Disclosure and Management of Research Findings in Stem Cell Research and Banking: Policy Statement

Abstract

Prompted by an increased interest of both research participants and the patient advocacy community in obtaining information about research outcomes and on the use of their biological samples; the international community has begun to debate the emergence of an ethical 'duty' to return research results to participants. Furthermore, the use of new technologies (e.g., whole-genome and -exome sequencing) has revealed both genetic data and incidental findings with possible clinical significance. These technologies together with the proliferation of biorepositories, provide a compelling rationale for governments and scientific institutions to adopt prospective policies. Given the scarcity of policies in the context of stem cell research, a discussion on the scientific, ethical and legal implications of disclosing research results for research participants is needed. We present the International Stem Forum Ethics Working Party's Policy Statement and trust that it will stimulate debate and meet the concerns of researchers and research participants alike.

Ethical Issues for Clinical Studies That use Human Embryonic Stem Cells: The 2014 Revisions to the Japanese Guidelines

“…However, the policy of disclosure depends on the types of cell used. The International Stem Cell Forum Ethics Working Party distinguishes research on hESCs from that on other pluripotent stem cells, and it cautions against returning any donor-specific results on hESCs (whether research or incidental) to donors because the embryos have the characteristics of two different individuals and may have mutations [22]. The California Institute for Regenerative Medicine considers that research on disease-specific iPSCs has the potential to benefit donors, and it recommends obtaining consent to re-contact donors to inform them of significant new findings that may affect them [23].…”

Identifiability and Privacy in Pluripotent Stem Cell Research

“…This imperative is underpinned by the principles of reciprocity, solidarity, and respect for all stakeholders. Data sharing is envisaged as a tripartite responsibility of data producers, users, and funders (Isasi et al, 2012; Knoppers et al, 2011). Scientific integrity and progress are dependent not only on the sharing of raw data between researchers, but also on the ability to widely disseminate research findings.…”

“…However, while hESC-associated data would not correspond directly to the genotype of the individual donor or donors, the information that can be gleaned using diverse molecular analyses could have medical and social significance for the donors and related individuals. Moreover, in some cases the interpretations of certain genetic data derived from numerous loci (e.g., ethnicity), combined with the laboratory of origin or partial genotype information for a putative donor or donors, could be sufficient for the donors to identify themselves or be identified by others by triangulation with public information (Knoppers et al, 2011; Isasi et al, 2012). …”

The Inherent Ethical Challenge of First-in-Human Pluripotent Stem Cell Trials

“…Participants should be made aware of the risks, and lack of information of risks. A consent form should also contain a section on the disclosure of significant (genetic) information detected during research that could influence the patients' quality of life [14].…”