Can I use an electronic signature?

Yes. Electronic signatures are legally recognized under the ESIGN Act (15 U.S.C. ch. 96) and UETA in most states, provided the signature meets intent, consent, attribution, and retention requirements.

Is a HIPAA authorization required?

If protected health information will be used or disclosed beyond treatment, payment, or operations, include explicit HIPAA authorization language and note any institutional or BAA requirements.

Do I need notarization or witnesses?

Generally no for routine consent, but specific state laws or institutional policies may require witnesses or notarization for certain documents; verify local practice and IRB guidance.

How long should I retain signed consents?

Retain consent records for the duration required by funder, IRB, or applicable law; HIPAA requires six years for HIPAA-covered records (45 CFR §164.530(j)), and research sponsors often specify additional periods.

What identity checks are sufficient?

Use risk-based authentication: email verification for low-risk contexts, SMS or knowledge-based authentication for higher risk, and stronger methods where regulations demand stricter identity proofing.

Can a signer revoke consent?

Yes. Include clear withdrawal instructions and explain any limits to withdrawal, such as data already used in aggregated analyses or regulatory reporting obligations.

Electronic Signature
Templates
Healthcare
Human Informed Consent Form

Human Informed Consent Form

This template is fully customizable. Edit the text, fill out the fields, and send it for signature. Give it a try!

What the Human Informed Consent Form Is and When it’s Used

A Human Informed Consent Form documents a participant's voluntary agreement to take part in a study, clinical procedure, or other activity after receiving clear information about purpose, risks, benefits, alternatives, and data handling. It records the material facts a reasonable person would need to decide, confirms capacity to consent, and includes signatures and dates to show informed, attested agreement. In many U.S. contexts an informed consent form also identifies the responsible investigator or clinician, describes confidentiality protections and retention, and explains how to revoke consent or ask questions about the activity.

Why a Proper Human Informed Consent Form Matters

A clear, complete consent form protects participant autonomy, documents legal compliance, and reduces risk by recording informed decision-making. It supports research integrity, institutional review board review, and regulatory audits while clarifying expectations for participants and investigators.

Who Prepares and Signs a Human Informed Consent Form

Common users include research teams, clinical staff, legal reviewers, and participants or their authorized representatives.

Research teams and principal investigators who design the study and obtain consent
Clinical staff and study coordinators who explain procedures and answer questions
Participants or legally authorized representatives who review, ask questions, and sign

Core Elements to Include in a Professional Consent Form

A professionally prepared Human Informed Consent Form is concise, readable, and organized so participants can locate key facts quickly. Use plain language, define technical terms, and structure sections for purpose, procedures, risks, benefits, alternatives, data use, and withdrawal rights.

Purpose

A short plain-language statement of why the activity is being done and what it intends to measure or accomplish.

Procedures

A step-by-step description of what participants will experience, including duration, frequency, and any follow-up required.

Risks

All reasonably foreseeable physical, psychological, social, or privacy risks, described with likelihood and severity when known.

Benefits

Potential direct benefits to participants and any anticipated benefits to others or to general knowledge.

Alternatives

Available alternatives to participation, including standard care options when applicable.

Data Use

How data will be collected, stored, shared, protected, and the participant's rights regarding access and withdrawal.

Step-by-Step: How to Complete and Sign a Human Informed Consent Form

Follow these sequential steps to ensure the consent is informed, voluntary, and properly recorded.

01

Review Disclosures: Read purpose, procedures, risks, benefits, and alternatives before discussing questions.
02

Ask Questions: Clarify any uncertainties with the investigator or clinician until comfortable.
03

Sign and Date: Participant signs, prints name, and dates the form; representative signs where applicable.
04

Provide Copy: Give the participant a dated copy; file the original with study records.

How to Configure an Online Consent Workflow

Set up the digital workflow to capture consent securely, verify identity where required, and preserve an audit trail.

