Devices Loaned to Human Subjects

[son...@umn.edu]

Does anyone loan devices to research subjects?

We have a faculty member that is interested in loaning virtual reality equipment that would total about $800 to research subjects over the course of about 4 weeks. The faculty are going to be giving subject payments and will be working with individuals from the general population.

Has anyone done something like this before?
Did you have an official agreement signed with the subject?
Did you withhold subject payments until the device was returned or did you have an incentive for them to return the device?
How did you handle if the device was not returned or returned broken?

Any advice on how to go about this would be much appreciated.

Thank you,

Sonya

[march016]

I'm just bumping this to see if anyone has some experience with this type of scenario.  Sonya, were the VR headsets purchased with grant funds?  Was this in the proposal?  Did you reach out to the IRB/HRPP to see if they had any suggestions or have seen this type of activity before?

[son...@umn.edu]

Currently, this seems to be mostly in the idea stages. The VR headsets for this specific purchase have not been purchased yet. The faculty are currently trying to get a protocol approved through the IRB. The questions we are asking were part of the feedback requested by IRB. I do not believe that the IRB gave any advice or suggestions for how to go about this.

Since posting the questions on this site, we have gone to OGC to ask about an equipment loan form. OGC said they had not encountered something like this before where the U would loan equipment like this to human subjects. We were told that the VR equipment is below the deductible for insurance so this will not help. Even if we have an agreement made with the subjects, we could not guarantee that we would be able to get compensation from the subjects through small claims court if something is lost or broken.

Ultimately, the VR headsets and associated phones will be purchased with non-sponsored funds but we thought we could reach out in this venue as it relates to work with human subjects. I believe they are trying to get initial data for use in future grant proposals.

[march016]

Thanks for the additional information.  A CA contacted me and she thinks she might know of something similar that another group dealt with.  She isn't certain but will dig a little and get back to me.  In the meantime, if anyone else has thoughts feel free to chime in. 

[olso...@umn.edu]

I reached out to one of our study coordinators. We have a NIH grant (not a clinical trial) that involves a heart monitoring device which our subjects wear for 2 weeks. The device costs less than $200. No official agreement between study and human subject but the consent form includes some language. Instructions are given to the subject to send device to supplier/vendor. Supplier provides postage paid box/w USPS tracking # for the return. Supplier does analysis and provides data and alerts to PI to discuss with subject and their doctor, if needed. We withhold incentive until the device is returned. No issues thus far with return and may be due to subject age group (70-95 yrs old). If faulty device, the subject sends to supplier and receives a replacement one.

Hope this helps a little bit.
Mary Olson, EpiCh