SCHOOL OF SPORT, EXERCISE AND HEALTH SCIENCES Material Transfer Agreement Request 1.0 Introduction If you wish to transport any material, be it biological samples, equipment, human material or any other article between institutions an MTA (Material Transfer Agreement) needs to be in place. A Material Transfer Agreement is a legally binding contract between provider of the tissue (as defined by the Human Tissue Authority); or, any other material/ equipment to be transported, and the recipient. An MTA also limits the right of the recipient to work with materials except under terms agreed by both parties and in compliance with the Human Tissue Act 2004. Any other relevant legislation for the transport of material, in instances where non-HTA relevant material is being transported, must also be complied with. This agreement is subject to English law and exclusive interpretation by the English Courts. 2.0 Purpose The purpose of this document is to source all relevant information, such that an MTA can be written to govern the transfer and receipt of relevant material between xxxxx (Originator Institution) and xxxxxx (Recipient Institution). The MTA, once written will also outline the responsibilities of each party, any relevant disclosures (if applicable) publication rights, funding restrictions and any other matter, relevant to the transfer of tissue/ any other materials or equipment between one institution and another. This agreement does not preclude the need to adhere to other regulatory or legal requirements relating to supply, receipt, storage, use and disposal of material. 3.0 Responsibilities 1|Page Responsibility for completion of this Material Transfer Agreement rests with the Originator organisation, who should also keep a copy of the completed agreement as a record of when the material was transferred and to whom. Systems should be in place to ensure samples can be tracked from dispatch by the Originator to receipt by the Recipient. The Originator agrees to provide the material detailed below on the basis that it has been collected, handled and stored in compliance with the terms of the Human Tissue Act 2004. In particular, the Originator assures that the material has been taken with informed consent for the use specified and that a record of this has been maintained and that this record will, if required, be provided to the relevant regulatory authorities. The material is supplied without warranty as to its properties or fitness for any particular purposes and without any other warranty whatsoever, expressed or implied. The material will be forwarded to the Recipient as detailed in the approved version of the study protocol. The Recipient agrees to receive the material on the basis that it will be handled, stored, used and disposed of in accordance with best practise, local policies and the terms of the Human Tissue Act 2004. The recipient must ensure that all efforts are made to secure the integrity and security of the material, and that it is used efficiently and appropriately. In particular the material will only be utilised for the purpose(s) specified in this Agreement, which are authorised according to the corresponding Originator consent forms and information sheets. Furthermore, the Recipient shall not dispose of any remaining material without the Originator’s agreement and shall ensure that the method of disposal is in accordance with the terms of the Human Tissue Act 2004. The Recipient agrees to conform to any requests to provide information on how the material has been stored and used and disposed of, and to return any remaining material at any time, if so requested by the Originator, the person from whom the tissue was obtained or the regulatory authorities. Any breach of the terms of this Material Transfer Agreement must be notified to the other party immediately. 4.0 Definitions Originator Institution: The Institution providing the relevant material. Designated Individual: The person who is authorised and, supervises the activities under a licence issued by the Human Tissue Authority. Relevant Material: The definition of relevant material in the Human Tissue Act is: Section 53: material, other than gametes, which consist of or include human cells. References to relevant material from a human body do not include: 2|Page (a) Embryos outside the human body or (b) Hair and nail from the body of a living person. Research: Is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. Standard Operating Procedure (SOP): Detailed written instructions to achieve uniformity of the performance of a specific function. 4.0 Confidentiality The Recipient must not disclose any information whatsoever with regards to the material and its use, to anyone other than the authorised personnel carrying out the investigation, without written approval of the Originator. Information with regards to the material must only be utilised for the indicated use. Any requests regarding access or retrieval by the test subject or their representative must be complied with. The Originator and Recipient must operate in accordance with the Data Protection Act 1998. 5.0 Publishing The Recipient must acknowledge the contribution of the Originator institution in any publication that may result from the use of the materials. Advance copies of any paper, including student work (thesis), to be published must be sent to the Originator for review. If there are publications likely to arise from the use of the material it must be agreed prior to any publication/ presentation/ oral disclosure of work arising from the use of this material, whom is to be credited for the work. This must be discussed with the Originator Institution and all points agreed set out in writing. 6.0 Intellectual Property If there is any potential Intellectual Property (IP) likely to arise from the use of the material this must be discussed with the Originator Institution. The policy surrounding IP should be written such that all legal considerations from all parties are taken into account. 7.0 Safety The Originator shall inform the Recipient of any known biological Hazards associated with the sample, and the Recipient takes responsibility for the appropriate management and handling of the sample. 8.0 Funding Arrangements 3|Page All funding arrangements for the project using the material provided must be transparent. 9.0 Transport of Material Transport must take place in a safe manner that will ensure the security and integrity of the samples during transit. A system should be in place to ensure that the material has been received safely, and stored appropriately. 10.0 GENERAL DETAILS Study Title Proposed start date End date (if applicable) Principal Investigators (please include name, address, email, telephone & fax details for each) Originator Institution contact details Recipient Institution contact details HTA ‘relevant materials’ Other materials Reason for transfer Responsibility for transport costs Loughborough University Responsibility for arranging transport Loughborough University How the material will be used (Please provide a very brief description of the intended permitted 4|Page use of the Material) About the Source material (Please provide brief details of your research work in terms of timings and location of the Material, from its source until it is disposed/stored) How the samples be anonoymised (please provide details of the process) Any information that the Recipient will be given relating to the test subject Has a risk assessment been carried out? Please evidence this! Please provide evidence of consent (supply a sample consent form) How the research project is funded Originator Institution Designated Individual (DI) (Where applicable) Recipient Institution Designated Individual (DI) (Where applicable) Originator Institution HTA 5|Page 12577 License number (Where applicable) Recipient Institution HTA License number (Where applicable) How is the sample being transported? Please state whether your method of transport (+packaging) complies with HTA legislation. Details of ethical approval to use this material Any patent issues surrounding this material Any other constraints on the use of the material Specific issues relating to publication and/or IP (Will there be any IP generated from the transfer of materials) Other Details for the planned disposal of any surplus material at the end of the permitted use (in compliance with the requirements of consent provided) 10.0 Signatures The signature of the Principal Investigators and Designated Individuals of the receiving organisation signifies the Recipient’s acceptance of the above by signing and dating two copies of this Agreement and returning both copies to the Originator 6|Page Institution. Upon receipt of two completed and signed copies of this Agreement, and any other documents required, the material will then be sent to the Recipient. Recipient’s Principal Investigator: Originator’s Principal Investigator: Signature: Signature: Name (print): Name (print): Date: Date: Title/Position: Title/Position: Recipient’s Designated Individual: Originator’s Designated Individual: Signature: Signature: Name (print): Name (print): Date: Date: Title/Position: Title/Position: 7|Page