How do I know when the specimens I’ve received contain codes that are considered identifiable would require IRB review?
Coded specimens may be considered identifiable and IRB review is required when you, the sponsor, or any other person involved in your study:
- Have any identifying information about the individuals from whom the specimens were obtained;
- Will or could acquire identifying information about the individuals from whom the specimens were obtained;
- Could acquire access to a code key or other information that links the specimens to the individuals from whom they were obtained;
- Could acquire identifying information about the specimen donors through a constellation of variables accompanying the specimens, such as an unusual pedigree describing a rare disease;
If you have questions about IRB review, please contact Arna Elezovic, Human Subjects Division, at 206-543-0098 or email@example.com.