uconn health

Resources Related to Contracts

OCTR Procedures for School of Dental Medicine

Laptop with Two PersonsThe purpose of the OCTR as it relates to the School of Dental Medicine clinical research/clinical trials do not change from our overall goal for researchers in the School of Medicine. Our goal is to provide clinical researchers administrative assistance with the following tasks:

  • Contract and clinical trial budget negotiations
  • Fiscal set up and oversight of Banner research accounts including account reconciliation and closeout
  • Development of viable study budgets
  • Identification of studies that qualify for Medicare reimbursement, as “qualifying clinical trials”
  • Identification of research subjects and research charges, through quality monitoring and audit, to assure research financial compliance

The Budget Workbook is used to standardize the research budget process. It provides accurate study budget calculations for clinical trials, regardless of the sponsor.

Some Helpful Information

  • School of Dental Policies supporting OCTR procedures can be found below
  • Flow charts that provide a visual representation of the dental procedures are available and each flow chart is followed by a companion narrative description
Procedure Title Description
OCTR Process Overview Understanding the Overall Process of the OCTR
Dental Procedure I Flow Sheet Dental Budget Process: Determination Schema Industry Sponsored, Industry Supported, University to University,
Co-operative Group or Foundation Supported Clinical Trials
Dental Procedure I Narrative Following Flow Sheet Dental Budget Process: Determination Schema Industry Sponsored, Industry Supported, University to University,
Co-operative Group or Foundation Supported Clinical Trials
Dental Procedure I.a Flow Sheet Dental Budget Process: Determination Schema Federal or Awards in Response to a Public Solicitation
Dental Procedure I.a Narrative Following Flow Sheet Dental Budget Process: Determination Schema Federal or Awards in Response to a Public Solicitation
Dental Procedure II Flow Sheet Registering Dental Clinical Trial
Dental Procedure II Narrative Following Flow Sheet Registering Dental Clinical Trial

 

OCTR Policies

Institutional Policies

Policy Number Policy Title
2006-06 Evaluation of a Clinical Research Trial for Medicare Reimbursement Download File >
2006-07 Clinical Research Trials Budget Review Download File >
2006-08 Clinical Research Trials Patient Billing Compliance Download File >
2006-10 Reconciliation of Research Accounts Download File >
2006-11 Contract Negotiations for Initiation of Clinical Research and/or Clinical Trials Negotiated by Staff in the Office of Clinical & Translational Research Download File >
2006-12 Monitoring/Auditing Policy for the Research Billing Compliance Program for Clinical Research/Trials Download File >
2006-13 Health Insurance Coverage for Cancer Clinical Trials in Connecticut Download File >
2007-06 Clinical Trials Under Contract – Administrative Requirements Download File >
2009-05 Institutional Discounts for Investigator Initiated Clinical Trials Download File >
2009-06 Stabilization of Charges for Clinical Research Trials Download File >
2010-01 Clinical Research/Trials “Facility Discount” for Hospital-Based Outpatient Programs Download File >

 

School of Dental Medicine Policies

Policy Number Policy Title
2012-1 Dental Clinical Research/Trials Budget Review and Exemption, October 31, 2012 Download File >
2012-2 Dental Clinical Research/Discounts for Investigator-Initiated Research, October 31, 2012 Download File >
2012-3 Dental Clinical Research/Discounts for Industry Sponsored Research, October 31, 2012 Download File >
2012-4 Dental Clinical Research/Routing Process, October 31, 2012 Download File >

 

Health and Safety Policy Statement

UConn Health is  committed to providing a safe and healthy environment for all activities under the jurisdiction of the University.

The health and safety of all faculty, staff, students and visitors shall be a principle consideration in the planning, operation and conduct of all University activities and programs.  As part of its responsibilities, UConn Health makes safety expertise and services available to all its programs through departments such as Environmental Health and Safety, Police, Facilities Management, and Employee Health Services. Faculty and staff provide oversight of safety and environmental protection activities through committees such as the Institutional Review Board, the Animal Care Committee, Hospital Safety and Disaster Planning Committee, and the Hospital Infection Control Committee. Institutional Safety Policies and Guidelines on special issues outline procedures to be followed by everyone.

