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| 357 | Training & Mentoring Resources | CTSA Program grantees have developed a set of national training resources for clinical and translational sciences, including educational core competencies, best practices for training mentors and curriculum materials for training courses. These educational resources are freely available, and many institutions have integrated them into their training programs. Research Training Collaboration Members of the regional Midwest Consortium for Education and Research Collaboration, a regional CTSA Program network, are partnering to strengthen clinical research education programs, mentoring and career development opportunities for scholars in the region. Eli Lilly Externship Opportunity NCATS has partnered with Eli Lilly and Company to offer externships for CTSA Program scholars, trainees and investigators. Participants receive training to enhance their skill sets and competencies in clinical trial design, clinical pharmacology, toxicology, regulatory affairs and other critical drug development processes. More Resources Training at NCATS Laboratories UCSF CTSI Mentor Development Program Course Materials NIH Loan Repayment Program Good Clinical Practice (GCP) Social and Behavioral Research E-Learning Course FAQ: NIDCR Administrative Supplements for CTSA Program Scholars (PDF - 169KB) | ||||||||
| 356 | Training & Career Development | Providing the resources to train, cultivate and sustain future leaders of the biomedical research workforce is a key CTSA Program goal. The program enables a coordinated, national effort to help ensure that our nation will have a pipeline of trained investigators who can move basic research findings into application for improving health as novel therapies, diagnostics and preventives. Scientists and clinicians gain practical research experience by working with interdisciplinary teams guided by experienced mentors. This team science approach helps prepare clinician-scientists to better address today’s complex research challenges. Find out how to access CTSA Program clinical research scholar and training opportunities. In addition, CTSA Program support enables open access to a wide variety of training resources and educational materials created by CTSA Program grantees and NIH. | Training & Career Development | Training & Career Development | ||||||
| 355 | Expired CTSA Program Funding Announcements | CTSA Program Feedback Video These now-expired funding announcements include details on the application process, eligibility and associated timelines for the CTSA Program. 75N95022R00054: NCATS Clinical and Translational Science Awards (CTSA) Program: Coordination, Communication and Operations Support (CCOS) NOT-OD-22-141: Notice of Special Interest: Administrative Supplements to NIH-funded T32 and TL1 Training Grants to Better Integrate Behavioral and Social Sciences (BSS) with other Health-Related Sciences PAR-22-122: Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional) NOT-TR-22-021: Notice of Special Interest (NOSI) Trial Innovation Center (TIC) Topic Area for Limited Competition: Clinical and Translational Science Award (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional) NOT-TR-22-020: Notice of Special Interest(NOSI): Recruitment Innovation Center (RIC) Topic Area for Limited Competition: Clinical and Translational Science Award Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional) Application Information for PAR-22-122: Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional) Video: Technical Assistance Webinar for NCATS CTSA Consortium-Wide Centers An audio described version of this webinar is available. NOT-TR-22-034: Notice of Information: Technical Assistance Webinar for the Clinical and Translational Science Award Program NOT-TR-22-033: Notice of Change to PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional) in Award Information NOT-TR-22-032: Notice of Change to PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional) in Eligibility NOT-TR-22-028: Notice of Technical Assistance Webinar for June 21, 2022 submission date of Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional) NOT-TR-22-023: Notice of Special Interest (NOSI): Research through NCATS’ Clinical and Translational Science Award (CTSA) Program: High Impact Specialized Innovation Programs (RC2) NOT-PM-22-002: Notice of Special Interest: Administrative Supplements to Advance Precision Medicine Using the All of Us Research Programs Data NOT-DE-22-001: Notice of Special Interest: NIDCR Administrative Supplements to NCATS CTSA Programs for Scholars Pursuing Dental, Oral, and Craniofacial Clinical and Translational Research Career Development FAQ: NIDCR Administrative Supplements for CTSA Program Scholars (PDF - 169KB) PAR-21-203: Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed) NOT-OD-21-177: Announcement of Childcare Costs for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Awards NOT-TR-21-035: Notice of Technical Assistance Webinar for Companion Awards for the Clinical and Translational Science Awards (UM1) Career Development and Training and Specialized Innovation Program Opportunities NOT-TR-21-031: Technical Assistance Webinar for: Clinical and Translational Science Award (UM1) (PAR-21-293) NOT-TR-21-030: Notice of Intent to Publish a Suite of Funding Opportunity Announcements (FOAs) for the National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) Program NOT-TR-21-025: Notice of Special Interest (NOSI): Topic Areas for PAR-21-203, Limited Competition: Clinical and Translational Science Award (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed) NOT-TR-21-024: Notice of Information: NCATS to Issue an Emergency Competitive Revision Sole Source Award in Support of ACTIV-6 NOT-TR-21-014: Notice of NCATS Withdrawal from Participation in PAR-20-168, "Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R21 Clinical Trials Not Allowed)" NOT-TR-21-013: Notice of NCATS Withdrawal from Participation in PAR-20-165, "Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed)" NOT-TR-21-012: Notice of NCATS Withdrawal from Participation in PAR-20-243, "Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19 (R01 - Clinical Trial Optional)" NOT-TR-21-011: Notice of Special Interest (NOSI): Availability of Emergency Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address 2019 Novel Coronavirus