Or. Admin. R. 333-116-0045 - Provisions for Research Involving Human Subjects
(1) A licensee may conduct research involving
human research subjects only if it uses the byproduct materials specified in,
and for the uses authorized by its license.
(2) If the research is conducted, funded,
supported, or regulated by a federal agency that has implemented the Federal
Policy for the Protection of Human Subjects (Federal Policy), the licensee
shall, before conducting research :
(a) Obtain
review and approval of the research from an Institutional Review Board , as
defined and described in the Federal Policy; and
(b) Obtain "informed consent," as defined and
described in the Federal Policy, from the human research subject.
(3) If the research is not
conducted, funded, supported, or regulated by another federal agency that has
implemented the Federal Policy, the licensee shall, before conducting research ,
submit a license amendment request to the Authority and receive approval by
amendment. The amendment request must include a written commitment that the
licensee must, before conducting research ;
(a) Obtain review and approval of the
research from an Institutional Review Board , as defined and described in the
Federal Policy; and
(b) Obtain
informed consent, as defined and described in the Federal Policy, from the
human research subject.
(4) Nothing in this rule relieves licensees
from complying with other requirements in this division .
Notes
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 - 453.807
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