Computer accessible methods for establishing informed consent
View Patent ↗A method for establishing certifiable patient informed consent for a medical procedure, where, in one embodiment, the patient interacts with a video training system until mastery of all required information is successfully achieved. Training techniques which permit elicitation of measurable behaviors from a patient as a guide to discerning the level of knowledge of the patient are utilized. Certification is only granted when the measurable behavior approximately coincide with the legal and medical standards for establishing informed consent. The system is capable of adapting to various medical procedures, as well as various patient attitudes and knowledge bases, while still maintaining a level of consistency throughout. In one embodiment, a minimum probability of understanding may be preset, and the training procedure will continue until the actual statistical probability of understanding is at least equal to the preset minimum. An interactive nature of the system is present in the present system for facilitating the training process and continuously monitoring the patient's knowledge.
1. A computer implemented method of establishing certifiable informed consent to a transaction, said method comprising the steps of:
a. estimating legal standards for establishing informed consent of a consumer to said transaction; then
b. defining computer measurable consumer behavior which can be approximately coincided with said estimated legal standards; then
c. computer training with a first set of instructions said consumer on desired aspects of said transaction through a computer controlled automatic utilization of preprogrammed information stored in a computer; and
d. computer interacting with said consumer in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in said computer to produce computer measurable consumer behavior said computer measurable consumer behavior automatically varying said interaction; and
e. automatically computer analyzing said consumer behavior; then
f. determining whether said training should be adjusted depending on said analyzing said consumer behavior;
g. identifying which portions of said training should be adjusted;
h. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted;
i. additionally computer interacting with said consumer in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in said computer to produce computer measurable consumer behavior; and
j. additionally computer analyzing said consumer behavior; then
k. additionally determining whether said training should be adjusted depending on said analyzing said consumer behavior; and
l. proceeding with said transaction upon computer determining that said consumer likely meets said legal standards for establishing informed consent to said transaction.
2. A computer implemented method of establishing certifiable informed consent to a transaction as described in claim 1 wherein said step of proceeding with said transaction upon computer determining that said consumer likely meets said legal standards for establishing informed consent to said transaction comprises the step of computer providing an automatic indication of certifiability that said consumer likely meets said legal standards for establishing informed consent to said transaction.
3. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of defining comprises the steps of:
a. translating said legal standards to computer measurable behavior; then
b. evaluating the validity of the correlation between said standards and said behavior.
4. A computer implemented method of establishing certifiable informed consent as described in claim 3 wherein said step of defining further comprises the step of continuously refining said step of measuring to achieve better approximation between said standards and said computer measurable behavior.
5. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of proceeding with said transaction upon computer determining that said consumer likely meets said legal standards for establishing informed consent to said transaction comprises the step of achieving defined computer measurable consumer behavior which approximately coincide with said legal standards.
6. A computer implemented method of establishing certifiable informed consent as described in claim 5 wherein said step of proceeding with said transaction upon computer determining that said consumer likely meets said legal standards for establishing informed consent to said transaction further comprises the step of statistically establishing a probability of satisfaction.
7. A computer implemented method of establishing certifiable informed consent as described in claim 6 wherein said step of statistically establishing comprises the steps of:
a. repetitively testing said consumer through use of said computer to elicit responses; then
b. evaluating said responses through use of said computer.
8. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of proceeding with said transaction upon computer determining that said consumer likely meets said legal standards for establishing informed consent to said transaction comprises proving mastery of aspects of said transaction by communicating with said computer.
9. A computer implemented method of establishing certifiable informed consent as described in claim 8 wherein said step of proving further comprises the step of storing said computer measurable consumer behavior.
10. A computer implemented method of establishing certifiable informed consent as described in claim 1 further comprising the steps of:
a. analyzing said transaction procedure comprising the steps of:
(1) compiling fundamental information on said transaction; then
(2) selecting information which may be stored within a computer and which is legally likely to be necessary for informed consent; then
b. designing a computer stored system utilizing an instructional system development model for computer training said consumer on said selected information.
11. A computer implemented method of establishing certifiable informed consent as described in claim 10 further comprising automatically periodically performing computer controlled criterion referenced testing on said consumer wherein said testing automatically varies said computer controlled presentation.
12. A computer implemented method of establishing certifiable informed consent as described in claim 11 wherein said step of automatically performing periodic, computer controlled criterion referenced testing comprises the steps of:
a. posing a set of applicable considerations to said consumer through use of said computer, wherein said considerations relate to said selected information; then
b. requiring said consumer to respond to said considerations by communicating with said computer.
13. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of determining whether said training should be adjusted comprises the steps of:
a. predetermining an acceptable statistical probability for indicating a correlation between said consumer response and said legal standards; then
b. periodically computing an actual statistical probability of said correlation through use of said computer; then
c. comparing said actual probability to said acceptable probability through use of said computer; then
d. adjusting said training until said actual probability is at least equal to said acceptable probability.