ECRIP 2014 Program Changes
Please note that the information provided below shall take precedence over any other written or verbal instructions related to ECRIP abstracts submitted to the New York State Department of Health.
- ECRIP project abstracts must be submitted to the New York State Department of Health electronically (in Microsoft Word or PDF format) to email@example.com at any time but no later than 4:00 p.m. on Thursday, October 16, 2014.
- Projects shall begin no earlier than April 1, 2015, and no later than December 31, 2015. ECRIP fellows must be hired and begin their ECRIP training within these dates.
- All abstracts submitted must be endorsed by an "officer of the institution" whose identity must be shared by the ECRIP principal contact with researchers at the institution.
- Institutions may have their own internal vetting process prior to the actual submission date. Each institution should advise its researchers to consult with its ECRIP principal contact for any internal deadlines and requirements.
- No supplemental information may be submitted after the due date. Abstracts and related attachments will be reviewed solely based upon the information submitted by the teaching hospital.
- Limit the number of separate files submitted. For example, all bio-sketches should be sent in one file. A cover letter is not necessary since all the relevant information should be included in the abstract.
Summary of Draft Proposed Regulatory Changes
- Amend eligibility of project directors and sponsor-mentors in teaching hospitals. These changes: (1) expand eligibility to include the Patient-Centered Outcomes Research Institute (PCORI) grants for individual and center awards; (2) expand eligibility to include funding from other federal agencies rather than solely from NIH for center awards; (3) adjust the time frame requirement from current awards to awards within the past two years for center awards and reduce the award requirement timeframe from five to three years for individual awards; and (4) exclude non-research grants and grants for conferences or for commercial product development.
- Qualification of research fellow. Removes the provision that physicians who are currently or have been funded by the teaching hospital within the past three years are not eligible to be a research fellow.
2014 Program Changes
- 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 (Center or Individual) is deemed to be out of compliance, then any portion of such funds may be evenly redistributed to the remaining Center projects only.
- 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. Such investigators who 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.
- Allow teaching hospitals to include more than one sponsor-mentor, provided that the project director that meets the federal research or PCORI grant requirements substantially works or practices 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.
- Require that the hospital that submitted the abstract provide a substantial portion of the research fellowship training at that hospital, in addition to training at any other site(s). Also, the abstract should include the significance of all sites for training the research fellow(s).
- Allow 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.
- A sponsor/mentor can train up to a maximum of two research fellows at one time.
- Abstract 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.
- All existing budget guidelines and allowable cost information are now available on the website. Budgets are still required after awards are made.
- For Individual projects, two fellows may be trained for one year each at the same time, or one fellow may be trained over two years. In either case, teaching hospitals would receive $75,000 in State Fiscal Year (SFY) 2015-16 and $75,000 in SFY 2016-17. If a hospital chooses to train two residents at the same time in the first year for one year each the teaching hospital must make their own arrangements to advance funds in order to support both fellows until the second year payment is made.
- Carefully review Clinical Research Position in the draft proposed regulation. This section includes 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 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.