Disease (COVID-19) Public Health Needs NOT-OD-21-001: Notice of Special Interest (NOSI): Administrative Supplements to NCATS CTSA Program KL2 Institutional Career Development Awards as Part of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome) Project PAR-20-165: Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed) NOT-TR-20-029: Notice of Special Interest (NOSI): New Administrative Supplement Applications to UL1 and U24 CTSA Awards to Address COVID-19 Public Heath Need NOT-TR-20-028: Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions and Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address 2019 Novel Coronavirus Disease (COVID-19) Public Health Needs NOT-OD-20-022: Notice of Special Interest (NOSI): Administrative Supplements to NCATS CTSA Program KL2 Institutional Career Development Awards as part of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project NOT-TR-20-019: Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects that Involve Human Subjects Research NOT-TR-20-018: Notice of Change in Eligibility and Activity Codes for NOT-TR-20-011, Notice of Special Interest (NOSI): Clinical and Translational Science Award (CTSA) Program Applications to Address 2019 Novel Coronavirus (COVID-19) Public Health Need NOT-TR-20-014: Notice of Special Interest: Clinical and Translational Science Award (CTSA) Program Administrative Supplements NOT-TR-20-011: Notice of Special Interest (NOSI): Clinical and Translational Science Award (CTSA) Program Applications to Address 2019 Novel Coronavirus (COVID-19) Public Heath Need NOT-AT-20-010: Notice of Special Interest: NCCIH Administrative Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development See: More Information on Notice of Special Interest (NOSI): Administrative Supplements to NCATS CTSA Program KL2 Institutional Career Development Awards NCATS CTSA Program FAQs for NCCIH Administrative Supplements NOT-TR-20-007: Notice of Special Interest: Research through NCATS’ Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Awards (U01 and R21) NOT-HL-19-724: Notice of Special Interest (NOSI): Availability of Administrative and Revision Supplements to Expand Vaping Research and Understand EVALI PAR-19-337: Limited Competition: Competitive Revision Awards for the Clinical and Translational Science Award (CTSA) Program (U54 Clinical Trial Optional) PAR-19-100: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Exploratory Collaborative Innovation Awards (R21 Clinical Trial Optional) NOT-TR-19-024: Notice of Change to PAR-19-100 Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (R21 Clinical Trial Optional) NOT-TR-19-017: Notice of Change to FOA PAR-19-100: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Exploratory Collaborative Innovation Awards (R21 Clinical Trial Optional) PAR-19-099: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional) NOT-TR-20-004: Notice of Change to Award Budget and Removal of Prior Approval Requirement for PAR-19-099, Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional) NOT-TR-19-023: Notice of Change to PAR-19-099 Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional) NOT-TR-19-016: Notice of Change to FOA PAR-19-099: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional) NOT-TR-19-027: Request for Information (RFI): Enhancing the Clinical and Translational Science Awards (CTSA) Program NCATS asked relevant stakeholders for input on ways to improve the CTSA Program. Watch this video or download the presentation slides that provide an overview of the public feedback NCATS received in response to RFI NOT-TR-19-027 and general feedback from CTSA application peer reviewers. NOT-TR-19-015: Notice of Information: NCATS Clinical and Translational Science Awards (CTSA) Programs Interest in Improving Rural Health Outcomes and Eliminating Health Disparities RFA-NS-19-021: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) NOT-NS-19-028: Notice of Change to Key Dates for RFA-NS-19-021 "HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" NOT-NS-19-022: Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Pain Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) PAR-18-940: Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-20-036: Notice of Change to Key Dates for PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-19-014: Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-19-026: Notice of Change to NOT-TR-19-014: Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-19-013: Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-19-010: Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional) CTSA Program PAR-18-940 Application Information PA-18-851: NIBIB Supplements to NCATS CTSA Programs to Support NIBIB Translational Research Scholars (Admin Supp Clinical Trial Optional) PA-18-648: NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed) PAR-18-245: Limited Competition: Exploratory CTSA Collaborative Innovation Awards (R21 Clinical Trial Optional) NOT-TR-18-024: Notice of Change of Application Due Date to PAR-18-245 "Limited Competition: Exploratory CTSA Collaborative Innovation Awards (R21)" PA-18-920: NCCIH Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development (Admin Supp Clinical Trial Optional) PAR-18-244: Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01 Clinical Trial Optional) NOT-TR-18-023: Notice of Change to Application Due Date to PAR-18-244 "Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01)" NOT-TR-18-013: Notice of Modifications for PAR-18-244 "Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01 Clinical Trial Optional)" PAR-18-464: Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-18-028: Notice to update Application Types Allowed for PAR-18-464: Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-18-015: Notice of Correction for PAR-18-464: Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-18-012: Notice of Correction for PAR-18-464 Clinical and Translational Science Award (U54 Clinical Trial Optional) NOT-TR-18-006: Notice of Clarification to PAR-15-304 Clinical and Translational Science Award (U54) NOT-TR-17-012: Notice of Information to Announce NCATS Policy on Management of the Participant and Clinical Interactions Component of a Clinical and Translational Science Award NOT-TR-16-016: Notice of Correction to Eligibility in PAR-15-304 "Clinical and Translational Science Award (U54)" NOT-TR-15-019: Notice of Correction to Application Instructions