uconn health

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.

    Institutional Policies Related to Human Subjects Protections

    Investigators and study personnel should be familiar with the following policies that relate to human subject protections. (Policies are in PDF.)

    iRIS Training

    iRIS Training Sessions:

    Departments/Centers are encouraged to select one or two individuals who will be the point persons for navigating the iRIS system. The Educational and Development Specialist (EDS) will provide training for using the system to these individuals; and they in turn can train others in their department/center.

    Individuals are invited and encouraged to request iRIS training. To schedule a session e-mail the HSPP at irb@uchc.edu. Classes are held in the L- Building – 5th Floor – Room  L5035.

     

     

     

     

     

     

    Terms & Definitions Used by OCTR

    Budget Workbook

    Electronic tool used by OCTR in conjunction with study team to identify, segregate and monitor charges

    Clinical Research

    1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:
    • Mechanisms of human disease
    • Therapeutic interventions
    • Clinical trials
    • Development of new technologies
    1. Epidemiologic and behavioral studies.
    2. Outcomes research and health services research.

    Clinical Trial

    A clinical trial is a systematic, organized, prospective intervention study in human subjects that is conducted according to a formal study plan (protocol) and that has measurable efficacy and/or safety-related outcomes that are amenable to statistical analysis. It employs one or more intervention technique(s) including prophylactic, screening, diagnostic, or therapeutic agents, devices, or procedures. It must have the approval of the IRB or the IRB’s review with a determination of exemption. Clinical trials are distinguished from other types of clinical research (e.g., behavioral research) that may need IRB approval but do not meet the other criteria of clinical trials.

    Clinical Trials Initiation Form

    Upon IRB approval, this form is generated by OCTR  to notify all departments involved of the services to be charged to the trial. This form includes critical billing information such as: BANNER account number,  party responsible for EPIC Research Billing Review, name of recipient of Transfer Vouchers, list of services to be charged, and category of sponsor.

    Preliminary Budget Information Packet

    OCTR document that initiates the Budget Workbook process. Packet is emailed to PI/Study Coordinator in response to query regarding doing a Budget Workbook; it is completed by the study team and returned to OCTR via email prior to study team meeting with OCTR staff

    Protocol Induced Costs (PIC)

    Items and services that are specifically excluded from the definition of Routine Clinical Services in a qualifying clinical trial such as:

    • The investigational item or service itself
    • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient
    • Items and services customarily provided by the research free of charge for any enrollee in the trial
    • Items and services provided solely to determine trial eligibility

    Qualifying Clinical Trial

    As per the Medicare National Coverage Determination (“Routine Costs in Clinical Trials, also known as the CMS Clinical Trial Policy or “CMS CTP”): Any clinical trial receiving Medicare coverage of routine costs must meet both the basic three requirements and seven desirable characteristics to qualify for coverage.

    https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R74NCD.pdf

    “Deemed” studies automatically meet the criteria for the seven desirable characteristics.

    Routine Clinical Services (RC)

    Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries regardless of whether they are assigned to the experimental or control arm of a qualifying clinical trial. “Generally available” means that the item or service falls within an existing Medicare benefit category that is not excluded from coverage by another provision in the law and that is not the subject of an NCD stating that the item or service is not covered. If an item is covered outside of a clinical trial it is covered within the clinical trial.

    Study

    In this context, synomous with clinical trial/clinical research