S.C. Code Regs. § § 88-805

Current through Register Vol. 48, 12, December 27, 2024

Section 88-805 - Definitions

A. Minimal risk- means the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

B. Research -is defined as a trial, special observation, or data collection usually made under conditions determined by the investigator, which aims to test a hypothesis or to discover some previously unknown principle, effect, or relationship. Research is further defined as a systematic investigation designed to contribute to generalized knowledge.

C. Activities which use experiments, tests, and/or observations designed to elicit information which is not publicly available are considered types of research.

D. Research participant- is defined as persons eligible for services from the Department about whom an investigator conducting the research obtains:

(1) Data through intervention or interaction with the participant, or

(2) Identifiable private information.

E. County Disabilities and Special Needs Boards (DSN Boards): the local public body administering, planning, coordinating, or providing services within a county or combination of counties for persons with Intellectual Disability, Related Disabilities, Head Injuries, or Spinal Cord Injuries and recognized by the Department.

F. Qualified Provider - A provider of services to persons eligible for services from the Department, other than a county DSN Board, that is qualified by the state to provide such services.

G. Informed Consent - The knowing and voluntary agreement by the research participant or an individual authorized by law to consent on behalf of an individual, without any element of coercion or undue influence. The research participant or the legally authorized representative must be given information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. The information that is given to the research participant or legally authorized representative shall be in language understandable to the participant or legally authorized representative.

S.C. Code Regs. § 88-805

Added by State Register Volume 46, Issue No. 05, eff. 5/27/2022.