How is it that we are nationally conducting COVID-19 research and collecting data on patients that have not been properly informed and educated and without obtaining consents?
People aren't given the information they need to properly consent. The fine print (that most people don't read) contains the information so when people sign they want the shot, they are giving consent, unfortunately. People are still getting inaccurate, and or false information to coerce them into getting these shots...
Anonymous data has been collected on patients for ages. This is how we know things like how many people are diagnosed with sepsis/year, how many die and what treatments make the biggest difference in outcomes. This is no different.
We have had the same discussion regarding informed consent related to experimental treatments with antibody infusions. Currently we are not obtaining consents but are documenting a standard education form was handed to the patient. I'm not sure how this is legally safe and have had the same question.
The databases are being queried and they are allowed to count individuals without the rest of their PHI. Also, this was a public health emergency at one point and this information will help for the next pandemic.
Welcome to America 🇺🇸
I participated in a number of COVID clinical trials as a Clinical Research Nurse from March of 2020 until January 2022. If you are talking about clinical trials testing therapies such as drugs or stem cells, there is a RIGOROUS consenting process for any of these trials. There was no deferred consent process. I would say that these were some of the most complex consents I have worked with, some running into 30+ pages. Additionally each trial has specific criteria that potential subjects must meet to be included in the trial, and other criteria that meeting any one of them would exclude participation. There are significant regulations at the federal level governing research and the protection of human subjects, and providing oversight for the IRBs that approve research at the institutional level.
This is huge topic area that has significantly varying uses and info that is collected.
Anonymous data collection - there is no limit to the amount of data being collected as there is no identifying info being shared.
Research for COVID treatment (drugs) - Deferred consent covers this. I think the pandemic has increased how much, how often this is being done and it is more difficult to verify that all the requirements are being met so there is legitimate concern.
there are many many levels of research. and many many rules, regulation and even international treaties.
There are national and state laws and regulation in place that require reporting of certain datapoints. they are always in place and ongoing. we are in a declared public health emergency - many standard rules are modified. allowing increased data collection.
regardless there is no limit on de-identified data collection, aggregation, and determination. Provided there is no experimental processes going on without consent.
if there is experimental treatment or medication use the patient (or person with legal authority to speak for the patient) still must be provided with education and consent. If the patient cannot answer and there is no designated proxy there re systems in place to obtain consent - those vary by state.
Uninformed patients leading unexamined Life
As far as COVID cases go, I’m sure they could cite it being a matter of national (and global really) security.
