Oregon Statutes 414.770 – Participants in clinical trials
(1) As used in this section:
Terms Used In Oregon Statutes 414.770
- Coordinated care organization: means an organization meeting criteria adopted by the Oregon Health Authority under ORS § 414. See Oregon Statutes 414.025
- Medical assistance: includes any care or services for any individual who is a patient in a medical institution or any care or services for any individual who has attained 65 years of age or is under 22 years of age, and who is a patient in a private or public institution for mental diseases. See Oregon Statutes 414.025
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
(a) ‘Approved clinical trial‘ has the meaning given that term in ORS § 743A.192.
(b) ‘Routine health care’:
(A) Means the types and extent of health care and services that the Oregon Health Authority requires to be provided in medical assistance in accordance with ORS § 414.065.
(B) Does not include:
(i) The drug, device or service being tested in an approved clinical trial, unless a coordinated care organization would provide or pay for the drug, device or service if provided to a member who is not enrolled in an approved clinical trial;
(ii) Items or services required solely for the provision of the drug, device or service being tested in an approved clinical trial;
(iii) Items or services required solely for the clinically appropriate monitoring of the drug, device or service being tested in an approved clinical trial;
(iv) Items or services that are provided solely to satisfy data collection and analysis needs associated with an approved clinical trial and that are not used in the direct clinical management of the member; or
(v) Items or services customarily provided by a clinical trial sponsor free of charge to any participant in an approved clinical trial.
(2) A coordinated care organization may not discriminate against a member on the basis of the member’s participation in an approved clinical trial by:
(a) Denying the provision of or payment for routine health care; or
(b) Excluding, limiting or imposing additional conditions on the provision of or payment for routine health care furnished in connection with the member’s participation in an approved clinical trial.
(3) A coordinated care organization that provides routine health care to a member enrolled in an approved clinical trial is not, based on the provision of that care, liable for any adverse effects of the approved clinical trial. [2016 c.26 § 5]