Review Article

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

Table 3

Review categories recommended to improve the supervision process.

Categories of review proposed for the oversight process

Category 1. Research that is permissible after review under existing mandates and/or committees and is determined to be exempted from the EMRO process
This category includes research with established human embryo-derived stem cell lines and research involving the reprogramming of human somatic cells to pluripotency.
Category 2. Forms of research that are permissible only after review by an EMRO process, possibly in association with other supervisory authorities
This category embodies activities based on the procurement and use of IVF embryos and human gametes, genetic manipulation of human embryos or gametes, derivation of new pluripotent cell lines from human embryos, creation of human totipotent cells with the potential to sustain embryonic or fetal development, and so forth.
Category 3. Prohibited research activities
Research that cannot be pursued due to the lack of a scientific rationale.