Informed Consent Form (Adult Participants)

Covers all required elements of 45 CFR 46.116. Use plain language (approximately 8th-grade reading level).

Study Title

[FILL IN: study title]

Invitation

You are invited to take part in a research study conducted by [FILL IN: PI name] at [FILL IN: institution]. Please read this form carefully. Ask questions before you decide whether to participate.

Purpose of the Study

[FILL IN: 2–3 plain-language sentences on what the study is trying to learn.]

What You Will Be Asked to Do

If you agree to participate, you will [FILL IN: procedures, instruments, duration, location, frequency]. Participation is expected to take approximately [FILL IN: time].

Risks and Discomforts

The risks of taking part are [FILL IN]. [FILL IN: mitigation.]

Benefits

You may not benefit directly. Your participation may help [FILL IN].

Alternatives

You do not have to take part. [FILL IN: alternatives or note that none apply.]

Confidentiality

Your responses will be kept confidential. [FILL IN: de-identification, storage, access, retention.] Results may be published, but you will not be identified.

Compensation

[FILL IN]

Voluntary Participation

Your participation is voluntary. You may skip any question or stop at any time with no penalty and no loss of benefits.

Contact Information

• Study questions: [FILL IN]
• Participant rights questions: [FILL IN: IRB office]

Consent Statement

By signing below, I confirm that I have read this form, had my questions answered, and voluntarily agree to take part. I am at least 18 years old.

Participant Name (printed):

Participant Signature / Date:

Person Obtaining Consent / Date: