Effective 28 Aug 1980

630.194. Professional review committee to review proposals, make report and recommendations — director to approve or disapprove — to review work in progress. — 1. Persons seeking to initiate any research in residential facilities or day programs funded, operated or licensed by the department shall submit their research proposals to the professional review committee for review. The committee shall prepare a report, which shall be available to the general public, of each research proposal it reviews, stating its finding and conclusions, and recommending either approval or disapproval of the project to the director. The director shall state his decision in writing and the decision shall be final.

2. The committee shall review the conduct of the research during the progress of the project. If during the research, harm or increased risk of harm to participants occurs, or if deviations in research protocol occur without approval of the committee, the committee shall investigate the project. The committee shall suspend or halt the project if deemed appropriate to prevent harm or the increased risk of harm.

3. The professional review committee shall review each biomedical or pharmacological research proposal according to, but not restricted to, the following criteria:

(1) Need for the research;

(2) Methodological adequacy;

(3) Duplication with other projects;

(4) Sufficiency of scientific and theoretical justification;

(5) Competence of the researcher;

(6) Funding sufficiency;

(7) Weighing risks against potential benefits;

(8) Appropriateness of subject population;

(9) Adequacy of consent information.

4. If the committee believes it lacks sufficient expertise in the subject area of the proposed research, it may obtain outside experts to review the project and recommend disposition.

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(L. 1980 H.B. 1724)