Clinical Research” and “Clinical Trials” in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch.)
• ACCESS Hub: An organization or group of organizations which consists of institutions that may be individual institutions with affiliate members, healthcare systems, successful practice-based research networks, other relevant institutions, or any combination thereof, that includes a single scientific leadership team that is responsible for study procedures and participant recruitment into CSRN trials and studies.
• Affiliate Organization (AO): An Affiliate Organization refers to a hospital, clinic, primary care practice, or other institution where participants are enrolled on a regular and ongoing basis to CSRN-approved clinical trials.
• NCI Central Institutional Review Board (CIRB): A centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Overall Goals of CSRN and Scope of this FOA

Overall Goals of CSRN: The overall goal of the CSRN is to evaluate technologies and strategies for the purpose of cancer screening in asymptomatic individuals.

To successfully achieve this goal, the CSRN must:

• Establish the organizational and administrative infrastructure of all necessary components needed to implement cancer screening clinical studies and trials, especially a large screening randomized control trial.
• Develop cancer screening trials to evaluate emerging cancer detection modalities for clinical utility.
• Assess the clinical utility of cancer screening programs or biomarkers of detection including downstream interventions and health outcomes.
• Apply precision medicine approaches to screening using novel risk assessment tools to individualize screening protocols.
• Evaluate the effectiveness, feasibility, and scalability of screening strategies in real-world settings.
• Identify and address technical, process, and/or cultural challenges to adapt the implementation of screening strategies for diverse practice settings.
• Conduct surveillance of cancer screening in populations to track progress and characterize reach and health outcomes across populations.
• Develop cancer screening studies to evaluate clinical workflow and coordination of care.

This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to established and emerging screening methods, technologies, and strategies.

Scope of this FOA: The scope of research conducted by the CSRN will include the evaluation of technologies for early detection of cancer, but not for the purpose of detection of recurrence of a previously treated cancer.

To support the CSRN goal, the SDMC will be expected to have the expertise and capacity to contribute the following:

• Provide the statistical leadership and expertise required to assure the effective scientific design and conduct of clinical trials and other cancer screening studies.
• Ensure the integrity of clinical trials including randomization and establishment of interim analyses and early stopping rules for safety and futility.
• Provide high-quality data management support (collection and monitoring) and procedures to ensure appropriate trial and study conduct, reporting of adverse events, and timely trial completion and publication.
• Collect, store, and provide quality control for all participant data for cancer screening trials and studies. This includes, but is not limited to the data management, the design of all trial forms and questionnaires, and the design and operation of systems for secure and timely receipt of trial data from the ACCESS Hubs.
• Support processes to promote the collection of long-term follow-up data for both screen positive and screen negative participants.
• Produce interim trial reports for the Data Safety Monitoring Board.
• Develop and implement a plan for sharing trial data with the research community.
• Collaborate with the NCI program staff including statisticians to develop and execute plans for analysis and quality control of trial data, and assist with trial publications. This will involve data sharing with the NCI statisticians and program staff at pre-specified time points for the Vanguard study.
• Coordinate auditing and trial conduct in a collaborative and integrated manner with the CCC.
• Ensure compliance with all federal and international standards for clinical research.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

Slots: 1

Deadlines

Internal Deadline: Friday, January 6, 2023, 5pm PT

LOI: January 28, 2023

External Deadline:  February 28, 2023, 5pm PT

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 10 – 15

Anticipated Award Amount: $8M 

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-020.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.

Materials to submit include:

• (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
• (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

Overall Goals of CSRN: The overall goal of the CSRN is to evaluate technologies and strategies for the purpose of cancer screening in asymptomatic individuals.

To successfully achieve this goal, the CSRN must:

• Establish the organizational and administrative infrastructure of all necessary components needed to implement cancer screening clinical studies and trials, especially a large, randomized control trial for cancer screening.
• Develop cancer screening trials to evaluate emerging cancer detection modalities for clinical utility.
• Assess the clinical utility of cancer screening programs or biomarkers of detection including downstream interventions and health outcomes.
• Apply precision medicine approaches to screening using novel risk assessment tools to individualize screening protocols.
• Evaluate the effectiveness, feasibility, and scalability of screening strategies in real-world settings.
• Identify and address technical, process, and/or cultural challenges to adapt the implementation of screening strategies for diverse practice settings.
• Conduct surveillance of cancer screening in diverse populations to track progress and characterize reach and health outcomes across populations.
• Develop cancer screening studies to evaluate clinical workflow and coordination of care.

This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to a wide variety of established and emerging screening methods, technologies, and strategies.

Scope of this FOA: The scope of research conducted by the CSRN will include the evaluation of technologies for early detection of cancer, but not for the purpose of detection of recurrence of a previously treated cancer.

