N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 86-1.46

Current through Register Vol. 46, No. 45, November 2, 2024

Section 86-1.46 - Empire Clinical Research Investigator Program (ECRIP)

(a)Definitions.

For purposes of this section, the following definitions shall apply:

(1)Clinical research means patient-oriented research, epidemiologic and behavioral studies, or outcomes research and health services research that are approved by an institutional review board by the time the research fellow position is filled.

(2)Clinical research plan means a plan submitted by a consortium or teaching general hospital for a research fellow position which demonstrates, in a form to be provided by the commissioner, the following:

(i) experience the sponsor-mentor and director have in clinical research and the medical field of the study;

(ii) methods, data collection and anticipated measurable outcomes of the clinical research to be performed;

(iii) training goals, objectives and experience the research fellow will be provided to assess a future career in clinical research;

(iv) scientific relevance, merit and health implications of the research to be performed;

(v) clear and comprehensive details on the research fellow position;

(vi) non-duplication with other clinical research positions from the same teaching general hospital or consortium;

(vii) methods to track the career of the research fellow once the term of the position is complete;

(viii) after awards are made, a budget including matching funds; and

(ix) any other information required by the commissioner to implement paragraph (b) of subdivision five-a of section 2807-m of the public health law. The clinical research plan submitted in accordance with this paragraph may be reviewed by the commissioner in consultation with experts outside the department of health.

(3)Clinical research position means a post-graduate residency position which:

(i) shall not be required in order for the research fellow to complete a graduate medical education program;

(ii) may be reimbursed by other sources but only for costs in excess of the funding distributed in accordance with paragraph (b) of subdivision five-a of section 2807-m of the public health law;

(iii) shall exceed the minimum standards that are required by the residency review committee in the specialty the research fellow has trained or is currently training;

(iv) may supplement an existing research project;

(v) shall be equivalent to a full-time position comprising of no less than 35 hours per week;

(vi) shall provide, or be filled by a research fellow who has formalized instruction in clinical research, including biostatistics, clinical trial design, grant writing and research ethics; (vii) shall be supervised by a sponsor-mentor who is a member of a research team directed by a researcher who must have been a principal investigator or co-principal investigator of a federal research grant or a Patient-Centered Outcomes Research Institute grant, excluding a grant for a conference or for commercial product development, in the two years preceding the date the clinical research plan is submitted to the commissioner; and

(vii) shall provide, or be filled by a research fellow who has formalized instruction in clinical research, including biostatistics, clinical trial design, grant writing and research ethics; and further provides that:

(a) for individual distributions, shall be supervised by a sponsor-mentor who must have been a principal investigator, co-principal investigator or co-investigator of a Federal research grant in the past five years from the date the clinical research plan is submitted to the commissioner; or

(b) for center distributions, shall be a member of a research team directed by a current principal investigator or co-principal investigator for an active grant from the National Institutes of Health and be supervised by a sponsor-mentor who must have been a principal investigator or co-principal investigator of a Federal research grant within one year from the date the clinical research plan is submitted to the commissioner; and

(viii) shall be filled by a research fellow who is:

(a) enrolled or has completed a graduate medical education program, as defined in paragraph (11) of this subdivision;

(b) a United States or Canadian citizen, national, or permanent resident of the United States or Canada; and

(c) a graduate of a medical, dental or podiatric school located in New York State, a graduate or resident in a graduate medical education program, as defined in paragraph (11) of this subdivision, where the sponsoring institution, as defined in paragraph (16) of this subdivision, is located in New York State, or resides in New York State at the time the clinical research plan is submitted to the commissioner.

(4)Co-investigator shall mean a person who collaborates with the principal investigator or co-principal investigators in a grant proposal approved and awarded by a Federal agency. Such person is responsible for certain aspects of the grant work but has no budget control.

(5)Consortium means an organization or association, approved by the commissioner in consultation with the council, of general hospitals which provide graduate medical education, together with any affiliated site; provided that such organization or association may also include other providers of health care services, medical schools, payors or consumers, and which meet other criteria pursuant to subdivision six of section 2807-m of the Public Health Law.

(6)Co-principal investigator shall mean one of two people, if applicable, who conceived of and submitted a grant proposal approved and awarded by a Federal agency. Such person is typically responsible for different aspects of the grant work with a separate budget from the second co-principal investigator.

(7)Council means the New York State council on graduate medical education.

(8)Direct medical education means the direct costs of residents, interns and supervising physicians.

(9)Distribution period means each calendar year set forth in subdivision two of section 2807-m of the Public Health Law.

(10)Faculty means persons who are employed by or under contract for employment with a teaching general hospital or are paid through a teaching general hospital's affiliated faculty practice plan and maintain a faculty appointment at a medical school. Such persons shall not be limited to persons with a degree in medicine.

(11)Graduate medical education program means a post-graduate medical education residency in the United States or Canada which has received accreditation from a nationally recognized accreditation body or has been approved by a nationally recognized organization for medical, osteopathic, podiatric or dental residency programs including, but not limited to, specialty boards.

(12)Indirect medical education means the estimate of costs, other than direct costs, of educational activities in teaching hospitals as determined in accordance with the methodology applicable for purposes of determining an estimate of indirect medical education costs for reimbursement for inpatient hospital service pursuant to title XVIII of the Federal Social Security Act (Medicare).

