Academic Integrity: Institutional Review Board and Research Ethics

"The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research." [from the U.S. Food and Drug Administration]

1. involves living individuals about whom "an investigator conducting research obtains data through intervention or interaction with the individual";
2. contains "identifiable private information" (Title 45 CFR, Part 46.102.f); and
3. includes secondary analysis of existing datasets where participants are individually identifiable."

"Research ethics is specifically interested in the analysis of ethical issues that are raised when people are involved as participants in research."

1. To protect human participants.
2. To ensure that research is conducted in a way that serves interests of individuals, groups and/or society as a whole.
3. To examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.