in PAR-15-304 "Clinical and Translational Science Award (U54)" NOT-TR-15-017: Notice of Correction to PAR-15-304 Clinical and Translational Science Award U54 PA-18-906: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed) PA-18-592: Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed) PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOT-OD-19-087: Notice of Availability of Administrative Supplements for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project (Administrative Supplement/ Clinical Trial Optional) NOT-AT-18-014: Notice of Intent to Publish a Funding Opportunity Announcement for NCCIH Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development (Admin Supp; Clinical Trial Optional) NOT-TR-18-022: Notice of Availability of Administrative Supplements for the NCATS Clinical and Translational Science Awards (CTSA) Program PA-17-090: NLM Administrative Supplements for Informationist Services in NIH-funded Research Projects (Admin Supp) NOT-TR-17-009: Notice of NCATS Participation in PA-17-090 "NLM Administrative Supplements for Informationist Services in NIH-funded Research Projects (Admin Supp)" RFA-DE-17-008: Limited Competition: NIDCR Supplements to NCATS CTSA Programs for Scholars Pursing Dental, Oral and Craniofacial Clinical and Translational Research Career Development (Admin Supp) RFA-TR-17-006: CTSA Program Data to Health (CD2H) Coordinating Center (U24) NOT-TR-17-010: Notice of a Pre-Application Technical Assistance Webinar for RFA-TR-17-006 "CTSA Program Data to Health (CD2H) Coordinating Center (U24)" PA-16-328: Limited Competition: Administrative Supplements to Enhance Network Capacity: Collaborative Opportunities for the CTSA Program (Admin Supp) NOT-TR-17-011: Notice of Change of Application Due Date to PA-16-328 "Limited Competition: Administrative Supplements to Enhance Network Capacity: Collaborative Opportunities for the CTSA Program (Admin Supp)" RFA-TR-16-021: Coordination Center for the CTSA Program (U24) NOT-TR-16-012: Notice of Early Expiration of PAR-15-173 "Pre-Application for Collaborative Innovation Award, CTSA Program (X02)" NOT-TR-16-004: Notice of Modifications to PAR-15-173 "Pre-Application for Collaborative Innovation Award, CTSA Program (X02)" to Expand the List of High Priority Translational Research Opportunities PAR-15-173: Pre-Application for Collaborative Innovation Award, CTSA Program (X02) NOT-TR-15-020: Notice of Corrections to PAR-15-173 "Pre-Application for Collaborative Innovation Award, CTSA Program (X02)" NOT-TR-15-011: Notice of Corrections to PAR-15-173 "Pre-Application for Collaborative Innovation Award, CTSA Program (X02)" RFA-TR-15-002: CTSA Network - Trial Innovation Centers (TICs) (U24) New Funding Opportunities for Trial and Recruitment Innovation Centers NOT-TR-15-016: NIA Announces Interest in Utilizing the CTSA Network - Trial Innovation Centers (TICs) to Study Alzheimer’s Disease and Other Aging-related Dementias RFA-TR-15-004: Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs) (U24) New Funding Opportunities for Trial and Recruitment Innovation Centers Notice of Pre-Application Technical Assistance Webinar for RFA-TR-15-004: "Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs) (U24)" NOT-TR-15-005: Notice of Intent to Publish a Funding Opportunity Announcement for Pre-applications for Collaborative Innovation Award, Clinical and Translational Science Award Program (X02) NOT-TR-15-006: Notice of Intent to Publish a Funding Opportunity Announcement for Collaborative Innovation Award, Clinical and Translational Science Award Program (U01) RFA-TR-14-009: Clinical and Translational Science Award (U54) NOT-TR-14-013: Notice of Corrections to RFA-TR-14-009 “Clinical and Translational Science Award (U54)” NOT-TR-14-012: Notice of Change in the Application Due Date in RFA-TR-14-009 “Clinical and Translational Science Award (U54)” | ||||||||
| 352 | Translational Science Training at NCATS | Developing the next generation of translational scientists is a top priority for NCATS. The Division of Preclinical Innovation (DPI) provides a variety of training opportunities for high school, undergraduate and graduate students, as well as postdoctoral trainees. DPI is the intramural (i.e., on-site) research program of NCATS and is located in Rockville, Maryland, a few miles from the main NIH campus in Bethesda, Maryland. DPI focuses on early stages of the translational process, from target validation to first-in-human studies. More than 200 scientists from a variety of disciplines and across the spectrum from early-career scientists to senior leaders are responsible for advancing the diverse research portfolio of DPI. In addition to conducting cutting-edge laboratory research, DPI scientists collaborate with more than 250 research organizations worldwide. Collectively, these individuals participate in a team science environment in which each project brings together expertise in: Biology (biological and disease assay development) Automation and engineering (high-throughput screening robotics) Informatics and data analysis Medicinal and analytical chemistry The research teams in DPI are organized around the following programs: Biomedical Data Translator Bridging Interventional Development Gaps (BrIDGs) Chemistry Technology NCATS Chemical Genomics Center (NCGC) RNA Interference (RNAi) Therapeutics for Rare and Neglected Diseases (TRND) Toxicology in the 21st Century (Tox21) To learn more about NCATS on-site research groups and opportunities, visit the links above or the: NCATS Staff Profiles (of individuals in DPI) NCATS Publications Database Feel free to contact any of the scientists or research groups to inquire about potential training opportunities. More information, including specific application requirements for certain programs, can be found below. Summer Internship Program in Biomedical Research The summer internship program at NCATS will provide participants with a full-time research experience in all aspects of drug discovery from chemistry to biotechnology to engineering. Interns range from high school to postbaccalaureate students; altogether, NCATS welcomes 20 to 30 interns each summer. During a summer at NCATS, interns will engage in various activities, including hands-on research. Seminars, career talks and journal clubs designed specifically for summer students are offered. At the end of the summer, interns will present their research in