ECRIP Announcement, Summary and Important Program Reminders

Announcement

The New York State Department of Health (DOH) is now accepting project abstracts for the 2019 cycle of the Empire Clinical Research Investigator Program (ECRIP). ECRIP provides Center awards to New York State teaching hospitals in order to make these institutions more competitive for federal funding. Beginning with this cycle, Individual awards will no longer be made. ECRIP project abstracts, biosketches, and a letter committing matching funds must be submitted to DOH electronically (in Microsoft Word or PDF format) to gme@health.ny.gov no later than 4:00 p.m. March 28, 2019. All abstracts submitted must be endorsed by an "officer of the institution." In order to expedite the review and award process, teaching hospitals are encouraged to submit their abstracts as soon as possible.

Up to $3.445 million in annual funding for two-year awards will be awarded to teaching hospitals that train physicians as clinical researchers in order to advance biomedical research in New York. Funding for this program is contingent on the continuation and authorization in the State budget.

Project abstracts will be reviewed by DOH staff and a panel of experts in clinical research. Award announcements are expected to be made in late spring, 2019.

In order to submit an ECRIP project abstract, teaching hospitals must provide information on the research project as detailed in the Abstract Outline included on this website. In addition to the summary information set forth in this document and in the Abstract Outline, this site also includes frequently asked questions (FAQs), the format for submitting a biographical sketch (biosketch) a request for expert reviewers in clinical research, and clinical research position requirements. In addition, this site also includes templates for budget information, start-up reports, mid-course and final summary reports, all that will need to be completed at later dates upon notification by DOH. Please forward this information to the medical director, clinical department chairs and other researchers in your institution.

If you have any questions, please contact Thomas Burke, Executive Director of the New York State Council on Graduate Medical Education, at gme@health.ny.gov or at (518) 473-7019.

Summary

The Empire Clinical Research Investigator Program (ECRIP) was created in 2000 upon the recommendation of the New York State Council on Graduate Medical Education to promote training of physicians in clinical research in order to advance biomedical research in New York State. Earlier research found that New York State slipped from first to third nationally in its share of National Institutes of Health (NIH) funding and was not producing the necessary clinical researchers to remain highly competitive with other states. While New York still ranks third nationally in NIH funding since ECRIP was created, it has narrowed the gap in the total number of awards between itself and second ranked Massachusetts. The program supports Governor Andrew Cuomo's commitment to develop a life sciences research cluster.

Beginning with the 2019 cycle, ECRIP provides only Center awards to teaching hospitals. Awards will be made in amounts determined by DOH based upon the number of abstracts submitted that meet all program requirements. Any costs associated with a proposed project in excess of the funding amounts awarded are expected to be supported by the institution. Awards will be made to teaching hospitals that meet specific program requirements and will be distributed pursuant to the methodology set forth in regulations.

Center Awards

Awards will be made for two years to promote development of clinician researchers while providing seed funding for new center grants by requiring teaching hospitals to form research teams around themes, such as "improved therapies for type 2 diabetes." A theme may not be one that currently has federal center (P- or U-type) funding at the institution. The research theme must represent a strategically important growth area for the institution, preferably associated with one or more federal funding opportunities with a realistic project timeline. Teaching hospitals may submit an optional secondary abstract formed around a theme that is independent of the primary abstract if it intends to split award funding between two projects andit receives $400,000 or more in an annual State award, depending on the number of other qualifying projects. If a secondary abstract is submitted, both the primary and secondary projects must meet all program requirements. If the primary project does not meet the program requirements, neither project will be funded. However, if the secondary project does not meet the program requirements but the primary project meets the program requirements, the primary project would qualify for the full award.

Each research team must be led by a director who will sponsor/mentor one project and coordinate the research team's activities. The director must be a PI, Co-PI or co-investigator of a federal research or PCORI grant within two years of the abstract deadline. ECRIP fellows must be supervised by a sponsor-mentor(s) at all training sites. For every $100,000 annually in State funding, the institution will be required to train at least one ECRIP fellow. Inter-institutional collaborations (with shared funding) involving other NY teaching hospitals and other NY entities such as private and public universities and colleges, government laboratories (e.g., Wadsworth Center, Nathan Kline Institute), local health departments, the New York City Health and Hospitals Corporation and federally qualified health centers (FQHCs) are encouraged. All abstracts must include a match of at least $100,000, per year, by the institution with real (not in-kind) funds. All ECRIP fellows will be expected to work in a collaborative team-based training model.

