- Where can I find the Record of Consent policy?
- When should a Record of Consent be used? (Revised)
- Why has there been a change to the UIHC Policy “IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC?” (NEW)
- How do I ensure my IRB application is consistent with the UIHC Policy “IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC?” (NEW)
- When can I stop using the paper Record of Consent? (New)
- I need to update my process to include the Record of Consent. What template language will I need to add to the Informed Consent Document? (Revised)
- Whom do I contact with questions on the Record of Consent policy? (Revised)
- Who is responsible for adding the Record of Consent to EPIC? (Revised)
- Where is the Record of Consent Form located in EPIC? (Revised)
- Do subjects that are not UIHC patients need a Medical Record Number (MRN) created?
- What information will be required in the new ROC section of the HawkIRB application? (New)
- What information will I be required to collect from subjects to add their information in the low risk research database? (New)
- Who is required to complete the EPIC Research Study training? (New)
- How do I find the awareness training or the "how to" training? (New)
- What if we have a study that currently does not collect the information that would be needed for the Low Risk Database and our IRB approval does not give us permission to collect the information? (New)
Where can I find the Record of Consent policy?
The Record of Consent policy can be found on The Point. Only those individuals with a formal appointment at UIHC have access to information found on The Point.
The link for accessing the policy on The Point can be found here. If this link does not automatically take you to the policy, manually open a folder labeled “Medical Records”. In that folder is a document titled, “Documentation of Patient Participation as Subject in Research Protocol”.
When should a Record of Consent be used? (Revised)
In accordance with the Record of Consent policy, documentation must be made in the subject’s UIHC medical record if any specimen collection is done, or any physical interaction occurs (e.g. cheek swab or single blood draw), at the UIHC. Participation in a written survey or oral interview only is NOT considered a physical interaction. The Record of Consent update is required regardless of whether a University of Iowa IRB (IRB-01) or other external IRB (i.e. WIRB, NCI CIRB, GPC, Quorum, etc.) is serving as the IRB of record for the research project.
Why has there been a change to the UIHC Policy “IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC?" (NEW)
The UIHC policy has been updated to 1) streamline the collection of the content found in the Record of Consent to make it easier for clinical and\or emergency personnel to identify patients involved in a human subjects research project, 2) add the use of the low risk database, and 3) incorporate training requirements for associating subjects in the EPIC Research Study Description section..
How do I ensure my IRB application is consistent with the UIHC Policy “IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC?” (NEW)
For all IRB applications either in “draft” or newly initiated on or after 2/11/12, a “ROC” or Record of Consent section will appear at the end of the Project Index in the eResearch (HawkIRB) application. All research under IRB-01 will be required to select one of three options. Either they are
- Exempt from IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC policy
- Required to collect limited subject demographic information for documentation in the low risk database to document participation in a research study at a UI Health Care Facility
- Required to complete an EPIC Research Study Description to document patient\subject participation in a research study involving a physical interaction.
As a general rule of thumb, if the research study has associated a physical interaction such as 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 that elicits hospital charges for the research related activities, the EPIC Research Study description will always be required. (i.e. requiring Research Billing Compliance oversight) If there are no associated hospital charges with the physical interaction(s) or the research related procedures occur in a UI Health Care facility, the low risk database may be appropriate.
The paper Record of Consent is now electronically integrated as part of the HawkIRB submission for those studies that require documentation in the hospital medical record. A paper Record of Consent is no longer required. All of the same information currently found in the paper Record of Consent is now collected electronically and will be “pushed” into the EPIC medical record in the EPIC Research Study Description section on behalf of the study team.
When can I stop using the paper Record of Consent? (New)
You do not need to make the transition from a paper Record of Consent to the eROC immediately. However, at the time of your next modification submission to the HSO\IRB for review, the ROC section will be a new section that appears and will require completion prior to submission to the HSO\IRB on all IRB-01 projects. You cannot opt out of completing this new section once a modification is initiated. All existing IRB approved research projects will be allowed a grace period to adopt changes to their IRB approved research related procedures. A modification is required for all existing IRB approved research projects on or before June 30, 2018 to adopt the new Record of Consent changes. Once the modification to the eROC is complete and IRB approved, the paper Record of Consent document will be removed from the eResearch application in HawkIRB.
