I am Martha (Marty) Henry, founder and President of M.A. Henry Consulting, LLC in St. Louis. Today I will be sharing a story and some hot tips about data confidentiality and data ownership.
My firm was evaluating a federally funded project at a university under IRB oversight with approved consents for participants. The consents stated that only evaluators (we were named in the consent as evaluators) would have access to the key that linked participant codes to participant names. Two-and-a-half years into the five-year project, the program staff required that evaluators turn over all data with identifiers for internal uses.
Discussions with the university IRB confirmed our position to provide coded data to the project without identifiers as conforming to the consents sent out on university letterhead and signed by the PI. The university program staff, none of whom had taken the CITI training in human subjects, referred to the university contract language that said that all data were the property of the university. Their interpretation was that the data should be turned over with participant names.
We maintained our position and were fired as evaluators. The university then demanded the data as we were no longer the evaluators for the project. After retaining legal council and discussions with IRB experts and federal oversight staff, we reiterated that we would turn over coded data at any point but not identifiable data. Thirteen months later the university agreed to receive the coded data.
Hot Tip: Before signing any contract that references data ownership, obtain interpretation from your legal counsel regarding congruity of the language as stated in the contract and in the participant consents. If there is any possibility for dual interpretation, add an amendment to the contract clarifying release of confidential, identifiable data and which staff may have access to it.
Hot Tip: Before agreeing to evaluate any project, assure that all project staff have passed CITI. CITI is a series of training and education modules about the history, ethics, and practices necessary for protecting human participants, which generally include anyone participating in a study. The CITI training modules and tests are available at https://www.citiprogram.org/Default.asp?
Hot Tip: If anything seems amiss in your beginning discussions with clients, trust your gut!