2.1 Review Processes
Recommendation 2.1.1: All research that (a) involves preimplantation stages of human development, in vitro human embryo culture, derivation of new embryo-derived cells or lines, integrated stem cell-based embryo models, or (b) entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos, shall be subject to review, approval, and ongoing monitoring, as appropriate, through a specialized oversight process capable of evaluating the unique aspects of the science and the associated ethical issues (see below).
The specialized scientific and ethics oversight process encompasses the review of human embryo and related stem cell research. The process can be performed at the institutional, local, regional, national, or international level or by some coordinated combination of those elements and need not be served by a single, specific committee, so long as the oversight process as a whole occurs effectively, impartially, and rigorously. Provided appropriate expertise is available to ensure that the scientific, ethical, and legal aspects of the research can be rigorously evaluated, the specialized oversight can occur through preexisting institutional review processes that assess the participation of human subjects in research, the procurement of human tissues in and for research, or biosafety and ethical issues associated with research. For example, existing review bodies such as the Embryonic Stem Cell Research Oversight (ESCRO; Institute of Medicine and National Research Council, 2005), Stem Cell Research Oversight (SCRO; ISSCR Guidelines, 2006), or Embryo Research Oversight (EMRO; ISSCR Guidelines 2016) committees in the U.S., or the UK HFEA and regional ethics committees (RECs), are well positioned to perform review and oversight of embryo and related research. A single rather than redundant review is preferable as long as this is thorough and capable of addressing any uniquely sensitive elements of human embryo research and hESC research.
Recommendation 2.1.2: The specialized scientific and ethics oversight process must include an assessment of the scientific rationale and merit of research proposals, the relevant expertise of the researchers, and the ethical permissibility and justification for the research as discussed below.
- Scientific rationale and merit of the proposal: Research involving human embryonic cells or human embryos and gametes requires that scientific goals and methods be scrutinized to ensure scientific rigor. Adequate and appropriate scientific justification for performing the research using the specified materials is required.
- Relevant expertise of researchers: Appropriate expertise and training of the researchers to perform the stated experiments must be ascertained in order to ensure the appropriate use of research materials. For the derivation of new human embryo-derived cell lines, the formation of human embryo models from stem cells, or experiments that involve the use of human embryos, relevant expertise would include prior experience with embryo culture and stem cell derivation in animal systems and competence in the culture and maintenance of human embryonic stem cells. Researchers performing derivations of embryo-derived cell lines should have a detailed, documented plan for characterization, storage, banking, and distribution of new lines.
- Ethical permissibility and justification: Research goals must be assessed within an ethical framework to ensure that research proceeds in a transparent and responsible manner. The project proposal should include a discussion of alternative methods and provide a rationale for performing the experiments in a human rather than animal model system, for the proposed methodology, and if the studies involve preimplantation human embryos, a justification for the anticipated numbers to be used.
Recommendation 2.1.3: The committee or body conducting the specialized scientific and ethics oversight process is responsible for (a) advising researchers on the categorization of research (see Recommendation 2.2), (b) determining whether a research proposal constitutes permissible or non-permissible research, (c) monitoring and periodically reviewing ongoing research, and (d) overseeing the provenance of the human pluripotent stem cell lines used in Category 2 Research (see section 2.2.2).
The responsible committee or entity should interpret these guidelines, define research practices, and monitor compliance. Researchers are encouraged to consult the committee or entity for advice on how to determine whether research is exempt as Category 1A (see 2.2.1)
Composition of Research Review and Oversight Bodies
Recommendation 2.1.4: The specialized scientific and ethics oversight process should be conducted by qualified scientists, ethicists, legal and regulatory experts, and community members who are not directly engaged in the research under consideration. The oversight process must include participants with the following perspectives:
- Scientists and/or physicians with relevant expertise, including representation from scientists that are not directly engaged in the research under consideration. Relevant expertise includes areas of stem cell biology, assisted reproduction, developmental biology, and clinical medicine.
- Ethicists with the ability to interpret the ethical justifications for, and implications of, the research under consideration.
- Those familiar with relevant local policies and statutes governing the research.
- Community members, unaffiliated with the institution where the research is conducted through employment, who are impartial and reasonably familiar with the views and needs of patients and patient communities who could be benefited by stem cell research, and community standards.
- Additional members with relevant expertise not already represented on the oversight body should be included as required, for example to cover research involving human genetics, physiology, molecular biology, etc.
The policies and regulations of each country or jurisdiction will determine whether the specialized scientific and ethics oversight process will be performed by internal or external bodies at the institutional or national level. Participants in the specialized scientific and ethics oversight process should be selected based on their relevant area-specific expertise (e.g., scientific, clinical, ethics, research policy). Those engaged in the oversight process must be cognizant of potential financial and non-financial conflicts of interest that might compromise the integrity of the review. Such conflicts must be disclosed, evaluated, and minimized, or eliminated as much as possible.