Okla. Admin. Code § 340:2-39-10

Current through Vol. 42, No. 7, December 16, 2024

Section 340:2-39-10 - Record requirements

(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.

Okla. Admin. Code § 340:2-39-10

Adopted by Oklahoma Register, Volume 32, Issue 24, September 1, 2015, eff. 9/15/2015

Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/15/2020