Nondisclosure/Confidentiality Agreement
No COEUS 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
Fibi records are no longer required to request a Data Use Agreement from School of Medicine Office of Research Administration.
DUA requests that do not include funding should be submitted to ORA for review via the new DUA Request Form. Requests that include nominal costs associated with the transfer of data are eligible to use this form.
Follow the prompts on the form, provide 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 pending contract agreements 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.
DUA’s that include incoming or outgoing funding should continue to be submitted to ORA via the Fibi routing system.
Please note, DUA requests for human subjects data being sent to a commercial entity will be triaged to the Clinical Research Contracting (CRC) office for review and negotiation.
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 CRC.
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 COEUS PD# if a COEUS record was submitted at the proposal stage.
Memorandum of Understanding
These agreements must be submitted via the Fibi system 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, ORA has templates for use.
- Proposed Budget, when applicable. No budget required for unfunded studies.
- Contact information (name, title, email address, phone #, mailing address, etc.) for Collaborator
- A JHU-specific Statement of Work or Scope of Work or description of the proposed collaboration
- Some MOU’s will require additional review by the Office of the Provost
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.