Before You Start
Before you can start, there are four questions you must be able to answer:
- Is My Project Considered Research?
- Does My Project Have Funding?
- Does My Project Require a CDA or NDA?
- What is My Role?
Once you’ve established the answers to these questions move on to the instructions on getting started.
Is My Project Considered Research?
All projects must start by getting a determination from the UTRGV IRB of whether or not your project is considered research. They will also let you know what level of oversight will be required for your project to move forward.
For more information, visit Non-Regulated Research | UTRGV.
Instructions for Submission:
- Complete the Request for Determination- Non-Regulated Research Form
- Submit the completed form by email to IRB@utrgv.edu
The Office of Research Compliance will review your request and will issue a determination letter within seven (7) business days or upon completion of required items.
Help with Funding your Research
Do you need help funding your research or applying for a grant?
There is a whole team at UTRGV to help you navigate the grants and funding process for research.
Use the information and resources in the Pre-Award page.
If your research is already funded by an industry partner, outside institution or sponsor, you will not need this step.
Does My Project Require a CDA/NDA?
A Confidential Disclosure Agreement (CDA), also referred to as non-disclosure agreement (NDA) or secrecy agreement, is a legal agreement between a minimum of two parties which outlines information the parties wish to share with one another for certain evaluation purposes but wish to restrict from wider use and dissemination. The parties agree not to disclose the non-public information covered by the agreement. CDAs are commonly executed when two parties are considering a relationship/collaboration together and need to understand the other's processes, methods, or technology solely for the purpose of evaluating the potential for a future relationship.
Confidentiality Disclosure Agreements or Non-Disclosure Agreements are required if:
- Your project is funded/sponsored by an outside organization that requires one.
- Your project is using information or technology provided from an outside organization.
In most cases, when you have research that is sponsored by an outside organization, they will send you a CDA/NDA to be signed before they release all the information regarding the project to you/your group/UTRGV.
If you receive one of these agreements from a sponsor/funding entity/research partner organization you will submit it to the Office of Clinical Research (OCR). The OCR will work with the Research Contracts and Industry Agreements office to complete your CDA/NDA.
Use this link to submit a CDA/NDA for clinical research
User Guide and FAQs - Hyperlink
If you have any questions about these agreements, reach out to Research Contract and Industry Agreements at rcia@utrgv.edu
What is My Role?
| Type of Study | PI | Co-I | Sub-I |
|---|---|---|---|
| Chart Review/Case Reports/QI | MD/PhD/Fellow/Resident/Med Students | MD/PhD/Fellow/Resident/Med Students | MD/PhD/Fellow/Resident/Med Students |
| Biospecimens | MD/PhD/Fellow/Resident | MD/PhD/Fellow/Resident/Med Students | MD/PhD/Fellow/Resident/Med Students |
| Clinical Trial –Non-Drug/Device | MD/PhD | MD/PhD/Fellow/Resident/Med Students | MD/PhD/Fellow/Resident/Med Student |
| Clinical Trial – Drug or Device | Physician with appropriate experience and education | Physician with appropriate experience and education | Physician/clinician with appropriate experience and education |
Faculty – Faculty may serve as a Principal Investigator on a research study. Faculty must have appropriate education, training and experience in order to serve as a Principal Investigator on a clinical trial.
Resident/Fellow - Depending on site of research, residents or fellows may or may not serve as a Principal Investigator. Contact the OCR at clinicalresearch@utrgv.edu for assistance. For assistance with non-clinical research or research that does not involve human subjects see the Graduate Medical Education website at SOM Graduate Medical Education | UTRGV.
Student – Students may not serve as Principal Investigators on clinical trials. For assistance with non-clinical trial or research that does not involve human subjects see the Undergraduate Medical Education page.
If you have any questions about these roles, reach out to clinicalresearch@utrgv.edu for assistance.