Confidentiality Agreements - Frequently Asked Questions
- Should a CDA cover the conduct of a research study?
- Should my disclosure agreement be two-way or one-way?
- Is the Office of Corporate Research the only University office that signs CDAs?
- Should an investigator just sign his/her own CDA as the sole University signature?
- When should I consider asking another party to complete a CDA?
- Should a CDA cover issues like publication pre-review and intellectual property?
- If I receive information under a CDA, can I give it to other University employees?
- Does the Office of Corporate Research sign CDAs for confidential information an investigator will receive in relation to outside employment or research as an independent consultant?
No. A CDA should not be used to cover the actual conduct of research, because it would restrict the University and investigator’s ability to publish or otherwise disseminate the results and knowledge gained by the research. In addition, the University may lose its ability to claim a fundamental research exemption from US Federal Export Control regulations if the results of research are restricted from dissemination. Appropriate provisions regarding confidentiality in the conduct of the research project shall appear in the sponsored research agreement itself.
Use a two-way (mutual) CDA, when you and the other party both exchange confidential information that should not be disclosed to third parties. Use a one-way CDA when only one party is disclosing confidential information and the other party is receiving that information.
No. The Office of Corporate Research is the appropriate business office to sign Confidentiality Agreements that relate to research activities related to clinical trials. Other University offices sign Confidentiality Agreements that pertain to their specific functional areas. For example, the Office of Research Services (ORS) signs agreements related to non-clinical research; and the Office of Technology Transfer (CTT) signs agreements related to licensing and commercialization negotiations.
No. An investigator is not authorized to sign a contract on behalf of the University. Doing so would put the investigator in a position of potentially being held personally (and solely) responsible for any legal or business issues related to the agreement. The University signs on behalf of the investigator or in addition to the investigator. If the CDA is formatted by the other party to depict only an investigator as the party and signatory, the Office of Corporate Research will alter the agreement to include an institutional signature.
Any time you are disclosing information that is not generally available to the public and you want to limit the other party’s use or dissemination of that information you should ask the other party to complete a CDA. For example, if you are sending a study design or protocol to a pharmaceutical company; giving a lecture to a pharmaceutical company that discusses your unpublished research; or sharing a potentially patentable idea with a collaborator outside the University in the context of a grant proposal a CDA should be completed In addition, a CDA should be executed if you are reducing the non-public information to written form (hand-outs, PowerPoint presentations, emails, diagrams, notes), clearly marked “Confidential” on each page.
No. A CDA should typically only allow use of provided information for evaluation purposes. The actual conduct of the project should be covered in a separate contract, like a clinical trial agreement or a sponsored research agreement. Accepting these kinds of clauses in a CDA can restrict the investigator or University from freely pursuing their research and results.
Possibly, depending on what the terms of contract are. Some agreements limit disclosures strictly to the point of contact referenced in the agreement, usually the primary investigator. In this case, post-doctoral fellows, students in the lab, and even other faculty collaborators would not be permitted to see the confidential information. Even if the agreement allows you to release the information, you want to limit exposure as much as possible. Do not allow anyone to access the confidential materials unless they absolutely must be privy to the information.
No. The University only can sign CDAs for University research purposes for an investigator who is acting in his/her role as a University employee.