- Research in education settings, involving normal educational practices. Examples include research on instructional strategies, curricula, or classroom management methods.
- Research involving cognitive, diagnostic, aptitude, or achievement tests, survey procedures, interviews, or observation of public behavior unless: (a) information is recorded in a way that allows subjects to be identified directly or through identifiers linked to the subjects, and (b) any disclosure of subjects’ responses could place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
**Exemptions do not apply to research involving prisoners.**
|
- Clinical studies of drugs and medical devices when an investigational new drug application is not required
- Research on medical devices for which an investigational device exemption application is not required; or the medical device is approved for marketing and the medical device is being used in accordance with its approved labeling
- Collection of reasonable quantities of blood
- Collection of biological specimens for research purposes by noninvasive means
- Collection of data through noninvasive procedures routinely employed in clinical practice when approved medical devices are used
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior that are not exempt from IRB review
- Under certain circumstances, continuing review of research
|
- Studies intended to evaluate the safety and effectiveness of a medical device, including studies of cleared medical devices for new indications
- Research involving x-rays or microwaves
- Collection of data through invasive procedures involving anesthesia or sedation
- Continuing review of research for projects not initially eligible for review under an expedited procedure
**All research that is neither exempt nor eligible for expedited review will undergo a full review by the Institutional Review Board at RSCC.**
|
