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. The Human Subjects Protection Office and the IRB welcome suggestions from research personnel on how to improve our forms, policies or processes.  Suggestions may be sent via e-mail to any staff member or dropped in the IRB drop-off box. 

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

• Adverse Event Classification and Reporting
• Census Data
• Cooperative Agreement with Hartford Hospital, CCMC, Storrs
• Embryonic Stem Cell Research Oversight (ESCRO) Committee
• Federal Regulations
• Federalwide Assurance
• Financial Compliance in Clinical Trials (OCTR web site)
• General Information and Tips for Student Investigators
• Glossary of Lay Terms
• HSPO/IRB Operating Policies
• Human Subjects Training Requirement
• ICH - Good Clinical Practice Guidelines
• Institutional Policies Related to Human Subject Protections
• Investigators Guide for Human Subject Research
• IRB Charges for Industry Sponsored Studies
• IRB Forms and Instructions
• IRB Meeting Dates and Submission Deadlines (pertain only to full board studies)
• Preparing a Protocol
• Public Act No. 05-149 An Act Permitting Stem Cell Research
• Quality Assurance or Improvement Vs. Research
• Recombinant DNA
• Stem Cell Guidelines for UCHC Faculty
• Translation Requirements

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 UCHC policy for reporting adverse events is found within the HSPO/IRB Operating Policies. All events that require expedited reporting must be reported using the on-line 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
• Common Terminology Criteria for Adverse Events
• Research Adverse Events Committee
• Adverse Event Reporting Policy - Memo for Sponsors

Cooperative Agreement with Hartford Hospital, CCMC, Storrs - This document outlines the operational details to follow when requesting to invoke the cooperative agreement between Hartford Hospital and the UConn Health Center, CCMC 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. 

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.

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. 

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 Language for Medical Terms (University of Kentucky)
• Lay Terminology (North Shore Long Island Jewish Health System)
• Plain Language (general tips for writing use friendly documents)

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 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.   

Institutional Policies Related to Human Subject Protections - investigators and study personnel should be familiar with the following policies that relate to human subject protections.

• 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

Preparing a Protocol (Word doc) – 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)
• Guide for Writing a Research Proposal

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.

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 UCHC.  Investigators or study personnel should call x2287 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 Dept. of Social Work holds.  The Dept. 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.