The following statements are intended to highlight selected minimum safety principles. All faculty, staff, and students are expected to know and comply with these precepts.

General

  • Safety is everyone’s responsibility and cannot be delegated!
  • All employees are expected to carry out their assignments in a way that prevents injury to themselves and others.
  • Faculty and all employees must set personal examples of safety for their students and other employees. The UConn Health’s Rules of Conduct must be followed.
  • Faculty and staff must be alert to recognizing and resolving potential safety and environmental hazards so that risks for employees, students, volunteers and visitors are identified and reduced or eliminated.
  • Supervisors and employees must establish, follow, and enforce safe practices and procedures.
  • In research, principal investigators have a key role in establishing and enforcing safe practices and procedures.
  • Every individual must know the potential hazards associated with their duties and follow all applicable safety practices and procedures.
  • Disciplinary action up to and including termination may be appropriate for failure to comply with or follow required safety procedures/policies.

Training

  • Mandatory training is a key component of many safety efforts.
  • Management at all levels MUST enforce attendance at appropriate training sessions (Laboratory Safety, Radiation Safety, General Chemical Safety, Universal Precautions, Humane Care and Use of Animals, etc.).
  • Supervisors are responsible for having their employees attend required training.
  • Supervisors/Principal Investigators MUST provide information to their employees and students on the specific hazards associated with their activities and the safety procedures to be followed.

Enforcement

  • Violations of this policy and/or subordinate Health & Safety policies, programs or procedures may result in disciplinary measures in accordance with University Laws and By-Laws, applicable bargaining agreements and the University Student Conduct Code.

Emergencies

Emergency assistance within UConn Health is summoned by dialing “7777”. Off campus activities would call “911”. Public Safety’s Fire and Police resources will respond to “7777” calls.

Accident/Incident Reporting

  • Employee Health Service will provide for the initial medical management of occupational injuries and illnesses. When Employee Health Service is not open (nights, weekends or holidays) or when the injury may require the resources of the Emergency Department, employees can report to the Emergency Department or to an approved in-network initial treatment provider.
  • Occupational injuries and illnesses of employees and students must be promptly reported by the employee to their supervisor and together they must report the accident/incident to Gallagher Bassett 1-800-828-2717 (State of Connecticut’s Worker’s Compensation third party administrator) regardless of severity. For each employee accident/incident, the supervisor will complete the “First Report of Injury” WC-207 form. Supervisors are responsible for evaluating such reports and taking prompt action.
  • Human Resources and/or Environmental Health and Safety will review each injury and illness report and coordinate the incident with the supervisor for their investigation/action. Human Resources is responsible for maintaining the Institution’s OSHA log of such incidents.

Hazard Reporting

It is the responsibility of every employee to report unsafe conditions to their supervisor or the supervisor having responsibility for the area. Unsafe conditions not promptly corrected will be reported in writing using the attached form which must also be sent to the appropriate supervisor and Environmental Health and Safety (MC 1514).

Oversight

All activities are encouraged to have their own programs that further emphasize safety and assist in ensuring a safe environment, regulatory compliance, accreditation, etc.  During each employee’s performance evaluation the supervisor needs to consider the individual’s adherence to prescribed safety responsibilities.

Environmental Health and Safety (EHS)

EHS is charged with implementing all University health and safety policies and procedures* in the Biological, Chemical and Radiation health and safety fields. EHS has been authorized by, and is accountable to the University President, Hospital Chief Executive Officer and Senior University Management to identify, assess and enforce this Health and Safety policy and subordinate health and safety regulations, policies and procedures.

