So, I went to try a med for depression. The dose was really high and the guidelines for us were strict. The study was canceled halfway through and 1200 dollars out of 3400 was retracted. We were 36 people put into a 1500 sq ft space for a mandatory 12 hours. The side affects were many and intense. The Study coordinator yelled at us and the staff humiliated us despite the number of AE's and intensity of the drug. We were put with 30 other people during this time on the second floor and not allowed to leave the carpeted area where lunch is served and the book cases are. Over 70 people were there for a 12+ hour period. We were then hid from sponsors at different points so the sponsors wouldn't know that different studies were being mixed together in such small areas. Despite the need for "confidentiality". Between being yelled at and out of our minds on meds the staff became passive aggressive and started to ignore the fact that we were 5 feet away from them packed into a room where all we could do was sit backs against the walls. The staff would pretend that we were not there or that we were late in to ridicule us and penalize us.
We were told the very minute of our second check that the study was canceled and the that 1200 was being withheld. When we tried to complain the coordinator yelled at us again and told us to stop complaining and that there was nothing we could do about it.
>stop complaining and that there was nothing we could do about it.
At a minimum you can forward your message to the sponsor and the IRB. Their info is listed on your consent form. Probably nothing will come of it. Also you can contact the higher-ups at wwct.
later edit: oh, what was i thinking. wwct is kendle, new name, probably same people. they pack you like rats - hard chairs during the day, bunk beds at night. they don't tell you what's going on. when i reported an AE they sent me home with half pay. i think i've been there 3 times; i'm used to their games. don't go there with high expectations. (2015 edit, got mixed up by the initials, not kendle.)
Wow... That sounds like it was uncomfortable, to say the least.
RE: What you might be able to do...
1) Regardless of the language of the IC form, you retain legal rights... 2) If you did not personally do soing warranting you being removed from the study (i.e. violence, theft, illicit drug use, etc.), than you may be entitled to full study compensation. 3) You may want to contact the IRB and/or the sponsor. Also, it is not commonly known, but a friend of mine, a fellow LabRat, once mentioned that there is a Federal agency that has oversight over ALL IRBs (either at) the FDA or the NIH--Natl. Inst. of Health). 4) It seems that there might have been information that should have been made available to the volunteers at the time of screening (INCLUDING the phone screening...), that would have impacted a person's deciding to participate in the study (or NOT). If such information was known, or reasonably SHOULD HAVE BEEN KNOWN, by WWCT or the sponsor, and was not disclosed to the POTENTIAL Volunteers, than it could be construed as being "COERCIVE" (a term of art). ANYTHING that is coercive is a no-no in the study world, i.e. there is no "informed consent", if any information is not made known that might cause a potential volunteer not to participate. Such information could be related to study compensation and/or study calendar. 5) You raise a number of issues regarding possible AEs and penalties, etc. 6) If the CRU/CRO gets all of their money (the same as if the study ran it's course), then the volunteers should get ALL of theirs. PERIOD.
Post by travelingrat on May 29, 2013 13:52:36 GMT -5
squeeker, that sounds horrible. do you have any way to contact any of the other participants? i definitely recommend contacting the IRB AND the sponsor ...if some other of the study volunteers will join you in drawing this to the attention of the IRB, the sponsor, and anyone else, that would be best as they are more inclined to pay attention then. while it is true that most IRB's are pointless rubber stamp entities, a few still have some employees who are trying to do their jobs, so it is worth it.
the whole incident is wrong on soooo many levels. i had a very bad experience a few years ago (not there however) so i can defintely sympathize with you. i certainly agree that if the clinic received full payment, the volunteers should as well. and that clinic should be investigated and censured. try to find some others who will join you in exposing the deplorable treatment of volunteers by the staff! best wishes to you.