IRB Issues

[Malarkey]

Time for the perennial IRB gripe session.

More specifically, I'm interested to hear whether your IRB forces you to put phrases or statements in informed consents that do not appear to have relevance or meaning for your studies. Do they expect you to exaggerate the description of risks?

This question is NOT research, and has not been reviewed by any IRB. I'm merely interested in hearing about your difficulties.

[darkstarrynight]

I serve on my institution's IRB. We provide an informed consent template for people to follow but require all statements from the updated regulations introduced around this time last year. However, if someone is doing something in social sciences, there is no need to mention anything on genome sequencing, for example. If people request a waiver for our template usage, then non-traditional forms require more scrutiny.

[Parasaurolophus]

I joined our IRB (REB, in our case) last summer and my university is pretty research-dinky, so my experience is still fairly limited, but:

We provide an informed consent template for people to follow but require all statements from the updated regulations introduced around this time last year. However, if someone is doing something in social sciences, there is no need to mention anything on genome sequencing, for example. If people request a waiver for our template usage, then non-traditional forms require more scrutiny.

It's the same with us.

Do they expect you to exaggerate the description of risks?

I don't know how representative my experience is, but I can tell you that one issue that often crops up for us is systematic underestimation of the risks associated with a project. Even for risks which seem pretty minimal, realistically-speaking, the Board likes to see researchers identify and address them in the application. That's not to say that everyone needs to address every possible risk no matter how minute. It's just that we get a lot of applications which claim 'no risk' and then leave the field blank, when in fact it's not that hard to identify potential risks (e.g. data breaches), or fixes which are unworkable given the nature of the project and data collection (e.g. 'participants can withdraw at any time').

I imagine these issues are less common at less research-dinky institutions where there's long-standing experience with IRB procedures and lots of institutional memory.

[Malarkey]

Parasaur...I'd be interested to know if these applications are socio-behavioral research, or a different field.

I also sit on an IRB committee, and I do research, so I see it from both sides.

[Parasaurolophus]

Parasaur...I'd be interested to know if these applications are socio-behavioral research, or a different field.

I also sit on an IRB committee, and I do research, so I see it from both sides.

I've mostly seen it with applications from the social sciences, yeah, and the unfeasability of scrubbing a particular dissenting participant's data pretty much just applies to qual stuff.

But like I said, I'm still new to the board, and we don't exactly go through tons of these! My perception may well be skewed.

[Malarkey]

I guess IRBs are operating more effectively these days since there are so few comments here. Perhaps the changes to the Common Rule have actually made IRBs easier to navigate.

[research_prof]

I guess IRBs are operating more effectively these days since there are so few comments here. Perhaps the changes to the Common Rule have actually made IRBs easier to navigate.

Or they simply do not approve any study because of COVID.

[youllneverwalkalone]

Time for the perennial IRB gripe session.

More specifically, I'm interested to hear whether your IRB forces you to put phrases or statements in informed consents that do not appear to have relevance or meaning for your studies. Do they expect you to exaggerate the description of risks?

This question is NOT research, and has not been reviewed by any IRB. I'm merely interested in hearing about your difficulties.

I never had that specifically (being forced to add specific statements) but it happened a few times that our IRB brought out potential risks we hadn't fully considered, which was very useful and their remarks were generally sensible and relevant. I am only annoyed with when they make comments that are only tangentially related to ethics (e.g. on the research design).

I guess IRBs are operating more effectively these days since there are so few comments here. Perhaps the changes to the Common Rule have actually made IRBs easier to navigate.

Or they simply do not approve any study because of COVID.

Really hope that's not the case cause I am about to submit to one protocol myself next week.