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

1. Administrative Review for all research
   
2. Research involving human subjects and the IRB packet
3. Required ethics training: RCR and CITI
4. Research involving the use of Biological Research Facility
5. Research Grants
6. Clinical Research Release Time
7. Property Control and Loaned Research Equipment
8. Associate Dean: Duties
9. Volunteers
10. Travel Policy
11. Salary Offset Policy
12. Acceptable Data Use and Maintenance Policy
    

Administrative Review of all research is required for all projects, particularly those involving UEC resources or patients as well as any institutional resources, i.e., funding, release time, space, etc. The administrative approval form must be completed before any research is initiated or an IRB proposal is submitted.  Please submit via email link on the form and save if you have Adobe Pro. If you prefer, you can save as a .xml file and email to the Associate Dean as an attachment.

Note that faculty who have submitted Sponsored Program Authorization forms for grant submissions do not have to submit the administrative approval form for research because appropriate signatures have already been obtained for this research.

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 9/5/2011. Our IRB # is IRB00000301 and expires 9/5/2012."

The process begins by notifying the Associate Dean of an intention to conduct research using human subjects.  The IRB information is found here: IRB application packet and Notice of Privacy Practices. The packet requests information about all personnel, the nature of the research, the human subject consent form, the completion of the human subjects research ethics educational program (see below) as well as completion of all HIPAA training requirements.  Once completed, the application should be e-mailed to the Associate Dean for preliminary review, who then forwards it to the Chair of the IRB for IRB review. For reviews preparatory to research, please use this form Researcher Certification For Reviews Preparatory To Research. For the institution's statement on HIPAA policy related to research, please read SUNY-O Policy and Procedure on Research Subjects' Right to Privacy -final 5/13/03.

After a decision regarding IRB approval is made by the IRB, 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 IRB approved research activity (as does the Chair of the IRB), monitors compliance, and sends annual written notification to each investigator at the end of the approval period.

Required Research Ethics Training:

(1) 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 and submit to the Office of the Associate Dean for Graduate Studies and Research evidence of completion on an online RCR tutorial . It is highly recommended that faculty and research PI’s also take the tutorial.  Evidence of completion must be sent to the Associate Dean no later than June 30, 2010.  Register as a member of SUNY, State College of Optometry.

This institution also complies with the Public Health Service's Office of Research Integrity (ORI) in all matters regarding accusations of scientific misconduct. This institution's Scientific Misconduct Assurance is current. In addition, this institution has a Plan for the Responsible Conduct of Research which includes a ten hour course for all graduate students; an online web-based training programs for all individuals involved in human subjects research (CITI); non-human subjects research (IACUC training), and an online RCR tutorial for all students, post docs, and research staff who are involved in any type of research (recommended for faculty).

(2) Requirements for Research Involving Human subjects
The Associate Dean also makes sure that all personnel 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. To complete this program, please select the SUNY Core Course section and check SUNY-Optometry's specific instructions. Note that this institution's requirements are to complete ONLY the Biomedical research section. The core modules are as follows: 1-5, 7, 9-10, 12, 14-16. The remaining four modules (6, 8, 11, 13) are only required if your research applies to those areas. After completing the training program, be sure to answer all survey questions and submit your test results for review. You should receive an e-mail attachment "Certificate of Completion" from my office in 7-10 days. Every 3-4 years, individuals will be asked to do "refresher" CITI training.

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 4/30/10

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.

Research grants

All faculty who apply for external funds from governmental, private or charitable foundations to support their own research ideas or who have been approached to conduct the research protocol of another external agency (e.g., ophthalmic or pharmaceutical industry) must submit to the Office of the Associate Dean for Graduate Studies and Research this College’s Sponsored Program Authorization Form.   Please carefully read the Procedure for Submitting Applications/Proposals for External Funding which contains instructions for this form. Completed forms must be signed and approved by appropriate College officials before submitting any application to an external agency.

Faculty who wish look for external agencies that might support their research ideas should read the Sponsored Programs Information packet. The college has established a salary offset and bridge fund policy which should be read by any faculty planning to submit a research grant proposal.

Clinical Research Release Time

All faculty assigned to the Department of Clinical Sciences must also complete a request for clinical research release time in order to be released from teaching or patient care duties.


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

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 equipment from others.  The College policy on equipment to be loaned to us is:

1. If the equipment is designated solely for patient care or clinical education, clinical faculty should inform their Clinical Service Chief.  Non-clinical faculty should inform their Department Chair. Form A/B should be submitted (see attached). 
2. If the equipment is designated for research, faculty should inform the Associate Dean for Graduate Studies and Research and submit Form A/B
3. If a piece of equipment has multi-purposes, e.g., clinical patient care and research, it should be submitted to both the Service Chief and the Associate Dean.
4. No faculty should independently negotiate the lending of a piece of equipment directly with a representative from a company or other entity.
5. The College supervisor (Service Chief, Department Chair, or Associate Dean) will review Form A/B and sign indicating approval or non-approval.
6. Form A/B will then be forwarded to the appropriate body for review and action:
7. Final approvals will be given by the appropriate VPs.  The President will be sent copies of these approvals.   
   - Patient Care equipment to the Clinic Council.
   - Teaching equipment to the Department Chair.
   - Research equipment to the IRB or IACUC, respectively.
8. As per HIPAA regulations, any UOC patient data in stored in the loaner equipment must be erased or removed prior to returning the equipment unless the equipment has been used as part of an IRB approved research study.  In that case, data collected under a Research Foundation contract data may be maintained, but all subject identifiers must be removed prior to return of the loaned equipment.