Further, there is a compelling interest in enacting these regulations immediately in order for teaching hospitals to attract clinical researchers before they commit to out-of-state programs and to leverage additional and substantial research funding from the National Institutes of Health and other sources.

Individual Award

These awards will promote development of clinician researchers by funding physician ECRIP fellows for one or two years of research training under a classic paradigm of one-on-one mentoring. Sponsor/mentors must have been a principal investigator, co-principal investigator or co-investigator of a federal research grant within five years of the abstract deadline. There will be one two-year award made per teaching hospital at $75,000 per year. Institutions are encouraged to train two fellows at the same time in a team-based collaborative training model using additional in-kind or other grant funds. In no event will an institution receive more than $150,000 for an individual award during the two-year period. The institution is expected to provide whatever additional funding and resources may be needed for support and training of the fellows.

Center Award

These two-year awards will 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 applicant institution, preferably associated with one or more federal funding opportunities with a realistic project timeline. In the event that more than three ECRIP fellow positions are funded, the abstract may describe two research teams formed around two different themes. 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 of an active NIH research grant and the other project sponsor/mentors must have been a PI of an NIH or other federal research grant within one year of the abstract deadline. 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, HHC and FQHCs are encouraged. All center awards must include a $100,000 match, 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.

Statutory Authority:

The requirement to distribute Empire Clinical Research Investigator Program (ECRIP) funding pursuant to regulation is set forth in paragraph (b) of subdivision (5-a) of section 2807-m of the Public Health Law.

Legislative Objectives:

The proposed rule redesigns ECRIP to maximize the impact of ECRIP funding, make New York State teaching hospitals more competitive for large NIH center awards and stimulate collaboration within and among New York’s teaching institutions. This redesigned program will continue individual physician research awards as well as provide larger center awards to teaching hospitals. Awards will be distributed using a reimbursement-type methodology to teaching hospitals that meet specific program requirements.

Needs and Benefits:

The ECRIP was created by the NYS Council on Graduate Medical Education in 2000 to promote training of physicians in clinical research in order to advance biomedical research in New York State. The program was created as a result of research that demonstrated that NYS slipped from first to third nationally in its share of National Institutes of Health (NIH) research funding and was not producing the necessary clinical researchers to remain highly competitive. The importance of training clinical researchers for New York to regain its competitive edge has been heightened by new policies at NIH that will increase funding for clinical and translational research. Moreover, New York is well below the national average in its share of NIH funding received as large center grants as compared to individual investigator grants.

Since 2001, 827 project abstracts have been submitted for funding with 529 awarded to 65 teaching hospitals, totaling over $64 million in funding. Each teaching hospital must provide matching funds to support the ECRIP researcher. These matching funds can be provided as in-kind support from the hospital directly or from other research entities such as national research institutes or private companies. These matching funds demonstrate the willingness of the institution to support a research agenda.

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 NYS. Of the total positions awarded to the teaching hospitals, 92 percent were filled.

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.

Costs:

Costs to the State Government:

There will be no additional costs to the State Government as a result of implementing the redesigned program. The total annual funding to implement ECRIP will remain at $8.6 million per year.

Costs to Local Government:

There will be no additional costs to the Local Government as a result of implementing the redesigned program.

Costs to Private Regulated Parties:

There will be no additional costs to Private Regulated Parties as a result of implementing the redesigned program.

Costs to the Regulatory Agency:

There will be no additional costs to the Regulatory Agency as a result of implementing the redesigned program.

Local Government Mandate:

The redesigned program does not impose any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or other special district.

Paperwork:

The redesigned program does not require any additional paperwork to be completed by regulated parties.

Duplication:

The redesigned program does not duplicate any existing federal, state, or local regulation.

Alternatives:

No significant alternatives are available. The Department is required to promulgate implementing regulations pursuant to Public Health Law § 2807-m(5-a)(b)(H).

Federal Standards:

The proposed rule does not exceed any minimum standards of the federal government for the same or similar subject area.

Compliance Schedule:

The proposed rule establishes distribution requirements for ECRIP funding; there is no period of time necessary for regulated parties to achieve compliance.

No regulatory flexibility analysis is required pursuant to section 202-b(3)(a) of the State Administrative Procedure Act. The proposed rule does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments. The proposed rule governs distribution of ECRIP funding and participation is voluntary.

No rural area flexibility analysis is required pursuant to section 202-bb(4)(a) of the State Administrative Procedure Act. The proposed rule does not impose an adverse impact on rural areas, and it does not impose reporting, recordkeeping or other compliance requirements on public or private entities in rural areas. The proposed rule governs distribution of ECRIP funding and participation is voluntary.

Nature of Impact:

ECRIP encourages teaching hospitals to conduct and train physicians in clinical research that will result in new positions in these facilities. Since 2001, 529 clinical research positions have been funded in 65 teaching hospitals, for a total of over $64 million. Funding for research generates an enormous return on investment. According to a 2010 Associated Medical Schools of New York study, for every dollar in Federal and State research funding invested in New York medical schools, New York State receives a return of $7.50. Sample data from the first eight years of the ECRIP 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 NYS.

Categories and Numbers Affected:

Jobs directly funded by this program are for physicians in clinical research. Other indirect job positions that are created include research fellows, faculty, administrative support and laboratory positions.

Regions of Adverse Impact:

There is no adverse impact on regions.

Minimizing Adverse Impact:

Not applicable.