Moral Considerations

Any proposal to address the problems raised by current policies and practices governing ownership and sharing of data, materials and intellectual property in stem cell science should be viewed against an analysis of the relevant moral considerations and broader philosophical questions underlying scientific endeavors. Below, we borrow the framework of the Manchester Manifesto to detail some of the moral considerations that are relevant to stem cell science, in particular. Per the Manifesto, “the regulation of frameworks of innovation should promote the following objectives: (At times these objectives may conflict and attention must be given to the most appropriate way of balancing them in each situation):

• Provision of public benefit

• • o   Sharing may be necessary for ethical stem cell science (Taylor, 2007)
    • §  Stem cell science should have just and real public benefit. Justice and public benefit may be limited by commercialization and costs restricting access to data, materials, and downstream benefits in the form of clinical application/interventions.
    • §  Distributive justice, societal value, and informed consent—ethical underpinnings of research—require that promises of safety, efficacy and public benefit are real
    • §  Justice/Beneficence converge to require that the research sharing that enables medical progress be required
  • o   Article 15 of the Universal Declaration of Human Rights states that “[b]enefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries.”
• Just recognition of interests (Key Stakeholders)
  • o   Tissue/Cell donors
  • o   Property rights holders/Inventors
  • o   Stem cell scientists
  • o   Research funders
    • §  Private (including shareholders)
    • §  Public (including tax payers)
  • o   Patients/Families
• Facilitating progress of science and innovation
  • o   Norms of Scientific Innovation in stem cell science
• Increasing access to fruits of research – information (data and materials) and products
  • o   Knowledge (sci and technical literature)
  • o   Data (databases)
  • o   Tools (cell line repositories, cells, reagents, standard methods, instruments)
  • o   Clinical applications/interventions
• Addressing welfare and resource inequities both locally and globally
  • o   Access to cell-based clinical applications/interventions is likely to be limited by high costs
  • o   Therapeutic targets are more likely to reflect market considerations that will result in greater benefits to patients in resource-replete settings (i.e, it’s more likely that stem cell research will focus on leading causes of morbidity/mortality in resource-replete settings (e.g., Alzheimer disease) rather than those in resource-limited settings (e.g., Chagas))
  • o   Current proprietary structures seem unlikely to result in scientific progress that will improve welfare and resource inequities
• Increasing trust in the relationships between scientists, innovators, corporations and public, and between nations
  • o   Norms of Stem Cell Science
    • §  Openness, Trust, Sharing in Stem Cell Science: Does stem cell science operate within a set of more or less Mertonian norms[1]?
    • §  What do the ‘norms of scientific communalism’ look like for stem cell science?
    • §  Is there a single set of identifiable norms?
    • §  How do norms vary by sector/context (per contextual considerations)? E.g.:
      • Academy/Industry
      • By Funding sources (Public/Private)
      • R & D stage of development
      • Specific technology
      • Stated motives (profit as a goal/not-for-profit with other stated goals)
    • §  Are the current proprietary structures at play in stem cell science/R&D consistent with the norms/standards of the science (as expressed via state policy, professional group guidance, norms of practice)?
    • §  (Per the TIP expert working group report) Existing systems for managing IP rights erode trust – IP is to be held tightly and not shared for fear of violated rights.  A lack of trust is at the root of “virtually all major controversies surrounding biotechnological innovation”.
  • o   Consideration of trust in the context of the ethically contentious nature of stem cell science
  • o   Consideration of trust in the context of the stem cell regulatory and patent policy patchwork
• [1] Communalism: entails that scientific results are the common property of the entire scientific community; a principle of openness is integral to this norm;
• Universalism: all scientists can contribute to science regardless of race, nationality, culture, or gender;
• Disinterestedness: scientists should not present their results entangled with their personal beliefs or activism for a cause. Scientists should have an arms length attitude towards their findings; and,
• Organised Scepticism: scientific claims must be exposed to critical scrutiny before being accepted.

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