Survey informed consent checklist: 18 checks for online research

An online research consent process should give a prospective participant understandable, decision-relevant information before any study questions and a genuine choice to take part. A click-through screen is not automatically sufficient: the governing jurisdiction, institution, population, risk, approved protocol and any ethics-board waiver determine what is required.

What is informed consent for an online survey?

Informed consent is an ongoing communication process that helps a prospective participant understand a study and choose freely whether to take part. The consent screen is one implementation of that process. It is different from a privacy notice, which describes data processing, and from a platform checkbox, which only records an interface action.

Under 45 CFR 46.116, research covered by the U.S. Common Rule generally requires legally effective consent before involving a human subject, unless an authorized waiver or alteration applies. The rule also requires understandable language, information a reasonable person would want and a presentation that facilitates comprehension. Other jurisdictions and institutions can impose different or additional duties.

The 18-check consent-screen checklist

Treat “not applicable” as a reviewed decision, not a shortcut. The exact required elements depend on the governing rules and the approved protocol; the checklist is an implementation aid, not an approval instrument.

Documentation decision tree

1. Does an applicable rule require prospective consent? If not, retain the exemption, nonresearch determination or approved waiver instead of inventing a consent screen.
2. Does the approved process require a signed form? If yes, use the approved form and a valid signature method. Under 45 CFR 46.117, covered written consent may be signed electronically, and a copy must be given to the signer.
3. Has an IRB waived signed documentation? A waiver of the signature requirement is not automatically a waiver of consent. Use the approved information and agreement process, and retain the IRB determination.
4. Is a short-form oral process approved? Follow the witness, signature, summary and copy requirements rather than translating them into a generic checkbox.

The HHS Office for Human Research Protections FAQ also notes that electronic signatures depend on applicable law and IRB review, and that participants need a form they can retain when a signed form is required.

Comprehension-first screen structure

Start with why the person is invited, what they will do, the most important risks, whether participation is voluntary and whom to contact. Then provide the complete approved information. For covered Common Rule research, §46.116 requires a concise, focused key-information presentation at the beginning and prohibits a presentation that merely lists isolated facts without supporting understanding.

Reproducible implementation test

Worked example

A minimal-risk university survey begins with an approved key-information panel and the complete study details. “I agree to participate” continues to the questionnaire; “I do not agree” exits. The export stores consent version v3, the event time and the route taken. It does not fabricate a signature field. Whether that process is adequate depends on the institution's determination and any approved waiver of signed documentation.

Transparent method

We mapped the checklist to the current elements and presentation rules in §46.116, separated consent from documentation using §46.117, and tested the online-specific boundary against OHRP guidance on electronic signatures and documentation waivers. We excluded a previously queued WHO URL because it now returns 404 and did not replace it with a secondary summary.

When to stop and seek qualified review

Seek institutional, ethics, privacy or legal review for covered research, vulnerable populations, children, deception, sensitive data, cross-border recruitment, interventions, clinical topics, biospecimens or uncertainty about waivers. Do not copy a template and assume compliance. A reviewing body may require different language, documentation or additional protections.

Limitations

This checklist is educational and not legal advice or ethics approval. It does not decide whether an activity is research, exempt, covered by the Common Rule or governed by another law. The cited U.S. rules do not govern every survey. Local law, institutional policy, funder rules, the approved protocol and the reviewing body control the real process.