Research Compliance

Policy Statement

  1. External Grant/Contract Submission
    All grant and contract applications submitted to external sponsors must be cleared through the Grants Development Office (grants and some contracts) and/or Sponsored Programs (contracts), and approved by the College’s Authorized Organizational Representative.
  2. Fiscal Administration
    All externally funded awards to SUNY Oneonta for research, training, programs, curriculum development, etc. are fiscally administered by the Research Foundation for SUNY.
  3. Responsible Conduct in Research (RCR) Training
    RCR training is provided by the Collaborative Institutional Training Initiative (CITI) online training program through the University of Miami: https://www.citiprogram.org/. The applicable module(s) of this web-based program must be taken by faculty, staff and students conducting research funded by campus-based or external funding prior to accessing awarded funds.
  4. Conflict of Interest 
    The College follows the SUNY RF policy on Conflict of Interest: http://www.rfsuny.org/media/RFSUNY/Policies/conflict_of_interest_policy_pol.htm. All researchers at SUNY Oneonta who are applying for and/or working on federally-funded projects are required to submit a Conflict of Interest Disclosure form annually: http://www.oneonta.edu/admin/spa/policies/disclosure%20statement%20COIP.pdf. All researchers applying for awards from Public Health Service funding sources (the National Institutes of Health [NIH] or other agencies affiliated with the U.S. Department of Health and Human Services [DHHS]) must complete the Conflict of Interest CITI online training course and the PHS Significant Financial Interest Disclosure Form.
  5. Human Subjects Research
    All research that involves human subjects requires review by the College’s Institutional Review Board (IRB) prior to the project commencing. SUNY Oneonta faculty and staff who intend to conduct research involving human subjects, whether using sponsored program (grant/contract) funds or not, should complete and submit an IRB Review Form early in the research design phase. These individuals must also be certified via the CITI course on use of human subjects in research (https://www.citiprogram.org/) before the IRB will approve their research involving human subjects. See http://www.oneonta.edu/admin/spa/humansubjects.asp.
  6. Animal Research
    All research that involves animals requires review by the College’s Institutional Animal Care and Use Committee (IACUC) prior to the project commencing. The IACUC is a self-regulating entity that, according to U.S. federal law, must be established by institutions that use laboratory animals for research or instructional purposes to oversee and evaluate all aspects of the institution's animal care and use program. See http://www.oneonta.edu/admin/spa/animalcareuse.asp.
  7. Export Controls
    Employees traveling to any country outside the United States must complete and submit an Export Control Survey form to the Sponsored Programs Office for review prior to travel. See http://www.oneonta.edu/admin/spa/exportcontrols.asp.
  8. Scientific Misconduct
    The College is committed to a confidential, diligent and thorough examination of any allegation of scientific misconduct. Any member of the campus community who has a concern about scientific misconduct should immediately contact either the Office of the Provost/Vice President for Academic Affairs or the College’s Scientific Misconduct Policy Officer (appointed by the Provost/Vice President for Academic Affairs), who can advise them on how to proceed. See http://www.oneonta.edu/admin/spa/scimisconduct.asp.
  9. Research Integrity Officer 
    Through its Office of Research Integrity (ORI) (http://ori.hhs.gov/) the U.S. DHHS requires each institution that will apply for and/or receive funding via DHHS-affiliated agencies (e.g. NIH) to maintain a Research Integrity Officer (RIO). The SUNY Oneonta RIO is appointed by the Provost/Vice President of Academic Affairs and is responsible for addressing allegations of misconduct involving DHHS-supported projects in accordance with the College Policy on Scientific Misconduct, as well as submitting routine reports on research integrity matters to the DHHS. Any member of the campus community who has a concern about scientific misconduct regarding a project funded by the DHHS should immediately contact either the Office of the Provost/Vice President for Academic Affairs or the RIO, who can advise them on how to proceed.
  10. Review
    The Responsible Conduct in Research Policy shall be reviewed every three (3) years.

Rationale 

RCR can be an important component of the intellectual vitality and integrity of an institution of higher education. From both the legal aspects of compliance with sponsor policies to the generation of data that is of high quality and capable of withstanding peer-review, RCR policies serve to guide the institution, investigators and students. SUNY Oneonta is committed to ethical and best practices in research. This policy has been developed to provide necessary training and routine administrative and faculty-led oversight in the responsible and ethical conduct of research. The training that the RCR mandates is focused on enhancing the educational experience and professional preparation of students, faculty and staff, while simultaneously demonstrating an institutional commitment to RCR and compliance with the requirements of various external sponsors.

