1. (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. (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:

   1. (a) Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and
   2. (b) Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.

3. (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;

   1. (a) Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and
   2. (b) Obtain informed consent, as defined and described in the Federal Policy, from the human research subject.
4. (4) Nothing in this rule relieves licensees from complying with other requirements in this division.

Statutory/Other Authority

ORS 453.635

Statutes/Other Implemented

ORS 453.605 - 453.807

History

PH 24-2014, f. & cert. ef. 8-15-14
PH 4-2007, f. & cert. ef. 3-1-07
PH 12-2006, f. & cert. ef. 6-16-06