45 C.F.R PART 46 Common Rule for the Protection of Human Subjects
PURPOSE: Trident Technical College (TTC) recognizes that scholarly work often involves the use of human subjects for data collection and analysis. In order to comply with federal policy as stated by the U.S. Department of Health and Human Services' "Common Rule for the Protection of Human Subjects" (45 C.F.R. Part 46), TTC has established an Institutional Review Board (IRB). The IRB will ensure that all college-related research activities protect the individual rights of human participants, particularly in regard to issues of safety and confidentiality. (Note: The Common Rule is the term used by numerous federal agencies who have adopted the same regulations governing human subjects of research.)
ROLE: The role of the IRB is:
- to review proposed research projects that involve the use of human subjects
- to ensure that all human subjects are treated ethically
- to ensure that confidentiality is maintained
- to ensure that all research subjects understand the methods, reasons for, and planned usage of research and give their consent freely.
The IRB has the authority to approve, require modification in, or disapprove all research activities involving human participants conducted under the auspices of the College.
Research that has been reviewed and approved by the IRB is subject to continuing IRB review and must be reevaluated at least annually or more frequently if specified by the IRB.
Federal regulations specify that Institutional Review Boards (IRB) must be made up of a minimum of five members and must include:
- A scientist
- An individual with expertise in a non-scientific area ("someone whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline")
- An individual not affiliated in any way with TTC
IRB MEMBER TRAINING
Federal regulations require IRB committee member training as specified in the Trident Technical College IRB Procedure.