The MTA should detail somewhere (whether in the body of the agreement or in attached statements of work) as exactly as possible the uses to which the samples and associated data can be put.
This Research Material will be used by Recipient’s Investigator solely in connection with the following research project (“Research Project”) described with specificity as follows (use an attachment page if necessary):
If possible the MTA might also explicitly state what uses of the provided samples and associated data are not permitted or require further consent, possibly under a subsequent agreement.
Unless with the prior written approval of Provider (whose approval may be withheld at its sole discretion) or unless expressly permitted by the terms of a separate written agreement entered into between the Parties, Recipient agrees that the Material and Information will not be used for any purpose other than the Purpose and will be used only by Recipient at Recipient’s organization.
Some MTAs also restrict the use of the materials being transferred by non-commercial entities.
The Material may not be used by the Recipient Scientist in research which is subject to the provision of any rights to a commercial third party without prior written consent.
The MTA sometimes also sets out conditions for the use of samples - for example restricting where they can be used, what biosafety provisions are necessary, and ensuring that any use is in compliance with relevant rules and regulations
The Material may only be used by those under the Recipient Scientist’s direct supervision in the Recipient Institution’s laboratories under suitable containment conditions, and in compliance with all applicable statutes and regulations.
The RECIPIENT shall use, store, and dispose of the MATERIAL and any MODIFICATIONS in accordance with good laboratory practice and shall ensure compliance with all applicable laws, rules, and regulations, including laws, rules, and regulations governing export control and safety.
The MTA might prohibit certain uses, for example, determining that they cannot be used in humans and/or animals, or as part of clinical trials.
The material may not be used in human subjects or for clinical or diagnostic purposes.
It will be important to define the types of intended investigations or activities to be conducted with the samples and associated data. Past consultations heard of a grey area between surveillance and clinical trials. When samples and associated data are being used to enhance surveillance, it will be important to carefully define exactly what activities the outbreak investigations will include.
These details might be contained in a section on the purpose of the MTA. It might be addressed in the section on definitions Alternatively, it might require a section or statement of work of its own, depending on the complexity of the intended use.
The ethical use of material – provisions relating to ethical approvals and appropriate consents (and any associated conditions on consent) should be included in the MTA so that they are clear to all parties.
Questions as to the necessity of shipping samples and associated data out of the country should be addressed. This might necessitate linking the use of samples and associated data to specific locations or facilities. Further movement of materials or information might need to be considered.
This section might also address who has access to the samples and associated data transferred or the results produced. For example, some MTAs limit access to only those that require it for the intended use.
Recipient’s Personnel: Recipient will limit provision and disclosure of Material and Information to those directors, officers, employees and consultants of Recipient who need to know or need to use the Material or Information in order to assist Recipient in carrying out the Purpose. The Recipient will ensure that Recipient’s directors, officers, employees, and consultants as aforesaid shall be bound by similar obligations of confidentiality and restrictions on use as contained in this Agreement.
The MTA might also determine how and when results and data produced can be shared with third parties. This will need to take into account the importance of data sharing in public health emergencies.
Access Rights for Implementation: During the Action, the Beneficiaries enjoy Access Rights to the Results of the other Beneficiaries, solely for the purpose and to the extent necessary for undertaking and completing the Action. Such Access Rights are granted under Royalty-Free Condition.
Somewhere in the MTA, possibly in this section, it will be necessary to address issues of confidentiality. How should any confidential information, such as patient identifiers, provided for the intended purpose or otherwise associated with the MTA, be handled? Some MTAs require that no patient identifiers are provided to the recipient.
Each of Recipient and Provider undertakes to retain in confidence and not disclose to any third party any confidential information and samples received from the other party. Such information may, however, be disclosed insofar as such disclosure is necessary to allow a party, or its employees to defend against litigation, to file and prosecute patent applications, or to comply with governmental regulations. Such obligation of confidentiality shall be waived as to information and samples which (i) is in the public domain; (ii) comes into the public domain through no fault of the receiving party; (iii) was known prior to its disclosure by the receiving party, as evidenced by written records; or (iv) is disclosed to the receiving party by a third party having a lawful right to make such disclosure. Such obligations of confidentiality shall continue for five (5) years from the completion or termination of the Research.
How should patient confidentiality be addressed? Perhaps through de-identification and an obligation to comply with these provisions.
Prior to the transfer of the Biological Material to Recipient, Provider will ensure that the samples are either coded or anonymised, so that under no circumstances will Recipient be supplied with the identity of the patient, or any basic clinical information, that in Provider’s opinion could identify the patient.
In other circumstances, a separate confidentiality agreement may be more appropriate. The type of material and its identifiability is likely to impact upon its ability to be shared with other researchers. Again, consideration of confidentiality should take into account the importance of data sharing in public health emergencies.