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Question about whether/how IRBs consider Terms of Service agreements

ethics IRB Terms of Service (TOS)

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Michelle De Mooy

Posts: 1

I'm looking into how (and whether) IRBs consider an app's Terms of Service provisions when doing an ethical review. Does anyone know of standards or guidance for IRBs on this subject? I found this: but very little else. Any help is appreciated!

Rubi Linares-Orozco

Posts: 34

Hi Michelle,

Your question is the reason I became involved with CORE. Essentially, there is no go-to "guidance" available to IRB's from OHRP on this topic. The Good News is you found CORE so hopefully the CORE community, and past CORE postings can provide you with some guidance.

From my own experiences as an IRB analyst, when a researcher was using a "commercial" application I would either look up the Privacy Statements and Terms of Use agreement, or ask the researcher to provide me with this information if I could not access it. I would then ensure that the infomation in the terms of use alligned with the information in the research protocol, or if it didn't, I would ask the investigator how they planned to bridge the gaps (as applicable). Our IRB also had an IRB member who was a technical expert in this arena who provided crucial guidance as well.

Common concerns I found were typically regarding data sharing, data access, which raised Privacy and Confidentiality concerns. Another concern was what happens to the data when a subject chooses to withdraw from the research study, what is the process for removing/or not removing data from the application. At times I would have to have our legal counsel/ compliance get involved, who would provide further management strategies to the design of the research protocol- Data Use Agreements, Contracts, etc.

Ultimately while the Terms of Use cannot be changed, as an IRB analyst my primary focus was on what information was being communicated in the informed consent, and what safeguards could be incorporated into the design of the research protocol to manage IRB concerns.

Happy to discuss your scenario in further detail.

Katie Shilton

Posts: 1

Hi Michelle,

As Rubi mentions, there's very little concrete guidance on this. I'm afraid I can't speak to what IRBs are doing, although PRIM&R leadership may be able to tell you whether there is specific guidance in this area.

Meanwhile, the ACM SigCHI Working Group on Research Ethics put together an update to Amy Bruckman's earlier post, which you already found:

I hope this might be helpful!