EHS is responsible for maintaining a comprehensive program that combines training, consultation, control, and inspection to protect the health and safety of all personnel in the course of University sanctioned activities.  EHS staff provides professional services to measure and evaluate hazards to which the University community may be exposed and ensure compliance with regulations and University policies.  EHS’s responsibilities include:

  • Ensure that all written policies, procedures, and training materials for applicable health and safety regulatory standards are established, current, and available for delivery to appropriate campus groups;
  • Maintain an up-to-date webpage to enhance access to health and safety policies, procedures, technical guidance documents, and compliance assistance information;
  • Facilitate health and safety communications with the University community, and stress the importance of campus wide adherence to appropriate regulations, standards and policies;
  • Provide inspection services to laboratory settings to enhance campus health and safety; and facilitate timely correction  of identified non-compliances through escalating notification and enforcement;
  • Promote EHS’s role as an environmental, health and safety information resource ready to meet the needs of the campus community; and
  • Take appropriate measures (including Stop Work Authority for imminent hazard situations) to maintain acceptable margins of safety and regulatory compliance over all University operations.

Special Topics

  • UConn Health’s Policy for the Control of Employee Occupational Exposure to Bloodborne Pathogens (OEBP) and Exposure Control Plan prescribes safety procedures that must be followed to reduce the risk of exposure to bloodborne pathogens. Guidelines for the Conduct of Activities with Biohazardous Materials at UConn Health are also applicable, especially to laboratory activities.
  • Research involving recombinant DNA molecules must follow the guidelines of the National Institutes of Health referenced below.
  • Safety Data Sheets (SDSs) are used by manufacturers to provide health and safety information on chemicals and commercial products. SDSs are available to faculty, staff, and students through the Environmental Health and Safety homepage. Questions on SDSs and their interpretation should be referred to supervisors, PIs, and/or Environmental Health and Safety.
  • As a Connecticut State Agency, the Connecticut Occupational Safety and Health Regulations apply. These regulations are enforced by the CT Department of Labor, CT OSHA. Employees must comply with these regulations. For example:
    • Appropriate equipment guards must be used and maintained.
    • Work with chemicals, as appropriate, may require goggles or goggles and a face shield, gloves and/or an apron. Such protective equipment is available for purchase from the warehouse and will then be provided to the employee at no cost.
    • Employees using respirators for chemical protection must have it selected and fit tested by Environmental Health and Safety (EHS). The EHS will also provide the required training and Employee Health Service will provide the required medical certification.
    • Potentially hazardous materials including compressed gases, flammable liquids, chemical reagents, infectious materials will be received and delivered by personnel trained in the potential hazard and appropriate emergency response.
    • Users of potentially hazardous materials will understand the potential hazards and ensure proper storage and labeling. Consistent with operational requirements, users are expected to minimize quantities kept in their area. Materials stored will be kept so as to prevent the contact of incompatibles and protected from breakage that could result from improper storage on unstable or overcrowded shelves.
    • Individuals will comply with established policies for the disposal of their hazardous materials (radioactive materials, chemicals, and regulated medical wastes).

Regulatory Inspections

  • Safety surveys or inspections by outside activities including regulatory agencies will be brought promptly to the attention of the offices indicated below to ensure proper coordination:
  • Nuclear Regulatory Commission – Radiation Safety Office (RSO) Environmental Protection Agency – Environmental Health and Safety
  • OSHA – Research Safety Office, CT Department of Energy and Environmental Protection – Environmental Health and Safety
  • CT Department of Public Safety or CT Fire Marshal’s Officials – Public Safety Office and Facilities Management
  • Building Code or Insurance Carriers – Facilities Management and Public Safety

