The following are things to keep in mind when creating a consent document:

Complete the HawkIRB Application First 

The ICD templates are “smart forms” that have template language added based on the response to questions in the HawkIRB application. If you change a response in the HawkIRB application AFTER you generate the consent template, just generate another ICD template and compare the two documents to make sure the original document includes all the required sections.

Keep All Required Elements of Consent 

You can tailor the ICD to thoroughly describe your study in a language that is readable by your subject population. But do not remove sections or information that must be presented to subjects. The IRB will not be able to approve an ICD that is missing required elements of consent.

Make Sure the ICD is Consistent With the HawkIRB Application 

The Human Subjects Office (HSO) provides an Informed Consent Document Checklist to help researchers maintain consistency in the study description between the HawkIRB application and the ICD. (NOTE: To access this document, you must log in with “HawkID@uiowa.edu” and your HawkID password.) There is a link to this ICD Checklist in the HawkIRB Help message in the “Consent” Attachment category. This checklist is also posted on the Educational Tools page of the HSO website.

Check for the IRB Approval Stamp Placeholder 

When you generate the ICD template, make sure you see the gray box in the upper righthand corner that will be populated when IRB approval is complete. If you are working on an Apple/Mac computer, you may not see this gray box when you open the document. Make sure you open the template in Word rather than the default text editor. There are instructions on the Human Subjects Office website to change the settings on your computer to always open rich text format (.rtf) documents in Word on a Mac.

Attach a Clean Document the First Time 

The first time you submit an ICD to the UI IRB, make sure it is a clean document, without any tracked changes or comments. Every time you edit the document after that, be sure tracked changes is turned on so the IRB can see all the changes.

Incorporate Sponsor Template Language into the UI ICD Template

If you receive an ICD template from a sponsor, generate the UI ICD template in HawkIRB and insert the sponsor’s template language into the UI IRB document. It is always a good idea to obtain sponsor approval for the ICD BEFORE you attach the ICD to the New Project form and each time the document is revised during the IRB review process. This can prevent back and forth with the sponsor after the IRB review process is complete.

You Can Have Multiple Consent Documents 

If you are enrolling different subject populations who are doing different study procedures, it makes sense to prepare separate ICDs for each population. Make sure the difference between the documents is clear in the filename and in the title section of the document (under the study title) or in the footer, so that research team members use the correct version when they conduct the consent process.

Use Plain Language for a Lay Audience 

Potential subjects will not necessarily be experts in your field of study. Avoid using jargon that subjects may not understand. If you must use technical or scientific terms, be sure to define them. Use simple language to describe your study. You may have to simplify the language even further if you are enrolling people with a low reading or education level or people with cognitive impairment that might affect their ability to read and understand the study description.

Proofread and Request Feedback

It can be useful to read your draft ICD out loud and think about how it might sound to your potential subjects. You can also give it to a friend or relative and request feedback from someone who is not an expert in your field. It is especially important to proofread the ICD when you make edits during the IRB review process. In the “Review” tab, under “Tracking,” turn off “Mark Up” to see what the document will look like when the IRB accepts the tracked changes. This can help you catch extra periods or weird spacing that will affect how the document appears to your potential subjects. We recommend proofreading a clean version of your ICD before the first submission and every time you edit the document during the IRB review process.

Use Tables and Charts to Present Information 

It can be much easier for potential subjects to absorb and understand what happens at each study visit by looking at a table or chart. It might take several paragraphs to explain what you can show in a single table. A table or chart can be an easier reference for enrolled subjects to review during the study to see what will happen at each study visit.

Write in Active Rather Than Passive Voice 

It is much easier for subjects to understand sentences written in active voice. According to the Purdue Online Writing Lab, using active voice makes your sentences more clear and less wordy. The University of Wisconsin-Madison Writing Center website suggests that passive voice sentences can be vague and “lead to a tangle of prepositional phrases.” Here is an example of passive and active voice in an ICD:

  • Passive Voice: Your pain can be reduced by administration of topical analgesics and use of distraction techniques.
  • Active Voice: You may use topical analgesics and distraction techniques to reduce your pain.

Electronic Consent Process

The informed consent process for non-exempt human subjects research must adhere to federal regulations.  Further, FDA regulated studies must adhere to FDA-specific criteria.  This is especially important when developing an electronic informed consent process (eConsent).

The Human Subjects Office has several tools to help with the development of eConsent processes.  The Electronic Informed Consent Checklist tool helps researchers ensure the eConsent process is compliant with federal regulations and also assists UI researchers with the use of UI-supported eConsent tools, such as DocuSign.

There are also educational tools describing alternatives to an in-person informed consent process, DocuSign guidance, and instructions for setting up secure Zoom meetings and recordings. 

Mailed Consent Process: Handling Corrections

Mailed consent materials may be returned incomplete or incorrectly completed. If documents will be returned to the subject for corrections, the research team must describe how this will occur in Sections VII.D.29 (for adults) and/or VII.D.30 (for parents/guardians of minors) in HawkIRB. Researchers can generate the template, edit and attach the letter in the miscellaneous category on the Attachments page of HawkIRB. Investigators utilizing a mailed consent process may also tailor the signature block of ICD so the research team can indicate whether consent was obtained in person, over the phone, or if no conversation took place between a member of the research team and the subject.

Please be sure to generate your template in HawkIRB, not from this web example.