Recent changes to section X.4. of HawkIRB have caused some confusion for users. Programmers are working on changes to the format and instructions for this section, however, the changes may take a week or two.
To reduce workflow and prevent delays in the IRB review process, it is important for researchers to review and respond to every applicable option. If there is a partial response or if the response is inconsistent with previously approved confidentiality protections (in the case of a modification form) HSO staff reviewers will route the form back to the researcher.
This article explains how to fully describe confidentiality protections for study data/samples in new projects. For modification forms, the section at the end of this article describes how to access the previously approved confidentiality protections to ensure consistency in the response to section X.4.
Section X.4 Confidentiality Protections and Data Security Plans
Section X.4 of the HawkIRB application asks “How will information be collected and stored for this study? (Check all that apply)” for three categories: paper records, electronic records and biologic specimens.
Previously, Section X.4 contained an open text field, but now there are checkboxes to specify:
- If access is limited only to research team members.
- Storage plans for records/specimens.
- What identifiers (if any) will be associated with the records or specimens.
The IRB requires that the response to section X.4 addresses each of these categories. This section was modified to prompt researchers to provide complete information that was not always included in the previous open text field. The new format allows researchers to describe multiple access restrictions, storage protections, and plans for subject identifiers associated with all data and specimens within a study.
Paper/Hard Copy Records
In section X.4 for Paper/hard copy records has the following options:
- Only research team members will have access to the data (does not include sponsors or external collaborators)
- Locked cabinet/room accessible only to authorized research team members
- Identifiable
- Coded
- De-identified/anonymized identifiers (whenever possible)
- Other
Access and Storage – Generally, the first two checkboxes are standard confidentiality protections for paper records. However, if data will be shared with researchers outside of the research team, and beyond external collaborators, it would be incorrect to select the option “Only research team members will have access to the data.” Describe this data sharing under the “Other” option and in Section X.5-6.
Identifiability - In the next three checkboxes, indicate whether identifiers will be associated with any paper records. (Note: Signed consent documents are considered to be identified.)
Select “Other” (if necessary) to describe anything that is not addressed in the checkboxes above. (Note: For a limited data set, select “Other.”)
Electronic Records
If Electronic records is selected, the researcher has the following options:
- Only research team members will have access to the data (does not include sponsors or external collaborators)
- Password protected files
- Identifiable
- Coded
- De-identified/anonymized identifiers (whenever possible)
- Other
Similar to the confidentiality protections for paper records, select responses that fully describe access, storage, and identifiability for all electronic records (including computer files, databases, photos, and audio/video recordings). Select “Other” (if necessary) to describe additional confidentiality protections and data sharing outside the research team. (Note: For a limited data set, select “Other.”)
Additionally, there is a follow up question: How will electronic data be stored at the University of Iowa (select all that apply)? This must be answered by indicating at least one of the following choices:
- UI One Drive
- Research Data Storage Service (RDSS)
- Large Scale Service (LSS)
- Iowa Health Data Resource Data Enclave (IHDR)
- R:Drive or UI Shared Drive
- Oncore/ICTMS/eReg
- eDC (electronic data capture system including REDCap)
- Other
Biologic Samples
If Biologic Samples is selected, the researcher has the following options:
- Only research team members will have access to the samples (does not include sponsors or external collaborators)
- Identifiable
- Coded
- De-identified/anonymized identifiers (whenever possible)
- Locked space accessible only to authorized research team members
- Other
Indicate the plans for access to samples and storage in a locked space. Also indicate whether samples will be identifiable, coded or deidentified/anonymous. Select “Other” (if necessary) to describe any additional access restrictions, data sharing outside the research team, or plans regarding identifiers associated with biologic samples.
The selections about access and identifiers should also be consistent with the response to the following question about shared or private lab or freezer space.
- Shared Lab / Freezer Space
- Private Lab / Freezer Space
- Other
Submitting a Modification Form
When responding to Section X.4 in a modification form for the first time after the question was revised in August 2025, it is essential to respond in a way that is consistent with the previous, IRB-approved response about confidentiality protections and data security. It is not possible to see the previous response within the Modification form. Follow these steps to see the previous response in the printer-friendly version of the IRB-approved project.
- Step 1: Open the PI’s HawkIRB inbox. From a Modification form, click the “HawkIRB” link in the gold menu bar OR the “Inbox” link in the white menu bar.
- Step 2: Click the IRB# in the “Projects” section to open the Project Summary page
- Step 3: Click the “Project Details” tab at the top
- Step 4: Click “View a printer friendly version of this form” in the upper right corner. This version opens in a new tab of the web browser. Keep this browser tab open.
- Step 5: Click the other web browser tab.
- Step 6: Click “HawkIRB” in the gold bar or “Inbox” in the white menu bar to go back to the PI’s inbox.
- Step 7: Click the title of the draft modification form.
Questions? You can email the HSO Education and Outreach team or come to Office Hours to speak directly to a member of the HSO team.