(a) Research activities shall be performed in accordance with ethical and professional practices and legal requirements, and these activities shall be periodically monitored by the governing body.
(b) The protocols for conducting research shall be approved by the governing body or its designee after medical and legal review.
(c) Any research activities carried out within the ambulatory surgical center (ASC) shall be appropriate to the expertise of staff and the resources in the ASC.
(d) Individuals engaged in research shall be provided with adequate facilities.
(e) Provisions shall be made to assure that the rights and welfare of all research subjects are adequately protected and that the informed consent of the subject, in the language spoken by him or her, is obtained by adequate and appropriate methods.
(f) All professional staff shall be informed of the ASC's research policies.
Source Note: The provisions of this §135.17 adopted to be effective June 18, 2009, 34 TexReg 3948