By Melissa Lopes, Fellow, Division of Medical Ethics, Harvard Medical School and Director of Research Policy and Compliance, Office of the Vice Provost for Research, Harvard University
The DISCUSS project is designed to develop consensus recommendations for the use of stored biospecimens (originally consented for research) to:
- derive iPSC lines and
- deposit the derived lines in a cell bank or repository for widespread distribution.
The project represents a formal collaboration of NIH, CIRM and the International Stem Cell Forum. The broadly stated aim of this collaboration is to evaluate consent protocols and ethical requirements in support of ongoing collaborations and the exchange of research materials.
Recognizing that research utilizing iPSC lines inevitably involves collaboration across institutions, the project necessarily requires outreach to those already engaged in the collection of biospecimens and the banking and distribution of iPSC lines. The collection of data and case studies from this class of respondents will contribute to the utility and broad applicability of the final recommendations. Thus, the nature of this session as a “working lunch.”
The lunch was well-attended by a diverse group of participants, including investigators engaged in such research, research administrators, persons expert in the ethical oversight of stem cell research, and representatives of committees convened to harmonize international guidance in this same area. Beyond experiential diversity, the group also spanned state and national boundaries, including perspectives from Australia and Japan.
Particular points of interest raised included the impact of participant conceptions/preconceptions on the consent process. Discussants tackled the issue of participant notions regarding the potential commercialized use of their own specimens. This discussion reflected on the outrage stirred by incidents such as Rebecca Skloot’s expose and research conducted on the Havasupi tribes. In particular, discussants explicated the effects of such events on research participants’ expectations and their relative trust in research institutions and the goals and parameters of research generally. Addressing such mistrust requires increasing understanding among research participants and strengthening existing structures for governance of such research. Discussants suggested focusing more broadly on existing institutional governance systems protective of participant’s interests, beyond a singular focus on informed consent provisions and processes. Attendees also discussed the need to educate research participants more broadly about the nature of research and the process of translating basic research into therapies as well as the need to deconstruct the often false perceptual boundaries between the roles of academia and industry along the research and discovery continuum.
Additional discussion points highlighted the need to understand and clarify issues surrounding the sharing iPSC lines, and the need to wed the IRB review process with the MTA process to better inform the process of respectfully and appropriately sharing such materials.
As clarified at the outset, this working lunch served as part of the ongoing process to collect data and inform the DISCUSS project. If you wish to learn more about the project, or weigh in with additional points for NIH and CIRM to consider, please contact Geoff Lomax, CIRM at: DISCUSS@CIRM.CA.GOV