(13)Principal investigator shall mean the person who conceived of and submitted a grant proposal approved and awarded by a Federal agency. Such person directs the work and controls the budget of such a grant.

(14)Research theme means a clinical research topic that represents a strategically important growth area for the consortium or teaching general hospital. Such theme shall be in a field of study suitable to train a resident or residents and cannot be one that has funding in the form of one or more federal center-type grants, such as a National Institutes of Health program project grant, specialized center grant, or research program grant or cooperative agreement at the consortium or teaching general hospital.

(15)Resident means a person in a graduate medical education program that has received accreditation from a nationally recognized accreditation body or in a program approved by any other nationally recognized organization for medical, osteopathic or dental residency programs including, but not limited to, specialty boards.

(16)Sponsoring institution means the entity that has the overall responsibility for a program of graduate medical education. Such institutions shall include teaching general hospitals, medical schools, consortia and diagnostic and treatment centers.

(b) Within funding amounts set forth in paragraph (b) of subdivision (5-a) of section 2807-m of the Public Health Law and appropriated to ECRIP, and with the objective of securing Federal funding for biomedical research, training research fellows, recruiting national leaders as faculty to act as mentors, and training residents and fellows in biomedical research skills, the following distribution methodology shall apply:

(1) Distributions shall be divided equally amongst all consortia and teaching general hospitals eligible for such distributions; provided that the consortia and teaching general hospitals are required to fund and train one research fellow position per each $100,000 received and shall provide a $100,000 match in each distribution period regardless of the dollar amount distributed pursuant to this subparagraph. If a consortium or teaching general hospital receives a distribution of $400,000 or more, excluding matching funds, in any distribution period then it may implement a secondary research theme in addition to the primary research theme provided both projects demonstrate all requirements. Distributions shall be made in increments determined by the commissioner.

(2) In order to be eligible for distributions pursuant to this subdivision, each consortium and teaching general hospital shall provide to the commissioner by a date specified by the commissioner, the following data and information on a hospital-specific basis. Such data and information shall be certified as to accuracy and completeness by the chief executive officer, chief financial officer or chair of the consortium governing body of each consortium or teaching general hospital and shall be maintained by each consortium and teaching general hospital for five years from the date of submission. Such data and information shall only be submitted by teaching general hospitals currently receiving Medicaid reimbursement for direct or indirect graduate medical education and such submission is limited to a single distribution per operating certificate issued by the commissioner pursuant to subparagraph (1)(i) this subdivision, provided however, that a teaching general hospital with two or more campuses where one campus is the major teaching affiliate with one medical school and the other campus is the major teaching affiliate with another medical school each of which provides clinical services and research facilities at their respective campuses associated with the medical school, shall be eligible for a separate ECRIP distribution at each campus.

(i) For each research fellow position, information on the type, scope, training objectives, institutional support, clinical research experience of the sponsor-mentor, the name of a principal contact person responsible for tracking the career development of researchers placed in clinical research positions, as defined in paragraph (a)(3) of this section, and who is authorized to certify to the commissioner that all the requirements of the clinical research training objectives set forth in this subpara-graph shall be met.

(ii) General information on all institutions collaborating on the clinical research plan, including each institution's role in the research and specific budget information.

(iii) Information for each sponsor/mentor, including experience in mentoring and current and pending federal research funding distribution.

(iv) Tracking information for all current and past research fellows, including but not limited to:

(a) background information;

(b) employment history;

(c) research status;

(d) current research activities;

(e) research grants and support;

(f) publications and presentations; and

(g) any other information necessary to track and obtain outcome data for all research fellows.

(v) A description of the primary research theme and secondary research theme, if applicable, and how such themes build upon the existing research activities within the consortium or teaching general hospital.

(vi) A description of relevant federal research funding opportunities (if any) and how the research team plans to target such funding.

(vii) Identification of the research team director who must have been a principal investigator or co-principal investigator of a federal research or a Patient-Centered Outcomes Research Institute grant within the two years prior to the submission of data pursuant to this subparagraph.

(viii) Identification of all sponsor/mentors who shall participate in the project.

(ix) A letter from the chief executive officer, chief financial officer or chair of the consortium governing body of each consortium or teaching general hospital attesting to the $100,000 match required pursuant to subparagraph (1)(ii) of this subdivision.

(x) Information on collaborations with entities located within New York State, including but not limited to, teaching general hospitals, universities, local health departments, government laboratories, and federally qualified health centers if applicable.

(xi) For each research fellow position, information on the name, citizenship status, medical education and training, and medical license number of the research fellow, if applicable, shall be provided by December 31st of the calendar year in which the distribution is made provided that if a change is requested in relation to the individual holding such position after that date, such information shall be submitted to the commissioner for approval, together with the reasons for such change.

(xii) Information on the status of the clinical research plan, accomplishments, changes in research activities, progress, and performance of the research fellow shall be provided upon completion of one-half of the award term.

(xiii) A final report detailing training experiences, accomplishments, activities and performance of the research fellow, and data, methods, results and analyses of the clinical research plan shall be provided three months after the research fellow position ends.

(xiv) Any other data or information required by the commissioner to implement this section.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 86-1.46

Amended, New York State Register, Volume XXXVI, Issue 27, effective 7/9/2014

Amended New York State Register November 18, 2020/Volume XLII, Issue 46, eff. 11/18/2020