Applicability of the Policy

This policy applies to all SUNY Oneonta faculty, staff and students applying for and/or receiving grant or contract funding from either campus-based or external funding sources.

Policy Elaboration
External Grant/Contract Submission 
All external applications for funding require routing to, and sign-off by, various campus officials, depending on project scope. It is not permissible for faculty, staff or students to independently accept funding for research being conducted by virtue of their relationship with the College, or which uses any space or equipment belonging to the College.
RCR Training
For external research grant/contract applications and applications to the campus-based Faculty Research Grant Program: RCR training certification for faculty or staff researchers (including postdoctoral research associates) is required prior to accessing awarded funds. Student assistants/researchers assigned to funded research must have RCR training certification prior to commencing work on the project. A maximum of twenty four (24) months can transpire between completions of the appropriate training modules in the CITI program. Training can be updated every 24 months by completing either (a) the full CITI course, or (b) if available, the appropriate CITI refresher course. The choice is at the discretion of the person completing the training.
For the campus-based Student Grant Program for Research and Creative Activity: RCR training certification is required prior to accepting awarded funding and commencing funded work; faculty member(s) named as sponsor/advisor on a student research project must also have CITI certification. The 24 month training refresher requirement also applies to students, faculty or staff (including postdoctoral research associates) applying to this program. 
Transfer of Training from Other Institutions: Training provided by other institutions, during the course of collaborative or subcontracted research, will be accepted if CITI courses or modules identical to those required at SUNY Oneonta have been completed. It is the responsibility of the individual completing the training to provide documentation of completion to the CITI Certification Administrator at SUNY Oneonta.
Follow instructions on the CITI website (https://www.citiprogram.org/) to take applicable course(s). Contact the campus CITI Certification Administrator if you are uncertain which CITI courses or modules apply to your area(s) of research.

Export Controls

“Export controls” are the U.S. regulations, technology control lists and entity/person denial lists that restrict the release to foreign nationals in the U.S. and abroad of controlled technologies, chemical and biological material, technical data and software code, and equipment and research tools. They apply to goods, materials, tests, software and technology (including information and technical data), and technology transfers from the U.S. to certain foreign nationals. A wide range of high-technology items and associated technologies are subject to export controls within the SUNY system. To facilitate compliance with these regulations, SUNY Oneonta requires that all employees who seek external or on-campus funding for projects that require international travel complete an export control survey and follow all applicable procedures. If the review indicates the possibility that an export control license may be required, the employee shall work with the Sponsored Programs Office to complete the license review and, if needed, the licensing process.

Forms
Conflict of Interest form: required annually by all externally-funded Principal Investigators: http://www.oneonta.edu/admin/spa/policies/disclosure%20statement%20COIP.pdf 
IRB Review form (application): required for all projects involving work with Human Subjects: http://www.oneonta.edu/admin/spa/export%20controls/IRBReviewForm.pdf
Export Control Survey Form (for overseas travel): http://www.oneonta.edu/admin/spa/exportcontrols.asp

The Sponsored Programs Office or The Grants Development Office to see the table below:

Inquiries On Operational Interpretation Policies
Office Contact

Authorized Organizational Rep (AOR)

Todd Foreman todd.foreman@oneonta.edu, x2081

 

Denise Straut denise.straut@oneonta.edu, x 2525

CITI Certification Administrator

Denise Straut denise.straut@oneonta.edu, x 2525

Conflict of Interest Statements

Melissa Nicosia melissa.nicosia@oneonta.edu, x2294

Export Controls

Denise Straut denise.straut@oneonta.edu, x 2525

Grants Development Office

Kathy Meeker kathy.meeker@oneonta.edu, x2632

IACUC Chair

Dr. Allan Green, allan.green@oneonta.edu, x3193

IRB Chair

Dr. Craig Bielert  craig.bielert@oneonta.edu, x3219

Research Integrity Officer

Dr. John Schaumloffel john.schaumloffel@oneonta.edu, x3432

Scientific Misconduct Policy Officer

Dr. John Schaumloffel john.schaumloffel@oneonta.edu, x3432

Sponsored Programs Office

Aleksandra Andreic aleksandra.andreic@oneonta.edu, x2476

 

Melissa Nicosia melissa.nicosia@oneonta.edu, x2294

 

Francis Althiser francis.althiser@oneonta.edu, x2731

 

Denise Straut denise.straut@oneonta.edu, x2525

 

Lara Woods lara.woods@oneonta.edu, x2493

Any item sent from the United States to a foreign destination is an export. "Items" include commodities, software or technology, such as clothing, building materials, circuit boards, automotive parts, blue prints, design plans, retail software packages and technical information.

