Electronic System Roll Out for Human Investigation Committee Submissions

Electronic System Roll Out for Human Investigation Committee (HIC) Submissions

The Beaumont Research Institute was established over 30 years ago, and has been improving patient's lives through quality clinical research since its' inception. Consistent with federal regulations, the Beaumont Human Investigation Committee serves as the Institutional Review Board for Beaumont Health System and is charged with the oversight of all human participant research conducted at Beaumont facilities.

After much planning, developing and testing, the HIC will be implementing theiMedRIS Electronic HIC System over the next several months. Following implementation, researchers will no longer be required to print and submit multiple copies of applications and forms. All transactions will be done electronically, including signoffs by the clinical research manager and department chairs, corresponding with the HIC, responding to modifications required and submitting other study forms. Researchers will have ready access to the status of their submissions and actions to be addressed. Most importantly, iMedRIS will be accessible from any computer - inside or outside the Beaumont system.

Please familiarize yourself with the following schedule and training opportunities:

  • August 14, 2013 - iMedRIS will be open to begin entering studies, follow up forms and reports. Additionally, an abbreviated study application must be completed for each open study prior to entry of a Progress Report, Amendment, Protocol Deviation or Unanticipated Event. We encourage you to begin entering these abbreviated applications as soon as iMedRIS opens on August 14.
  • October 5, 2013 - All initial HIC Application submissions, Amendments, Progress Reports, Unanticipated Problems, Protocol Deviations and Final Reports must be submitted in iMedRIS. No paper forms/documents will be accepted after October 4, 2013.
  • November 1, 2013 - The first HIC meeting using iMedRIS will be held. All submissions to be reviewed at this meeting must be entered into iMedRIS (e.g., Initial Applications, Amendments, Progress Reports, Protocol Deviations, Unanticipated Problems, Final Reports).

Planning your initial study submission

  • Submissions prior to October 5 - use the current paper application.
  • Submissions on October 5 or later - must be via the electronic application in iMedRIS. The system will be open August 14 to begin entering studies.
  • Initial full-board applications entered in iMedRIS will not be reviewed until the November 1 meeting. Review of expedited and exempt projects in iMedRIS will begin on October 5.

Planning for Progress Reports, Amendments and other submission forms

For existing studies (those reviewed prior to iMedRIS implementation), will require completion of an abbreviated iMedRIS application, comprised of limited information taken from the original HIC application. This entry activity should take less than 30 minutes. The HIC will confirm the entered information is consistent with the original HIC approval, which may take up to two weeks. Following this confirmation, you may submit your Amendment, PD, UP or Progress Report. To avoid a lapse in HIC study approval at time of annual continuing review (Progress Report), we recommend entering the abbreviated application for each of your studies, as soon as possible.

Training sessionswill commence July 24. All Research Institute staff who submit forms or documents to the HIC must attend a training session prior to an iMedRIS submission. Researchers not employed by the Research Institute are highly encouraged to attend one or more sessions.