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2.5 Mechanisms for Enforcement

Recommendation 2.5.1: These guidelines should be upheld and enforced through standards of academic, professional, and institutional self-regulation. 

These guidelines were developed collaboratively to form an international consensus for the ethical standards and practices in human embryo and stem cell research. These standards and practices represent a comprehensive code of conduct applicable to all researchers in the field. They are a critical catalyst that ensures international collaboration and research can proceed with confidence from anywhere in the world in a manner accepted as valid by the scientific and ethics communities. 

Grant applicants, in particular the individual scientists undertaking the research, should provide funding bodies with sufficient documentation to demonstrate that the proposed research complies with relevant local and national regulations and these guidelines or their equivalent. Funding organizations should pledge to follow these guidelines or their equivalent and require entities whose research is funded by such organizations to do the same.

Senior or corresponding authors of scientific publications should specifically be charged with the responsibility of ensuring that the code of conduct embodied in these guidelines is adhered to in the course of conducting human embryo and stem cell research; this includes the supervision of junior investigators that work for their respective organizations or on their research projects. Institutions where human embryo and stem cell research is undertaken should strive to provide researchers working on any such projects under their auspices, particularly junior investigators, with current information on such standards and practices.

Ensuring that research is performed according to scrupulous ethical standards is a legitimate concern for the peer review and editorial process of scientific publication. Journal editors and manuscript reviewers may request access to research protocols and provenance documents to enable adequate review of the ethical framework and oversight of the research process and may request an authors’ statement of adherence to these or an equivalent set of guidelines or applicable regulations. Authors should include a statement that the research was performed after obtaining approvals following a suitable research oversight process.

Finally, as stated previously, the ISSCR has made available for download examples of informed consent documents for obtaining human materials for research (gametes, embryos, and somatic cells) and a material transfer agreement for the sharing and distribution of materials in order to facilitate the adoption of globally accepted standards and practice of human embryo and stem cell research (Appendices 2 and 3). These templates may be modified to comply with the policies and regulations in their respective jurisdiction.