Transfers of Research Materials
All transfers of research material in and out of Johns Hopkins University must be memorialized in an agreement that outlines the rights and obligations (i.e. rights of publication, inventorship, liability, etc.) of the parties involved in the exchange of tangible and intangible research material. Research materials may include human biospecimens, cell lines, DNA, RNA, mice, etc. Research materials may be exchanged in a Material Transfer Agreement (MTA) or as part of sponsored research agreement (including clinical trials) (SRA), collaboration agreement, Data Use Agreement (DUA), or Cooperative Research and Development Agreement (CRADA). The type of legal agreement required to support a transfer of material, and the office responsible for creating and negotiating it, depends on the nature of the transfer.
Johns Hopkins Technology Ventures (JHTV) drafts, negotiates, and reviews MTAs covering most transfers of material in and out of JHU, unless one of the exceptions listed below is met.
For JHU School of Medicine researchers, if your transfer, either inbound or outbound, involves any of the following characteristics, you will need to submit a request to the School of Medicine Office of Research Administration (ORA) or Clinical Research Contracting (CRC) office, as detailed below.
A note on FIBI records: Faculty do not have access to submit records in FIBI directly to ORA or CRC. If your agreement requires a FIBI record, faculty should contact their department Grants & Contracts Analyst for assistance.
- Clinical Research: If the material (drug or device) will be transferred between JHU and another entity as part of an active clinical trial or clinical research study – please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI Service Request (SR Type: Material Transfer Agreement).
- Clinical Research material transferred between JHU and a commercial entity will be reviewed by CRC.
- Material transferred between JHU and a non-commercial, academic, or government entity will be reviewed by ORA.
- Human Biospecimens: If the transfer out involves human biospecimens (e.g. tissues, blood, cells, urine, stool, DNA, RNA, protein, etc.) obtained from JHU patients, please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI Service Request (SR Type: Material Transfer Agreement). Please upload a completed Human Biospecimen Transfer Information (BTI) sheet to the Fibi record.
- Human biospecimens transferred between JHU and a commercial entity will be reviewed by CRC.
- Biospecimens transferred between JHU and a non-commercial, academic, or government entity will be reviewed by ORA.
- Protected Health Information: If the transfer involves ONLY the sharing or receipt of a data set/Protected Health Information (including limited data sets), please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI record to ORA or CRC (Fibi Service Request, Type: Data Use Agreement).
JHTV does not handle MTAs that include limited datasets or PHI. - Exchange of Funds/Sponsored Research: If the transfer is part of establishing a funded research grant or contract, in which protocols, materials, data, and/or results are shared back and forth with the Provider/Recipient, please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI Proposal Development (PD) record to ORA or CRC.
- Collaborations (funded or unfunded): Collaborative research projects are characterized by jointly developing research protocols, jointly analyzing results, or if the PI is committing measurable effort to the research project. Joint publication alone does not constitute a formal research collaboration requiring a collaboration agreement. If the transfer of material is only one element of a larger collaborative research project between JHU and the Provider/Recipient of the materials, please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI record to ORA or CRC (Fibi PD record for funded collaborations or Fibi Service Request, Type: Unfunded Collaboration for unfunded).
- Cooperative Research & Development Agreements (CRADA): CRADA involve a formal agreement between JHU and one or more Federal laboratories. These agreements are processed by ORA. Please work with your department Grants & Contracts Analyst (GCA) to submit a FIBI Service Request (Type: Unfunded Collaboration) to ORA.
Purchasing Goods and Services: Agreements for the purchase of goods and services are handled through the JHU Procurement office, and relevant documents and materials from your supplier should be submitted via the Procurement Portal https://jhuprocureprod.service-now.com/ as a purchasing agreement to be reviewed by their contracts team. More information about purchasing agreements is available here: https://finance.jhu.edu/depts/procurement/service_portal.html
Please do not submit the same MTA request to both ORA and JHTV – this causes confusion and significant delays.
If you are uncertain where to submit your request for the transfer of research materials, please contact [email protected] for guidance.