Sponsored Projects Administration

Confidentiality Disclosure Agreements (CDAs), or sometimes referred to as Non-Disclosure Agreements (NDAs), are contracts that govern the obligations of the entities who receive and/or disclose confidential information.

The types of CDAs/NDAs are described below:

  • Sponsor-initiated CDA/NDA

A Sponsor-initiated CDA/NDA is entered into when another entity discloses confidential information to UTHealth Houston, but UTHealth Houston is not disclosing any confidential information to the other entity. The terms of this CDA/NDA govern UTHealth Houston’s obligations of confidentiality with respect to the other entity’s confidential information being disclosed. This is a one-way CDA/NDA that is typically managed and negotiated by the Clinical Research Finance Administration (CRFA) through UT START.

For example, an entity may wish to disclose a study protocol to a UTHealth Houston PI for a feasibility review, but the protocol may include confidential information that must be safeguarded.

  • Mutual CDA/NDA

A Mutual CDA/NDA is entered into when another entity and UTHealth Houston both exchange confidential information to determine a business or research relationship. The terms of this CDA/NDA govern both entity’s obligations of confidentiality with respect to the other entity’s confidential information being disclosed. This is a mutual CDA/NDA that is typically managed and negotiated by the Office of Technology Management -- https://www.uth.edu/otm/.

For example, a UTHealth Houston PI may disclose a protocol that (s)he authored to another entity and the other entity may share proprietary information about the drug/device to determine whether both entities wish to engage in a clinical research study using UTHealth Houston’s protocol and the other entity’s drug/device.

  •  Investigator-initiated CDA/NDA

An Investigator-initiated CDA/NDA is entered into when a UTHealth Houston PI discloses confidential information to another entity, but the other entity is not disclosing any confidential information to UTHealth Houston. This is a one-way CDA/NDA that is typically managed and negotiated by the Office of Technology Management -- https://www.uth.edu/otm/.

For example, a UTHealth Houston PI may disclose information about a proprietary device that (s)he has developed and UTHealth Houston has patented to determine if a company wants to support a first in-human clinical trial with our proprietary device.

PROCESS

When an entity desires to share confidential information with UTHealth Houston, the entity will generally send a CDA/NDA to the PI or the department for signature. If no UTHealth Houston confidential information will be shared, the PI/department will enter a request following the instructions below in the “Department Tasks/Responsibilities” section. In the event that the UTHealth Houston PI expects to share any UTHealth Houston confidential information, the department should contact the Office of Technology Management (https://www.uth.edu/otm/).

INTERNAL DOCUMENTATION REQUIRED*

  • UT START Agreement Record
  • Protocol and/or scope of work, if applicable

*Negotiations on the agreement cannot begin until these documents are submitted. The information provided in these documents will dictate what terms are needed in the agreement, assist SPA in negotiations with the industry sponsor, and assure that all potential compliance and conflict of interest issues are identified and addressed.

DEPARTMENT TASKS/RESPONSIBILITIES

  • Create a confidentiality/nondisclosure agreement record in UT START
    • Upload agreement, if provided by the other entity. If an agreement is not provided by the other entity, notify SPA via UT START and SPA will draft the agreement
    • Submit AGT record to be reviewed and assigned to SPA Specialist

How to submit a Confidentiality Agreement in UT START:

  1. Login to UT START
  2. Navigate to the Agreements Module
  3. Select “Confidentiality/Nondisclosure” agreement type
  4. Fill out the intake form under the “CDA Infor e-Form” and press “Submit” once complete. If you received an agreement draft from the other entity, you may upload that in the Intake Form or under the separate “Attachments” Tab

**Please note that pressing submit is essential for SPA to receive the request**

If you have any additional questions about Confidentiality Agreements or the submission process, please reach out to [email protected].

SPA TASKS/RESPONSIBILITIES

  • SPA Intake will route CDA/NDA to applicable contract specialist in SPA.
  • Determine whether the agreement is an Industry Sponsor-initiated CDA/NDA, Investigator-initiated CDA/NDA, or a mutual CDA/NDA.
    • If the agreement is a mutual CDA/NDA, determine whether UTHealth Houston PI plans to provide confidential information to the other entity.
    • If the UTHealth Houston PI does not plan to provide confidential information to the other entity, ask the other entity to send a one-way CDA/NDA.
    • If the UTHealth Houston PI does plan to provide confidential information to the other entity, ensure that the CDA/NDA is forwarded to the person/office designated to handle mutual CDA/NDAs and/or Investigator-initiated CDA/NDAs.
  • Negotiate the legal terms of the agreement with the other entity on behalf of PI and UTHealth Houston.
  • Route the final agreement for review, approval, and signature, as applicable, to the PI and an authorized signatory for UTHealth Houston.
  • Confirm agreement has been fully executed, all appropriate documentation has been received, all applicable compliance elements have been obtained, etc.
  • Update the status of the agreement record to “Fully Executed” in UT START.