Ethical issues associated with collecting biological specimens

There is an extensive literature about ethical issues related to research involving human subjects and the collection of biological specimens (see Other Resources for a few). Researchers planning to include specimen collection in their protocols are advised to consult these references, their Institutional Review Board (see the UNC Office of Human Research Ethics), and other CPC researchers who have collected specimens to gain insights into any special procedures required for consent forms, field protocols, and follow-up procedures. The core’s director can also provide guidance.

Because so much has been written on this topic, only a few items that should be considered are listed below.

• Should subjects be informed about test results?
• What should a researcher do if a participant does not want to know the result of a test, even if it is an infectious disease?
• What arrangements can be made for treatment or counseling?
• Should/must regular caregivers be informed about a test result?
• Does collecting genetic materials present special challenges regarding confidentiality?
• What should be included in an informed consent form to address long-term storage and future use of specimens not envisioned when the initial research is planned?