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The Institution is responsible for adherence to federal, state and local research regulations.
Administrative review and approval is required for all research projects, be they externally funded projects from federal funds, foundation or industry sources, as well as internally funded projects through the Schnurmacher Institute for Vision Research or faculty discretionary funds. The research authorization form (RAF) should be completed and must be accompanied by an appropriate budget and an executive summary of the research. Approval must be granted prior to IRB or IACUC submission and before any documentation is sent to external sponsors.
To submit the Research Authorization Form, please read the Instructions for completing the Research Authorization Form and download the Research Authorization Form.
To submit a Research Authorization Form Staffing Amendment (RAFSA), please read the Instructions for completing the Research Authorization Form Staffing Amendment (RAFSA) and download the Research Authorization Form Staffing Amendment (RAFSA).
Questions about the RAF process? Contact RAFsubmissions@sunyopt.edu.
Note: Make sure your version of Adobe Reader or Acrobat is updated before filling out the form. Find out how to update here.
Financial Conflict of Interest Form
Sponsored Program Guide
All investigators must disclose any financial interests through the Financial Conflict of Interest (FCOI) Form, a required part of the administrative review process. This form is submitted through the PACS system and must be updated annually and as financial interests change.
Investigators conducting externally funded research should review the Sponsored Program Guide for instruction.
All faculty, staff, or students planning to conduct research involving human subjects must adhere to our institutional Human Research Protection Program (HRPP) and Institutional Review Board (IRB) policies. Our institution conducts its research involving human subjects under a Federalwide Assurance (FWA), a legally binding federal commitment that our institution makes to follow strict ethical guidelines to protect the rights and welfare of people participating in research.
Our Federalwide Assurance number is FWA00001460 and expires 11/19/2030. Our IRB number is IRB00000301 and expires 11/19/2028.
An Institutional Review Board (IRB) is a committee that reviews and regulates research involving human participants. The IRB is responsible for protecting participants’ rights, privacy, and welfare, evaluating the research’s benefits versus risks, ensuring that informed consent is properly obtained, and confirming that studies comply with federal and state regulations, institutional policies, and commonly accepted ethical standards. The IRB evaluates project submissions and issues official determinations—e.g., approval, requiring modifications, disapproval, or deferral—based on how well these criteria are met. Reviews may be conducted as full-board, expedited, or exempt, depending on the type of project involved.
The SUNY College of Optometry (SUNY Opt) maintains a single IRB that oversees all Human Subjects Research (HSR). While approval of a project via the Research Authorization Form (RAF) process is first required in order to submit an IRB application, the SUNY Opt IRB is the sole entity with final authority to approve human research studies at the College. Only human research projects that have both RAF approval and IRB approval may be conducted at the College.
Researchers are responsible for the timely submission of study materials and updates to the IRB, and for adhering to its determinations throughout the research process. More information on IRB policies and processes as well as access to resources and the HSR email distribution list can be found by navigating to the IRB main page.
Requirements for All Types of Research: The Responsible Conduct of Research and Scientific Misconduct
CITI training has just released a group of new RCR (Responsible Conduct in Research) modules. These new modules will now be included in the required CITI Training for everyone who does research at the College of Optometry.
This new training modules will need to be completed by all researchers and key personnel listed on RAF application submissions beginning Monday, February 8th, 2021.
Requirements for Research Involving Human subjects
The Associate Dean also makes sure that all individuals listed in the application have completed the College’s Human Subjects Research Ethics Education program requirement, the CITI program, as mandated by our Federal Wide Assurance with the Office of Human Research Protection. Individuals are required to do a refresher training every three years and the complete course should be repeated every 9 years.
BASIC program requirements: Please select the SUNY Core Course section and check SUNY-Optometry’s specific instructions in the Biomedical research section.
The Core modules: 1-5, 7, 9-10, 12, 14-16. Modules 6, 8, 11, 13 are only required if your research applies to those areas.
CLINICAL research requirements: If you or team members plan to conduct Clinical Trials Research or Clinical Research Sponsored by Industry, you are also REQUIRED to complete:GCP Course for Clinical Trials Involving Investigational Medical Devices (international focus), Stage 1
Good Clinical Practice Course (US FDA focus), Stage 1
After completing the training program, be sure to answer all survey questions and submit your test results for review. You should receive an email attachment “Certificate of Completion” from CITI.
