Excluding participants who do not consent to sharing data per Ultimate Consent Form

[elizabeth-bartlett]

Hello,

My question is regarding this portion of the Ultimate Consent Form: "Letting us use and share your data is voluntary. However, you must be willing to share your data in this way in order to participate in this study. If you are not willing, you cannot participate in this study."

I would like to include this requirement so I can ensure data from my study can be shared. However, NIMH NDA policy says the following: “Participants who do not consent to share data through NDA are not excluded from the study, but their data cannot be uploaded to NDA.” (https://nda.nih.gov/nda/exceptions-to-data-submission)

Therefore, I’m wondering if I’m allowed to exclude participants who are not willing to share their data, and therefore the NIMH NDA policy would just be indicating that we are allowed to include participants who don’t want their data on the NDA, but that it’s the investigator’s discretion whether to add an exclusion for participants who do not wish to share. Did this issue come up at all in the formulation of the Open Brain consent form language? Do you have any suggestions for figuring out the policy? I’m looking for a more global research ethics policy than anything at an individual institution or IRB level.

Thanks!

[yarikoptic]

That is a great question to which ATM I do not have a formal answer unfortunately. I know that participants of imaging studies could be refused participation for various "technical" reasons such as relating to MRI safety. I think I saw consent forms which did not make "sharing" clauses optional. I think the best would be to clear it up with the IRB committee of your institution, through which that consent form text needs to go through anyways AFAIK before you could do your study.