Information for Investigators

The following general information may be helpful to investigators and study personnel when preparing material for the IRB and to the IRB when reviewing material. Investigators and study personnel are encouraged to call the office for assistance in preparing an application for the IRB or with any other questions, comments, suggestions and / or concerns. Contact information is available on the Contact Us page.

The IRB is located at 16 Munson Road on the 2nd floor.

Adverse Event Classification and Reporting

The following documents provide additional guidance on how to classify an adverse event and information about what types of events require expedited reporting. The UConn Health Center policy for reporting adverse events is found within the HSPO/IRB Operating Policies. All events that require expedited reporting must be reported using the online system. A standard memo is also provided for the purpose of communicating our operating policies to sponsors.

• ICH - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF)
• Common Terminology Criteria for Adverse Events (PDF)
• Research Adverse Events Committee
• Adverse Event Reporting Policy - Memo for Sponsors (Word)

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Cooperative Agreement with Hartford Hospital, Connecticut Children's Medical Center, and Storrs

This document outlines the operational details to follow when requesting to invoke the cooperative agreement between Hartford Hospital and the UConn Health Center, Connecticut Children's Medical Center and the UConn Health Center or Storrs and the UConn Health Center. Under this agreement the institutions may elect to rely on each others Institutional Review Boards for review, approval and continuing oversight of a study or to require local review. An initial application must be submitted to each site for purposes of making this determination. Once the IRB of records is determined, materials are submitted to only the IRB of record.

• Cooperative Agreement Procedures (Word)

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Federalwide Assurance

The FWA is an agreement between the Health Center and the government, in particular the Office for Human Research Protections within the Department of Health and Human Services, that all human subject research will be carried out in accordance with the terms of the assurance. Dr. Peter Deckers is the institutional official for the FWA and has delegated the responsibility All investigators and study personnel must be familiar with the terms of our assurance. Our assurance number is 00006064. The number is followed by -1 or -2 to indicate the IRB panel responsible for oversight of a study.

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General Information and Tips for Student Investigators

General Information and Tips for Student Investigators (PDF) – This tri-fold brochure is intended to provide students with a general overview of the field of human subject research, the IRB process and tips for navigating through the process. While intended for student investigators, others may also find this document helpful. Students may also wish to refer to the Information for Students web page.

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Glossary of Lay Terms

The following documents will provide guidance in writing informed consent documents in terms understandable to the subjects.

• Glossary of Lay Terms (medical terms in lay language, from Stanford)
• Lay Terminology Word Document (North Shore Long Island Jewish Health System)
• Plain Language (general tips for writing user friendly documents)

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Human Subjects Training Requirement

All key personnel associated with a study, including those authorized to obtain consent, must complete training in the protection of human subjects in research. The CITI course is the official method of satisfying this requirement for all Health Center employees and students involved in human subject research. Instructions for registering for the course are available here as well as from the CITI web site.

After the initial modules are completed, a refresher course must be taken every three years. Information for earning CME/CEU credits is available from the CITI website. Individuals may check their training completion date on the master training list (Excel) which is updated approximately every two weeks. Completion of required training will be verified by the IRB Office prior to IRB approval being granted. Training is required regardless of the type of review being requested.

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Institutional Policies Related to Human Subject Protections

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

• Authority of the Human Subjects Protection Office, Policy 2004-02
• Compliance Expectations and Goals, Policy 2003-35
• Confidentiality, Policy 2002-43
• Conflicts of Interest in Research Policy
• Data Ownership Policy, 2003-42
• IRB Approval of Human Research Conducted by Subcontractors, Policy 2004-04
• Manufacturing of Drugs, Devices or Biologics for Human Research
• Reporting Compliance Concerns, Policy 2003-33
• Review and Approval of Research Involving Human Subjects, Policy 2002-42
• Review of Alleged Misconduct of Research, Policy 2003-41
• Rules of Conduct, Policy 2002-03
• Written Agreements for Sponsored/Funded Research Involving Human Subjects, Policy 2004-05

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Preparing a Protocol

These documents are intended to provide guidance in preparing a research protocol. Protocols may vary according to the nature of the study and preference of the investigator. However, all protocols must contain at least the problem statement and justification for the research, the general and specific objectives, the methodology, the plan for analysis and the timetable for the study. The IRB reserves the right to request additional information, such as research budgets.

• ICH Guidelines for Good Clinical Practice - refer to chapter 6 (PDF)
• Guide for Writing a Research Proposal (Word)

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Recombinant DNA

The NIH Guidelines for Research Involving Recombinant DNA Molecules require that “Institutional Biosafety Committee [IBC] approval be obtained from each institution at which recombinant DNA material will be administered to human subjects.” Investigators should refer to http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm for detailed requirements of the NIH regarding recombinant DNA.

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Translation Requirements

Information must be provided to subjects in a language that is easily understandable to them, preferably in their native language. However, if the subject is fluent in more than one language information may be presented in any of those languages. Interpreter services to aid in the consent process are available through the Department of Social Work at the UConn Health Center. Investigators or study personnel should call 860-679-2287 in advance to arrange for assistance for scheduled appointments with research participants.

This area may also aid in the translation of documents via an outside contract which the Department of Social Work holds. The department will pay the cost upfront and then charge the translation expense back to the appropriate account of the investigator. The IRB must approve all translated versions of documents prior to use by the investigator. The investigator may hire other translation services that will certify the accuracy of the translation or use the back-translation method. Links to other translation services are provided on the Resources page. The back-translation method is described in the revised version HSPO/IRB operating policies. Investigators may also contact the IRB Office with any questions regarding translation requirements.

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