Thinking Group Meeting on Regenerative Medicine, Stem Cell Research and Associated Therapies
Ethical Issues in Muslim and Global
The speed at which stem cell science is developing has generated considerable enthusiasm among scientists, industry, health-related advocacy organizations, and patient populations that perceive benefit from these advances. It is also raising concerns, among policy makers and other interested parties to voice concerns about whether appropriate systems are in place to govern the technologies and whether societal values will be reflected in how stem cell research is conducted and will eventually be applied in practice.
The Aga Khan University (AKU) recognizes that stem cell research and associated potential stem cell treatments, xeno-transplantation for organ donation, and human genome editing whilst hold promise, pose significant challenges. Hence, AKU convened a committee tasked with examining the scientific underpinnings as well as the clinical, ethical, legal, and social implications of the use of human stem cells and genome-editing technologies in biomedical research and medicine to address the following issues:
What is the current state of the science of stem cell research and human gene editing, as well as possible future directions and challenges to further advances in this research?
What are the potential clinical applications that may hold promise for the treatment of human diseases? Are there ethical concerns that would preclude certain applications? What alternative approaches exist?
What is known about the efficacy and risks of potential stem cell treatments, xeno-transplantation and gene editing in humans, and what research might increase the specificity and efficacy of these while reducing risks? Further advances in stem cell research (e.g. generating gametes), and gene editing may introduce additional potential clinical applications. Are there disease areas where applying these emerging technologies will raise ethical challenges?
Can or should explicit scientific standards be established for determining the risk of stem cell treatments, xenotransplantation and quantifying off-target genome alterations and, if so, how should such standards be applied for use in the treatment of human diseases?
What are the current ethical, legal and regulatory standards in Muslim countries? If these standards exist, do they adequately address the questions raised in 4 including human gene and germ line editing? What are the ethical, legal, and social implications of the use of current unproven stem cell therapies and gene-editing technologies in humans?
If there are either minimal or no ethical, legal or regulatory standards, how will these evolve? Will Muslim countries adopt and adapt standards from a western optic?
What principles or frameworks in a Muslim context might provide appropriate oversight for somatic and germline editing in humans? How might they help determine whether, and which applications of, gene editing in humans should or should not go forward? What safeguards should be in place to ensure proper conduct of stem cell and gene-editing research and use of gene-editing techniques?
Provide examples of how these issues are being addressed in the Western context and in Muslim countries. What are the prospects for harmonizing policies? What can be learned from the approaches being applied in different jurisdictions?
The esteemed panel of experts in the fields of Stem Cell Research and Regenerative Medicine, Theology, Law and Ethics included:
Professor Arnold Kriegstein, University of California, San Francisco, USA
Professor Azim Surani, University of Cambridge, UK
Professor Angel Chomorro Raya, Center of Regenerative Medicine in Barcelona, Spain
Professor Janet Rossant, University of Toronto, Canada
Ms Rose M Carter, Partner, Bennett Jones, Canada
Professor Timothy Caulfield, University of Alberta, Canada
Professor Ilhan Ilkilic, Istanbul University, Turkey
Professor Helena Pereira de Melo, Universidade NOVA de Lisboa, Portugal
Professor Rana Dajani, Hashemite University, Jordan
Professor Mohammed Ghaly, Hamad Bin Khalifa University, Qatar
Mr Ehsan Masood, Massachusetts Institute of Technology, USA
Her Excellency Dr Maryam Matar, UAE Genetic Diseases Association, UAE
Professor Maria Do Ceu Patrao Neves, University of the Azores, Portugal
Professor Ana Sofia Carvalho, Universidade Catolica Portuguesa, Portugal
Professor Laurie Zoloth, University of Chicago, USA
Professor El-Nasir Lalani, Aga Khan University, Pakistan
Professor Azim Nanji, Aga Khan University, Pakistan
Dr Bashir Jiwani, Fraser Health Ethics Services, Canada
The committee addressed the questions and prepared a report containing its findings and recommendations on how the fundamental, underlying principles may be adapted and adopted by Muslim countries that are considering the development of ethical, legal and regulatory standards. The deliberations from the participants of the Thinking Group resulted in curation of the “The Lisbon Statement", which concluded that:
The Lisbon Statement
Stem cell research is a global activity and is being practiced around the world with particular emphasis on the biology of pluripotent stem cells and their application to disease modeling and regenerative medicine. This issue affects populations across the spectrum of economic and educational status, so there is a duty to enlarge the ethical and legal discussion on stem cells. This discussion is beginning to encompass communities that have not been previously engaged, including in various Muslim contexts, creating greater and more enriching pluralistic dialogue. Advancing opportunities to learn from diverse perspectives and enhance transcultural and transdisciplinary approaches will enable better, more credible science which, in turn, will lead to better outcomes.
As the research and dialogue extend to more countries and contexts, a central goal should be to build upon established, transcultural guidelines (such as ISCCR). These should increasingly be inclusive of wide, pluralistic representation from multiple competency areas; dynamic and flexible to enable responding to new advances and discoveries; and advisory, providing direction to different governing bodies to incorporate in their respective jurisdictions. The guidelines should be ethically justified, legally legitimate, and socially acceptable. Populations in parts of the world without access to health systems may be disproportionately vulnerable to commercial interests. Guidelines meant to have global reach should ensure that the implications for these contexts are carefully understood.
To enable more inclusive dialogue and deliberation, it will be key to support the creation of multiple deliberative spaces. These forums should be accessible to a full range of participants in civil society including scientists, ethicists, lawyers and journalists. The participation of policymakers, religious scholars and community leaders from traditions and contexts impacted by but not currently involved in the conversation should be enabled wherever possible.
Areas of advancement to focus on to support this dialogue include:
A glossary of terms – to support effective deliberation and consensus-building
Accessible updates on the state of the science in different countries – to ensure deliberation is based on the latest information and make scientific advances truly global
Improved science communication – to facilitate effective participation by non-scientists
Thoughtful public engagement – to inform and engage perspectives of the citizenry
Articulation of multiple existing ethical frameworks – that reflect global, regional, religious, and legal perspectives in diverse societies, highlighting areas of consensus
The development of an ethical framework for application in Muslim societies