D.C. Mun. Regs. tit. 22, r. 22-B10925
An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and Department approval.
An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable Department regulations, and any conditions of approval imposed by an IRB or the Department.
An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this section to receive it.
A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required in 21 C.F.R., part 54. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for one (1) year following completion of the study.
Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
D.C. Mun. Regs. tit. 22, r. 22-B10925