How to Write an Informed Consent Form That Your IRB Will Actually Approve

If you've submitted to an IRB before, you've probably experienced this: you spend weeks on the protocol, and the consent form is what comes back with revision requests. It makes sense when you think about it. The consent form is the one document participants actually read and sign, so IRBs go through it line by line. The good news is that the requirements aren't ambiguous. If you know what the regulations ask for and write in plain language, you can get approved without a drawn-out back-and-forth.

Why consent forms attract so many revisions

IRBs are responsible for confirming that participants give informed, voluntary consent. So the form has to be accurate, complete, understandable, and free of anything that could coerce or mislead. The problem is that researchers tend to write consent forms the way they write grant applications: dense, technical, full of qualifications. Reviewers don't want that. They want something a participant can actually sit down and read. When the form doesn't meet that bar, it comes back for revisions, sometimes more than once.

What the regulations actually require

Two sets of federal rules govern informed consent. 45 CFR 46.116 covers research under the Common Rule (typically federally funded studies). 21 CFR 50.25 covers FDA-regulated clinical investigations. The two are nearly identical. If you're unsure which applies to your study, our post on when HHS vs. FDA regulations apply walks through that.

Required elements of informed consent (every form must include all of these):

1. A statement that the study involves research, its purposes, expected duration, and what the participant will actually do
2. Reasonably foreseeable risks or discomforts
3. Benefits to the participant or others that may reasonably be expected
4. Alternative procedures or treatments, if any
5. How confidentiality of records will be maintained
6. For more-than-minimal-risk studies, whether compensation or medical treatment is available if injury occurs
7. Contact information for questions about the research, participant rights, and research-related injuries
8. A statement that participation is voluntary and that refusing or withdrawing carries no penalty

Additional elements (include when relevant to your study):

• Whether the research involves unforeseeable risks
• Circumstances under which the investigator may terminate participation
• Any additional costs to the participant
• Consequences of withdrawing and procedures for orderly termination
• A commitment to share new findings that might affect willingness to continue
• The approximate number of participants

These are not suggestions. If an element applies and it's missing, you'll get the form back.

Write for a real person, not a regulatory audience

Both 45 CFR 46.116 and 21 CFR 50.25 require that consent information be in "language understandable to the subject." Most IRBs interpret that as roughly an 8th-grade reading level.

What does that look like in practice? Short sentences. Try to keep them under 20 words. Use common words: "blood draw" instead of "venipuncture," "side effect" instead of "adverse event." Write in active voice: "We will collect your data" reads more clearly than "Data will be collected." And if you must use a technical term, define it in parentheses the first time. Run your draft through a readability checker (example).

The exculpatory language rule

This is one of the most common reasons we send consent forms back. Both regulations prohibit language that waives, or appears to waive, any of the participant's legal rights, or that releases the investigator, sponsor, or institution from liability for negligence. Here's what that looks like in practice:

• "By signing this form, you agree not to hold [sponsor] liable for any harm."
• "You understand that complications are inherent and accept all risks."
• "You waive any claims arising from participation in this study."

Even softened versions of these get flagged. If a sentence could be read as asking participants to give up their right to seek recourse, take it out.

Formatting matters

A wall of single-spaced text tells the IRB (and participants) that this form was not designed to be read. Use section headers so people can find information about risks, benefits, confidentiality, and their rights without reading front to back. Use bullet points or numbered lists for risks, procedures, and contact information. Bold the key points, like voluntariness and the right to withdraw. And keep the form as short as it can be while covering every required element. A longer form is not a more thorough form if people stop reading halfway through.

eConsent for digital health studies

More and more studies, especially in digital health, are collecting consent electronically rather than on paper. If you're going this route, be aware that reviewers will look at more than just the consent text. Participants need to be able to review the full form before signing, not just a summary screen. You need an audit trail showing when the form was presented, how long the participant spent with it, and when they signed. The system should let participants print or save a copy. If you're under FDA jurisdiction, 21 CFR 11 requirements for electronic signatures and records may apply. And include your eConsent process details in the IRB submission itself. Reviewers need to understand the technology, not just the text.

Our submission readiness checklist covers what to include about your consent process in the overall submission package.

Mistakes we see

We've reviewed a lot of consent forms, and the same problems keep showing up. Vague risk descriptions are probably the most common: "There may be some risks" is not going to cut it. Name the specific risks and, where you can, say how likely they are and how serious. Inflated benefits are close behind. Consent forms are not marketing materials. If the participant may not benefit directly, say that. Overpromising is both an ethical problem and a near-certain revision request.

Missing elements come up a lot too, usually the compensation-for-injury statement or the alternatives section. Check your form against the regulatory list above before you submit. We also see forms that are just too long. A 15-page consent form for a low-risk survey means the language hasn't been tightened, and nobody is going to read all of it. And exculpatory language has a way of sneaking in through boilerplate copied from another form or drafted by a legal team that doesn't deal with research regulations day to day.

Start with a template

We have a consent form template that covers the required elements in a format we know works. You'll still need to adapt it to your specific study, but it saves you from starting with a blank page.

How Tempus IRB can help

If you're working on a consent form and want to make sure it's solid before you submit, we're happy to look at it. Tempus IRB does fast, flat-rate protocol reviews, and most decisions come back within a day. Sign up to submit directly, or email us with questions before submitting.

This post is for informational purposes only and does not constitute legal advice.