poster format, both at NCATS and on the NIH main campus. To be selected for an NCATS summer internship, interested candidates must apply to the NIH Summer Internship Program (SIP) in Biomedical Research. This program is for high school students age 16 and older, undergraduate students, graduate students and professional (e.g., medical, dental) school students. Applicants can apply online from mid-November to March 1 each year. Watch the Applying Successfully video. Postbaccalaureate Intramural Research Training Award Program Recent college graduates who are planning to apply to graduate or professional (medical/dental/pharmacy) school can spend one to two years performing full-time research at NCATS through the NIH Postbaccalaureate Intramural Research Training Award Program. Applications are accepted year-round on a rolling basis. Watch a videocast on how to apply. In addition to the research experience, DPI has a vibrant postbaccalaureate program, with a seminar series, professional development opportunities, and a strong network of peers and mentors. NIH Medical Research Scholars Program NCATS participates in the NIH Medical Research Scholars Program, a comprehensive, yearlong research enrichment program designed to attract the most creative, research-oriented medical, dental and veterinary students to the Intramural Research Program (IRP) of NIH. Applications are open on October 1 for entrance in the following academic year. Graduate Partnerships Program The NIH Office of Intramural Training & Education hosts the Graduate Partnerships Program, which is designed to attract Ph.D. students to the NIH IRP for dissertation research. Participants enjoy the academic environment of a university, the extensive research resources of NIH and the breadth and depth of research programs at their host university and at the NIH IRP. The goal is to create a different kind of graduate experience that focuses on training the next generation of scientific leaders by emphasizing communication and collaboration skills, integration of information, and interdisciplinary investigation. NCATS participates in both the institutional and individual Graduate Partnerships Program arrangements. Postdoctoral Training in NCATS Research Groups DPI scientists work in a collaborative, team-based environment. Postdoctoral fellows are recruited to work on a specific project and have ample opportunities to collaborate with scientists, both within and outside of NCATS on additional projects. Postdoctoral fellows are expected to present the results of ongoing work at meetings (such as internal group meetings and national conferences) and to submit their work for publication in scientific journals. Postdoctoral fellows also gain additional professional skills and exposure to a variety of career paths through participation in the DPI training program. Immediate openings are posted on the NCATS Job Opportunities page; however, potential applicants should directly contact the DPI scientists with whom they would like to work to inquire about openings. NIH Visiting Program The NIH Visiting Program provides opportunities for foreign scientists in Ph.D. programs or foreign scientists who have received doctoral degrees to train and conduct collaborative research at NIH, including at NCATS. Individuals interested in training and/or conducting research at NCATS should directly contact the DPI scientists with whom they would like to work to inquire about openings and become familiar with the NIH process for appointment. This includes the NIH Visiting Program for research training and Visiting Scientists appointments to conduct research. | Developing the next generation of translational scientists is a top priority for NCATS. | /sites/default/files/chemist3_900x400.jpg | Translational Science Training at NCATS | Developing the next generation of translational scientists is a top priority for NCATS. | /sites/default/files/chemist3_900x400.jpg | Translational Science Training at NCATS | ||
| 351 | Concept Clearances | Concepts describe the basic purpose, scope and objectives of proposed initiatives and represent an early planning stage for potential NCATS activities. Concepts are discussed with the NCATS Advisory Council and Cures Acceleration Network (CAN) Review Board and through other public venues. Council approval of a concept does not guarantee it will become an initiative. That decision is made based on scientific and programmatic priorities and the availability of funds. Learn more about NCATS Council concept clearances: Advisory Council Concept Clearances CAN Review Board Concept Clearances | ||||||||
| 350 | CAN Review Board Meetings (Old) | Upcoming MeetingsThe Cures Acceleration Network (CAN) Review Board meets four times each year; each meeting is typically videocast.Next MeetingTBDPast Meetings2020Jan. 16Agenda (PDF - 218KB) • Minutes (PDF - 295KB) • WebEx Recording • Federal Register Notice2019Jan. 10Agenda (PDF - 159KB) • Minutes (PDF - 340KB) • WebEx Recording • Federal Register NoticeMay 16Agenda (PDF - 190KB) • Minutes (PDF - 454KB) • Videocast • Federal Register NoticeSept. 19Agenda (PDF - 253KB) • Minutes (PDF - 265KB) • Videocast • Federal Register NoticeDec. 13Agenda (PDF - 149KB) • Minutes (PDF - 311KB) • WebEx Recording • Federal Register Notice | ||||||||
| 348 | Cures Acceleration Network (CAN) Review Board | ContactAnna L. Ramsey-Ewing, Ph.D.Gregory P. Jarosik, Ph.D.Authorized to reduce significant barriers to successful translation and accelerate the development of high-need cures, the Cures Acceleration Network (CAN) provides NCATS with flexibility in how it funds projects. Implementation of this authority is guided by the CAN Review Board, which according to its charter (PDF - 24KB), advises and provides recommendations to the NCATS director on the policies, programs and procedures for carrying out the duties of the Office of the Director and on identifying significant barriers to successful translation of basic science into clinical application. The CAN Review Board also discusses concept clearances for potential NCATS initiatives.The CAN Review Board is composed of members who are appointed by the Secretary of the U.S. Department of Health and Human Services. Members serve four-year terms. Ex-officio members from NIH, the Office of the Assistant Secretary of Defense for Health Affairs, the Office of the Under Secretary for Health for the Department of Veterans Affairs, the National Science Foundation, and the U.S. Food and Drug Administration also are appointed and serve three-year terms.In 2019, NCATS established a Cures Acceleration Network Review Board (CAN RB) working group to assess how NCATS can accelerate translational science implementation and foster the uptake of mature CAN RB-supported tools and technologies into real-world use and practice.Next MeetingTBDView more meeting information. | ||||||||
