On Wednesday, February 7, 2018, UI Health Care (UIHC) announced a change in the policy about documenting research study participation in the electronic health record (EHR). This change affects many currently approved research projects, those with a Record of Consent and some without. These changes are being done for the following reasons:
Make it easier for clinical and\or emergency personnel to locate the information contained in the Record of Consent identifying patients involved in a human subjects research project
Automate the collection of information in the iCart\CRU application,
add a database for tracking participation in lower risk studies, and
Incorporate training requirements for documenting study participation in EPIC.
As of February 11, 2018, the IRB processes have been updated to accommodate the UI Health Care policy change. See this announcement for more information about the changes, including changes to billing compliance and training requirements associated with the change.
Research Involving Physical Interaction
Under the revised UIHC policy, researchers must complete the EPIC Research Study Description for each enrolled subject when the research protocol in a UI Health Care facility involves a physical interaction. This includes procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or clinical equipment, or any patient care services, including services conducted in the Clinical Research Unit. The content of the EPIC Research Study Description is the same as the former Record of Consent (ROC) paper document that was scanned and attached in the Media tab in EPIC.
The contents of the former paper ROC are now a new eROC section of the HawkIRB application. All new projects will complete this section prior to submission to the IRB. All existing studies will need to submit a HawkIRB Modification form (see the “Action Required” section below).
Research Without a Physical Interaction
If the study does not meet the requirements for the completion of an EPIC Research Study Description, the Principal Investigator (PI) must record basic information in a new Low Risk Research Database in REDCap. This database, maintained by the Institute for Clinical and Translational Science (ICTS) on behalf of UI Health Care, can be accessed at https://redcap.icts.uiowa.edu/redcap/surveys/?s=yjnt3X
Research locations that must register in the Low Risk Research Database include, but are not limited to:
- Fieldhouse (FH)
- Medical Education Building (MEB)
- Preventive Intervention Center (PIC)
- Magnetic Resonance Research Facility (MRRF)
- Westlawn (WL)
- Bowen Science Building (BSB)
- Medical Education Research Facility (MERF), and or Carver Biomedical Research Building (CBRB)
Studies that only involve observation of subjects, surveys or oral interviews or participation in a data repository, with no physical interaction, DO NOT require documentation in the UIHC EHR or the Low Risk Research Database.
All currently approved studies that meet the requirements for posting in the UIHC EHR or the Low Risk Research Database must submit a HawkIRB Modification form by June 30, 2018. If you submit a modification prior to this date, these changes will be required.
Existing projects with a physical interaction must do the following by June 30, 2018:
- The entire research team must complete awareness training about these changes.
- One research team member must complete the full EPIC Research Study training.
- Submit the HawkIRB Modification for the transition to the electronic Record of Consent (eROC), either at the time of another HawkIRB Modification form or as a separate Modification form for this purpose. The modifications will include completing the new ROC section (visible on the HawkIRB Index ribbon), and adding new template language to the “What About Confidentiality” section of the Informed Consent Document. The new template language is posted on the Record of Consent Frequently Asked Questions (FAQ) page of the Human Subjects Office website. It is also in the Informed Consent Document Template that is available on the attachment page of the HawkIRB application.
Existing projects without a physical interaction must submit a HawkIRB Modification form to describe plans to collect and record subject information in the Low Risk Research Database. This may require collecting information (name, date of birth, gender) that is not currently being collected from subjects in the IRB-approved protocol.
Please use the links below for additional information about this new policy and procedures:
- UIHC Policy IM-MR-06.21 (Documentation of Patient Participation as a Subject in a Research Protocol or use of an investigational medication, study medication, investigational device, or biologic) – available here or in the The Point.
- Record of Consent Frequently Asked Questions (FAQ) – on the Human Subjects Office website.
- To learn more about this policy and the resources and training available, please go to this site.
Where to Direct Questions
People are available to assist you with the changes required to comply with this new UIHC policy.
For questions or assistance with the eROC in the HawkIRB system and basic policy interpretation regarding whether a study requires documentation in the UIHC EHR or in the Low Risk Research Database Contact the Human Subjects Office.
Email: email@example.com(link sends e-mail)
IRB Office Hours (through May 2018):
- Mondays from 2-4 pm (S108 Lindquist Center)
- Wednesdays from 2-4 pm (101 Hardin Library)
- Thursdays from 10 am-12 pm (101 Hardin Library)
For questions about on the UIHC policy or the EHR, contact the Health Information Management Director (Erin Dufrane Woods(link sends e-mail)) or the UIHC Chief Medical Information Officer (Maia Hightower(link sends e-mail)).