A few weeks ago, the International Society for Stem Cell Research (ISSCR) released a new set of guidelines, updated for 2016, for Stem Cell Research and Clinical Translation. The guidelines, developed by an international task force of 25 experts in stem cell science, clinical research, and bioethics, and reviewed by 85 external individuals and organizations, seek out to establish the ISSCR’s current sentiments on stem cell research, clinical translation, as well as the responsibilities that the ISSCR feels scientists involved in the work have to the general public.
Available here, the Guidelines are built around five main areas:
- Embryonic Stem Cell Research
- Clinical Translation of Stem Cells
- Standards in Stem Cell Research
These guidelines are meant to outline, according to the ISSCR, “common principles of research integrity, patient welfare, respect for research subjects, transparency, and social justice.”
What do they mean and how important are they? The ISSCR is very clear to state that these guidelines are in no way meant to supersede or replace any laws or official regulations and are merely meant to be viewed as “best practices” for those involved in the activities discussed.
A big focus is on ethics, with embryo and related research issues receiving significant focus in the guidelines, which highlights the ISSCR’s continuous focus on continuing to promote responsible use of human subjects in stem cell research. The guidelines also hint at the ISSCR’s concern with the communication of new discoveries to the general public and media, favoring restraint over hyperbole and suggesting that any forward-looking statements should be “accurate, circumspect and restrained.”
While commendable, the guidelines, at 37 pages, are not comprehensive and are even reductive in certain areas. For instance, raw material sourcing and related manufacturing recommendations and standards are relegated to a few paragraphs, summarized as follows:
All reagents and processes should be subject to quality control systems and standard operating procedures to ensure the quality of the reagents and consistency of protocols used in manufacturing. For extensively manipulated stem cells intended for clinical application, GMP procedures should be followed.
This is not to say that there is expectation that the ISSCR should in any way be comprehensive in their guidelines in a way that would eliminate recourse to applicable laws, though further clarification as to certain statements and processes could be provided. For instance, the FDA has climbed a steep hill in trying to define “extensive manipulation” of cell-based products, and such efforts should ideally be acknowledged.
We invite you to consult these guidelines and applaud ISSCR for updating their 2008 version of the same, and hope that, as we move forward, with everyone’s help, the industry will be able to further tighten these guidelines as the field advances toward better regulation, standardization and commercialization.