S.C. Code Regs. § § 88-815
Current through Register Vol. 48, No. 10, October 25, 2024
Section 88-815 - Protection of Rights and Welfare of Research ParticipantsA. Any research conducted must conform to the scientific, legal, and ethical principles which justify all research and should emerge from a sound theoretical basis or follow previously accepted research design.B. Any research involving routine medical examinations or behavioral intervention techniques shall be conducted only by qualified professionals in adequately equipped settings and with the appropriate liaison or supervision during which a suitably qualified clinician is used. Where body integrity may be violated or when otherwise appropriate, medical liaison or supervision shall be included.
C. All caution in exercise of research is limited not only to physical harm, but also includes unwarranted psychological or emotional impairment to the research participant or his/her family or legal guardian.D. All experimentation shall be planned in such a way as to avoid pain, suffering, or inconvenience to the research participant and his/her family or legal guardian.E. A copy of the signed informed consent form, for each research participant, shall be maintained by the Department.F. All investigators who are not employees of the Department, a DSN Board or a Qualified Provider and who are allowed access to information about individuals served shall sign a confidentiality statement which shall be maintained in a file containing the research proposal and approval at the Department. This shall be maintained in the file containing the research proposal and approval at the Department.
G. Facilities and programs are required to meet provisions of the federal regulations 45 CRF 46 Protection of Human Subjects.H. Any concerns or complaints regarding the research may be addressed directly to the chairperson of The Department Review Committee and shall be investigated.Added by State Register Volume 46, Issue No. 05, eff. 5/27/2022.