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Informed Consent for Surgical and Diagnostic Procedures

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Georgia Regents Medical Center
Informed Consent for Surgical and/or Diagnostic Procedures

Patient Label

CONSENT

Date:    Time:

1. I, , understand and acknowledge that I am to undergo the following procedure(s):

2. This procedure is to be performed by:

I further understand that my physician may be assisted during this procedure by other physicians or practitioners whom he designates; and who may assist or perform portions of the procedure(s) at the request or under the direction of my physician.

3. I understand that the purpose of this procedure is:

4. I understand that this procedure involves certain risks. These may include risk of infection, allergic reaction, disfiguring scar, severe loss of blood, loss of function of any limb or organ, paralysis, brain damage, cardiac arrest, or death. In addition to these risks, there may be other possible risks as a result of this procedure, including, but not limited to:

5. I acknowledge and understand that during the course of the procedure(s) described above, it may become appropriate to perform additional procedures which are unforeseen or not known to be needed at the time this consent is given. Therefore, I hereby consent to and authorize Georgia Regents Medical Center (GRMC), its medical staff and those other medical personnel selected by GRMC to make decisions concerning the performance of such procedure(s) as they deem reasonably appropriate in the exercise of their professional judgment. This consent shall also extend to the treatment of all conditions which may arise during the course of such procedures including those conditions which may be unknown or unforeseen at the time this consent is given. If conditions permit, an attempt to notify an authorized family member of changes occurring in the operating room will be made.

6. I understand that if I do not undergo this proposed procedure(s), my prognosis is:

7. I understand that the practical alternatives to this procedure include:

8. I authorize GRMC to dispose of any severed tissue, organs, or body parts in accordance with the law and with GRMC policies.

9. I also consent to diagnostic studies, tests, anesthesia, x-ray examinations and any other treatment or courses of treatment relating to the diagnosis or procedures described herein. A separate informed consent document may be required prior to some of these procedures.

10. If a medical device is implanted in me, I authorize GRMC to provide the manufacturer of such implanted device with my name, address, telephone number, and social security number for implant tracking purposes.

11. I understand that GRMC is an academic medical center with education as an integral part of its mission. Consequently, I authorize the presence of students and other observers for educational purposes during my procedure.

12. I authorize the taking and publication of photographs or films (including videotape and television monitoring) of the procedure(s) subject to the following conditions:

a. that said photographs, films, or video be used only for purposes treatment and/or for the purposes of education and research both internal and external to GRMC, and

b. that the above described use and disclosure may continue without expiration except and unless I rescind authorization for such use and disclosure in writing, and

c. that the name of neither me nor my family will be used to identify said photographs, films, or videotapes.

13. I understand that I have the right to ask questions and I hereby certify that I have been given the opportunity to ask questions and that any such questions have been answered or explained to my satisfaction.

14. I understand that no guarantees, assurances, or promises have been made to me concerning the results of this procedure.

Page 1 of 2


CONSENT

For Procedure(s):

15. By signing this form, I acknowledge that I have read it carefully or had it read or explained to me and that I understand this form and its contents, and I hereby voluntarily consent to and request GRMC, its medical staff, and all other medical personnel which may otherwise be involved in my treatment to perform the procedure(s) described or otherwise referred to herein.

(This consent will be valid for thirty (30) days from date of signature unless revoked.)

Patient / Guardian [Printed Name]:

Patient / Guardian [Signature]:

Date:    Time:

Witness [Printed Name]:

Witness [Signature]:

Date:    Time:

I, , certify that I explained the above referenced procedure(s) to , on .

I further certify that the patient was given an opportunity to ask questions regarding the procedure(s), potential risks, and possible alternatives.