To support the CSRN goal, ACCESS Hubs will be expected to possess the capacity to contribute the following:

• A multidisciplinary team of investigators that, together, have expertise in cancer screening and/or other disease screening with a history of successful recruitment and retention of participants to cancer screening and prevention trials or other disease screening trials or studies with the demonstrated collection of high-quality data for those trials or studies.
• Investigators who will participate in the scientific development of the trials and studies. The principal investigators will participate in the CSRN Steering Committee and other investigators may participate in a variety of working groups or committees.
• Research staff who will be responsible for entering and ensuring quality control of data from enrollment through study completion including long-term follow-up.
• Research staff who will ensure regulatory compliance, participant protection requirements, and compliance with the CCC and SDMC’s policies for auditing, training, and quality assurance.
• Institutions that will be responsible for recruiting, consenting, and registering participants from diverse populations for cancer screening trials and studies.
• Institutions that will be responsible for performing cancer screening and any diagnostic workup as prescribed by a CSRN-approved protocol or for clinical follow-up.
• Institutions that will be responsible for research oversight and data monitoring at each of their affiliate organizations.
• Institutions that will work collaboratively with the CCC and the SDMC. They will ensure trial and study data is securely transferred to the SDMC. ACCESS Hubs will coordinate with the CCC and the SDMC on efforts for long-term data collection through linkages with existing state registries and other entities, such as the virtual pooled registry and the National Death Index.
• Institutions that will be responsible for specimen collection and will also work with the CCC to coordinate the processing and shipping of all biological samples collected from trial participants to be stored at Frederick National Laboratory for future research, as well as coordinating with the CCC as needed to facilitate the shipment of specimens for protocol testing.
• A large potential participant population including individuals who are not living with cancer and who are representative demographically of the greater community.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

Slots: 1

Deadlines

Internal Deadline: Friday, December 2, 2022, 5pm PT

LOI: December 20, 2022

External Deadline: January 20, 2023

Award Information

Award Type: Cooperative Agreement

Anticipated Award Amount: NIOSH intends to commit $486,000 in FY 2023 to fund 2 awards.

Who May Serve as PI: When multiple PDs/PIs are proposed, NIOSH requires one PD/PI to be designated as the “Contact” PI, who will be responsible for all communications between the PDs/PIs and the NIOSH, for assembling the application materials outlined below, and for coordinating progress reports. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-23-004.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.

Materials to submit include:

• (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
• (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

The purpose of this FOA is to enhance the quality and complement the availability of health and safety training for miners in the Western United States. Availability includes the frequency, geographic considerations, channels or partners of dissemination, culturally and/or educational appropriate training material, and other characteristics of a successful training program.
For this announcement, the Western Region States are the same as considered by the NIOSH Western States Division (WSD) map, see link. 

NIOSH invites applications that support the development and implementation of training and education programs with objectives that:

1. address the training needs of mining personnel in the Western United States,
2. develop and deliver health and safety training to miners (NOTE: this excludes training in emergency response and hazmat materials) through qualified instructors and faculty,
3. develop/offer and implement “train the trainer” courses,
4. provide qualified instructors and faculty to conduct the training, and increase the number of trainers,
5. evaluate training effectiveness and impact on reducing injuries and illnesses to miners, and
6. coordinate with existing training programs, like those offered by MSHA and MSHA-funded state programs, and in partnerships with industry, miners, and other agencies.

NIOSH intends that the training provided by this program will be consistent with recommendations and guidelines of the Occupational Safety and Health Administration (OSHA) and MSHA, and that the training provided will not duplicate existing MSHA or OSHA training programs, or those developed by current NIOSH grantees. Applications duplicating training provided by MSHA or OSHA training programs, or those developed by current NIOSH grantees will be found non-responsive.  This is a collaborative grant and NIOSH expects grant recipients to work with NIOSH researchers and subject matter experts to the maximum extent.

1. complementing the availability and improving the quality of miner training
2. providing an opportunity to address gaps that exist in current training materials, particularly those related to Western mining operations
3. improving the transfer of best safety practices to the workplace
4. increasing the safety focus, total health awareness, and leadership competency of miners, frontline supervisors, superintendents, and managers representing operations throughout the United States, spanning all major commodity sectors in surface and underground mining

An immediate goal of safety and health training for miners is to provide workers with relevant knowledge regarding hazards encountered in the mining environment, personal protective equipment for protection of health and safety in an emergency, along with practical tools for reducing risks for injuries and illness. The training program should assist workers in becoming active participants in determining and improving the health and safety conditions under which they work, and in establishing collaborative employer-employee relationships for creating safe workplaces.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.