Instruments and methods for obtaining informed consent to genetic tests

Abstract

This invention provides an instrument for obtaining consent for a genetic test that comprises three or more integrated elements including an information element for conveying information to an individual concerning a genetic test, and instruction element for use by a practitioner in instructing individuals on the genetic test and use of the instrument, a collection element for collecting an individual's medical and family history, a assessment element for assessing the individual's retention and understanding of information concerning a genetic test, a certification element for certifying the individual's consent to said tests, as well as housekeeping elements useful for recording a medical record, labeling a sample, and billing. Also provided is a method for obtaining informed consent for a genetic test using an integrated instrument. The instruments and methods disclosed have utility in obtaining informed consent for genetic tests.

I claim: 
     
         1 . An instrument for obtaining from an individual informed consent to a genetic test, said instrument comprising:
 (a) an information element;   (b) an instruction element, integrated with said information element; and   (c) a certification element, integrated with said instruction and said information elements.   
     
     
         2 . An instrument according to  claim 1  wherein said genetic test is selected from the group consisting of a test for one gene, a test for more than one gene, a test for related genes, a test for genes associated with a specified clinical outcome and a gene screen test. 
     
     
         3 . An instrument according to  claim 1  comprising at least one additional element selected from the group consisting of a collection element, an assessment element, a labeling element, a billing element, a recording element, a training element, a quality control element, and an indemnification element. 
     
     
         4 . An instrument according to  claim 3  wherein said additional element comprises an assessment element. 
     
     
         5 . An instrument according to  claim 3  wherein said additional element comprises a collection element. 
     
     
         6 . An instrument according to  claim 3  wherein said additional elements comprise an assessment element and a collection element. 
     
     
         7 . An instrument according to  claim 6 , additionally comprising at least one element selected from the group consisting of a labeling element, a billing element, a recording element, a training element, a quality control element and an indemnification element. 
     
     
         8 . An instrument for obtaining from an individual informed consent to a genetic test, said instrument comprising:
 a) an information element;   (b) an instruction element, integrated with said information element;   (c) a certification element, integrated with said instruction and said information elements;   (d) an assessment element, integrated with said information and said instruction elements; and   (e) a collection element, integrated with said information and said instruction elements.   
     
     
         9 . An instrument according to  claim 8  wherein said genetic test is selected from the group consisting of a test for one gene, a test for more than one gene, a test for related genes, a test for genes associated with a specified clinical outcome and a gene screen test. 
     
     
         10 . A method for obtaining informed consent to a genetic test from an individual comprising the steps of:
 (a) procuring an integrated instrument for obtaining informed consent to the genetic test, said instrument including an information element, an instruction element integrated with said information element, and a certification element integrated with said information and said instruction elements;   (b) conveying to the individual information concerning said genetic test using said information element;   (c) instructing an individual according to the directions contained in said instruction element; and   (d) certifying the individual's consent for said test using said certification element.   
     
     
         11 . The method according to  claim 10 , wherein said integrated instrument additionally includes a collection element integrated with said information and said instruction elements, and said method comprises the additional step of collecting a personal medical history and family history using said collection element. 
     
     
         12 . The method according to  claim 10  wherein said integrated instrument additionally includes an assessment element integrated with said information and said instruction elements, and said method comprises the additional step of assessing the individual's retention or comprehension of the information using said assessment element. 
     
     
         13 . The method according to  claim 10  wherein said integrated instrument additionally includes a labeling element integrated with said information and said instruction elements, and said method includes the additional step of labeling a sample with the identity of the individual using said labeling element. 
     
     
         14 . The method according to  claim 10  wherein said integrated instrument additionally includes a recording element integrated with said information and said instruction elements, and said method includes the additional step of recording information concerning the informed consent process using said recording element. 
     
     
         15 . A method for obtaining informed consent to a genetic test from an individual comprising the steps of:
 (a) procuring an integrated instrument for informed consent to a genetic test, said instrument including an information element, an instruction element integrated with said information element, a certification element integrated with said information and said instruction elements, a collection element integrated with said information and said instruction elements, and an assessment element integrated with said information and said instruction elements;   (b) conveying to the individual information concerning said genetic test using said information element;   (c) instructing an individual according to the directions contained in said instruction element;   (d) certifying the individual's consent for said test using said certification element;   (e) collecting a personal medical history and family history using said collection element; and   (f) assessing the individual's retention or comprehension of the information using said assessment element.   
     
     
         16 . The method according to  claim 10  wherein said genetic test is selected from the group consisting of a test for one gene, a test for more than one gene, a test for related genes, a test for genes associated with a specified clinical outcome and a gene screen test. 
     
     
         17 . The method according to  claim 15  wherein said genetic test is selected from the group consisting of a test for one gene, a test for more than one gene, a test for related genes, a test for genes associated with a specified clinical outcome and a gene screen test.