| 347 | GRDR® Frequently Asked Questions | Why is the NIH/NCATS GRDR program needed? What are common data elements (CDEs), and why are they important? Can a patient organization interested in starting a registry collaborate with NCATS through the GRDR program? If so, what are the steps involved? Does NCATS provide institutional review board (IRB) services through its GRDR program? Can a patient organization that already has a patient registry underway or in development adapt its program to the GRDR program? Why should an organization participate in the GRDR program? Why is the informed consent document essential to the GRDR program? Who owns the data once these are part of the GRDR program? Who can access the data to conduct research? What type of research projects can be conducted? How are patients’ identities protected? Why is the NIH/NCATS GRDR program needed? Because many rare diseases share biological pathways, analyses across diseases can speed the development of new therapeutics. To facilitate cross-disease analyses, the GRDR program enables the integration of patient data from multiple rare disease registries in a standardized manner, and the data are mapped to GRDR program common data elements and other national standards. These efforts are designed to advance research for rare diseases and, through application of scientific insights gained, to further research for common diseases. What are common data elements (CDEs), and why are they important? A CDE consists of both a precisely defined question and a specified format or set of permissible responses. Using CDEs ensures data are defined in the same way, using the same standards and with the same vocabulary, so that the data can be used across diseases or registries. Can a patient organization interested in starting a registry collaborate with NCATS through the GRDR program? If so, what are the steps involved? Although establishing new registries is not part of the GRDR program,NCATS staff have developed a number of tools and services to help patient organizations establish registries and participate in GRDR program. Examples of such tools include: A set of CDEs. A template informed-consent form (Word - 40KB) for participating in patient registries, which can be modified according to the specific needs of each group. Global unique identifier (GUID) software. Does NCATS provide institutional review board (IRB) services through its GRDR program? Yes, GRDR staff can provide complimentary IRB services to participating organizations through the NIH IRB. Although not specifically endorsed by NCATS, organizations participating in the GRDR program can use external IRBs, for example: Western Institutional Review Board Chesapeake Research Review, Inc. Can a patient organization that already has a patient registry underway or in development adapt its program to the GRDR program? Any organization with a registry under development can incorporate the GRDR program CDEs. The CDEs should include all the elements needed to generate the GRDR program GUID. The informed consent forms of participating organizations must include patients’ permission to share their de-identified information with the GRDR program for broad use (i.e., for any disease). Also, the registry protocol must be IRB-approved. Why should an organization participate in the GRDR program? Patients and their families: Increase awareness of their specific rare disease. Physicians and nurses: Facilitate contact with others who are dealing with the same issues and compare notes. Provide access to outcomes data. Provide awareness about novel treatment regimens. Foster collaboration between all stakeholders. Rare disease organizations: Provide resources and tools and map data to national standards to facilitate interoperability with other databases. For investigators and industry: Allow free access to curated and standardized clinical and genomic data. Facilitate the recruitment of patients to multicenter clinical trials for rare diseases. Why is the informed consent document essential to the GRDR program? The GRDR program is designed for interaction only with the registry representing the patient (as opposed to individual patients). Participating organizations sharing de-identified patient data must first obtain permission from their patients to share data with the program. Informed consent includes two main steps: Patients receive an explanation of the nature of their involvement in the registry, study or procedure. They are given information about the risks and benefits as well as the option to change their minds and opt out of participation. Once patients have a full understanding of their involvement, they are required to sign a form to document their understanding and agreement. More information about the informed consent process can be found at the following links: Informed consent and patient registry for the rare disease community: Editorial. Contemp Clin Trials. 2012;33(1):3–4. Informed consent template for patient participation in rare disease registries linked to biorepositories. Rare Dis Orphan Drug. 2014;1(2):69–74. Who owns the data once these are part of the GRDR program? The GRDR program does not control or own any registry or its data. The contributing organization retains ownership and control of its registries. De-identified patient data shared by the registry owner will be mapped to national standards, integrated and stored in the GRDR data repository. De-identified data that have been shared and integrated into the GRDR program belong to the community, under the NIH auspices, which protects the data and the confidentiality of the patients according to federal regulations and NIH policies. Who can access the data to conduct research? The GRDR program data is accessible to all users who agree to the policies for its use. There are two levels of access: Open Access, which provides summaries, statistics, trends and general information. There