In the stem cell field, international initiatives are now emerging to address harmonization and standardization processes for research and banking.
Below, we address harmonization, scientific considerations, ethical, legal and societal implications (ELSI), and sustainability in detail, as a basis for further discussion.
International initiatives are emerging to address harmonization and standardization processes for stem cell research and banking; these include the International Society for Stem Cell Research ISSCRR) and the International Stem Cell Banking Initiative ISCBIInternational Stem Cell Banking Initiative ISCBI
Many of these challenges are already being addressed through ELSI harmonization initiatives aiming to implement data sharing codes of conduct and policies [ 32] and are encouraged by empirical studies indicating that research participants generally support wide data sharing for research purposes given that privacy and confidentially concerns are appropriately handled and secured [ 33- 35].
Addressing issues of harmonization of regulations, intellectual property rights, and trade policies across international borders can also be helpful but may not be enough, and, in some cases, may cause additional conflicts.
An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD.
These differences need to be addressed as part of the harmonization effort.
Human tissue banks and related international initiatives, such as the Organisation for Economic Co-operation and Development [ 11, 21] and the International Society for Biological and Environmental Repositories [ 22], have long addressed issues of safety and harmonization, while stem cell banks, beginning with the fundamental step of registries [ 23], have only recently joined this effort.
One of the topics discussed at the second ICAP workshop, and addressed in this paper, was the harmonization of reporting ANA test results.
The levels of knowledge and the topics to be addressed need to be country specific, promoting harmonization in both areas (clinical practice and training).
