§ 27-8-25-2 — "Clinical trial"

Indiana § 27-8-25-2

• Jurisdiction: Indiana
• Title 27: INSURANCE
• Art. 8: LIFE, ACCIDENT, AND HEALTH
• Ch. 25: Coverage for Care Related to Clinical Trials

Text

As used in this chapter, "clinical trial" means
a Phase I, II, III, or IV research study:
(1) that is conducted:
(A) using a particular care method to prevent, diagnose, or treat
a cancer for which:
(i) there is no clearly superior, noninvestigational alternative
care method; and
(ii) available clinical or preclinical data provides a reasonable
basis from which to believe that the care method used in the
research study is at least as effective as any
noninvestigational alternative care method;
(B) in a facility where personnel providing the care method to
be followed in the research study have:
(i) received training in providing the care method;
(ii) expertise in providing the type of care required for the
research study; and
(iii) experience providing the type of care required for the
research study to a sufficient volume of patients to maintain
expertise; and
(C) to scientifically determine the best care method to prevent,
diagnose, or treat the cancer; and
(2) that is approved or funded by one (1) of the following:
(A) A National Institutes of Health institute.
(B) A cooperative group of research facilities that has an
established peer review program that is approved by a National
Institutes of Health institute or center.
(C) The federal Food and Drug Administration.
(D) The United States Department of Veterans Affairs.
(E) The United States Department of Defense.
(F) The institutional review board of an institution located in
Indiana that has a multiple project assurance contract approved
by the National Institutes of Health Office for Protection from
Research Risks as provided in 45 CFR 46.103.
(G) A research entity that meets eligibility criteria for a support
grant from a National Institutes of Health center.

Legislative History

As added by P.L.109-2009, SEC.3.