Informed Consent Form Generator

How to Use the Informed Consent Form Generator

1. 1. Name the study and the contacts. Enter the title, the researcher, the institution, and the IRB office participants can call about their rights — the form needs both contacts.
2. 2. Write each box for a participant. Purpose, procedures, time, risks, benefits and confidentiality, in short sentences and the second person. Put the main point first: the key-information summary at the top quotes each box's first sentence.
3. 3. Choose the options that fit. Risk level, future use of the data, payment, recording, and whether people sign or — only with an IRB waiver — agree by continuing.
4. 4. Clear the checklist. Anything marked "Needs your words" still shows a bracketed prompt in the form. Rewrite whatever the plain-language check flags.
5. 5. Move it into your IRB's template. Copy it for Word or Google Docs, or as plain text, and submit it with your protocol.

What 45 CFR 46.116 Requires

The Common Rule is the U.S. federal policy for research with human participants, and 45 CFR 46.116 sets out what consent must contain. Its general requirements come first: consent must be sought in a way that minimises coercion, in language the participant understands, with the information a reasonable person would want — and with no exculpatory wording that asks people to give up legal rights or release the researcher from liability for negligence. The 2018 revision, in force since January 2019, added that a consent form must begin with a concise key-information section and be organised to help people understand, not merely list facts.

Section 46.116(c) adds nine elements to include when appropriate — risks that cannot be foreseen, circumstances in which the researcher may end someone's participation, extra costs, what happens when someone withdraws, notice of significant new findings, the approximate number of participants, commercial profit from biospecimens, whether individual results will be shared, and whole genome sequencing. The generator offers each one as an optional box or switch.

Key Information, With an Example

The regulation does not list what key information means, but the preamble to the 2018 rule suggests five things a brief summary would usually cover: that consent is being sought for research and taking part is voluntary; the purpose, duration and procedures; the main foreseeable risks; the expected benefits; and any alternatives. For a 20-minute online survey of first-year students' sleep and study habits, the generator opens the form like this:

Each bullet is the first sentence of the matching box, so the summary and the detail below it can never disagree. If a bullet reads badly, the box it came from does not lead with its point.

Common Mistakes in Consent Forms

• Promising anonymity you cannot deliver. If a name, an email address, an IP address or a signed form can link answers to a person, the data are confidential, not anonymous.
• Writing for the IRB instead of the participant. Federal rules require understandable language without fixing a reading level, but many IRBs ask for roughly grade 8 or lower. Short sentences and everyday words do most of the work; check the draft with the Readability Score Checker.
• Listing payment as a benefit. FDA guidance treats payment as a recruitment incentive, not a benefit, and most IRBs expect the same. Put it under payment.
• Leaving out the future-use statement. Whenever identifiable information or biospecimens are collected, (b)(9) requires one of its two statements, even for a simple survey that asks for names.
• Exculpatory wording. "I release the university from all claims" is prohibited outright by §46.116(a)(6).
• Dropping the signature without a waiver. An agree-to-continue page is only acceptable when the IRB has waived documentation under §46.117(c).

Frequently Asked Questions

What are the required elements of informed consent?

Under 45 CFR 46.116(b) there are nine basic elements: a statement that the study is research with its purpose, duration and procedures; foreseeable risks; expected benefits; alternatives; confidentiality; compensation and treatment for injury when risk is more than minimal; contacts; voluntary participation; and, when identifiable data or biospecimens are collected, a statement about future research use. Since 2018 the form must also open with a concise key-information section.

What is the key information section of a consent form?

It is a short summary at the very start of the form that helps someone decide whether to take part. The preamble to the 2018 rule suggests it cover the voluntary nature of the research, its purpose, duration and procedures, the main risks, the benefits, and any alternatives. Keep it to a few sentences or bullets — the detail belongs in the sections that follow.

Is a consent form from this generator IRB-approved?

No. It is a draft built on the federal requirements, not an approved document. Your IRB must review and approve every consent form before you use it, and many institutions require their own template, so paste the generated sections into that template and keep its mandatory wording.

Can I use an online consent form without a signature?

Only if your IRB waives the signature requirement. Under 45 CFR 46.117(c) it may do so when the signed form would be the only record linking a person to the study and the main risk is a breach of confidentiality, when the research is minimal risk and involves nothing that would normally need written consent, or for certain cultural groups where signing is not the norm. Choose "No signature" in the generator only after that waiver.

What is the difference between anonymous and confidential data?

Anonymous means nobody, including the research team, can link a response to a person. Confidential means the team can, but promises to protect that link and limit who sees it. A survey that collects names, emails or IP addresses, or that is tied to signed forms, is confidential at best.

Do I need a consent form for a class project or student survey?

It depends on whether the project counts as research. The Common Rule defines research as a systematic investigation designed to contribute to generalizable knowledge (45 CFR 46.102(l)), and many class exercises meant only for learning fall outside it. Your IRB decides, not you — ask before collecting any data, and use a consent form whenever it says the project is research.