New Policy and Procedures: Documenting Research Participation in the UIHC Medical Record
On Wednesday, February 7, 2017, 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 the original announcement found on the HSO website.
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.
- Announcement on the Human Subjects Office website.
- 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 (https://icts.uiowa.edu/investigators/documenting-subjects-epic).
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.
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)
The revised UI Health Care policy affects the Research Billing Compliance process
The “EPIC Research Study Description,” serves as an electronic Record of Consent (eROC), replacing the paper Record of Consent. The association of a subject with a study verifies that the patient/subject provided appropriate informed consent to participate in the research. This association must be made by a member of the research team who has completed the EPIC training and is approved by the IRB to serve in this capacity.
The Research Billing Compliance staff (formerly known as JOC Research Billing) will no longer associate patients to the study in Epic on behalf of the research team. If the research team previously emailed Research Billing Compliance to request associating a newly enrolled subject to the study, going forward, a member of the research team (as designated in Question ROC.3 in the HawkIRB application) must be trained and have the access to complete these steps in a timely manner.
This change in procedures affects all pending “draft” IRB applications and all HawkIRB New Project Forms created on or after 2/11/18. Please direct questions to email@example.com.
Training Requirements Associated with the UI Health Care Policy Change
There are two levels of training available to researchers under the New UI Health Care (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).
The first training module is a required awareness training for all named research team members on a human subjects research project
- with a Biomedical or Health Sciences Principal Investigator or
- where research is occurring in an UI Health Care facility
The training is available in HR Self-service “My Training”, Course: #WICTS1. The training will be tracked in the “My Training” portion of HR self-service and is a one-time requirement. It takes approximately five to ten minutes to complete. The Principal Investigator will be responsible for ensuring all research team members have completed this required training.
The second level of training is a “how to” course on how to associate patients\subjects participation in research studies for those research studies required to document patient participation as a subject in the EPIC medical record. At least one research team member of each IRB protocol is required to complete this training course.
Starting June 30, 2018, all IRB protocols will require at least one team member who has completed the “how to” training for this policy. If the identified research team member has not completed the required training, the HawkIRB application will halt the submission until the training is complete. To complete the “how to” training required to associate subjects to a study in Epic, please follow these steps:
- Review the training video and other resources on the Research page on the Epic Education site at: https://hcis.healthcare.uiowa.edu/EpicSupport/resources/modules/research/research.html
- Contact Jimmy Schappet at firstname.lastname@example.org and tell him you have completed the required training. Include the IRB number(s) of the study(ies) to associate subjects.
To learn more about this policy and the resources and training available, please go to https://i cts.uiowa.edu/investigators/documenting-subjects-epic