Innogen · Research · Current projects
Legal and Bioethical Regulatory Mechanisms

Shawn H.E. Harmon

Principal investigator(s):   Graeme Laurie

December 1 2004 – September 1 2007


Globalisation of scientific developments has not been matched by `internationalisation' or `standardisation' of legal and ethical norms in response to genomics advances. This project examined the role of legal and ethical principles in guiding the regulation of genetic research and activities, and the mechanisms by which these can take effect nationally. Key features include: the search for a universal bio-ethical code; relationships between national and international advisory and regulatory bodies in regulating scientific developments; and the role of advisory commissions and ethics committees to provide public legitimisation for scientific developments.

Aims and objectives

Why, how, and how effectively do ethical principles influence legal instruments and regulatory policy in the genomics field at each of the national, regional and international levels?

How do ethics translate to law? For example, why have we started to focus on ethics? Which principles do we rely on (dignity, consent, privacy, etc), and why? In what form do these principles appear in legal documents, and how well do these instruments work? Are there patterns across jurisdictions or in different regions?

Research methods

The methodology used has been case studies supported by documentary analysis (international and domestic legal instruments and policy papers), literature reviews (civil society submissions and academic articles), and interaction with civil society through conferences, workshops and public engagement exercises.

Outcomes include the identification and definition of key moral values relevant to genomics, the assessment of various legal instruments for their interaction with same, and the furtherance of the appreciation of the importance of moral values to the governance of human genetics and biotechnologies (as evidenced by personal contacts and requests received by academics and policymakers).

Key findings

The research programme supports a number of general findings, namely that:

  • Although civil society appears quite concerned with the moral element of genomics and biotechnology, stakeholders are not as exercised
  • The law (and policymakers and regulators) are not comfortable with engaging directly with the moral issues and legal
  • Instruments often do not effectively translate the moral values claimed
  • Certain values are more embedded in our collective (legal) psyche (autonomy, dignity) than others (solidarity) and are represented in regulatory instruments much more effectively (and more often) than others; moral values can be indeterminate and, as a result, clear understandings and therefore applications of them are difficult (and rare)


Harmon, S., Law and Ethics: The Implications of Biotechnology Innovation for Practitioners of Medical Law – The Case of Advance Directives (with G. Pradella), (2007) submitted to Osgoode Hall Law Journal.

Harmon, S., Emerging Technologies and Developing Countries: Stem Cell Research Regulation and Argentina (2007) forthcoming in Developing World Bioethics.

Harmon, S., Biotechnology Innovation and Patenting in the Developing World: China – A Giant Among Nations? (2007) 12 Journal of Intellectual Property Rights 72-85.

Harmon, S., Solidarity: A (New) Ethic for Global Health Policy (2006) Health Care Analysis 14(4)  215-236.

Harmon, S., The Rules of Re-Engagement: The Use of Patent Proceedings To Influence the Regulation of Science (‘What The Salmon Does When Comes Back Downstream’) (2006) 4 Intellectual Property Quarterly 378-403.

Harmon, S., From Engagement to Re-Engagement: The Expression of Moral Values in Patenting Proceedings, Present and Future (2006) European Law Review  31(5) 642-666.

Harmon, S., A Penny For Your Thoughts, A Pound For Your Flesh: Implications of Recognizing Property in Human Body Parts (2006) Medical Law International 7(4) 329-354.

Harmon, S., The Significance of UNESCO’s Universal Declaration on the Human Genome and Human Rights (2005) 2:1 SCRIPT-ed 18-47, at

Harmon, S., Ethico-Legal Issues in Genetics (with R. Gertz and G. Pradella), in A. Wright & N. Hastie (eds.), Genes and Common Disease – Genetics in Modern Medicine (Cambridge: CUP, 2006) ch. 12.

Harmon, S., The Law and Ethics of Medical Research (2007) 4:3 SCRIPT-ed 237-240, at (Book Review)

Further information

For further information contact Shawn Harmon,