Current through Vol. 42, No. 1, September 16, 2024
(a) The Oklahoma
Department of Human Services Institutional Review Board (DHSIRB) prepares and
maintains documentation of its activities, per Section 46.115 of Title 45 of
the Code of Federal Regulations (
45
C.F.R. §
46.115) and
21
C.F.R. §
56.115, including:
(1) a list of the DHSIRB members identified
by:
(A) name;
(B) earned degrees;
(C) representative capacity, including a
brief statement of competence, scientific concerns, and affiliation;
(D) indications of experience, such as board
certifications and licenses, sufficient to describe each member's anticipated
contributions to DHSIRB deliberations; and
(E) any employment or other relationship
between each member and the Oklahoma Department of Human Services (DHS),
including whether the member is a full-time or part-time employee, member of a
governing panel or board, or a paid or unpaid consultant;
(2) copies of:
(A) all research proposals reviewed;
(B) scientific evaluations, if
any, that accompany the proposals;
(C) approved sample consent documents;
(D) progress reports submitted by
investigators; and
(E) reports of
injuries to subjects;
(3) DHSIRB meeting minutes to document:
(A) attendance;
(B) actions taken by the DHSIRB;
(C) the vote on actions including the number
of members voting for, against, and abstaining;
(D) declarations of any DHSIRB member's
conflict of interest with regard to any research projects;
(E) any recusal of a member with a brief
explanation why recusal was necessary;
(F) the basis for requiring changes in or
disapproving research; and
(G) a
written summary of the discussion of controverted issues and their resolution;
(4) records of
continuing review activities, including the rationale for conducting continuing
review of research that otherwise would not require continuing review, per
45 C.F.R. §
46.109(f)(1);
(5) copies of all correspondence between the
DHSIRB and investigators; and
(6)
records documenting DHSIRB activities, per Oklahoma Administrative Code
340:2-39-7(b)(8).
(b) Records are
retained:
(1) for at least three years from
the date of creation for general administrative record; and
(2) for at least three years after research
completion.
(c) All
records are accessible for inspection and copying by authorized representatives
of the United States Department of Health and Human Services (DHHS) or the
Office of Human Research Protection (OHRP) at reasonable times and in a
reasonable manner, per
45
C.F.R. §
46.115(b).
(d) DHS or the DHSIRB may maintain
the records in printed form or electronically.