Practitioner’s Signature / Title:

Date:    Time:


OPERATIVE CONSENT FOR TRANSFUSION

SECTION NOT APPLICABLE FOR THIS PROCEDURE

I understand that it may be deemed necessary by my surgeon and/or anesthesiologist during or after surgery to give me blood or blood component in order to restore blood volume or clotting factors and/or to improve oxygen carrying capacity. Though the risks today are very low and blood is screened for transmittable diseases, potential risks of the transfusion of blood or blood components include, but are not limited to, transfusion reactions, such as headache, fever, chills, rash, difficulty breathing, excessive blood volume, and blood-borne infections. Potential risks of not receiving blood or blood components include bleeding, stroke, heart attack, and death. Potential alternatives to receiving blood or blood components that may be available are self-donation, directed donation, or cell saving technologies.

CONSENT     DO NOT CONSENT

Patient / Legal Guardian* [Signature]:

Date:    Time:

Witness Signature:

Date:    Time:

* I, , hereby represent and certify that I am the spouse, parent, or legal guardian of the patient, as evidenced by my signature above.


TELEPHONE CONSENT

When a telephone consent is being obtained, the above information must be read to the person consenting.

I, , read the above information to at Date:

states that he/she is of and he/she authorized the treatment/procedure described above and has been provided an opportunity to ask any desired questions.

Practitioner’s Signature / Title: Date: Time:

I witnessed and overheard the telephone conversation in which the above consent was given to perform the desired treatment/procedure.

Signature of First Witness:

Address of First Witness:

Signature of Second Witness:

Address of Second Witness:

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What this informed consent document covers

An Informed Consent for Surgical and Diagnostic Procedures is a written record that documents a patient’s voluntary agreement to a proposed operation, diagnostic test, or treatment after disclosure of the nature of the procedure, anticipated benefits, material risks, and reasonable alternatives. The form records that the patient had an opportunity to ask questions, received understandable answers, and has the capacity and authority to consent. Properly executed consent establishes decision-making intent, identifies the parties, and becomes part of the medical record to support clinical, legal, and billing processes.

Why a formal consent form matters and its legal standing

A properly completed consent form protects patient autonomy and documents clinical disclosure, reducing legal exposure for clinicians. Electronic signatures and records are generally enforceable under the federal ESIGN Act (15 U.S.C. ch. 96) and state UETA statutes; however, state-specific rules or statutory exceptions may affect admissibility and procedures.

Why a formal consent form matters and its legal standing

Who completes and relies on the consent form

The form is used by clinical teams, patients (or authorized surrogates), and health records or legal staff to document agreement to care.

  • Surgeons and procedural clinicians responsible for explaining the procedure and obtaining consent.
  • Patients, legally authorized representatives, or guardians who must understand and sign the form.
  • Medical records, risk management, and billing staff who retain and reference the signed consent.

Use the completed form as part of the patient chart; retain according to medical record retention rules and institutional policy.

How to complete the consent step by step

Follow a consistent process to ensure clarity and legal sufficiency before any non-emergency procedure.

  • 01
    Prepare: Confirm patient identity, review history, and ensure the correct procedure is named.
  • 02
    Disclose: Explain purpose, expected benefits, material risks, and reasonable alternatives.
  • 03
    Confirm understanding: Ask the patient to restate key points and address any questions or concerns.
  • 04
    Document: Obtain required signatures, date/time, witness or notary if applicable, then file.

Common questions and quick answers

Answers to typical issues encountered when obtaining, executing, or storing informed consent for procedures.


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Essential sections a professional consent should include

A well-structured consent includes specific, auditable sections so clinicians and patients share a clear record of the decision.

Procedure Details

A concise statement of the procedure, including laterality, sites, and any specific techniques, to eliminate ambiguity about what is being authorized.

Risks and Benefits

Clear description of material risks and expected benefits, tailored to patient context and the most relevant statistical likelihoods when available.

Alternatives

List reasonable alternatives, including non-surgical options and the risks of declining treatment, so the patient can compare choices.

Questions and Responses

A record that questions were invited and answered helps confirm understanding and supports the informed-consent process.

