Current through Register Vol. 61, No. 4, April 1, 2022
(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
(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.
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
(b) The findings have
significant implications for the subject's or the public's health;
(c) A course of action to
ameliorate or treat the subject's or the public's health concerns is readily
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. R.
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