From Regulations- DHHS
Research involving materials (data, documents, records or specimens) that have been collected solely for non-research purposes (such as medical treatment and/or diagnosis). (Note: Some research in this category may be exempt from IRB regulations for the protection of human subjects (45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.
Wording from Federal Register- preamble to expedited review categories Nov 9, 1998
" Categories four and five on the proposed list have been combined into one new category, category five, addressing research involving materials collected or which will be collected solely for nonresearch purposes. This new category five was formed in response to comments that raised questions about why the two categories separated out existing and prospectively collected materials. The term " non research purposes' was maintained in the new category five to describe the origins of the research materials."
Proposed wording from SACHARP
Research involving materials (data, documents, records, or specimens) that
- have previously been collected for non- research purposes;
- have previously been collected for research purposes, provided the materials were not collected for the currently proposed research or
- will be collected solely for non- research purposes