In the current cycle, projects and ECRIP fellows may begin after funding is awarded but no later than December 31, 2019. ECRIP provides funding for community-related research that is specific to an institution's region or population served. It is an open and flexible program, allowing for teaching hospitals to hire physicians in all subject areas of clinical research to perform patient-oriented, epidemiologic, behavioral, outcomes, health services and translational research. ECRIP is also leveraged by teaching hospitals to draw additional and substantial research funding from other sources (e.g. NIH, pharmaceutical companies, foundations) to continue the research.

ECRIP encourages teaching hospitals to conduct and train physicians in clinical research that will result in new positions in these facilities. Funding for research generates a substantial return on investment. According to a 2010 study prepared by Tripp Umbach for the Associated Medical Schools of New York (2010, The Impact of Medical Education on the State of New York), for every dollar in Federal and State research funding invested in New York medical schools, New York State receives a return of $7.50. More recently, a report published by the Association of American Medical Colleges in 2018 concluded that the economic impact of medical schools and teaching hospitals (including research) contributed to nearly 545,000 jobs and $54 billion to New York State's economy.

Since 2001, 623 awards totaling over $120 million, including required matching funds, have been awarded to teaching institutions, including academic health institutions and community teaching organizations. These awards have resulted in over 790 physicians trained in ECRIP projects. Over 65 percent of all projects submitted received an award. Sample data from the first eight years of the program show that 73 percent of ECRIP funded researchers have continued in research and 81 percent of those that continued in research have remained in New York State.

Important Program Reminders

  1. Responses included in the Abstract Outline, biosketch, matching fund letter from the institution and other relevant documentation (e.g. grant notices) must substantially meet all program requirements and should be clear, concise, comprehensive, organized and include only relevant and sufficient detail addressing the specific question. Any question that does not meet the above conditions will be deemed to not meet the program requirements and the institution will not be awarded funding.
  2. The Abstract Outline includes a requirement that a Notice of Grant Award or other documentation be provided to demonstrate proof of the principal investigator (PI), co-PI or co-investigator status relating to a federal research or PCORI grant. A situation in which such investigators were subcontractors within a multi-site grant is permissible, provided a budget justification or other appropriate documentation is included to demonstrate overall responsibility and budget authority for the research at the site and substantial involvement in the development of the overall multi-site project beyond enrolling research participants. The Abstract Outline also includes a requirement to clearly note which federal research or PCORI grant qualifies such investigator as an ECRIP project director or sponsor-mentor.
  3. Teaching hospitals may include more than one sponsor-mentor, provided, however, that the project director that meets the federal research or PCORI grant requirements must substantially work or practice at the teaching hospital that is submitting the abstract. In addition, if the research fellow is training at any other site(s), a sponsor-mentor must be identified and provide direct supervision to the research fellow at each site.
  4. Teaching hospitals submitting abstracts must provide a substantial portion of the research fellowship training at that hospital, in addition to training at any other site(s). Also, the Abstract Outline should include the significance of all sites for training the research fellow(s).
  5. ECRIP allows existing faculty at the institution to participate as a research fellow, provided that such faculty are pursuing career development in clinical research. ECRIP fellow positions are full-time of no less than 35 hours per week.
  6. A sponsor/mentor can train up to a maximum of two research fellows at one time.
  7. Abstracts must identify subsequent federal or other sources targeted for future research project funding since a key purpose of ECRIP is to lay the groundwork for future federal funding.
  8. Carefully review Clinical Research Position requirements. They include the minimum requirements of the research fellow, including (but not limited to): that the position shall not be required in order for the research fellow to complete a graduate medical education program; and that the position shall exceed the minimum standards that are required by the residency review committee in the specialty in which the research fellow has trained or is currently training. A research fellowship cannot be used for credit toward completion of any GME residency program requirement.
  9. Budget guidelines and allowable cost information are available on the website. Budgets and Start-Up Reports (templates available on this website) are required after awards are made.
  10. A Mid-Course Summary and actual budget expenses shall be submitted to DOH for all awarded projects fourteen months after the project begins. A Final Report shall be submitted to DOH no later than three months after the project ends. Report templates are available on this website. In addition, on an annual basis for 10 years after the project ends, the institution shall submit to DOH information outlined in question 7 of the Final Report template for each fellow.
  11. A hospital may not change the project theme after submission but may submit changes to the plan (such as a new director, etc.) after the project is awarded, either prior to or after the start date. Any changes would require DOH review and approval and must meet the program requirements. If the project is deemed to be out of compliance, then any portion of funds not yet distributed to the hospital may be evenly redistributed to the remaining projects in other teaching hospitals.