Delaware Code Title 16 Sec. 5172 – Rules and regulations
(a) Prior to the participation of any patient in pharmaceutical research, the Department shall adopt rules and regulations governing such research. Such rules and regulations shall conform to the requirements of the Food and Drug Administration and to this chapter. In the course of promulgating such rules and regulations, the Department shall request the assistance of the Food and Drug Administration and the State Police Drug Diversion Unit and shall hold at least 1 public hearing. The Department shall review the rules and regulations pertaining to pharmaceutical research annually.
Terms Used In Delaware Code Title 16 Sec. 5172
- Department: means the Department of Health and Social Services except that Department means the Department of Services for Children, Youth and Their Families in the context of a treatment facility serving minors. See Delaware Code Title 16 Sec. 5181
- Indemnification: In general, a collateral contract or assurance under which one person agrees to secure another person against either anticipated financial losses or potential adverse legal consequences. Source: FDIC
- Patient: means any individual receiving involuntary or voluntary care, supportive lodging, treatment or other mental health provider services from a facility. See Delaware Code Title 16 Sec. 5181
- State: means the State of Delaware; and when applied to different parts of the United States, it includes the District of Columbia and the several territories and possessions of the United States. See Delaware Code Title 1 Sec. 302
(b) Department rules and regulations governing pharmaceutical research shall include, but not be limited to, the following provisions:
(1) No patient should be approached to participate in a pharmaceutical research program where the most recent certification by a psychiatrist indicates that the patient is incapable of voluntary consent to care or treatment, is unable to make responsible decisions regarding hospitalization or is mentally incompetent to waive legal rights. Patients who show marked improvement should be reevaluated only by psychiatrists who will receive no financial benefit from the research as to whether the patient is now fully competent before being approached about participation in research.
(2) Diagnosis of a patient’s condition prior to the patient’s participation in pharmaceutical research shall be done only by psychiatrist or psychiatrists who will receive no financial benefit from the research.
(3) Prior to the inclusion of a patient on a research project, examining psychiatrist or psychiatrists shall consider whether the patient would respond to accepted pharmaceutical or other therapies.
(4) To ensure that patients retain their capacity to freely consent to participate in research, patients shall be monitored by psychiatrists who will receive no financial benefit from the research.
(5) If any patient participating in a research project shall be found not to be mentally ill, the patient shall be removed from the research immediately.
(c) Any indemnification agreement which purports to bind the hospital shall be approved by a deputy attorney general representing the Department and by the Department before signature by the research psychiatrist.
(d) The use of state time shall be adequately documented so that research compensated by private companies is properly segregated from that time.
64 Del. Laws, c. 421, § ?3; 70 Del. Laws, c. 186, § ?1; 78 Del. Laws, c. 155, § ?7;