Frequently Asked Questions
These FAQs provide guidance that represents OHRP's current thinking on these topics.Visit OHRP's website at http://www.hhs.gov/ohrp/policy/faq/, NIH at http://grants.nih.gov/grants/policy/hs/faqs_specimens.htm or click each link below to learn more:Princeton
- Human Research Regulations FAQs
- Research with Children FAQs
- Research with FAQs
- Informed Consent FAQs
- Investigator Responsibilities FAQs
- Quality Improvement FAQs
Human Subjects Research - Human Specimens, Cell Lines or Data
- When does research with human specimens, cells, cell lines, or data involve human subjects?
- What are examples of research involving human specimens, cells, cell lines, or data that would not be considered human subjects research under HHS regulations at 45 CFR Part 46?
- What are examples of research involving coded human specimens, cells, cell lines, or data that is not human subjects research?
- Am I proposing human subjects research if my studies will use ONLY cell lines?
- Am I proposing human subjects research if I obtain specimens/data from a repository or database?
- What are the requirements for Exemption 4 (E4)?
- Is research that meets the criteria for Exemption 4 considered human subjects research?
- How can I determine whether my research meets the criteria for Exemption 4?
- What is meant by “existing” data or specimens?
- What is meant by “publicly available sources”?
- What is meant by “identifiers linked to the subjects”?