Established Health Center Safety Policies and Guidelines Include

  • UConn Health Chemical Hygiene Plan for Occupational Exposure to Hazardous Chemicals in the Laboratory
  • Policy for the Control of Employee Occupational Exposures to Bloodborne Pathogens (OEBP) and Exposure Control Plan
  • Regulated Medical Waste Disposal Policy
  • NIH Guidelines for Research Involving Recombinant DNA Molecules
  • Chemical and Laboratory Safety Training Policy
  • Guidelines for the Disposal of Chemical Waste
  • Standards for the Handling of Compressed Gases in Cylinders
  • Guidelines for the Laboratory Use of Carcinogens
  • Chemical Hood Policy
  • Policy and Procedures, Permit Required Confined Spaces
  • Policy for the Control of Hazardous Energy (Lockout/Tagout)
  • Information and UConn Health Policies Governing the use of Controlled Substances in Laboratories
  • Small Children and Babies in the Workplace
  • Smoking Policy
  • Rules of Conduct

Focused Subject Matter Safety Committees

A number of safety committees reporting to the Associate Vice President for Research Integrity and Regulatory Affairs under the Vice President for Research have been established that address aspects of health and safety specific to research activities or focused subject matter.   These committees serve as advisory boards and research protocol review boards working in partnership with EHS to fulfill University goals.

Environment of Care Safety Committee

Health & Safety Committee – Union

Institutional Animal Care and Use Committee

Institutional Biosafety Committee

Institutional Review Board

Laser Safety Committee

Radiation Safety Committee

Workers Compensation Health & Safety Committee

 

Return to Environmental Health and Safety Policies

Safety Training Sessions

Online Training Sessions

Training Forms

Training Videos

OSHA Bloodborne Disease Training

Initial Training is required for everyone potentially exposed to human blood and other potentially infectious material (as described by the UConn Health’s Exposure Control Plan) must complete this training prior to accomplishing any task presenting such a potential exposure risk. These exposure determinations are made by the supervisor. For new employees, the initial UConn Health Bloodborne Pathogen Training is completed as part of UConn Health’s New Employee Orientation. Once this initial requirement has been met, completion of an annual Refresher Session (part of SABA) is mandatory. Researchers may opt to take the Annual Bloodborne Pathogen Refresher Training PowerPoint Presentation  (http://content.research.uconn.edu/pdf/uch/rcs/ehs/BBPRefresher.ppsx) on our website.  On the last slide, please click on the Annual Bloodborne Pathogen Refresher Training Confirmation Form to get credit (may have to right click on link and “Open Hyperlink” with certain web browsers for input form).

WARNING: Employees must not perform tasks with potential exposures to human blood and other potentially infectious materials until they have completed the initial training. Contact the Environmental Health and Safety Office (x2723) if assistance is needed. Back to Top

Laboratory Safety Training

Per UConn Health’s policy and OSHA’s Hazard Communication Standard, also known as “The Laboratory Standard” it is mandated that ALL people working in laboratories covered by the standard at UConn Health (including the vivarium and TIPS space) require training upon their initial assignment. This is in addition to the basic training they attend at orientation. The training in the safe use of chemicals, biosafety, emergency response and waste management is essential for a safe working environment.  To stay current with regulatory updates, Laboratory Safety training must be refreshed annually.

NOTE: A UConn NetID is required. Your administrative office can provide you with a NetID.  If you do not have access to one, please call x2723 for assistance.

The sessions must be watched 100% in their entirety in order to receive credit. The system tracks how much of the video is viewed, simply taking the quizzes is NOT sufficient. It is best to take these sessions on a desktop, from within the UConn Health firewall, and using the Chrome browser. Upon completion of the sessions, you must follow the 4 steps below or you will NOT get credit for completing training.

1. Email Liz Pokorski  when you have completed both training sessions.
2 The email must state:
Your name:

Contact information:

That you have completed both training sessions.
3. The email must contain a completed copy of your Initial Bloodborne Pathogen form.
4. The email must contain either statement, or a statement and a question:
“I have no questions about the Initial Bloodborne Pathogen Training or the form I filled out”;

or

“I have a question about the Initial Bloodborne Training or the form I filled out. My question is: …” and then there should be a question, which I will answer. This is legally part of the initial BBP training under OSHA. We will provide these to Employee Health Service.
If you require assistance or experience difficulty accessing the training sessions, please contact EH & S at x2723.

