Exception to informed consent for screening, recruiting or determining eligibility (§___.116(g))

An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subject without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or

(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing record or stored identifiable biospecimens.



Keywords:
exception IRB biospecimens purpose investigator oral written communications accessing 
Doc ID:
144359
Owned by:
Tom B. in NDSU Research and Creative Activity
Created:
2024-11-05
Updated:
2025-05-30
Sites:
NDSU Research and Creative Activity