Any research study conducted by individuals must seek the approval of the Institutional Review Board (IRB). This regulatory group offers exemption for six categories of studies. The IRB carefully reviews each research study to determine if it can be approved for exemption.
Explanation:
The exempt categories include
- Research of an educational nature, involving educational practices;
- Surveys and various cognitive or achievement tests conducted on adults;
- Research about the behavior of official figures, including interviews;
- Research that collects or studies existing information;
- Research that aims to introduce benefits to public and social services or federal research; and
- Research that aims to examine food taste or quality and does not violate any of the regulations of related official organizations, such as the FDA.
The Office for Human Research Protection reviews the categories of research that are outlined in 45 CFR 46 (Code of Federal Regulation). Each study must strictly meet at least one of the criteria to pass the evaluation and decision process. In other words, to obtain exempt status, the research should have educational objectives, involve educational tests (such as cognitive or diagnostic exams), or aim to contribute to existing knowledge and data.
Another crucial point regarding research that is eligible for exemption is compliance with all federal regulations concerning humans as research subjects. A study must not put participants at risk nor disclose information that could reveal an individual’s identity or potentially harm them. Minimizing risks to participants is key for a study to pass the IRB review and qualify for release.