UI Health Care Policy on Record of Consent

The Policy

According to UI Health Care policy, “Documentation of Patient Participation as Subject in Research Protocol” (IM-MR-6.21), there should be documentation in the patient’s medical record of patient participation in a research protocol, or use of an investigational medication, study medication, investigational device or biologic. In 2017, this policy replaced the previous process of placing a copy of the signed consent document in the Media Tab of the electronic health record. The policy also automates collection for I-CART (Iowa Catalog and Research Tracker) for the Clinical Research Unit (CRU) application. It added a new database for tracking low risk research and added a training requirement for documenting participation in Epic.

This documentation in the medical record is referred to as a ‘Record of Consent’ (ROC). It provides a mechanism for healthcare providers to have basic information about research participation that might have significance for clinical care.

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 an external or commercial IRB (WCG, Advarra, Great Plains Collaborative, National Cancer Institute CIRB, Quorum 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 may 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 someone participates in a research study who does not have an Epic medical record, the research team will be required to create one.

Information collected in the HawkIRB application will be pushed to Epic 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). NOTE: Researchers will be required to collect all information required by this database, including subject name, date of birth, gender and address (street address, city, state, ZIP) NOTE: Collection of address is recommended, but not required).

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

HawkIRB Application

In the ROC section of the HawkIRB application, the PI has three options:

  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

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. The PI can also choose whether to advertise the project on the Iowa Clinical Research and Trials website.

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.

The Process

Follow the instructions provided in the required training and in the policy (IM-MR-06.21).

Training Requirements

  • Awareness Training – Available in HR Self Service, under “My Training,” Course: #WICTS1. This is a one-time training requirement. It takes approximately 5-10 minutes to complete. The PI is responsible for ensuring that all research team members complete this training.
  • ‘How To’ Training – This training covers how to request an Epic Research Study Description build and how to associate patient/subject participation in research. At least one research team member must complete this training. They will be identified in the ROC section of the HawkIRB application.

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: