Method And Software Product For Establishing Informed Consent

• US 20080281628A1
• Filed: 06/29/2005
• Published: 11/13/2008
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: MCA Medicorp Pty Limited
• Original Assignee: MCA Medicorp Pty Limited
• Inventors: Flynn, John
• Application Number:
  US11/570,973
• Publication Number:
  US 20080281628A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records

Abstract

A method and software product by which a medical practitioner (30) is able to obtain verifiable informed consent from a patient (32) involves the use of a computer system (3) executing a software product (18). The software product contains instructions to generate a series of forms on display (6). Initial forms are used to capture identification details of patient (32). Patient biometric data, such as retinal, iris, or fingerprint scans may also be captured by means of a biometric device (29). Software product (18) further includes instructions to generate a series of question forms about a medical procedure proposed for the patient. The software product is structured so that the patient is restricted from progressing through the series of questions unless a correct answer is elicited at each stage. At the termination of the questioning phase patient (32) is prompted to reconfirm their identity details. A log of the question session is written to an optical disk (28) and an informed consent form (27) printed for signature by the patient (32). The informed consent form will preferably include an identifier uniquely identifying the optical disk (28).

Claims

1. A method to elicit informed consent of a patient to a medical treatment by means of a computer system;

the method including the steps of;

capturing information identifying the patient;

confirming the patient'"'"'s identity with the computer system using the captured information;

presenting the patient with a series of questions concerning the medical treatment;

processing patient answers to the questions;

subsequent to each question restricting progress through the series of questions on the basis of the patient'"'"'s answers;

prompting the patient to confirm the captured identifying information upon successful completion of the patient'"'"'s answers;

recapturing information identifying the patient;

reconfirming the patient'"'"'s identity with the computer system using the recaptured information; and

generating a consent form upon the patient successfully reconfirming the patients identity and answering the predetermined set of the questions correctly.

2. A method according to claim 1, wherein the predetermined set of the questions comprises all of the questions concerning the medical treatment.

3. A method according to claim 1, wherein the method includes a step of recording a log of the questions and the patient'"'"'s answers.

4. A method according to claim 1, including terminating the method prior to generating the consent form in the event that the patient does not confirm the captured information.

5. A method according to claim 1, wherein the steps of capturing and recapturing information identifying the patient involves using biometric means and includes operation of one or more of:

a retinal scanner;

an iris scanner;

a fingerprint scanner.

6. A method according to claim 3, including saving the log to a removable data storage medium.

7. A method according to claim 6, including recording a unique identifier in respect of the removable data storage medium and printing the unique identifier upon the consent form.

8. A method according to claim 1, wherein the step of restricting progress through the series of questions on the basis of the patient '"'"'s answers includes repeatedly presenting an incorrectly answered question until a correct answer is solicited.

9. A method according to claim 8, including presenting information as to why an answer to a question was deemed incorrect.

10. A method according to claim 3, including converting the consent form into an electronic file and storing same within the computer system upon the consent form being signed by the patient.

11. A method according to claim 10, wherein the electronic file of the consent form is stored upon the removable storage medium with the log.

12. A method according to claim 3, including capturing an identifier uniquely identifying an optical storage medium to which the log is to be written.

13. A method according to claim 12, including printing the identifier on the consent form.

14. A computer software product bearing instructions readable by a computational device to implement a method according to claim 1.

15. A computational device programmed to implement a method according to claim 1.