Sensitive Identifiable Human Subject Research
Sensitive identifiable human subject research data is regulated by
the Federal Policy for the Protection of Human Subjects (also called the
“Common Rule”). Among other requirements, the Common Rule mandates that
researchers protect the privacy of subjects and maintain
confidentiality of human subject data.
A human subject is defined by federal regulations as a "living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
“Identifiable” means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (for example, Social Security number, health care record).
Personally identifiable data is sensitive if disclosure of such data would pose increased social/reputational, legal, employability, or insurability risk to subjects
- Research data referring to illegal behaviors
- Research data referring drug or alcohol abuse
- Research data referring sexual behavior
- Research data referring mental health or other sensitive health or genetic information
- Any data collected under a National Institutes of Health (NIH) Certificate of Confidentiality is considered sensitive.
- Health Human Services Human Subjects website
- Federal Policy for the Protection of Human Subjects or Common Rule
- Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects, §46.102 (Definitions)
- Data Security Guidelines
- IRB Regulations, Policies, and Guidance
- U-M Human Research Protection Program
- U-M Compliance Resource Center - Human Subject Research
- Not Permitted
- Permitted with Encryption