Okla. Admin. Code § 340:2-39-12.2

Current through Vol. 42, No. 4, November 1, 2024

Section 340:2-39-12.2 - Continuing review requirements

(a) Except as provided for in (b) of this Section, the DHSIRB conducts continuing review of any research study it approved at intervals appropriate to the degree of risk, but not less than once per year. Principal Investigators are responsible for submitting a continuing review application at annual intervals unless directed by the DHSIRB to submit more frequently.

(b) Unless the DHSIRB determines otherwise, continuing review of research is not required in the circumstances in (1) through (3). The:

(1) research was eligible for expedited review, per Oklahoma Administrative Code (OAC) 340:2-39-12(c);

(2) proposed research was reviewed by the DHSIRB using one of the limited review procedures, per OAC 340:2-39-12(g); or

(3) research progressed to the point that it involves only:

(A) data analysis, including analysis of identifiable private information or identifiable biospecimens; or

(B) accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

(c) Notwithstanding the provisions of (b) of this Section, the DHSIRB may require a continuing review of any research when it determines there is a good reason for doing so. A determination to conduct a continuing review must be made in a DHSIRB-convened meeting, and a rationale for conducting continuing review of research must be stated. DHSIRB requires the investigator to submit a continuation request that must include a:

(1) specific request to continue the research project;

(2) copy of all currently approved informed consent forms when subjects are still involved; and

(3) brief status report on the research project including:

(A) the protocol's progress to date;

(B) the reasons for continuing the research;

(C) plans for the next approval period;

(D) a description of any adverse events or unanticipated problems involving risks to participants or others;

(E) a discussion of the number of refusals, withdrawal of participants from the research, or complaints about the research;

(F) a summary of any recent literature;

(G) findings obtained thus far; and

(H) modifications to the research.

(d) The continuing review by the convened DHSIRB may be supplemented by other review activities, as determined appropriate by the DHSIRB, such as:

(1) progress report(s) submitted by the principal investigator; or

(2) compliance report(s), if any, prepared by the human protections administrator or others, including:

(A) reports on observations of the consent process, per 45 C.F.R. § 46.109(g);

(B) reports on observations of the research, per 45 C.F.R. § 46.109(g);

(C) reports on any material changes that occurred in the research project since the previous DHSIRB review; per 45 C.F.R. § 46.108(a)(3)(ii);

(D) any complaints received from human subjects, legally authorized representatives, or others; and

(E) any findings of serious or continuing noncompliance with this Part or the DHSIRB requirements or determinations, per 45 C.F.R. § 46.108(a)(4)(i).

(e) As a result of its continuing review, the DHSIRB may suspend or terminate approval of research that is not conducted in accordance with the DHSIRB's requirements or that was associated with unexpected serious harm to subjects. Any suspension or termination of approval includes a statement of the reasons for the DHSIRB action and is reported promptly to the investigator, appropriate DHS officials, and others as appropriate, per 45 C.F.R. § 46.113.

(f) When the DHSIRB decides to suspend or terminate research activity approval, it includes, in its written notification, a statement of the reasons for its decision and gives the investigator an opportunity to respond in person or in writing, per 45 C.F.R. § 46.109(d).

Okla. Admin. Code § 340:2-39-12.2

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