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Types of Agreements

ORA maintains and makes available a comprehensive library of standard model agreements for contracting with research collaborators and can create custom agreements as needed. Determining the appropriate type of agreement will depend upon several factors, including the nature of the activity being conducted (i.e. research, services, etc.), project funding, and nature of any proprietary information, data or materials being exchanged. When School of Medicine faculty and staff discuss potential projects with research partners, we strongly recommend engaging ORA as early as possible in that process to determine the appropriate type of agreement.

The status of any agreements pending in ORA are viewable in MyRap. Please contact your ORA Contracts Team member with any questions. ORA contract agreement templates can be found on our Award Management: Forms & Templates page.

JHU investigators interested in collaborating with the Applied Physics Laboratory (APL) can review the APL collaborations page for University guidance.

Examples of agreement types include:

A Materials Transfer Agreement (MTA) is a contract used for the transfer or acquisition of various biological and research materials (i.e. plasma, sputum, urine, cell lines, reagents, chemical compounds), developed by nonprofit, government and private industry. JHU will ensure that MTA terms permit dissemination of research results and do not conflict with other University policies. The usual areas of negotiation for MTAs relate to publications, use of the research results, and the ownership of the technology generated by the research. JHU has institutional policies and procedural requirements that must be followed when transferring human biospecimens to an external organization. Click here to view the policies and procedural requirements. 

A Data Use Agreement (DUA), also known as a Data Transfer Agreement or Data Sharing Agreement, is an agreement between JHU and another party (academic institution, government entity, or company) to exchange data for furthering research. This type of agreement ensures appropriate treatment of the exchanged data under applicable laws.

Fibi records are  no longer required to request a DUA from the School of Medicine Office of Research Administration. Instead, all DUA requests that do not include funding should be submitted using the Data Use Agreement Request Form. DUA requests that include nominal costs associated with the transfer of data are also eligible to use the DUA Request Form. Follow the prompts, provide the information about your request (incoming vs. outgoing, de-identified vs. identifiable), and upload any additional documents that you may have with your request (Scope of work, Provider’s Agreement template). Your request will be triaged to an ORA Contracts Team member who will contact you with the status of your request. The status of any contract agreements pending in ORA are viewable in MyRap.

Some outgoing transfers of JHM data will require the submission of a Change in Research to the IRB and/or approval by the Data Trust prior to the execution of the DUA. When submitting a Change in Research in eIRB2, please enter the MyRap number assigned to your DUA when prompted for a record number.

Requests for funded agreements will still require submission through Fibi.

Please contact your ORA Contracts Team member for questions.

A Sponsored Research Agreement (SRA) is a contract entered into when an external entity, often industry, provides funding to JHU to support a specific research project with an expectation of receiving certain deliverables. While initial discussions between industrial sponsors and JHU faculty may occur in a variety of ways, sponsored projects should not be undertaken without a carefully defined research proposal and budget. ORA negotiates the terms of the SRA, ensuring compliance with JHU policies. SRAs typically include terms governing the following for each project:

  • Scope of Work and Budget
  • Reporting or deliverable requirements
  • Payment terms and invoicing schedules
  • Publication rights
  • Intellectual property generated
  • Use and treatment of confidential information disclosed
  • Compliance with regulations
  • Termination provisions
  • Other items as appropriate for the specific project

All School of Medicine CDA/NDA requests for review and inquiries, irrespective of whether they are with clinical or non-clinical parties; or whether they are for clinical or pre-clinical projects, should be sent to SOMNDA@jh.edu

A Confidential Disclosure Agreement (CDA), also known as a Non-Disclosure Agreement (NDA) or Confidentiality Agreement, is a legal contract between at least two parties which outlines confidential materials or knowledge the parties wish to share with one another for certain purposes, but wish to restrict from generalized use. In other words, it is a contract by which the parties agree not to disclose information covered by the agreement. CDAs can be “mutual,” meaning both parties plan to exchange confidential information with the other, or they can be “one-way,” meaning only one party will disclose confidential information.

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P: 410-955-3061

 

School of Medicine Office of Research Administration
Clinical Research Contracting and
Clinical Research Support Services

P: 667-208-8910

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