is no process of approval for this access. Controlled Access, with which investigators can access detailed information about patients to enable the design of new research studies. In this case, the investigator must submit an IRB-approved project and sign a confidentiality form. The GRDR program has no information about, nor access to, the identity of the patient. Investigators can contact the patient only through the contributing registry. What type of research projects can be conducted? Once the GRDR data are accessible, the data can be used for various types of studies such as epidemiological, basic science, natural history, comparative effectiveness, and clinical studies and trials across many diseases. As more patient registries are added to the program over time, the range of studies that could be conducted may increase. How are patients’ identities protected? Each registry, before submitting data, must remove all patient identifiers, according to the Department of Health and Human Services regulations at 45 C.F.R. Part 46. Data submitted with patients’ identifiers will be discarded and will not be processed. In addition, to tracking each set of patients’ data over time and across diseases, registries, studies and countries, a GRDR program GUID will be assigned to each data set using an encrypted one way hash code. The code for the patient is saved only within the contributing registries and will never be shared with the GRDR program. Patient recruitment for subsequent studies can be facilitated only through the contributing registry. | ||||||||
| 346 | Education & Training Resources | Providing the resources to train, cultivate and sustain future leaders of the translational research workforce is a key NCATS goal. The Center offers translational education and training to support a pipeline of investigators who can move basic research findings into the clinic to improve human health. The following examples of translational research resources, organized by audience, highlight the wide variety of education and training opportunities available. These resources are designed to prepare clinician-scientists to better address the unique challenges of translational research. Find resources for: Clinicians, Researchers and Health/Science Professionals Undergraduate and Graduate Students High School Students Clinicians, Researchers and Health/Science Professionals Courses and Training FDA Perspective on Drug Development Foundation for Advanced Education in the Sciences The Clinical Research Methodology Curriculum Weill Cornell Medical College Postgraduate Education Program in Clinical and Translational Science Harvard University Catalyst NCI-FDA Joint Fellowship Program in Research and Regulatory Review National Cancer Institute, NIH Certificate Program in Clinical and Translational Science Tufts University Certificates and Degree Programs Certificate in Applied Biostatistics Harvard University Catalyst Clinical Research Methods University of Illinois at Chicago School of Public Health Certificate in Translational Science University of Texas Health Science Center at San Antonio Master’s Program in Clinical and Translational Investigation Harvard University Catalyst Master of Science in Clinical and Translational Science University of Florida Undergraduate and Graduate Students Courses and Training Introduction to Clinical Investigation Harvard University Catalyst Introduction to Translational Medicine Harvard University Catalyst Translational Science Training Across Disciplines University of Texas Health Science Center at San Antonio Clinical and Translational Research Course for Ph.D. Students NIH Clinical Center A New Era of Targeted Drug Discovery and the Path of Development: From Molecular Signaling to the Global Market and Back Again, an Educational Program New York University School of Medicine Certificates and Degree Programs Clinical/Translational Science Certificate University of Florida Certificate in Clinical and Translational Science for Doctoral Students in the Health Sciences University of Pittsburgh (for University of Pittsburgh Ph.D. students) Advanced Training in Clinical Research University of California, San Francisco M.S. in Clinical and Translational Sciences Rutgers University Robert Wood Johnson Medical School Master of Science in Clinical and Translational Investigation University of Miami Miller School of Medicine Molecular Medicine and Translational Science Ph.D. Program Wake Forest University School of Medicine Ph.D. in Basic and Translational Science Medical College of Wisconsin Internships College of Medicine Urban Health Program, Center for Clinical and Translational Science Summer Research Fellowship University of Illinois at Chicago Indiana CTSI Summer Internship Program Indiana Clinical and Translational Sciences Institute High School Students SMART (Students Modeling A Research Topic) Milwaukee School of Engineering | ||||||||
| 345 | General Council Operating Procedures | Advisory Councils at the National Institutes of Health (NIH) provide second-level review of all grant applications under consideration for Institute or Center funding. Each Council is required to establish general operating procedures for the review of grant applications. These procedures must be in writing and should be reviewed once a year. The sections below explain the operating procedures associated with the National Center for Advancing Translational Sciences Advisory Council (hereafter referred to as Council) for the following activities: Council may vote in either en bloc or individual actions. Council with give special consideration to well-funded Investigators. Council may conduct expedited reviews as well as early concurrence voting. Council may delegate selected activities to staff. Council has the ability to form subcommittees to perform its duties. Second-Level Review of Grant Applications En Bloc and Special-Action Voting Prior to a Council meeting, Council members review an electronic summary of the peer review results for grant applications assigned to NCATS for funding consideration. Council members consider the adequacy of the review and are asked to concur with the review. Most of the concurrence voting occurs through en bloc actions. Specific Council discussion and consideration are required for special actions that include, but are not limited to, applications meeting the following criteria: Foreign