MTA (Assurance Form)
All materials require material transfer agreements. The customer will find these online under the appropriate collection from which they are requesting the samples. You will also be notified during the checkout process of the MTA(s) needed for the order. The Principal Investigator (PI) and Institutional Official (IO) associated with the account should be the same PI and IO who will sign the Materials Transfer Agreement.
Signatory Guidelines
The Principal Investigator is the person responsible for the Repository Sample(s), the conduct of the Statement of Research Intent, and possesses the authority to enforce all guidelines and requirements included in the MTA. The Principal Investigator supervises the research team performing the work. At an academic institution, the Principal Investigator will typically hold the rank of Assistant, Associate, or Full Professor. At a commercial, for-profit institution, the PI should be a staff scientist or a scientist at the Director-level or higher. The Institutional Official needs to also sign the MTA. In our experience, the individual who can make such legally binding commitments is usually a senior institutional official (for example President, Vice President, Chief Operating Officer, Chief Executive Officer, Chief Scientific Officer, General Counsel or Director of Research) with responsibility for scientific and technological research and development or legal affairs. This individual is likely to be a signing official or the person who can make legal commitments on behalf of the institution receiving biomaterials. This person is typically authorized to sign grant applications, contracts or material transfer agreements on behalf of the institution. With regard to the requirement for the signature of an "Institutional Official" who can make legal commitments on behalf of the institution receiving biomaterials (DNA samples or cell cultures):
The MTA (Assurance Form) requires that the institution (in addition to the principal investigator receiving the biomaterials) assure:
- That the biomaterials will be used in compliance with all regulations protecting human subjects.
- That the biomaterials or any products derived from them will not be commercialized.
- That the biomaterials will not be distributed to a third party (that the researcher will not "share" with a colleague) without authorization by the Coriell Institute for Medical Research or sponsoring organization (National Institutes of Health or private foundation).
- That the research laboratory is properly equipped and provides the appropriate training for the handling of potentially hazardous biomaterials.
- That the institution will assume liability for use of the materials, as detailed in the MTA (Assurance Form).
These are legal commitments by the institution. If the researcher or end-user (or laboratory technician or other staff) fails to abide by the commitments or misuses the biomaterials in any way, the institution is liable for failure to fulfill the terms of the assurance agreement. In our experience, the individual who can make such commitments is usually a senior institutional official (president, vice-president, director of institute) with responsibility for scientific and technological research and development or legal affairs. This individual is likely to be the person authorized to sign grant applications, contract proposals or material transfer agreements on behalf of the institution.
At a university or college, an appropriate individual might be an executive in the Office of Grants and Contracts, Office of Sponsored Projects, Office of Technology Transfer or the Office of Intellectual Property. The Department Chairperson or a Lab Director or a lab manager is unlikely to meet the requirements of the Institutional Official.
At a private institution or commercial entity, an appropriate individual might be the President, Vice President, Chief Operating Officer, Chief Executive Officer, Chief Scientific Officer, General Counsel or Director of Research.
It is unlikely that staff of a purchasing department would be authorized to make legally-binding assurances about the scientific use of biomaterials.
Please include sufficient detail in the "job title" used by the proposed signers of the MTA (Assurance Form)(s) so that the level and scope of responsibility is clear and unambiguous. (The title of "Dr." or "Professor" does not in itself provide sufficient information about the responsibilities of the signer).
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