1. Assoc. Professor Anne-Maree Farrell ARC Future Fellow, Faculty of Law Monash University

2. Future Fellowship Project: Regulating Human Body Parts: Principles Institutions and Politics (2014-2018) 2

3. Advances in scientific research and technological innovation have led to a huge growth in the use of human body parts in research and medicine, whether on their own or as part of a range of technologies. Adopting a predominantly legal analysis, this project considers whether a common approach to regulating across a range of human body parts is desirable for the purposes of managing risk, promoting innovation and enhancing legitimacy. In line with such purposes, new regulatory models and strategies will be formulated which will make a significant contribution to theoretical development on the topic in health law and regulation, as well as Australian and international policy and practice in the field. 3

4.  Increase in regulation of human body parts at both national and international levels  Examples of ‘one-size-fits-all’ regulatory approach across human body parts ◦ EU; ◦ Attempt in the UK?  Complicated position in Australia ◦ Political ◦ Institutional ◦ Legal 4

5.  Will investigate and formulate new regulatory models for sourcing supply and use of human body parts for research and non-research purposes  Redress theoretical under-development on the regulation of human body parts ◦ Regulatory studies ◦ Human Rights ◦ STS 5

6.  Consider whether a common approach to regulating across a range of human body parts is desirable for the purposes of ◦ managing risk ◦ promoting innovation ◦ enhancing legitimacy  Will explore both commonality and difference in law and regulation in the field across different human body parts 6

7. (A) To what extent is there a common approach to the principles which underpin the regulation of human body parts in Australia and internationally? (B) How do institutional arrangements in Australia and internationally impact upon the regulation of human body parts? (C) How are risk, innovation and legitimacy conceptualised in the regulation of human body parts? (D) Is a common approach to regulating human body parts desirable? 7

8.  Theoretical Framework: why choose particular literatures?  Human body parts: which ones?  How to gain insight into policy and practice?  Development of academic and practitioner collaborations 8