All faculty, staff or students planning to conduct research using Biological Research Facility must follow this institution’s research policy by submitting an IACUC protocol form to the Associate Dean who will then forward it to our local IACUC (Institutional Animal Care and Use Committee) for review. The Office of Laboratory Animal Welfare (OLAW), handles all institutional assurances. Our document specifies this institution’s assurance with respect to Biological Research. Our Federal OLAW Assurance # is A4329-01. After a decision regarding IACUC approval is made, a letter is generated to the principal investigator of the research. Included in this letter is a statement regarding administrative approval for the use of institutional resources. The Associate Dean maintains records of all IACUC-approved research activity (as does the Chair of the IACUC), monitors compliance and sends annual written notification to each investigator at the end of the approval period. Biological Research Facility is also in compliance with all regulations mandated by the United States Department of Agriculture (USDA).
All faculty and staff are required to follow the college guidelines with respect to property control.
All faculty and staff are required to follow the college guidelines with respect to loaned or borrowed (non-institutional) research equipment. With respect to loaned equipment, any faculty member who is approached or approaches a corporate sponsor regarding the loan of a piece of equipment to the College must follow the guidelines below. This can occur if the loaned equipment is for individual use, teaching, clinical patient care activities, part of a clinical trail (evaluative testing agreement, ETA, see above) or a research grant.
Equipment Loan Policy, SUNY College of Optometry
Companies may periodically contact clinical or non-clinical faculty or staff of this College and offer to lend us equipment. Faculty or staff may also sometimes request the use of specific equipment. Loaner equipment may be requested for patient care activities that may or may not involve IRB approved research projects. The following is the procedure for loaner equipment:
1. If any loaner equipment is required for approved research project, (whether the research is either externally funded or internally funded), an “Authorization for the Use of Third Party, Loaned Equipment” must be signed off by the appropriate parties. (See attached). IRB approval does not guarantee the funding of any research project or the approval of loaner equipment. Administrative approval is required for all research projects conducted in the institution.
2. Loaner equipment for non-research purposes requires the completion of a “Loaner Equipment Request Form.” This request requires the approval of the requestor’s service chief and the clinic council. An “Authorization for the Use of Third Party, Loaned Equipment” must be signed off by the appropriate parties No clinical faculty member should independently negotiate the lending of a piece of equipment directly with a representative from a company without the written consent of the service chief(s) on whose floor(s) the equipment will be placed via the Loaner Equipment Request form (see attached). A written protocol for the use of loaner equipment will be developed by the service chief. Once these approvals are obtained, the requestor can initiate the process of having the equipment delivered. A completed SUNY “Business Associates Agreement” is also required. This form can be obtained in the UEC’s Policy and Procedure Manual.
3. If the equipment is designated for both patient care and research, administrative approval for the research is required as well as the approval by the appropriate Service Chief(s).
4. A completed SUNY “Business Associates Agreement” is required.
5. As per HIPAA regulations, any University Eye Center (UEC) patient data stored in the loaner equipment must be erased or removed prior to returning the equipment (as verified by our IT department) unless the equipment has been used as part of an IRB approved research study. In this case, the data collected under a Research Foundation contract may be maintained, but all subject identifiers must be removed prior to return of the loaned equipment to the ophthalmic company.
Forms
Loaner Equipment Request Form
Loan Equipment Authorization Form
Equipment Loan Policy
All individuals who wish to volunteer in research, clinical and educational programs at the College of Optometry may do so by reading Volunteer Policies and Procedures and completing the Volunteer Form. Volunteers are individuals who are not compensated by the College. In all cases, volunteers and trainees may not perform work that would otherwise be performed by a University employee, and the donated services may not be considered compensable work. All volunteers and trainees are subject to College policies and procedures, as well as applicable federal, state and local laws that may apply to their activities
All individuals who plan to do any travel, including international travel are required to abide by the following guidelines.
Travel Policy
All employees are subject to College policies and procedures, as well as applicable federal, state and local laws that may apply to their activities
The policy is designed to:
The SUNY RF and this institution have policies on Conflict of Interest for researchers and on Export Controls for Researchers. All SUNY employees are expected to abide by these policies. Please read
The State College of Optometry HRPP, in partnership with its research community, delineates all policies and procedures for ensuring the ethical and equitable treatment of all human subjects in research conducted under its auspices.