Or. Admin. R. 333-025-0140 - Informed Consent Procedures

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Unless exempted by ORS 192.535(1)(a)-(f), all persons collecting genetic information must conform to standards of informed consent as follows:
(a) Physicians licensed under ORS Chapter 677, and any other licensed health care providers or facilities, shall obtain informed consent according to ORS 677.097;
(b) Except as provided in OAR 333-025-0120, a person conducting research shall obtain informed consent according to the procedure given in OAR 333-025-0115; and
(c) If genetic information is collected in connection with an insurance transaction governed by ORS 746.135, informed consent will be conducted in the manner described by the Department of Consumer and Business Services under authority of ORS 746.135(1).
(2) For persons not described in (1) above, informed consent must be obtained using the form and process contained in Appendix 1 of these rules or a form which is substantively similar.
(3) Elements to be contained in a consent form for obtaining genetic information include:
(a) The name of the individual whose DNA sample is to be tested;
(b) The name of the individual, company, or organization requesting the genetic test for the purpose of obtaining genetic information;
(c) A statement signed by the individual whose DNA sample is to be tested indicating that he/she authorizes the genetic test; and
(d) A statement that specifies the purpose of the test and the genetic characteristic for which the DNA sample will be tested.
(4) Process for obtaining informed consent using the form contained in Appendix 1 or a form that is substantively similar:
(a) Explain that the genetic test is voluntary;
(b) Inform the individual that he/she may choose not to have his/her DNA sample tested;
(c) Inform the individual that he/she has the option of withdrawing consent at any time;
(d) Explain the risks and benefits of having the genetic test, including:
(A) A description of the provisions of Oregon law pertaining to individual rights with regard to genetic information and the confidential nature of the genetic information;
(B) A statement of potential consequences with regard to insurability, employability, and social discrimination if the genetic test results or genetic information become known to others;
(C) The implications of both positive and negative test results; and
(D) The availability of support services, including genetic counseling.
(e) Inform the individual that it may be in his/her best interest to retain his/her DNA sample for future diagnostic testing, but that he/she has the right to have his/her DNA sample promptly destroyed after completion of the specific genetic test which was authorized;
(f) Inform the individual about the implications, including potential insurability, of authorizing disclosure to a third party payer that the genetic test was performed, and that he/she has the option of paying the cost of the genetic test out of pocket rather than filing an insurance claim;
(g) Ask the individual whether he/she has any further questions, and if so, provide the individual with the opportunity to ask questions and receive answers from either a genetic counselor or another person who is sufficiently knowledgeable to give accurate, understandable and complete answers to his/her questions;
(h) Request that the individual read, complete, sign and date the consent form; and
(i) Provide the individual with a copy of the completed form for his/her personal records.

[Forms and Appendices referenced are available from the agency.]

Notes

Or. Admin. R. 333-025-0140
HD 1-1997, f. & cert. ef. 1-10-97; Renumbered from 333-024-0510 by OHD 14-2002, f. & cert. ef. 9-27-02; Renumbered from 333-024-0510 by PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04; Renumbered from 333-024-0510 by PH 9-2004, f. & cert. ef 3-23-04; PH 21-2005, f. 12-30-05, cert. ef. 1-1-06

Stat. Auth.: ORS 192.535

Stats. Implemented: ORS 192.535

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