I need to update my process to include the Record of Consent. What template language will I need to add to the Informed Consent Document? (REVISED)
The below template language should be added to the Confidentiality section of the Informed Consent Document:
‘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 in the medical record 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.’
Whom do I contact with questions on the Record of Consent policy? (REVISED)
The Human Subjects Office can provide some assistance as it relates to IRB approved content of the Record of Consent. If you have questions above and beyond basic policy interpretation to determine whether your study qualifies to documentation research study participation in a subject's medical record, contact the Health Information Management Director (Erin Dufrane Woods) or the UIHC Chief Medical Information Officer (Maia Hightower).
Who is responsible for adding the Record of Consent to EPIC? (REVISED)
The PI must ensure the EPIC Research Study Description section is updated per IRB approved content. The Record of Consent form will no longer be scanned and placed into the media tab in EPIC. The EPIC Research Study Description now serves as the Record of Consent. The patient association of participation in a research study serves as verification the patient\subjects has provided appropriate informed consent to participate in the research. This association should occur by an IRB approved member of the research team.
Where is the Record of Consent Form located in EPIC? (REVISED)
The information contained in the Record of Consent will be documented in the EPIC Research Study Description section.
Do subjects that are not UIHC patients need a Medical Record Number (MRN) created?
Yes. ANYONE entering the hospital to undergo a physical interaction or specimen collection at the UIHC requires an MRN# be created and a Record of Consent be used, as defined by the Record of Consent policy.
What information will be required in the new ROC section of the HawkIRB application? (New)
The HawkIRB application will electronically collect the following information:
- A publicly viewable title to be used as part of the EPIC Research Study Description for this study
- One research team member who has completed the “how to” EPIC training
- A 24/7 study contact name and number that individuals providing normal clinical care can contact in the event questions arise regarding the subject’s participation in the study.
- Key complications from participating in the research study
- Any other information that may be pertinent to emergency personnel
The new Record of Consent section in HawkIRB replaces the paper record of consent that was placed in the subjects medical record in the Media tab. Upon IRB approval, the Record of Consent responses, as well as several other sections of the HawkIRB application, will be “pushed” via a web service to the ICTS to create the EPIC Research Study Description to reduce administrative burden on the research study team. This web service will replace the Redcap survey previously required by the research team to create the EPIC Research study description section.
What information will I be required to collect from subjects to add their information in the low risk research database? (New)
You will need research study related information such as the IRB ID#, PI first and last name, and your contact information. You will also need to collect limited information from the research subject such as their name, date of birth, and gender to document their participation in the low risk database. The subject’s address is recommended but not required. The IRB encourages the study team to evaluate what is the minimum amount of information necessary to collect from the subject for their participation in the study. If the subject’s address is not already demographic data point collected as part of the research protocol, you would not need to collect it expressly for this purpose.
Who is required to complete the EPIC Research Study training? (New)
There are two levels of training available to researchers. The first training module is a required awareness training for
- all named research team member on a human subjects research project where there is a Biomedical or Health Sciences named Principal Investigator or
- where research is occurring in an UI Health Care facility.
How do I find the awareness training or the "how to" training? (New)
The awareness 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 request an EPIC Research Study description build and 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 complete the “how to” training for this policy. The research team member identified in ROC.3 will be the individual required to complete the “how to” training. This training focus provides step by step instructions on how to associate patients in EPIC to the information contained in the EPIC Research Study Description section. After June 30, 2018 if the individual named in ROC.3 has not completed the “how to” training, the IRB application will be automatically prevented from submitting any form to the HSO\IRB for review until the training has been completed. 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
To learn more about this policy and the resources and training available, please go to https://icts.uiowa.edu/investigators/documenting-subjects-epic
What if we have a study that currently does not collect the information that would be needed for the Low Risk Database and our IRB approval does not give us permission to collect the information? (New)
All existing projects will be required to submit a modification prior to June 30, 2018 to address all applicable requirements under this policy.