grants including domestic grants with foreign involvement. Principal Investigator (PI) covered under NIH’s Special Council Review Requirement (PI currently awarded $1.0 million in direct costs through certain NIH research mechanisms). Unresolved human subject, animal subject and/or biohazard concerns identified by the initial peer review group. Unresolved issues regarding recruitment of women, minorities, or children or data monitoring identified by the initial peer review group. In addition to the applications identified above, the NCATS director or any Council member may ask that any individual application or group of applications be discussed. Options Available to Council Voting options include: Concurrence — Concurrence with initial review recommendation A Council may not change the numerical ratings (e.g., impact/priority scores, percentile, criterion scores) resulting from the initial review; however, the Council may recommend that program staff change the order of consideration of certain applications for funding. The following codes shall be used to indicate Council action in relation to the numerical rating: High Program Priority (HPP) — Raised in order of consideration for funding Low Program Priority (LPP) — Lowered in order of consideration for funding Other — An unusual action that cannot be identified as Concurrence, HPP or LPP, such as changes in recommended budget and/or duration of support. Use of this code is optional at the IC’s discretion. Deferred — This action could be taken if additional information is required prior to voting or if an error requires the re-review of an application. Not Recommended by Council — Non-concurrence with initial review Special Council Review of Pending Applications from Well-Funded Investigators In an effort to continue responsible stewardship of public funds and to support meritorious and innovative research, NIH has instituted a policy of Special Council Review (SCR) of applications from well-funded investigators. Applications before Council from Program Directors/Principal Investigators (PD/PI) who have more than $2 million in total costs from active NIH Research Project Grants (RPGs) grants will be subject to additional consideration. Council members will receive a list of those PIs and their applications that fall under this requirement. It is important to recognize that this is a threshold for special review only: investigators who have research support in excess of $2M in total costs may continue to receive additional awards as warranted. When making funding recommendations, staff and Council members will take into account factors such as: how innovative and distinct the pending project is from the PD/PI’s other grants; the type of research (since costs requirements differ substantially by field); the public health priority of the research; and how the absence of an award impacts other collaborative or translational research efforts. Expedited Review Staff may request expedited electronic review for eligible applications. All Council members will be asked to participate in the expedited review and will be notified of the applications under consideration and will have secure access to the summary statements. Expedited electronic review may be designated for, but not limited to: Applications that require the immediate availability of time-limited, unique resources Applications that were administratively deferred or re-reviewed due to a successful appeal Applications received in response to Request for Applications (RFAs) Early Concurrence The chair of Council will select two members or more of Council to provide the en bloc early concurrence on behalf of the full Council for a specified group of applications. The executive secretary of Council will determine which applications, meeting the following criteria, are eligible for the en bloc early concurrence voting process: Have a ranking percentile (1–10 percent), or for those mechanisms without percentile rank, with priority scores no greater than 25 or otherwise within the fundable range for a specific group of applications; From neither a foreign institution nor that include a foreign component; No unresolved human subject, animal, or biohazard concern identified by the study section or NCATS staff; No unresolved issues regarding the recruitment of women, minorities, or children or data monitoring identified by the study section or NCATS staff; and No unresolved appeal letters or other issues requiring attention of full Council. All Council members will be provided with a list of the names, institutions, project titles, requested dollars and priority scores/percentile ranks proposed for the en bloc early concurrence. If any Council member determines an application should come to the full Council for discussion or should not be expedited for any reason, he or she needs to notify only the executive secretary by the response date and the application will be removed from the early concurrence en bloc list. Two or more designated Council members will receive and review the list of the names, institutions, project titles, requested dollars and priority scores/percentile ranks for all eligible early concurrence en bloc applications, as well as summary statements. The selected Council members will notify the executive secretary of the results of their review by the requested response date. Concurrence by the majority of selected members is required for approval. Any single vote for non-concurrence will result in that application going before the Council for full consideration at its upcoming meeting. A report of the Early Concurrence en bloc recommendations will be presented at each Council meeting. Applications receiving early concurrence will be eligible for funding as soon as the executive secretary of Council has certified that the review is complete. Concept Review As the Center continues to address its mission through the support of most currently relevant research and research training, it may be necessary to develop specific research initiatives in order to solicit applications on a given topic. Descriptions of planned research initiatives are presented to Council in the form of Concept Clearances for proposed Funding Opportunity Announcements (FOAs) or contract solicitations. These documents present the objectives and rationale for the concept, and the current scientific needs and opportunities. Two Council members