August 2013

By definition, “human subject” under the Common Rule means “a living individual about whom an investigator (whether professional or student) conducting research obtains

1. data through intervention or interaction with the individual, or
2. 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; however, certain types of human pluripotent stem cell research do require review by The Johns Hopkins University Institutional Stem Cell Research Oversight Committee (JHU ISCRO).

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.

The following types of hPSC research overseen by the JHM IRBs shall be subject to oversight by the JHU ISCRO Committee:

1. All research using human embryonic stem cells (hESCs);
2. All research involving somatic cell nuclear transfer (SCNT) involving human cells;
3. Other hPSCs (e.g., human induced pluripotent stem cells [iPSCs], human embryonic germ cells [hEGCs] where the research involves:
   1. Introduction of the cells into humans;
   2. Introduction of the cells into the central nervous system of non-human primates;
   3. Introduction of the cells into non-human animals and there is a reasonable  possibility of the cells giving rise to gametes; or
   4. Creation of gametes or embryos.

All such research must be approved by the JHU ISCRO Committee prior to implementation. The JHM IRB review process will be conducted independently of the ISCRO review process. The ISCRO Committee collaborates with a variety of entities charged with other aspects of research oversight and will continue to serve as a consultative body for related research that does not fall under its purview.