September 2025 IRB Connection Newsletter
Compliance with Digital Content Requirements under Title II of the Americans with Disabilities Act
New Consent Summary Template and Educational Tool
HawkIRB: Submitting a Modification Form with Recent X.4 Changes
New Policy Requirement: Research Security Training for Senior/Key Personnel
Compliance with Digital Content Requirements under Title II of the Americans with Disabilities Act
By Erin Feltes, MA, JD
The U.S. Department of Justice issued a rule in April 2024 pursuant to Title II of the Americans with Disabilities Act (ADA) requiring that state and local government entities, including the University of Iowa, make all forms of their digital content accessible to people with disabilities.
To comply with this rule, all university digital content, including websites and apps, must conform to the Web Content Accessibility Guidelines (WCAG) 2.1, Level AA standards by April 24, 2026. WCAG 2.1AA standards include, but are not limited to, use of alt text, keyboard navigation, screen reader compatibility, color contrast, and video captions.
This rule has significant implications for research studies conducted by university researchers as software, digital tools, apps, and online platforms used as part of a study must be accessible. This includes:
Recruitment websites, including social media posts
Online recruitment advertisements
Digital informed consent forms
Online surveys
Online data collection tools or software
Participant portals, dashboards, or mobile apps
Press releases, study results, or study publications shared on University websites
Additionally, the rule requires that when using a third party to provide any of the above, those third-party platforms must also be accessible.
Failure to make the digital content used in research studies accessible, may result in complaints alleging violations of Title II of the ADA. It may also lead to individuals with disabilities being excluded from participation in research, which undermines equitable selection of subjects as addressed in the Belmont Report's ethical principle of Justice. This principle states that the people who participate in research should not have an unequal share of the risks or benefits of the research.
To ensure compliance with digital accessibility standards by April 24, 2026, the university is encouraging all employees to get started by taking the following steps:
Build your understanding of creating accessible content through new training opportunities, as well as in-depth information about specific topics such as documents, social media, and websites.
Review and inventory digital content for which you are responsible—this may include your documents, webpages you manage, videos, social media, training content, research applications you use, and more. This will help you know what kind of resources, support, and training to seek to help you improve the accessibility of your content.
Delete or archive digital content that is no longer accurate, up-to-date, or relevant. A webpage without extra pages and files is easier to make accessible.
The university established an Accessibility Task Force to coordinate accessibility efforts on campus, and to provide resources, training, tools, and technical support to meet these accessibility requirements.
For additional resources check out the following:
Accessibility at Iowa: https://accessibility.uiowa.edu/
Creating Accessible Content: https://accessibility.uiowa.edu/create-accessible-content
ADA Fact Sheet: https://www.ada.gov/resources/2024-03-08-web-rule/
The Human Subjects Office (HSO) is rolling out a new consent summary of key information template in HawkIRB. To support researchers in utilizing the new template, the HSO also published a new educational tool Consent Summary of Key Information: Guidance and Alternative Formats.
The current update to the template is the result of draft guidance issued in 2024 by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). “Key Information and Facilitating Understanding in Informed Consent.” The intention of the draft guidance is to harmonize the differences between HHS regulations and FDA regulations.
Since 2017, the HSO has required a consent summary for all research studies unless the complete consent document is four pages or fewer. Utilization of the new consent summary is considered an institutional human research protection program policy that will apply to all research regardless of IRB of record. Researchers submitting to an external IRB will be required to apply the same key information standards outlined in this guidance unless an equivalent process can be defined during the local context review process.
Consent Summary of Key Information
The original regulation related to the addition of a ‘key information’ section was published in the Revised Common Rule in 2018. 45 CFR 46.116(a)(5)(i) The purpose the key information is to help facilitate discussions between a prospective subject and an investigator about whether the prospective subject should participate in the research.
New Template
The new template provides instructions in tinted boxes instead of using bold and bracketed text. When the template language has been edited for the specific study, the tinted boxes (including the instructions on the cover page) are to be removed.
