In recent years, the transfer of materials to and from academic laboratories has become more regimented as a result of the use of documents called Material Transfer Agreements (MTAs). While it has been a longstanding academic tradition to freely share the results of research, the complexity of managing such research results has increased tremendously in recent years. Many investigators' laboratories receive funds from varying sources; federal, non-profit foundation, and/or industry; and each such sponsor may have requirements or expectations that must be met with respect to the sponsored research. In addition, there may be liability issues associated with the transfer of certain materials, and from a risk management perspective, it is advisable to track materials entering or leaving the organization through written mechanisms.
In 1995, a diverse group of federal, university and industry representatives worked to create a simple, streamlined process by which materials could be transferred. Entitled the Uniform Biological Material Transfer Agreement (UBMTA) (view Adobe Acrobat PDF), this provided a means by which institutions could agree to the overarching principles regarding the transfer, and thus simplify the investigator-to-investigator requirement. An Implementing Letter (view Adobe Acrobat PDF) specifying the materials to be transferred is executed by the providing scientist, the recipient scientist and an authorized official of the recipient organization. This Implementing Letter is subject to the terms and conditions spelled out in the UBMTA. A Simple Letter Agreement (view Adobe Acrobat PDF) for the transfer of non-proprietary biological material has also been developed as part of the UBMTA. This agreement requires authorized signatures on both sides and can be modified if additional terms or conditions are needed.
In 1999, based on concerns voiced by a number of individuals, the National Institutes of Health released "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources". "Research resources" as defined in the Principles and Guidelines is broader in nature than just biological materials and includes the full range of tools scientists utilize in the laboratory including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines. Scientists receiving federal funds from the NIH are asked to be cognizant of these regulations that have the following objectives: ensure academic freedom and publication, ensure appropriate implementation of the Bayh-Dole Act, minimize administrative impediments to academic research, and ensure dissemination of research resources developed with NIH funds.
Investigators may be guided regarding the transfer of materials based on the proprietary nature of such materials. In the event that the materials are non-proprietary (not subject to contractual regulations or patents and/or patent applications), the Simple Letter Agreement provides a streamlined mechanism by which to transfer materials. In the case of proprietary materials, an investigator may consult with the OTT in order to determine if special handling is required. In the event that materials are subject to contractual regulations either through sponsored research agreements or license agreements, additional arrangements and review may be required in these instances to ensure Tulane meets its obligations to all sponsors and reserves a royalty free, non-exclusive right to use the materials for academic and research purposes.
The research environment is becoming increasingly more complex and regulated. As a result of new federal guidelines and the somewhat complicated matrix of overlapping agreements and responsibilities, the OTD has developed a database in which to track both incoming and outgoing materials. This database will help us meet our obligations to sponsors.
Tulane University, New Orleans, LA 70118 504-865-5000 firstname.lastname@example.org