Project 170020

The implementation of DNA repositories has brought to the forefront certain ethical and legal challenges surrounding genomic research. One such challenge is related to the regulation and control of the ethical and legal obligations of researchers who will utilize these research infrastructures. This project will investigate the possibility for population biobanks to use Material Transfer Agreements (MTAs) as a regulatory tool in promoting the rights of various stakeholders. In the absence of specific legislation addressing the ethical and legal obligations of researchers using population based research infrastructures, MTAs may be able to provide a flexible and efficient alternative. Even though MTAs are widespread within the research sector, they need to be specifically tailored to issues relevant to population biobanks. Thus, this study will focus on how publicly funded infrastructures (DNA repositories) can use a Uniform Material Transfer Agreement (UMTA) to: 1) better define and respect the rights of participants, funding agencies and potential researchers; 2) preserve the open-source approach of publicly funded infrastructures; 3) preserve patentability and licensing of resulting intellectual property; 4) clearly define research limits in light of public purpose and the participant's informed consent; 5) establish national and international transfer modalities for biological samples and data; and 6) define related risks and responsibilities. A proper analysis of these aspects may reveal that MTAs can, at least provisionally, in the absence of specific legislation, be used as a flexible and efficient tool in the context of research infrastructures improving predictability, public protection (and incidentally confidence), decreasing negotiation delays and setting important standards in the field. It is hoped that these proposed standards will influence the private sector as well.

genetic studies of regulatory polymorphisms in apoptosis genes