UI Health Care (UIHC) Policy on Documenting a Patient's Participation as a Subject in a Research Protocol

The Policy

According to UI Health Care (UIHC) policy, “Documentation of Patient Participation as Subject in Research Protocol” (IM-MR-6.21), documentation is required in the patient’s medical record of their participation in a research protocol, or use of an investigational medication, study medication, investigational device or biologic. The policy also 

This documentation in the medical record is referred to as a ‘Record of Consent’ (ROC) in the IRB application. This documentation provides a mechanism for clinical healthcare providers to have basic information about research participation that may impact a patient's clinical care outside of the context of the research procedures.

The policy is available in The Point for people with an appointment at UI Health Care. If necessary, manually open the folder labeled “Medical Records” and open the document titled, “Documentation of Patient Participation as Subject in Research Protocol.” There is also a link to the policy in the ROC section of the HawkIRB application.

Documentation in the medical record is required for research conducted at UI Health Care that is overseen by any IRB of Record – UI IRB-01 (Biomedical) or any external or commercial IRB (WCG, Advarra, National Cancer Institute CIRB, or any IRB of record for a single IRB model). This policy applies to projects under all types of IRB review (full board, expedited review, exempt status).

UI Health Care facilities/spaces that may have to apply the requirements of this policy include (but are not limited to):
  • The Fieldhouse
  • Medical Education Building (MEB)
  • UI Preventive Intervention Center (PIC)
  • MRI Research Facility (MRRF)
  • Westlawn (WL)
  • Bowen Science Building (BSB)
  • Medical Education Research Facility (MERF)
  • Carver Biomedical Research Building (CBRB)
Epic Research Study Description

Documentation is required for patients participating in research involving physical interactions, procedures, tests, examinations, specimen collection, hospitalizations, use of Pathology services, use of clinical facilities or equipment or any patient care services or physical intervention. Documentation in the medical record is required for any research activities in the Clinical Research Unit (CRU). If an individual is participating in a research study meeting the policy definition and does not have an Epic medical record, the research team will be required to create one.

Information collected in the HawkIRB application (ROC section) will be pushed to Epic or Iowa Clinical Trial Management System(ICTMS)\Oncore on behalf of the research team.

Low Risk Database

If the study does not meet the requirements for registration, the research team must record subject information in the Low-Risk Database managed by the Institute for Clinical and Translational Science (ICTS). Researchers will be required to collect all information required by this database, including subject name, date of birth, gender. Collection of address (street address, city, state, zip) is recommended, but not required when using the low risk database. Be sure the informed consent document is clear what information will be retained by the study team to fulfill this requirement.

For any questions about this database, contact research-navigator@uiowa.edu.

Use of the ICTMS to fulfill UIHC policy requirements

If a research study elects to use either the ICTMS\Oncore for Oncology or the ICTMS\Oncore for general research purposes, there is integration in place between the ICTMS\Oncore and EPIC to automate the documentation of a patient's participation in research that fulfill the UIHC policy requirements.  To utilize the ICTMS for oncology use select yes in V.22 in the HawkIRB application.  To utilize the ICTMS for general research use select yes in V.27 in the HawkIRB application. 

Identifying the UIHC Policy Requirement in the HawkIRB Application

The ROC section of the HawkIRB application collects the necessary research related information to automatically pass to EPIC upon IRB approval.  The PI has three options when determining if their research is required to apply this policy:

  1. Exempt from requirements – observational studies without a physical intervention (surveys, interviews, etc.) and data collection for a registry or repository are not required to document subject participation in the UI Health Care electronic health record or in the Low-Risk Database
  2. Does not meet the requirements – must report subject enrollment information in the  Low-Risk Database managed by the Institute for Clinical and Translational Science (ICTS).
  3. Does meet the requirements – additional questions open in the HawkIRB application to automate the detail found in the EPIC record for a patient's clinical care team.

When registration is required, the PI must select an option for the title to be displayed in the medical record. A member of the research team must complete Epic training. The HawkIRB application must indicate the name of the 24/7 contact person, key complications from the study drug(s), and other information important to emergency personnel. 

Research studies that indicate the use of the ICTMS\Oncore platform for managing their clinical trial should select "does meet."  This will allow the documentation in EPIC to occur automatically for any subject enrolled in the research study.

The PI can also choose whether to advertise the project on the Iowa Clinical Research and Trials website in this section. (ROC.7)

Informed Consent Template Language

The UI IRB Informed Consent Document Template contains a paragraph in the “Confidentiality” section about the Record of Consent.

The University of Iowa Hospitals and Clinics generally requires that we document your participation in research occurring in a University of Iowa Health Care facility.  This documentation will be in either your medical record or a database maintained on behalf of the institution reflecting that you are participating in this study. The information included will provide contact information for the research team as well as information about the risks associated with this study. We will keep this Informed Consent Document in our research files; it will not be placed in your medical record chart.

Training Requirements

The ‘How To’ Training covers how to request an Epic Research Study Description build and how to associate patient/subject participation in research. All research team member who are assigned to document in the subject's medical record must complete this training. 

  • Additional information on how to register and complete the training requirements can be found on the Institute for Clinical and Translational Science website under "Documenting Subjects in Epic."  
  • The training requirement is "E0092 Epic Documentation for Research Students, Staff, & Faculty."

Questions about the UIHC Policy

Human Subjects Office staff can provide guidance for completing the HawkIRB applications. For questions beyond basic interpretation of the policy, contact:

 

Updated 2/15/26