Indiana Code 27-8-25-2. “Clinical trial”
(1) that is conducted:
Terms Used In Indiana Code 27-8-25-2
- care method: means the use of a particular drug or device in a particular manner. See Indiana Code 27-8-25-1
- Contract: A legal written agreement that becomes binding when signed.
- United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
(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 C.F.R. § 46.103.
(G) A research entity that meets eligibility criteria for a support grant from a National Institutes of Health center.
As added by P.L.109-2009, SEC.3.