The new template was written with a focus on the grade reading level of the text: the instructions are written at a tenth grade reading level, and the template language for the participant is written at a sixth grade reading level. Study-specific additions should also be written at a grade reading level appropriate to the study population.
The new template includes eight headings:
It is up to you whether you take part in the research: You can stop taking part in this study at any time without any penalty.
Why are we doing the research, how long will it take, and what will be done?
What are the most common or serious risks?
What are the benefits?
What can you do instead of being in the research?
What if you are injured during the research?
What are the costs or payments?
(Optional) How participating in the research may affect your daily life:
The eighth section is optional and is intended to included information that would not be classified as a “risk” or “benefit.” It should be used to highlight additional facts that may “assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research." (45 CFR 46.116(a)(5)(i))
Examples are provided in the instructions for each of the headings to assist researchers with customizing the template to their study. The examples for the optional eighth section include other supplemental information such as risks to others not participating in research (i.e., radioactive interventions, potential shedding of a virus in gene therapy studies).
Educational Tool
The draft guidance encourages researchers to “develop innovative ways and utilize available technologies to provide key information” and to “consider developing alternate ways to present key information…” Along with the new consent summary template, the new educational tool will assist researchers with utilizing the new template. The education tool provides additional guidance about presenting and formatting information that will “facilitate comprehension.”
HawkIRB Application
The information provided by the researcher in Sections VII.D. 29 (for adults) and VII.D.30 (for minors) should contain a complete description of the ways the research team will conduct the process of obtaining consent. This should include both:
A description of the ways the key information will be conveyed.
A description of any materials that are used (e.g., consent summary, consent document, video, PowerPoint) to convey the key information.
HawkIRB Application Attachments
If a PI is using an alternate format (e.g., video or PowerPoint) to present the key information summary, the IRB must approve the format that will be presented to subjects, as well as a text version (i.e., transcript of a video).
If utilizing a video,
The PI should provide a transcript on a blank stamped template (available in the dropdown menu in the Consent & Assent Document section) and attach it in the “other consent document” section.
If the video is available on a study website, the PI should include the hyperlink in Section VII.D.29 and/or VII.D.30.
Any other alternative key information materials that cannot contain an IRB approval stamp (e.g., PowerPoint presentation, brochure) should be uploaded to the “miscellaneous attachments” category of the attachments section.
Questions about this topic? You can email the HSO Education and Outreach team or come to Office Hours to speak directly to a member of the HSO team.
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Recent changes in Section X.4 of HawkIRB will result in the need to provide updated responses to previously answered questions about confidentiality protections and data security in the next modification form. To reduce workflow, it is important that the descriptions are consistent throughout the application.
Because it is not possible to see the previous response to X.4 from within the modification form, the following steps are provided to assist you in creating a printer-friendly version of the IRB-approved project containing the previous responses.
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.
For a modification form, the printer-friendly version shows changes to the form at the beginning and then shows the entire application with the changes incorporated. To ensure that all intended revisions have been made, it is a best practice to review the entire HawkIRB application before submitting the 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.
New Policy Requirement: Research Security Training for Senior/Key Personnel
Several federal sponsors—including the Department of Energy (DOE), National Institutes of Health (NIH), and National Science Foundation (NSF)—now require researchers designated as Senior/Key Personnel to complete research security training. To meet this requirement, University of Iowa researchers must complete the CITI Research Security Training (Combined) Course developed by NSF. Training must be completed prior to proposal submission.
CITI Research Security Training (Combined) Course Instructions.
- Go to the CITI home page (https://about.citiprogram.org/)
- Click the “Login” button on in the top right hand corned of the page.
- Click the blue button to “View Courses” next to the University of Iowa.
- Scroll down to the box with “Learner Tools for University of Iowa” and click “Add a Course.”
- Scroll down to the bottom of the list, and check the box “I am required to complete Research Security (Combined) Training”
- Choose the “Research Security Training Combined” course by clicking “Start Now”
For more information, visit the Research Security Training page.