New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter L - Hospitals and Related Facilities › Part 86 - Reporting and Rate Certifications for Facilities › Subpart 86-1 - Medical Facilities › Section 86-1.46 - Empire Clinical Research Investigator Program (ECRIP)

Current through Register Vol. 46, No. 28, July 10, 2024
(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.