AP PSYCHOLOGY

Detailed explanation-1: -Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Detailed explanation-2: -IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

Detailed explanation-3: -The Institutional Review Boards (IRB), or Institutional Ethics Committees (IEC), represent American configurations designed to evaluate the ethical aspects of research involving human subjects. Other countries have similar organizations, termed Research Ethic Committees or Ethical Review Boards.

Detailed explanation-4: -A study requires IRB approval if it is research which involves human subjects or collecting information from or about human subjects.

Detailed explanation-5: -The purpose of the IRB is to ensure that the investigator complies with the protocol and to demonstrate that the trial is necessary and that the risk-benefit ratio is acceptable by reviewing key trial documents to ensure that the subjects’ rights and well-being are protected.