The overarching goal of research oversight is to ensure that the research is safe, protects human subjects, has scientific and medical merit, and is designed and carried out to yield credible data and enhance scientific and medical understanding.
Recommendation 220.127.116.11: All research involving clinical applications of stem cell-based interventions must be subject to prospective review, approval, and ongoing monitoring by independent human subjects research review committees.
Independent prospective review and monitoring are critical for ensuring the ethical basis of research with human subjects, regardless of funding source. A competent review will be predicated on the absence of conflicts of interest (both financial and non-financial) that can bias assessment of the research design, maximize the alignment of the goals of the research with the subjects’ rights and welfare, and promote valid informed consent.
Additional independent evaluation of the research may occur through other groups, including granting agencies, peer review, the specialized oversight process (see Section 2.1), regulators, and data and safety monitoring boards. Of crucial importance is that these groups collectively have the scientific, medical, and ethical expertise to conduct necessary review and oversight. To initiate stem cell-based clinical research, investigators must also follow and comply with local and national regulatory approval processes.
Expert Review of Clinical Research
Recommendation 18.104.22.168: The review process for stem cell-based clinical research should ensure that protocols are vetted by independent experts who are competent to evaluate (a) the in vitro and in vivo preclinical studies that form the basis for proceeding to a trial and (b) the design of the trial, including the adequacy of the planned endpoints of analysis, statistical considerations, and disease-specific issues related to human subjects protection.
Peer review as well as institutional review boards/research ethics committees should also judge whether the proposed stem cell-based clinical trial is likely to lead to important new knowledge or an improvement in health. Comparing the relative value of a new stem cell-based intervention to established modes of therapy is integral to the review process. Peer review should be informed, where feasible, by a systematic review of existing evidence supporting the intervention including a review of its utility against other therapies that already exist for that condition. If decisions must be made based solely on expert opinion because no relevant literature is available, this should be described explicitly in the recommendations regarding a particular trial.