Or. Admin. Code § 333-025-0130

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-025-0130 - Recontact

(1) Recontact of a research subject should not occur unless the subject was informed during the initial consent process that recontact may occur under specified circumstances and with this understanding, the research subject consented to participate in the study.

(2) If recontact of subjects is contemplated, the researcher must provide research protocols to the IRB describing the circumstances that might lead to recontact, as well as a plan for managing the process. If a subject declines the possibility of recontact, the researcher may not recontact the subject.

(3) Notwithstanding (1) above, in order to consider recontact in a situation where recontact was not contemplated and therefore not addressed in research protocols a researcher must seek approval from the IRB for re-contact and must assure the following conditions exist:

(a) The findings are scientifically valid and confirmed;

(b) The findings have significant implications for the subject's or the public's health; and

(c) A course of action to ameliorate or treat the subject's or the public's health concerns is readily available.

(4) Under conditions described in (3), the researcher shall determine and adhere to the expressed wishes and desires of the research subject in relation to disclosure of genetic information to that individual.

(5) When research results are disclosed to a subject, appropriate medical advice and referral must be provided.

(6) In all cases, a decision to recontact research subjects must have prior approval of the IRB.

Or. Admin. Code § 333-025-0130

OHD 14-2002, f. & cert. ef. 9-27-02; PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04; PH 9-2004, f. & cert. ef 3-23-04

Stat. Auth.: ORS 192.547

Stats. Implemented: ORS 192.547