are asked to serve as primary and secondary reviewers of each concept. Following discussion of the concept, Council members may take one of the following actions: Approval with or without modifications; Disapproval; or, Deferral for further development and discussion. Delegations of Authority The Council delegates the following authority to the NCATS staff for the administrative actions described below. Program staff, in consultation with Grants Management staff, may take administrative action without prior Council approval to award funds in excess of the amount recommended by Council for research and training grants and cooperative agreements to support increased operational costs not anticipated at the time the Council recommended approval of the project. Administrative increases and extensions should be provided only when necessary for the successful conduct of the project and must not represent changes in the basic goals or intent of the project. Generally, these administrative increases will be no more than 25 percent of the current year’s awarded direct costs. A list of all administrative supplements will be provided to Council members for informational purposes only. These increases may cover unanticipated costs of a project and can include, but are not limited to: Cost increases due to state, university, or labor union stipulated salary increases in fringe benefits Increased federally negotiated facilities and administrative cost rates or loss of equipment originally available to the project from other sources Increased cost of equipment and related services (e.g., data analysis) Making minor modifications for the purpose of taking advantage of serendipitous and other unanticipated opportunities to increase the value of the project consistent with the originally approved objectives and purposes of the project Preparing and disseminating materials concerning the project and for the purpose of ensuring that important findings from the project are made widely available in a timely and effective manner Orderly termination of a project Bridge funding Administrative correction to an error in the submission of an application Consistent with NIH policy, administrative supplements and extensions may be made for the purpose of extending the period of support to ensure orderly termination of a project or to support a project for a limited time, pending a decision or action to continue or discontinue support (e.g., when there is an Initial Review Group or Council deferral) where support would terminate before completion of review. Extensions of projects made for this purpose should be for periods as brief as possible, but usually should not exceed one year. All administrative supplements must be endorsed by the NCATS director. In addition, the Council will be informed of all such administrative actions at its next closed meeting. Subcommittees As necessary, subcommittees may be established by the executive secretary or other designated government official within the Council’s jurisdiction. The advice/recommendations of a subcommittee must be deliberated by the parent advisory committee. A subcommittee may not report directly to a federal official unless there is statutory authority to do so. A member of a standing subcommittee may serve as a voting member of another standing subcommittee, but may not be counted toward determining a quorum. The quorum for a standing or ad hoc subcommittee is three. Exceptional Circumstances As circumstances require, based on programmatic considerations, the Director, NCATS, after consultation with Council, may make exceptions to these guidelines. Exceptions to these procedures should be extremely rare because there needs to be consistent application of these procedures across extramural divisions. Nonetheless, circumstances may require the deviation from the prescribed procedure in order to achieve the mission of the NCATS. By NCATSAC delegated procedures, the Director, NCATS has authority to act upon unusual or extenuating circumstances. These actions are usually discussed by a subset of Council members selected by the Director and Executive Secretary of NCATSAC. Any actions of this exceptional nature must be appropriately documented as necessary for the official record, and should be reported to Council at its next scheduled meeting. References Public Health Service Act as amended, 42 USC 52h, 42 USC 241, 42 USC 284a NIH Manual Chapter 1805, Use of Advisors in Program and Project Review and Management (https://oma1.od.nih.gov/manualchapters/management/1805/) NIH Manual Chapter 1810-1, Procedures for Avoiding Conflict of Interest for Special Government and other Federal Employees serving as Advisory Committee Members (http://oma1.od.nih.gov/manualchapters/management/1810-1/) NIH Manual Chapter 3005, Review and Evaluation of Intramural Programs (https://oma1.od.nih.gov/manualchapters/intramural/3005/) NIH Manual Chapter 4204-204B, Peer Review Process (https://oma1.od.nih.gov/manualchapters/grants/4204-204B/) NIH Manual Chapter 54104, NIH Research Grants Involving Foreign Institutions and International Organizations (https://oma1.od.nih.gov/manualchapters/grants/54104) PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) NIH Manual Chapter 54513, Management and Procedures of National Advisory Councils and Boards in Their Review of Extramural Activities (https://oma1.od.nih.gov/manualchapters/grants/54513/) NIH Manual Chapter 7410, Review and Documentation of Protections for Human Subjects in Grant Applications and Contract Proposals (https://oma1.od.nih.gov/manualchapters/comgc/7410/) OER Policy & Guidance: Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page (http://grants.nih.gov/grants/funding/women_min/women_min.htm) OER Policy & Guidance: Inclusion Across the Lifespan (http://grants.nih.gov/grants/funding/lifespan/lifespan.htm) NOT-OD-12-140: Notice of Special Council Review of Research Applications from PDs/PIs with More than $1.0 Million Direct Costs in Annual NIH Support (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html) and NOT-OD-22-049: Notice of Change to NIH’s Policy on Special Council Review of Research Applications (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-049.html) Anna L. Ramsey-Ewing, Ph.D. Executive Secretary National Center for Advancing Translational Sciences Advisory Council January 26, 2023 |
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