Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles
February 2007 By definition, “human subject” under the Common Rule means “a living individual about whom an investigator (whether professional or student) conducting research obtains - data through intervention or interaction with the individual, or
- identifiable private information.”
DHHS conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human participants research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. (See OHRP Guidance for Investigators and IRBs dated March 19, 2002.) The Organization does not require JHM IRB review for such research. Note: Although research on cadaver material does not fall within the Common Rule, it does fall under HIPAA. Researchers using identifiable private information from deceased individuals must submit a HIPAA Form 5 to JHM IRB. In January 2007, the Johns Hopkins University School of Medicine established the Embryonic Stem Cell Oversight (JHU SOM ESCRO) Committee. It is the policy of the JHM that all research using human embryonic stem cells (hESCs) or somatic cell nuclear transfer (SCNT) involving human cells being conducted by JHU SOM faculty, staff or students or involving the use of JHU SOM facilities or resources shall be subject to oversight by the JHU SOM Embryonic Stem Cell Research Oversight (ESCRO) committee. All such research must be approved in advance by the JHU SOM ESCRO committee. The JHM IRB review process will be conducted independently of the ESCRO review process.
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