Where can I find the Record of Consent policy?
When should a Record of Consent be used?
We just submitted a Modification/Adverse Event to WIRB. Do I need to update the Record of Consent?
Whom do I contact with questions on the Record of Consent policy?
Who is responsible for adding the Record of Consent to EPIC?
Where is the Record of Consent Form located in EPIC?
Do subjects that are not UIHC patients need a Medical Record Number (MRN) created?
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 above. 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?
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 template “Record of Informed Consent” is available on the HSO website in the Western IRB section under WIRB Policies & Procedures. All content in the Record of Consent template, including the open text fields, must be revised to reflect your particular study and approved prior to use.
I want to add a new subject population from the UIHC in a modification to WIRB. Do 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?
Yes, now that you are enrolling subjects at the UIHC you must include a Record of Consent in the medical charts. The below template language should be added to the Confidentiality section of the Informed Consent Document when you submit it to WIRB:
‘The University of Iowa Hospitals and Clinics generally requires that we document in your medical record chart that you are participating in this study. The information included in the chart 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.’
Note: WIRB is NOT involved with the Record of Consent process. Do not send the document to them.
We just submitted a Modification/Adverse Event to WIRB. Do we need to update the Record of Consent?
Once the study has been approved by WIRB and you have received the stamped Record of Consent from UI/WIRB contact, it is at the investigator’s discretion to update the Record of Consent.
Note: WIRB is NOT involved with the Record of Consent process. Do not send the document to them.
Whom do I contact with questions on the Record of Consent policy?
Nathan Levin, Associate Director - Joint Office of Compliance, is the primary point of contact for the UIHC policy.
Nathan Levin
200 Hawkins Drive, C-431 GH
Iowa City, IA 52242
319/353-6909
Who is responsible for adding the Record of Consent to EPIC?
The PI must ensure the consent form is provided to the appropriate chart control departmental contact in order to have the form entered into the system. The form will be scanned and placed into EPIC.
For a list of departmental chart control contacts, click here. Please note, the departmental chart control contacts may be changed without prior notice.
Where is the Record of Consent Form located in EPIC?
Forms with a patient signature are scanned into the Media tab in EPIC. These items may be sorted alphabetically by clicking on the Document Type heading in the Media tab. The Document Type for Research Consent forms is: External—UIHC Research Consent Form. By clicking on this Document Type, all Research Consent Forms will be grouped together.
Please click here for the EPIC Tips & Tricks document on creating a Quick Filter to show only documents of a certain type, such as UIHC Research Consent Forms.
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.
