to the coordinator of the PRC within ten (10) Committee days of the filing of the complaint. The facil- (Rescinded March 30, 1996) ity director may chose to suspend or halt the project after receiving notification of a complaint. The facility director shall notify the principal investigator and the coordinator of any decision to suspend or halt a research project.

1. (4) The PRC may investigate any research project which it has approved. The PRC shall investigate any approved research project when it has reason to believe that harm or increased risk of harm to the subjects or deviation from approved protocol has occurred.

   1. (A) The PRC may halt the research project while it is under investigation.
   2. (B) The principal investigator shall provide information requested by the PRC that is necessary for the investigation.
   3. (C) Employees of the department shall provide information requested by the PRC that is necessary for the investigation.
   4. (D) Staff of vendor agencies serving clients of the department shall provide information requested by the PRC necessary for the investigation.

   5. (E) The PRC shall rule on projects which have been investigated.

      1. 1. The PRC may take into account infor-

mation received from the facility director where the project is conducted, from the principal investigator, and from other sources having information pertaining to the project.

1. 2. The PRC may rule to halt the project

or suspend the project until deficiencies are corrected.

1. 3. The principal investigator and the

facility director shall be notified of the decision of the PRC.

1. (5) At the request of a facility director, the PRC may investigate research activities which have not been reviewed including archival studies and program evaluation projects.

AUTHORITY: section 630.194, RSMo (1994).* Original rule filed Nov. 30, 1987, effective May 12, 1988. Rescinded: Filed Sept. 1, 1995, effective March 30, 1996. Readopted: Filed May 20, 1996, effective Dec. 30, 1996.

*Original authority 1980.