The Word Game --- Should Human Embryonic Stem Cell Research Be Considered As Human Subject Research?

Human embryonic stem cell (hESC) research has been categorized as human subject research under exemption category 4 where the proposed research involves the study of existing data, documents, records, human tissue or specimens. Those sources are publicly available and the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The author recently noted that NIH has begun to list it as NO human subject research, therefore, sent her inquiry, below is the answer from NIH:

“In terms of human subjects, none of the NIH-approved hESC lines has any identifiers attached, and so research using these lines is not considered human subject research under NIH definitions.”

Which definitions seem fall into the human subject research exemption category 4 too, so the author asked again, below is the answer from NIH:

“Here is the guidance from OER:

·  When does research with human specimens, cells, cell lines, or data involve human subjects?
In order for research with human specimens, cells, cell lines, or data to involve human subjects,

1. The specimens, cells, or data:

• Must be or must have been obtained from individuals who are alive; AND
• Must be or must have been obtained by an investigator conducting research

AND

2. The investigator EITHER:

• Must be obtaining or must have obtained specimens, cells, or data through interaction or intervention with living individuals; OR
• Must be obtaining or have obtained individually identifiable private information.

IF providers of coded human specimen, cells, cell lines or data:

• Obtained or will obtain the specimens or data, AND
• Can link the specimens or data to living individuals, AND
• Will also collaborate on other activities related to the conduct of a proposed research project with the investigators who obtain the specimens or data;

THEN both the providers and recipients will be considered to be involved in the conduct of the research and are conducting human subjects research.”

Now it goes back to the controversy surrounding human embryonic stem cell research again --- when does life begin? should an embryo be considered as a living human being? Since those questions remain controversial, it gives NIH the legal definitions to take completely different stand points.