3.4 Clinical Research
The rights and welfare of human subjects participating in clinical trials must be protected in any clinical research, including trials involving stem cell-based interventions and novel reproductive technologies. Clinical research should be designed to generate scientifically rigorous information that will be used to guide important decisions for patients, clinicians, clinical investigators, sponsors, and policymakers.
Sponsors, investigators, host institutions, oversight bodies, and regulators bear responsibility for ensuring the ethical conduct of clinical trials. In addition, members of the broader research community have a responsibility for encouraging ethical research conduct. As with all clinical research, clinical trials of stem cell-based interventions must follow internationally accepted principles governing the ethical design and conduct of clinical research and the protection of human subjects (Department of Health, and Education and Welfare, 1979; European Parliament and Council of the European Union, 2001; World Medical Association, 1964; Council for International Organizations of Medical Sciences 2016). Key requirements include having adequate preclinical data, a rigorous research design that minimizes risk, independent oversight and peer review, fair subject selection, informed consent, research subject monitoring, auditing of study conduct, and trial registration and reporting. Ideally this should include the involvement of the relevant patient/carrier groups.
Some interventions and conditions present challenges for standard trial designs. Nevertheless, research in such settings should similarly involve a pre-specified protocol, independent review for scientific merit and ethics, and a plan for reporting. Translational research on novel assisted reproductive technologies ideally combines both specialized oversight process (see Section 2.1) and human subjects review.
What follows in this section pertains to clinical trials as well as innovative care pathways and observational studies.