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Post by idoitforthepong on Nov 19, 2020 11:31:49 GMT -5
Just curious if the clinics are implementing any long term bans or other measures for a positive test. And is there any chatter of clinics shutting down again for this 2nd wave?
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Post by vark on Dec 5, 2020 23:49:10 GMT -5
i would not expect a long term ban. you get it, you get over it or die. the clinics seem to have covid protection plans in place by now.
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Post by veteran2 on Feb 15, 2021 13:24:08 GMT -5
Just curious if the clinics are implementing any long term bans or other measures for a positive test. And is there any chatter of clinics shutting down again for this 2nd wave? For them to be in jurisdictions that are serious about containing Covid they need comprehensive plans for worker and patient safety. I remember being in a clinic one week and for the next phase the rules were even stricter for patients sharing the bathroom and distancing. The staff told be me if they didn't implement the stricter safety protocols the clinic would have to suspend study trials.
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Post by labrat1 on Jun 8, 2021 19:14:46 GMT -5
I was at a certain Texas clinic in December 2020. I was in a small group of test subjects. There were many other volunteers in other studies. The clinic was big or at least bigger than other clinics in that the entire building "belonged" to the particular research clinic. In this particular study, the volunteers were required not to have traveled by airplane to the clinic no matter where they came from. The volunteers have to have driven or been driven there. However during phone screening I was merely asked if I were going to fly and told that the study requires no flying to the facility (if one is from a state far enough that you have to fly). It was a precaution apparently because the clinic staff felt that it is a greater "contamination risk" in an airplane than in a car. But also the clinic did not go as far as to , let's say, ask for receipts from a car service or ask for a notarized letter from your friend if your friend drove you. They took my word for it that I would not fly. It seems they know that they would be limiting their pool of lab rats to have very forbidding requirements. It can cut both ways. While in the clinic, different groups were called into the dining facilities at different times. There were more than one dining facility in the clinic at least on the one floor that I and my group were on, and while normally the tables were meant to have some four to six persons per table, the staff had only two persons per table and they had to sit apart as much as possible. In the dorm rooms it seemed that beds were practically only three or four feet from each other but the facility attached transparent plexiglass to the side of each bed so that it is harder for a person to breathe on the person on the bed next to him or her. Also certain beds in the dorm room were to be vacant, but some volunteers sat on the vacant beds to do things such as read or play games like checkers with other volunteers. A cleaning staff member once scolded some of the volunteers for sitting on a bed that was supposed to be vacant because the staff member was angry that she would have to clean and sanitize the bed now that volunteers had touched it or sat on it but the volunteers argued with the staff that the though the beds in the room have plexiglass attached to them, it is still being penny wise and pound foolish since a lot of volunteers in one room can still breathe into the air and eventually on each other and volunteers remove their masks while in the room and in their beds even though they have to wear masks in other parts of the facility. In this study only a blood test was required for the COVID test, not the nasal swab.
Then months later I did a study in a Nebraska facility. In that study a nasal swab was required at the screening and at the check in. Still though certain volunteers may have been in the facility for days or weeks at a time, different staff were going in and out of the facility. Masks were required but certain volunteers did not wear masks and often the staff were too busy to notice.
In this study the consent stated that if someone is found to have Covid that they will be sent home (or removed from the facility).
Since the protocol of the study was that no Covid testing would be done on people who were already in the study and who had been dosed, I am not sure how it would have just been found out that someone has Covid. No Covid test was done when the volunteers had to exit the study.
But the consent did also state that anyone found to have Covid while participating in the study will be released from the study for the protection of other volunteers. From what I now recall there was terse mention in the consent that the research facility will not take responsibility to pay for any treatment or hospitalization and it is for the released volunteer to determine when and what medical facility to go to for treatment. Apparently the clinic does not want one sick volunteer to ruin other studies that are being conducted in the facility.
I guess that most or all other clinics would do this. There is probably little or no regulation regarding what a CRO's or research facility's responsibility is if a volunteer contracts Covid while in a study.
Should the facility try to determine if it is because of some thing they overlooked or did? Maybe one of their staff persons also worked in a hospital and brought it into the clinic? Is the clinic accountable because the volunteer is in their custody and in a study?
Should the research facility check up on the volunteer? (I was once told by a research staff person that if a female volunteer gets pregnant while participating in a study she will be removed from the study and banned forever but the research staff and/or sponsor has a responsibility to try and keep track of the female to see if the medication affects the fetus. I will have to make a different post about this but if a volunteer gets Covid during a study it could be the research facility's fault even though the volunteer did not directly get sick because of the medication).
It is still a new and mostly unaddressed area of law or regulatory process.
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