Purpose
Explain what will happen and why; keep language plain and specific so the signer understands the objective.
A concise Basic Informed Consent Form reduces misunderstanding, documents legal consent, and creates an auditable record for compliance and risk management under applicable laws such as HIPAA and state rules.
Use and exact content vary by industry; include the minimum legally required content for the applicable jurisdiction and sector.
An adult or a legally authorized representative who understands the information, demonstrates intent, and signs the form; their identity and capacity must be documented to support validity.
The licensed clinician or study representative who explains the procedure, answers questions, and documents that required disclosures were made and understood.
Explain what will happen and why; keep language plain and specific so the signer understands the objective.
List expected positive outcomes or purpose-related advantages the signer should reasonably expect.
Disclose material risks, common side effects, and likelihoods so consent is informed.
Describe reasonable alternatives, including the option of no action and any associated tradeoffs.
Confirm that consent is voluntary, revokeable, and that the signer can ask questions or withdraw consent.
Provide full name, signature, printed name, date, and signer role; include witness or representative fields where required.
| Field | Configuration |
|---|---|
| Signature | Required, date-stamp enabled |
| Authentication | Email link + optional SMS code |
| Witnessing | Conditional witness field if required |
| Storage | Secure archive with audit trail |
Choose platform settings that capture intent, consent, attribution, and retention to satisfy the ESIGN four‑part validity test.
Capture consent before the procedure or data use
Process and document within reasonable business timelines
Respond to records requests per HIPAA timelines
Obtain consent prior to any study procedures
Keep I-9s per 8 CFR §274a.2 retention rules
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Plan | 7-day free trial | Varies | Varies | Varies | Varies |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |