Policies and Requirements

The Institution is responsible for adherence to federal, state and local research regulations.

Primary Regulations

Administrative Review

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.

Research Authorization Form

Financial Conflict of Interest Form

Sponsored Program Guide

Research involving human subjects and the IRB Packet       

All faculty, staff or students planning to conduct research using human subjects must adhere to our Institutional Review Board IRB research policy. Our Federal Wide Assurance (FWA) document specifies this institution's assurance with respect to human subjects research and is listed at the NIH website. Our Federalwide Assurance # is FWA00001460 and expires 8/8/2016. Our IRB # is IRB00000301 and expires 4/2/2015.

Federal Wide Assurance (FWA) document

The IRB submission process begins by the principal investigator (or the research coordinator) registering your own user name and password on IRBNet. Even before registering, you can use 2 videos and 3 pdfs which will guide you through the process.
IRBnet Resources

Username: optometry    
Password:  training1

When you wish to submit, please register using a log in name and password at IRBnet Resources. Once registered, you will receive an email which you have to use and click on that link to activate your account. When you are ready to submit an IRB application (new or renewal or amended), log on to IRBNet.  Next, begin the IRB application process for conducting research using human subjects.  This is done for new, renewal or amended IRB proposals.  The actual IRB documents you will be submitting are downloaded directly from IRBNet.  The documents are the IRB application itself, an IRB sample consent form, the Notice of Privacy Practices form and other forms you may need.  Once you have downloaded the form(s), you work on them as a word file on your own computer.  Once completed, they are then uploaded onto IRBNet and submitted for initial review by the IRB committee. A determination is made if the IRB application requires expedited or full board review, or is exempt for research review.  If your IRB documents are approved, a letter is generated and sent to the principal investigator (PI).  If the application needs revision, you will be notified via IRBNet to make appropriate changes and resubmit.  IRBNet maintains records of all IRB approved research activity, monitors compliance and sends annual written notification to each investigator at the end of the approval period.

Note that there are at least 4 scheduled full board review periods annually. These are the first Tuesday in September, December, March and June. 

Please have your application submitted at least 4 weeks before these dates if you think your application may require full board review.  Generally, any application involving invasive procedures, non-FDA-approved devices, young children or a procedure with more than minimal risk is likely to require a full board review.

Please note that all IRB applications must first have administrative approval by completion of a separate administrative approval form (see Administrative Review above).  Furthermore, all IRB personnel must complete human subject research ethics training (see below).  Any research involving UEC patients or UEC resources must fulfill all HIPAA training requirements.

If you would like, you can also download the IRB application form and the IRB consent form here.

There is a $3,000 charge for IRB review and monitoring of industry-initiated and industry-funded studies. This is a one-time fee for initial review, and covers up to 4 continuing reviews.

Required Research Ethics Training

Requirements for All Types of Research: The Responsible Conduct of Research and Scientific Misconduct

All students, post docs and research staff who are involved in any type of research at this institution are required to complete an online RCR tutorial  regarding research ethics. It is highly recommended that faculty and research PIs also take the tutorial. Register as a member of SUNY College of Optometry.

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. 
 

Research Involving the Use of Biological Research Facility

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 and expires November 30, 2014. 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).
IACUC Protocol Form

Property Control and Loaned Research Equipment

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

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

Volunteers

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

Volunteer Policies and Procedures

Travel Policy

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

Salary Offset Policy

The policy is designed to:

  • Assist funded researchers with their research programs by making resources available for additional support personnel, development of new lines of investigation and grant applications.

  • Work toward a philosophy of equitable salary support for faculty performing funded research.

  • Provide greater incentives for faculty to obtain and maintain extramural funding for their research.

  • Acknowledge and reward funded investigators, particularly during periods of reduced funding.

Salary Offset Policy

Export Control Policy

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

Export Control Policy
 

Conflict of Interest Policy

Conflict of Interest Policy

Project Specific Disclosure of Financial Interest form