Best Practices for Unsolicited Interactions with Industry – Digital Health Clinical Trial

While there are many types of scenarios and questions you may be asked, below are a few best practices as well as some expert advice for when outside industry solicits your advice in the digital health field.

Scenario

A company asks you to be a PI or participate in a digital health clinical trial at Mass General

Best Practices

• Ensure that the research, not the funding, is aligned to your interests
• Collaborate with the company in drafting the protocol
• Ensure that the study is unbiased
• Use proper Massachusetts General Hospital or Partners HealthCare channels, which may include Partners HealthCare’s Office for Interactions with Industry (OII) and/or your supervisor

Expert Advice

• Start to draft a protocol for protection of human subjects to make sure it is plausible. Go to Mass General’s Division of Clinical Research (DCR) for a human subjects consult if you are not clear that it is plausible
• Develop an agreement through Partners CTO). Then, as soon as possible, begin to engage in review processes including supplemental review, Research Information Security Office (RISO) review, and Vendor Information Security Profile (VISP) processes
• Contract, the IRB, and supplemental reviews are not formally in sequence, but should be viewed as circular dependences that need to be de-risked in an interactive fashion. Unless you have deep technical knowledge, aim to contract with a clear feasibility, discovery phase up front

Resources

• Instructions: Please click on the link below to access helpful information
• You must be a Partners employee to access some of the links below
• DCR: https://www.massgeneral.org/research/division-clinical-research
• CTO: https://cto.partners.org
• RISO: https://rc.partners.org/security/information-security-program/riso-ancillary-review