Or. Admin. Code § 333-010-0650

Current through Register Vol. 63, No. 10, October 1, 2024

Section 333-010-0650 - Research Studies

(1) Prior to any confidential data from the database being released to a researcher, the researcher must:

(a) Obtain approval from the Oregon Health Authority, Public Health Division Institutional Review Board, established in accordance with 45 C.F.R. 46.

(b) Obtain approval from the Diabetes Program.

(2) In reviewing research proposals for approval under section (1)(b) of this rule, the Diabetes Program, with input from its advisory committee, shall consider whether the research will:

(a) Further knowledge of the prevalence and incidence of diabetes occurring in the pediatric population;

(b) Better define causes of and treatment for childhood diabetes; or

(c) Inform decision-making about the allocation of public resources.

(3) The Diabetes Program shall also ensure that the research proposal has been reviewed for scientific excellence by a nationally recognized peer review group.

(4) Prior to confidential information being released to a researcher, the Diabetes Program will contact the family and offer the option to decline contact regarding research opportunities.

Or. Admin. Code § 333-010-0650

PH 6-2007, f. & cert. ef. 4-13-07

Stat. Auth.: ORS 444.300

Stats. Implemented: ORS 444.300-444.330