Export Control requirements also apply to employee travel. Employees traveling to any country outside the United States must submit the Export Control Survey to the Sponsored Programs Office.

“Export controls” are the US regulations, technology control lists and entity/person denial lists that restrict the release to foreign nationals and the US and abroad of controlled technologies, chemical and biological material, technical data and software code, and equipment and research tools. They apply to goods, material, tests, software and technology (including information and technical data), and technology transfers from the US to certain foreign nationals. A wide range of high-technology items and associated technologies within the SUNY System are subject to export controls.

To facilitate compliance with these regulations, SUNY Oneonta requires that all employees who seek external or on-campus funding for travel or projects complete a web-based export controls survey and follow all applicable procedures. If the survey results indicate the possibility that an export control license may be required, the employee shall work with Sponsored Programs office to complete the license review and, if needed, the licensing process.

How an item is transported outside of the United States does not matter in determining export license requirements. For example, an item can be sent by regular mail or hand-carried on an airplane. A set of schematics can be sent via facsimile to a foreign destination, software can be uploaded to or downloaded from an Internet site, or technology can be transmitted via e-mail or during a telephone conversation. Regardless of the method used for the transfer, such transactions are considered exports. Further restrictions and definitions apply, even if items are being transferred temporarily, provided to foreign nationals within the US, or given as gifts. 

Export control regulations are established by three federal agencies: Department of CommerceDepartment of Defense, and the Treasury Department.

For more information please contact Denise Straut, Director of Sponsored Programs, denise.straut@oneonta.edu, 607.436.2525.

Studies involving human subjects (participants) at SUNY Oneonta are subject to review by the College’s Institutional Review Board (IRB), a committee designated by the Provost to approve, monitor, and review biomedical and behavioral research involving humans with the aim of protecting the rights and welfare of the research subjects. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.  In the United States, the Food and Drug Administration (FDA), the Department of Health and Human Services and the DHHS Office for Human Research Protections have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research.

Studies must have formal, written approval from the IRB prior to the commencement of a project.  In addition, Responsible Conduct in Research Training must be completed by all investigators named on a study. 

SUNY Oneonta now participates in a comprehensive application for IRB processing, the SUNY Research Foundation Pre-award Compliance System – PACS.  All documents for your IRB application are loaded into this application, and you are then able to visually follow your application through the entire process to approval.  This new module provides streamlined support for submissions, modifications, reportable new information, and continuing reviews.  Although the PACS module is intuitive and easy to use, a training video is available if you would like assistance getting started.

To submit your application, please go here and register to use the PACS system:  

https://pacsprd2.rfsuny.org

Registrants are approved daily – you will be notified when your user name and password are assigned and you will then be able to access the application to begin your submission process.

To access the training course for use of the PACS system:

http://www.rfsuny.org/Our-Work/RF-Projects-/SUNY-Pre-Award-and-Compliance-System-PACS/PACS-Training-Videos-/

Questions regarding these processes should be addressed to the IRB mailbox at IRB@oneonta.edu or the Sponsored Programs Office 607-436-2525 or 2473.

Members of the SUNY Oneonta community who intend to conduct research involving human subjects should complete the IRB Review Form early in the research design phase and submit the form via the PACS module:  https://pacsprd2.rfsuny.org    
Along with the form, you will be required to submit: 

  • Consent document
  • Assent document (if applicable)
  • Questionnaires to be used
  • Site approval (if research is occurring at another location)
  • Appropriate signatures.

Formal follow up is required on research projects within one year of original approval date. 

 
In preparing their IRB Review Forms, faculty/staff and student researchers should be reminded that particular attention is given to the consent process, which typically requires written consent. Please consult the Consent Form Help Document for guidelines on and examples of written consent forms.

An Investigator’s Guide to Research with Human Participants (subjects) is available for more information to assist investigators in designing Human Subjects research and preparing information to be submitted in the IRB Review Form protocol application.

Questions regarding these processes should be addressed to the IRB mailbox at IRB@oneonta.edu or the Sponsored Programs Office 607-436-2525 or 2473 or the IRB Chair.

Sample content.

The SUNY Oneonta Institutional Animal Care and Use Committee (IACUC) is a self-regulating entity that, according to U.S. federal law, must be established by institutions that use laboratory animals for research or instructional purposes to oversee and evaluate all aspects of the institution's animal care and use program.

