I recently attended a screening and signed the required forms (including consent forms data and DNA sharing info) during the informed consent conference, then, once I gave samples and went through the second interview and learned more about how the drug worked and the AE's involved, decided it was not for me.
Everything happened as they requested.
I was supposed to receive copies of the paperwork right after signing, which included the study name/number/internal contacts/IRB involved, and who to write to should I choose to change my consent status, but as soon as I informed them that it was not a good fit, they treated me like riff raff and shooed me out...without giving me copies of the signed paperwork I am entitled to. I went back to retrieve it (and was totally polite), and they pretended not to know who I was or who the alleged study coordinator was and threatened to call security.
In addition to being very sketchy behavior, I am concerned (pretty much convinced after their actions) they will market my DNA and other info for profit using the previous consent, which I do NOT agree to.
HAS THIS HAPPENED TO ANYONE ELSE?
All I have are my personal notes, without the particulars. I prefer to settle this peacefully without hiring an attorney. Is there a single IRB for the LA?Orange County, CA area?
How can I remedy this and withdraw my consent, as is my right?
Wow. Of course I am late addressing this topic, but it seems that some thing such as trying to get a copy of your signed papers should be what the IRB can help you with. However it seems that since the clinic did not give you the original papers you do not know who the IRB is for the clinic. I don't know if it is too late to try and get your signed papers now. It probably is, but often a clinic has one IRB. At best this can be some thing others can learn from. At screening try to get information from the paperwork such as study number and IRB name and address and also study doctor name and study drug name or number. Write it down on a notebook or paper and this way should the staff take away the papers to "copy " them, you will have some information should, as what happened to "brat," the staff decide not to give you the consent form if you then decide to opt out of the study.
As far as the clinic selling your DNA, it is definitely possible but it is still hard to just say whether they will do that even if the staff seem shady in other ways. The consent would absolutely have to out rightly state that your DNA will be sold.
OH BTW did you give a blood sample before choosing not to accept the study?
Mostly it seems this is a problem because so much time has gone by. They probably destroyed that consent that you signed. At best they might give you an "archived copy" that they may have in their records if they keep copies of consents from years back.
Last Edit: Jun 20, 2021 19:10:21 GMT -5 by labrat1: To correct typographical errors, clarify things, add information, & try to add words that are altered by the strange spell-check system of this site