What should human research subjects know about the data they help create?


Participating in a medical study voluntarily is no different than using your Walgreen’s card, both sets of data should be available to the individual that donated it, regardless of how inconsequential the data might be on its own. Just another form of identity theft IMO.

Under HIPAA guidelines the sponsor of the study is not allowed to know personal information about the subjects. All data captured is stripped of any identifying info, so the results are based on the general data itself, so there is no way that an individual can access their data. Subjects have to sign Informed consent forms that would explain what the study protocol is and what it will be used for. If it is going to be used for something else other than that the subject would have to sign other IC forms. A subject should also not know about the specifics of the study (control) so not to invalidate.
As for results, the subject would know who was doing the study and what it was and could access the final publication through journals or the FDA.

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The difference between (US) federally-funded human subjects research and companies collecting is that human subjects need to give their informed consent, except in a few situations where they would be non-identifiable. Companies, TV shows, and the like routinely get away with things that would be unethical if it were truly research.

Requiring back-reporting to participants seems reasonable, but this would probably actually be a bigger threat to identity theft, and a huge burden of additional red tape. A lot of human subjects research goes on with anonymous participants. Once you start collecting contact information, you need to store this in a secured manner, have a policy for destroying it, etc. Tying identity to the data makes for medical-record-type security requirements, even for things like visual priming and social psychology tests. Would you really want your behavior on a test (maybe of implicit attitudes toward racist sterotypes) tied to your identity in a database ‘secured’ on a graduate student’s laptop? Thousands of such data sets exist, but currently it is usually anonymized so there is no contact information or identifying data. The results of such scientific tests, if tied to identity, can usually be compelled to be released with a court order unless the experimenter makes special arrangements upfront. Do you want your genetic screening done when you were a college freshman subpeonaed in divorce court?

The need to make individual reports is mindboggling complicated, knowing the typical technical abilities of most researchers in behavioral and biomedical areas. Merging data and finding mean differences between groups is hard enough; taking those back to individual results, and producing dozens or hundreds of individual reports for participants who mostly don’t care is a huge waste of resources. You would need professional data handlers on many studies, and it would really eliminate the feasibility of a lot of small-scale and pilot studies that are not funded by large grants, studies people run as an undergrad or in graduate school as they learn about a topic. I’d guess that more than half of all studies conducted on humans go unpublished, many of them of this nature. If a researcher deems the results not worth reporting, or not being likely to make it through journal review because it is not ‘surprising’ enough, or if the results reveal a confound that needs to be eliminated in a further study, would you still report back to the individual? Sharing data that has not undergone peer review could be a big mistake.

Finally, even highly unreliable measures can be used to understand differences if you collect enough data. Giving specific results for unreliable measures, or giving people results if they were in a ‘control’ group, would be useless and might be unethical in some cases.

The law and policy over here (Norway) is that participants in medical studies have a right to “person-identifiable and pseudonymous health information about themselves, and information about the security measures taken as far as possible without weakening them” 1 . In practice, patients are not informed about the results of analysis done on their samples (after all, everything we use is labeled “not for diagnostic use”), though I guess the data could be made available if anyone actually asks. If we detect anything obviously bad, especially if it’s also inheritable and/or treatable, we are required to track down the patient and family 2 and inform them.

I was at an ethics discussion once where the question was if we should inform about untreatable diseases, or if we should wait to see if they become treatable … it’s not like you can contact someone out of the blue and ask “say, if we found out you had a horrible and incurable disease, would you like to know about it?”. I honestly can’t remember what was concluded, but luckily I’m also not in a position to say. I think modern studies have something about it in the enrollment; the default might be “only inform if inheritable or treatable; if neither then wait and see if a treatment becomes available”, but don’t cite me on that.

1 Helseforskningsloven §40 .
Norwegian authoritative edition
English translation
2 Which is always fun, given that we work with anonymized data - but there is a mapping table encrypted and behind a few different keys somewhere.

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