3 ms·

I spent 10 years in the medical research world. Not having IRB approval is such a basic error. IRBs are set up to ensure that all research conducted on humans i

I spent 10 years in the medical research world. Not having IRB approval is such a basic error. IRBs are set up to ensure that all research conducted on humans is safe and ethical. If this was not Theranos and someone was say giving high level of radiation as part of an experiment I doubt you would be as forgiving. Or maybe PII gets published as part of a study on STDs and people are publicly identified. IRBs exist to protect patients and prevent researchers from harming them, either intentionally or unintentionally.

JoeAltmaier 10y ago
We're talking a finger stick here.
- apathy 10y ago
  Think about that for a moment. If you can test for the virus with a finger prick, you can potentially transmit this and other viruses as well. That needs to be addressed in the protocol, along with any other relevant details. It should be mundane. That's why it's shocking to hear that they did not do it! IRBs exist to ensure that these sorts of things are not overlooked. Too many times in the past, they have been. So now the burden of proof lies with the investigator. Like it or not, a few fast-and-loose protocols ensured that this situation will not be changing any time soon.
- enzamatic 10y ago
  You're also talking about telling someone they either do or do not have a disease. The finger stick alone is not all the damage that you can do. Is that person pregnant? Is their spouse? Are they going to act on what you told them?