Material Transfer and Data Use Agreements

Abstract

Medical research often involves the use and analysis of various materials developed and held by one entity and provided to researchers in another entity pursuant to terms and conditions set forth in a Material Transfer Agreement (“MTA”). Such materials might include human tissue specimens, cell lines, plant varieties, bacteria, transgenic animals (which are frequently mice and other rodents), compounds, proteins, peptides, nucleotides, plasmids, vectors, antibodies, pharmaceuticals and other chemicals or biological substances.

Transfers of human biological materials and associated information are becoming more common as the analysis of large cohorts of data and/or specimens are proving essential to advances in medical care and treatment, especially in the area of personalized medicine.1 This article will focus on the terms typically found in an MTA for the transfer of human biological materials and associated information.

A Data Use Agreement (“DUA”) might also be required under certain circumstances, as discussed below.

Regardless of the nature of the material transferred under an MTA, one central element of the agreement is that the material is only to be used for in vitro or non-clinical research purposes or for data analysis and not for use in human subject research or in clinical care.

Keywords: material transfer agreement, data use agreement, MTA, DUA