Authorization & Signatures

Signature area for patient or authorized representative, clinician attestation, date/time, and space for witness or notary if required.

Documentation Notes

Space for procedure-specific notes (e.g., sedation consent, blood product consent) and fields for attaching supplemental documents or imaging consent.

Key security and compliance safeguards

Encryption: TLS 1.2/1.3 in transit, AES-256 at rest.
Audit Trail: Timestamped signer events and IP logging.
Access Controls: Role-based permissions and session timeouts.
HIPAA Support: BAA required for protected health information.
Regulatory Certifications: SOC 2 Type II and ISO 27001 available.
Authentication Options: Email, SMS code, or stronger multi-factor methods.

Consequences of inadequate or incorrect consent

Invalid Consent: May render the procedure unauthorized.
Civil Liability: Exposure to malpractice claims.
Criminal Risk: Unconsented invasive acts can trigger criminal charges.
Regulatory Penalties: HIPAA breaches may lead to fines.
Insurance Denial: Payment disputes for lack of valid consent.
Care Delays: Missing consent can postpone time-sensitive treatment.

Frequent errors to avoid when preparing consent

  • Omitting a clear procedure description or using shorthand that creates ambiguity about the authorized intervention.
  • Failing to document that risks and alternatives were discussed or that the patient had an opportunity to ask questions.
  • Accepting a signature from an unauthorized surrogate without verifying legal authority or lacking supporting documentation.
  • Using inconsistent dates, missing timestamps, or unsigned pages that break the chain of attribution in medical records.

Typical e-signature workflow for clinical consent

Digital workflows can capture consent efficiently while preserving attribution and audit logs required for clinical use.

  • Upload Document: Add the consent PDF or template to the signing platform and place required fields.
  • Assign Signers: Enter patient and clinician email addresses or generate a secure signing link.
  • Authenticate: Authenticate signer via email link, SMS code, or stronger verification where required.
  • Store & Audit: Save the signed record to the EHR, retain an audit trail, and flag for billing or legal review.

Recommended digital workflow settings

Configure your e-signature workflow to balance accessibility with verification appropriate for medical consent.

Field Configuration
Authentication Method Email link by default; require SMS or MFA for high-risk procedures.
Signer Order Patient first, then clinician attestation for chain of custody.
Required Fields Procedure, alternatives, risks, signature, date/time, witness if needed.
Retention Destination Automatically attach signed PDF to the patient EHR and backup archive.

Technical compatibility and file formats

Ensure the signing tool supports common clinical file types, secure storage, and integrations with health systems.

  • File Formats: PDF and DOCX are standard; ensure platform preserves embedded fields.
  • Integrations: Connectors for EHRs and cloud storage (e.g., Microsoft 365, Google Workspace, NetSuite) streamline filing.
  • Accessibility: Support for mobile devices and assistive technologies (WCAG 2.0 Level AA).

Confirm the platform can enforce audit trails, export signed PDFs, and meet any BAA or 21 CFR Part 11 needs before use.

Timing considerations and critical windows

Timing depends on procedure type and clinical urgency; document the time relationship between disclosure and the intervention.

Pre-procedure Consent:

Obtain prior to the procedure except in emergencies where implied consent may apply.

Elective Procedures:

Allow sufficient time—commonly at least 24 hours for major elective surgery when practicable.

Minors and Guardians:

Parental or guardian consent must be obtained per state law before non-emergent procedures.

Revocation Window:

Patients may revoke consent before action; document revocation and notify clinical team immediately.

Documentation Timing:

Enter signed consent into the record promptly and include timestamps for auditability.

Representative e-signature vendor comparison for consent workflows

Compare baseline pricing and key capabilities when selecting an e-signature provider for clinical consent management; signNow is listed first per vendor comparison conventions.

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 Varies by plan Varies by plan Varies by plan Varies by plan
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies
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