Title: Basic Biosafety & Initial Bloodborne Pathogen Training

Duration: 1:20:51

Link:  https://uconnhealth.mediasite.com/Mediasite/Play/ca4496f9397746f988584ea1f526db891d

Initial Bloodborne Pathogen Form

 

Title:  Lab Safety & Chemical Waste Management

Duration: 1:07:57

Link: https://uconnhealth.mediasite.com/Mediasite/Play/2d4d8c943b194bad8b4f7e426232d6241d

 

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Tuberculosis/TB Respirator Training and Fit Testing

Please call Infection Control (x4376) or email FitTesting@uchc.edu for individualized training.

Employees must have fully completed all requirements of this training prior to being allowed to enter a TB respiratory isolation room. New and existing employees identified as needing to enter a respiratory isolation room must complete this UConn Health Program. The requirements of the UConn Health’s TB/Respirator Program involve employee training, medical evaluation and fit testing annually as mandated by OSHA. Training sessions are scheduled upon request.

Chemical Safety

Chemical Safety Guidance

Chemical Safety Forms

    Other Resources

    Educational Material – Online Resources

    Translation of Documents and the Consent Process

    Study related documents (e.g., the informed consent document, the HIPAA authorization, a survey) must be presented in a language understandable to the subject. Two methods of translation are acceptable to the HSPP/IRB. The preferred method is that the document be translated by a professional translation service that will attest to the accuracy of the translation. The second is the use of back-translation into English. In this scenario

    • the English version of the document is translated into the foreign language,
    • the name and credentials of the individual who did the translation are provided to the IRB by the investigator,
    • another individual who has not seen the English version of the document translates the foreign language document back into English,
    • this individual provides his/her name, credentials and a statement that s/he has not seen the original English version to the IRB via the investigator,
    • both English versions of the form and the foreign language version are submitted to the IRB for review, and
    • the IRB will compare both English versions of the documents.

    If the IRB determines the translation is accurate the foreign language document will be approved for use.

    The informed consent process must also be conducted in a language understandable to the subject and may therefore require the use of a translator. The translator may be a family member or friend of the subject, an employee of the institution or may be hired by the principal investigator.

    Obtain Approval of English Versions First

    Although you are not required to do so, you may want to obtain approval of the English version of your documents before you go through the process of having them translated. In this manner, if the IRB requires changes to the English version in order to secure approval, you will not have to go through the translation process again. If you plan to obtain approval for the English version documents first you should indicate this on the IRB Application Checklist that translated documents will be submitted for approval via a request for addendum/modification before they are used with subjects.

    The PI is responsible for covering the cost of the translation. The cost of the translation will not be incurred by the subjects.

    Professional Translation Services

    Quality Assurance, Quality Improvement and Research

    Federal regulations define research as the systematic investigation, including development, testing and/or evaluation, designed to develop or contribute to generalizable knowledge.   Federal regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Investigators must seek IRB review and approval for research projects involving human subjects before the project commences.

    However, investigators are not required to obtain IRB approval for other activities (e.g. clinical care, quality improvement, quality assurance, public health activities); unless the proposed activity also meet the definition of human subject research. If an investigator has any questions as to whether an activity also constitutes human subject research, it is strongly recommended that a Human Subject Research Determination Form be submitted to the IRB to obtain an official ruling as to whether IRB approval is required before the activity commences.

    The Office for Human Research Protections (OHRP) has posted several Frequently Asked Questions regarding Quality Improvement activities.

    Public Health Research: Surveillance, emergency responses, and program evaluations do not meet the definition of human subjects research. These activities constitute public health activities with the primary intent to prevent disease in a particular population, improve a public health program, or to provide emergency disaster relief. Therefore, these activities do not have to be reviewed by an IRB.