An IACUC performs critical oversight functions for research conducted on animal subjects.  Members of the SUNY Oneonta faculty and staff who intend to conduct research involving animal subjects, whether using sponsored program (grant award) funds or not, should fill out the  SUNY College at Oneonta Animal Care and Use Protocol form early in the research design phase and submit the form electronically to the IACUC mailbox at IACUC@oneonta.edu.

All SUNY Oneonta faculty, staff and students who are conducting research involving animal subjects must be certified via a CITI course before the IACUC will approve their research.  The College subscribes to CITI, a web-based course for instruction of use of animal subjects in research.  The course can be accessed at www.citiprogram.org; it can be completed over a period of time and the applicable pre-set modules are determined by the status of the individual taking the course.

For more information about the use of laboratory animals by SUNY Oneonta, please contact Dr. Allan Green, Chair of the IACUC, allan.green@oneonta.edu.  For information regarding submission of IACUC applications or the required CITI certification course, please contact Denise Straut, Director of Sponsored Programs: denise.straut@oneonta.edu, 607.436.2525.

The Research Foundation for SUNY College at Oneonta (RF) adheres to the Conflict of Interest Policy of the Research Foundation for SUNY, as adopted by its Board of Directors by Resolution

Summary of Policy:  No officers or employees of the Research Foundation should have any interest, financial or otherwise, direct or indirect, or engage in any business or transaction or professional activity or incur any obligation of any nature that is in substantial conflict with the proper discharge of their duties in the best interests of the Research Foundation.

Research Foundation Principal Investigators (PI) applying for or working on federally funded awards will be required to file the SUNY RF Disclosure Statement as follows:

  • At time of application for a federally funded project
  • While working on a federally funded project, a Disclosure form will be required from PI each calendar year in January.

The Sponsored Programs Office will send Disclosure forms annually to all applicable PIs in early January.  Completed form will be required back by January 31.

Any perceived or possible conflicts will be discussed between the PI, Sponsored Program management, and Research Foundation legal staff to reduce or eliminate the conflict.

The College at Oneonta follows the State University of New York and the Research Foundation for the State University of New York Policy on Conflicts of Interest in Public Health Service Sponsored Programs.   A copy of the full policy can be found by clicking here. This policy deals with the requirement for disclosure of financial interests for awardees of Public Health Service (PHS) Funding. 

This policy applies to  Principal Investigators (and any other person who is responsible for the design, conduct or reporting of research) receiving funding from the NIH, U.S. Dept. of Health and Human Services, or other federal health agencies.   The main points of the policy include:

  1. Investigators and their Related Parties must disclose their financial interests and outside activities to the State University via the PHS Significant Financial Interest Disclosure Form.  This form must be submitted prior to work on any PHS award.
  2. Investigators must complete the CITIprogram training on Conflict of Interest prior to beginning work on any PHS award.   https://www.citiprogram.org/ .   The College is automatically notified of completion of course.
  3. Any FCOI (financial conflict of Interest) shall be subject to a management plan developed by the College.

The Sponsored Programs Office will work with investigators receiving PHS funding to ensure that all requirements under the applicable Federal regulation are met (Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, Federal Register, vol. 76, No. 165, August 25, 2011.)

The College takes all allegations of scientific misconduct seriously and is committed to a confidential, diligent and thorough examination of any allegation of scientific misconduct in accordance with its policies. SUNY Oneonta has a Scientific Misconduct Policy Officer appointed by the Provost/Vice President for Academic Affairs. Any member of the campus community who has a concern about scientific misconduct should immediately contact either the Office of the Provost/Vice President for Academic Affairs or the Scientific Misconduct Policy Officer, who can advise them on how to proceed.

An excerpt from the College’s Scientific Misconduct Policy Statement appears in the College Handbook (http://www.oneonta.edu/collegehandbook/). A full pdf copy is available here.

The Scientific Misconduct Policy Officer is John Schaumloffel x3432.

For further information, please call Norman Payne, Hazardous Materials Officer at 436-2021

The College at Oneonta has established policies and procedures to be followed by all faculty, staff and students in the order, receipt, storage, use and disposal of radioactive materials and in the use of certain radiation producing equipment.   The Campus Radioactive Materials Safety Committee is the body responsible for advising faculty, establishing procedures and maintaining records relative to radioactive materials policies and procedures.  The Committee operates under the New York State Department of Health Radioactive Materials License Number 1192.

Questions regarding radiation safety policies and procedures should be directed to the campus Radiation Safety Officer, Dr. Keith Brunstad.

Email: Keith.Brunstad@oneonta.edu  
Phone: 607-436-3066