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Institutional Review Board (IRB)

Policies & Procedures  |  Submissions  |  Online IRB Application  |  IRB Training Requirements

The Human Research Protections Program (HRPP) supports the Hartford HealthCare (HHC) Institutional Review Board (IRB).

This includes research conducted at Hartford Hospital; MidState Medical Center, Windham Hospital, The Hospital of Central Connecticut (HOCC), and Backus Hospital. The IRB conducts the ethical review on potential research studies involving human subjects.

Research is a systematic investigation, including research investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject means 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.

The HRPP makes the initial determination whether a potential activity is research involving human subjects. If the activity is not research, or does not involve human subjects, the researcher will receive a letter stating this determination.

If the activity is research and involves human subjects, the IRB will make the determination whether the activity qualifies for:

  • An IRB review exmption
  • An IRB expedited review
  • IRB full board review

Important: The IRB review must happen before the research activity starts because the review’s purpose is to assess the study’s potential benefits and risks. Please be sure that you have your IRB approval or exemption letter before you start your study.

If you have any questions about whether IRB review is required, please contact us at: 860.972.2893 or irb@hhchealth.org.


Click Here for IRB Policies & Procedures

Click Here for Instructions and Forms

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IRB Submissions

A New Study
The Hartford HealthCare (HHC) Integrated Research Information System (iRIS) is used for all new study submissions. The HHC Main Research Application Form (located in iRIS) is a combined application that includes the study’s grants and contract details and research subject involvement. Study materials, including the research protocol, informed consent document, investigator’s brochure and patient materials are included with the application for IRB review. Once the submission is received in Research Administration, the HRPP staff will process the study’s IRB review. The principal investigator will receive an IRB approval letter and IRB-stamped Informed Consent Document via the iRIS system after the study is IRB approved.

Determination.
The HRPP makes the initial determination whether a potential activity is research involving human subjects. If the activity is not research, or does not involve human subjects, the researcher will receive a letter stating this determination. A determination form (“Request Form - Determination that a Proposed Activity is Not Research or is Not Human Subjects Research” can be submitted using the HHC iRIS system (iRIS). If there is a question of whether a project is research or not, please contact the IRB.

Changes to a Study
The IRB must review all changes to a study. These include changes to the informed consent document, revised study procedures, changes in risk, and study ads. Changes may be submitted to the IRB by submitting a “Modification/Amendment Form” via the HHC iRIS System (iRIS). The principal investigator will receive an IRB approval letter via the iRIS system once the study change is IRB approved.

Adverse Events/Unanticipated Problems
An “Unanticipated Problem/Event Report” must be submitted within 7 days of any serious or unanticipated event involving risk to subjects or others if the event occurred at Hartford HealthCare or another institution overseen by the Hartford HealthCare IRB. The Unanticipated Problem/Event Report form is submitted using the HHC iRIS system (iRIS). Anticipated events (i.e., described in the protocol and ICD), and those of mild or moderate severity may be reported as they occur or at the time of review for continuation on an EVENT ACCUMULATIVE TRACKING LOG.

Project Renewal
IRB review is an on-going process. The principal investigator must submit a “Continuing Review (Progress Report) - Human Studies” report, within the timeframe specified in the IRB approval letter using the HHC iRIS system (iRIS). This is usually annually, but some studies may require more frequent reporting.

Final Report
A Hartford HealthCare Study Closure Report form and final report must be submitted to close out a research study. This is done when the human subject component is complete. This form should be completed using the HHC iRIS system (iRIS) and the final report should be attached prior to submission to the IRB. Please note: The IRB will not review new research applications if the investigator has not completed the required termination form for another study.

If you have any questions about these requirements or the review process, please contact us 860.972.2893 or IRB@hhchealth.org.

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Online IRB Application

iRIS Webpage:
Click here to use the iRIS forms system.
If you do not have an iRIS sign-in, please login with your HHC Login Information or Select "Request new account" on iRIS Home Page.

iRIS- What is it?
The Enterprise version of iRIS by iMedRIS Data Corporation is a complete, easy-to-use software solution, designed to help commercial, academic, and government institutions of all sizes integrate research operations under a single database platform. iRIS, a web-based framework application, empowers users to be more accurate and efficient and streamlines the research process.

iRIS Help Guides:
Instructions and Guides can be found once you login into iRIS.  Select the "Help" option or the orange question mark icon located on top right.

iRIS Support:
If you are having technical problems with iRIS:
Please call 860.972.5621 during regular business hours or email a short description of the problem along with contact information to Research@hhchealth.org

iRIS System Requirements:
Recommended Browsers:  Internet Explorer 9.0+ (Windows Only). (Internet Explorer 11.0 Preferred), Safari 6.0+.
Supported Browsers:  Chrome 30.0+, Firefox 24.0 +.

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IRB Training Requirements

As part of our institutional goal of maintaining training within the research community and promoting an organizational culture that encourages integrity and compliance at Hartford Hospital, the Human Research Protections Program (HRPP) has adopted the web-based modules within the Collaborative Institutional Training Initiative (CITI) for certification in Human Subject Protection (HSP). These web-based modules are available at https://www.citiprogram.org/. Please click here for abbreviated background and instructions.

Once initial training is completed, a Refresher Course must be taken every 3 years. Information for earning CME/CEU credits is available from the CITI website.

We highly encourage everyone to PRINT your completion certificate when you finish the course, keep a copy for your personal records, and give a copy to any study coordinators that may be managing the regulatory aspects of your research activities. It is very time consuming for HRPP staff to provide copies and takes away from time attending to other aspects of protocol reviews.

New studies and continuations of existing studies will not be approved by the IRB until all personnel have completed this required training.

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