Field	Configuration
Signature Field	Required — signatories must complete to finalize consent
Date Field	Auto-fill option with MM/DD/YYYY format
Authentication	Email verification by default; use SMS or KBA for stronger ID
Audit Trail	Enable detailed logs: IP, timestamp, and actions

Typical Digital Signing Flow for Informed Consent

A standard e-signing process captures consent electronically while preserving auditable evidence of the signing event.

Upload Form: Institution uploads PDF or DOCX of the consent form into the signing platform.
Place Fields: Drag signature, date, and initial fields to the required locations.
Send to Signer: Send secure link or email invite to the participant or authorized representative.
Complete Signing: Signer authenticates, reviews, and signs; system records an audit trail.

Technical Considerations for Electronic Consent and eSubmission

Verify platform features and security before using digital consent for regulated activities.

Authentication: Email, SMS, KBA, or stronger methods depending on sensitivity.
Audit Trail: Detailed event logs with timestamps and IP addresses.
Integrations: Connectors for EHR, LMS, or institutional records for secure archival.

Real-World Examples of Electronic Consent in Practice

These examples show how organizations used electronic workflows to collect informed consent securely while preserving compliance records.

Optica Ventures LLC

A mid-size research organization adopted e-consent for field studies to reduce turnaround time.

Implementation focused on mobile signing for participants.
Brian Fitzgibbons, COO, said the interface is simple and easy to use for staff and customers and supported faster document handling while maintaining necessary records.

Fertility Centers of Illinois

A clinical practice standardized consent across clinics and integrated signed records into EHR.

Integration automated filing and audit logs.
John Butler, Founder, reported the team was pleased with the API and responsiveness, enabling compliant, efficient consent collection across locations.

Consequences of Incomplete or Invalid Consent

Regulatory Action: Fines or sanctions by oversight bodies for noncompliance

Legal Liability: Civil claims for battery, negligence, or breach of privacy

Data Breach Risk: Inadequate protection of PHI can trigger HIPAA penalties

Study Invalidity: IRB may deem collected data unusable without valid consent

Reputational Harm: Loss of participant trust and institutional credibility

Operational Delay: Required corrective actions can halt study or clinical activity

Common Preparation and Execution Pitfalls

Using overly technical language that participants do not understand
Failing to document the participant’s questions and investigator responses
Mismatched names or missing dates on signature blocks
Neglecting to preserve an auditable copy of the signed consent

Comparison: eSignature Pricing and Compliance Options

This vendor comparison shows starting prices and core features relevant to organizations collecting consent electronically. Pricing reflects typical annual billing tiers or published starting plans.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial	No	No	Yes, limited	Yes, limited
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes (BAA)	Yes (BAA)	Yes (BAA)	No	No

Frequently Asked Questions About Human Informed Consent Forms

Answers to common questions about form validity, e-signatures, identity verification, and recordkeeping for informed consent.

Need help? Contact support

Can I use an electronic signature?
Yes. Electronic signatures are legally recognized under the ESIGN Act (15 U.S.C. ch. 96) and UETA in most states, provided the signature meets intent, consent, attribution, and retention requirements.
Is a HIPAA authorization required?
If protected health information will be used or disclosed beyond treatment, payment, or operations, include explicit HIPAA authorization language and note any institutional or BAA requirements.
Do I need notarization or witnesses?
Generally no for routine consent, but specific state laws or institutional policies may require witnesses or notarization for certain documents; verify local practice and IRB guidance.
How long should I retain signed consents?
Retain consent records for the duration required by funder, IRB, or applicable law; HIPAA requires six years for HIPAA-covered records (45 CFR §164.530(j)), and research sponsors often specify additional periods.
What identity checks are sufficient?
Use risk-based authentication: email verification for low-risk contexts, SMS or knowledge-based authentication for higher risk, and stronger methods where regulations demand stricter identity proofing.
Can a signer revoke consent?
Yes. Include clear withdrawal instructions and explain any limits to withdrawal, such as data already used in aggregated analyses or regulatory reporting obligations.

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