Nondisclosure/Confidentiality Agreement
No Fibi record is required for review of a Confidentiality Disclosure Agreement (also called CDA or Non-Disclosure Agreement or NDA). A MyRAP record will be generated by the Clinical Researching Contracting (CRC) office for these agreements. 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 [email protected].
For the review of a Confidentiality Disclosure Agreement:
- Email an editable version of the document, if available, to [email protected]. If no document is available, CRC has templates for use.
- Provide the contact information (name, title, email address, phone number, mailing address, etc.) for the Sponsor; and
- Identify the purpose and your timeline.
- A MyRap record will be created for the agreement and you will be contacted upon review.
Data Use Agreement
A Data Use Agreement (DUA) is required to send JHU data outside the University or to receive data from an outside entity.
As of August 4, 2025, DUAs should be submitted via a Fibi Service Request record (Service Request type: Data Use Agreement). For a step-by-step guide on how to submit a DUA Service Request in Fibi, please review the ORIS DUA snapshot guide.
Agreements that include incoming or outgoing funding with a data transfer component should continue to be submitted via Fibi as a new funded contract (Proposal tab in Fibi).
Some outgoing transfers of JHM data will require the submission of a Change in Research (CIR) to the IRB and/or approval by the Data Trust prior to 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.
Please note, DUAs with a commercial entity will be reviewed and negotiated by the Clinical Research Contracting (CRC) office.
- For an initial or original agreement:
- Editable version of the Data Use Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Contact information (name, title, email address, phone #, mailing address, etc.) for the other entity
- A JHU-specific Statement of Work or Scope of Work, clearly describing the data being transferred and how the data are intended to be used.
Please download and complete the DUA SOW Attachment 1 document from Fibi. - IRB/IACUC approval or application number, if applicable. If these approvals are pending, please indicate.
- If this request has been approved by the Data Trust, please provide confirmation of the approval. For questions on which transfer require review by the Data Trust, click here.
- For a modification of an existing DUA, please submit a Fibi Service Request (Type: “Modification of an Unfunded Contract”) and provide:
- Editable version of the Data Use Agreement modification (preferably MS Word), if one is available.
- Contact information (name, title, email address, phone #, mailing address, etc.) for the other entity
- Explanation of what is being revised (e.g. end date, PI change, type of data, etc.)
- If the type of data or location is changing, please provide an updated DUA SOW Attachment 1 document
- If changes necessitate new or revised Data Trust approval, please provide confirmation of the approval.
Materials Transfer Agreement
A Fibi record should be routed to ORA, unless an information sheet for the MTA has already been filled out and submitted to JHTV. If a JHTV MTA request has already been submitted, no Fibi record is required.
Please provide the following:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use. If ORA is to draft the agreement, please indicate.
- Proposed Budget, when applicable. No budget required for unfunded MTA’s.
- A JHU-specific Statement of Work or Scope of Work, clearly describing the materials being transferred and how they are intended to be used.
- Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Provider/Recipient
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
- Outgoing transfers of human biospecimens will require approval from the IRB’s Biospecimen Transfer Committee (BTC). If this applies to your project, please submit a Biospecimen Transfer Information Form to the JHM IRB via the eIRB2 system. For more information on the BTC review process, please consult the IRB’s website.
Contract/Agreement (funded)
A Fibi record should be routed to ORA
Fibi Activity Type must be “Organized Research” as these agreements will be handled by ORA.
- For an initial or original agreement:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Sponsor
- Proposed Budget
- A JHU-specific Statement of Work or Scope of Work
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
- Agreements for commercially sponsored clinical research should be routed with an Activity Type of “Clinical Research” and will be handled by the Clinical Research Contracting (CRC) office.
Clinical Trial Agreement (commercial sponsor)
Fibi Activity Type must be “Clinical Research” as these agreements will be handled by CRC.
- For an initial or original agreement:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Supplemental Information Sheet (“SIS”) for Commercial Agreements (available here)
- Proposed Budget, when applicable. No budget required for unfunded studies.
- A JHU-specific Statement of Work or Scope of Work
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
Clinical Trial Agreement (non-commercial sponsor)
Fibi Activity Type must be “Organized Research” as these agreements will be handled by ORA.
- For an initial or original agreement:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Provide the contact information for the Sponsor.
- Proposed Budget, when applicable.
- A JHU-specific Statement of Work or Scope of Work
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
Collaboration Agreement (unfunded)
A Fibi record should be routed to ORA
- For an initial or original agreement:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Contact information (name, title, email address, phone #, mailing address, etc.) for Collaborator
- A JHU-specific Statement of Work or Scope of Work
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
- Outgoing transfers of human biospecimens will require approval from the IRB’s Biospecimen Transfer Committee (BTC). If your collaboration will include the transfer of human biospecimens to an external collaborator, please submit a Biospecimen Transfer Information Form to the JHM IRB via the eIRB2 system. For more information on the BTC review process, please consult the IRB’s website.
Grant Award
These agreements/awards must be submitted via the Fibi system with the following documents uploaded:
(Note: if a Fibi record for the proposal associated with this award was previously routed to ORA, no additional Fibi record is required)
- For an initial or original agreement:
- Editable version of the Award/Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
- Proposed Budget if different from proposal submission.
- Contact information (name, title, email address, phone #, mailing address, etc.) for Funder
- A JHU-specific Statement of Work or Scope of Work
- IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
- Proposal Fibi PD# if a Fibi record was submitted at the proposal stage.
Memorandum of Understanding
A Memorandum of Understanding (MOU) is a formal agreement between two or more parties to establish a relationship/partnership with a broad intent to collaborate, but with no project-specific details or obligations. These non-binding MOUs constitute a written “handshake” and are often the first step in beginning a new relationship between the parties.
Research-related MOUs for School of Medicine should be submitted to ORA via Fibi. These include agreements titled “MOU”, but include binding terms and conditions for carrying out research projects in the School of Medicine.
All non-binding MOUs for the University, regardless of school, are handled by JHURA.
Agreements related to the creation or delivery of academic program agreements, whether called educational agreements, placement agreements, memoranda of understanding, etc. are also handled by JHURA.
Non-binding MOUs and academic program agreements must be submitted via the JHURA routing system, JAWS, with the following documents uploaded:
- For an initial or original agreement:
- Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, JHURA has templates they can use.
- A completed copy of the International Agreements Intake Form should be uploaded to the JAWS record prior to submission.
A short guide for department staff on how to submit these requests in JAWS can be downloaded here. General questions related to non-binding MOUs and academic program agreements submission difficulties should be directed to [email protected].
Other Agreements
Most agreements must be submitted to ORA through Fibi. If you have questions as to whether ORA is the proper office for a particular agreement you can reach out to the ORA Specialist that supports your department for information – click here for commercial clinical research agreements (CRC Office) or here for all other sponsored research agreements (ORA Office).
Modification to an Existing Agreement
Except for Confidentiality/Non-Disclosure Agreements, a Fibi record is required to formally modify an agreement. Please see our Modify An Award/Contract page for additional details on how to submit a modification request to ORA.