A “gray” area will continue to exist. If an applicant doubts whether an investigation falls under the WMO, a so-called nWMO Declaration can be requested from a recognized Medical Ethics Review Committee (METC). An nWMO Advisory Committee can also advise an applicant to submit this to a METC when the nWMO Advisory Committee has reason to believe the research project falls under the WMO.
A non-WMO Statement is not the same as a positive advice after review by an nWMO advisory committee.
Non-WMO Declarations can also be requested for other purposes, for example a publication in a scientific journal.