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Camille Nebeker

Posts: 56

How much responsibility should a PI have for reviewing the Terms and Conditions when using a commercial device in a research study?

Rubi Linares-Orozco

Posts: 33

To address your questions I will stick to the institutional policies regarding the research responsibilities for Investigators.

The Principal Investigator (PI) is the steward of Research Data owned by the University, and of any other data acquired or used during his or her research. 
The PI is responsible for:
1. Ensuring that Research Data is maintained in accordance with Institutional Guidelines and other applicable University policies, guidelines, and practices.
2. Ensuring that Research Data is recorded and stored in accordance with the standards of his or her respective discipline and any requirements of applicable federal or state law or regulations, University guidelines, or sponsored awards. 
3. The appropriate use of Research Data, whether generated by the Principal Investigator or obtained through material transfer agreements, license agreements or other means, and is responsible for ensuring that such use does not violate University contractual commitments. 
4. Consulting the appropriate campus office regarding the use and stewardship of Research Data that may be subject to applicable export control regulations, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), or other applicable laws and regulations.

So based on institutional policies, I would indicate that YES, the PI has an obligation to be diligent in the design and scope of the research study, and the investigator is held accountable to the multiple issues that may arise with utilizing a commercial product.

Best Advice I can give to a researcher embarking on "uncharted waters" is to schedule an appointment with the IRB to identify these areas of concern early on in the development process, and also reach out to Institutional Risk Management or Legal Counsel to address the legal agreements (user agreements) with using commerically available applications/products.

Hope this information helps.

~ Rubi