Kristy Ski
Region: US
Wednesday 09 July 2025 18:52:35 GMT
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Syd :
I’m a clinical researcher coordinator and I’ve worked in the field for ~7 years. (I am not speaking on behalf of my employer) You are supposed to thoroughly explain every section of the consent form, allow patients to ask questions, and allow enough time to review to make an informed decision. Usually with drug trials, it is a requirement that there is a physician available to discuss the research with you. That doesn’t mean that the physician will be the one who consents you, but one should be available upon request at least by phone. The person who does the consent can play a big part in how well this is followed. Although there are human subjects research trainings we are required to keep up on certifications for, the actual patient interaction and the amount of knowledge the person consenting you has about the study is highly variable. It could be great or terrible, unfortunately. This may be their main study and they’re deeply involved or you could get a fresh college kid juggling five studies who is barely familiar with the details. In terms of what we call inclusion or exclusion criteria- things that make you eligible or ineligible, those are not things they can push aside willy nilly. There is a set list of things that make it so you can or cannot participate in the trial, which is regulated by the institutional review board (IRB) for that study. What you see on the consent is not the language of the protocol (the document outlining exactly what the trial will do, approved by the IRB). The consent form is required to be in what is called plain language. So it is possible that although they list a drug you cannot take alongside this drug, the actual specifics of the protocol allow a certain amount of it to be taken. It would be unusual for them to enroll someone who is not actually eligible- they could get in a lot of trouble if they are routinely doing that and get caught during an audit. It sounds like you were not given the respect or care you deserved and you have a right to be upset. Please let me know if you have any other questions and I’ll see if I can answer them!
2025-07-09 20:19:04
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Jennifer Nichole :
That sounds like a very sketchy trial. But as someone who has done Botox for migraines I did get (29-32) injections in the head and neck. That is the only part of this that sounds legit.
2025-07-10 05:00:38
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Indie Rogue :
This is what informed consent is and it's important. Any good researchers are going to go through each part and let you know what they mean and allow you to ask any questions. It's also pretty unusual for a medication trial to not exclude you if you have been taking another medication that's used for the same issue they are studying. You can go on clinicaltrials.gov to look at information on the study to see if it's legitimate. They also should have some contact information for the coordinator or head researcher on the packet if you have questions
2025-07-10 04:35:39
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orinoco.rat :
I’ve done clinical trials for migraines before and the experience varies widely depending on who it’s through, you’ve really trust your gut as others have said and remember that you can leave at any point.
2025-07-09 19:54:02
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cindysue494 :
My sister has fought migraines most her life. She got the piercing in her ear in the cartridge and it has reduced her migraines by 90%. Just an idea for you
2025-07-09 19:16:43
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Angel :
I haven’t, but that sounds super sketchy!!
2025-07-10 05:40:42
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Michigan Lady :
Red flags 🚩 everywhere
2025-07-09 20:35:14
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Brittany ✌🏻 :
I worked at a trial site for the Covid vaccine as a Nurse Practitioner. The person who is consenting you (anyone on the staff) should have gone through the consent with you paragraph by paragraph and answered any questions you had in the moment and if they can’t answer they find someone who can before you sign. Our consents also included a basic “Schedule of Events” so you’d know what was happening at each visit. And $800 for the whole study sounds pretty good actually, but that payout is set by whoever is sponsoring the study. Sounds like your site wasn’t following federal and international regulations for drug trials. Also— the Nurse Practitioner shade you seemed to be throwing is unnecessary. I promise we are qualified to be helping run clinical trials.
2025-07-09 21:50:09
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tiktalk_to_me :
Sounds like a mixed bag. Not telling about side effects can be normal to avoid nocebos. Vitals are normal. But they absolutely should have communicated way better and let you take the info home and given you time to look it over.
2025-07-09 19:35:49
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