Clinical Trials....

[Sarahsmom46]

Do we really know what we're getting In to?

Here's my question.  Say you were in a clinical study and as part of that study you went through a procedure and developed a complication as a direct result of that procedure, nothing life threatening, but noneless required treatment.  Who do you think should pay for the treatment?  Let me add one more thing...The study facility had the resources to handle treating the complication, but instead instructed you to go to a hospital. What would you do?

I am in that situation right now and can honestly not afford to take on the financial burden of paying for my treatment in the ER earlier this week.  I had a substantial financial burden paying off medical bills from being sick last May that totaled in the thousands and that was with insurance coverage.  The thought of having to pay the bill myself just doesn't set well. In fact it didn't even cross my mind until I was being prepped for the procedure and someone from admitting came to my room in the ER asking for insurance information.  I felt a panic after handing over my card.  I felt that if I didn't give it they would send me away without treatment.  

Any thoughts you guys might have would be much appreciated.  

[Jenn0030]

I have been involved in (runnung at a clinical level) numerous research trials over the last 10+ years.  The extensive consent form should be very specific to what the liability the facility will hold in case of complications.  If you have questions there should b a specific # to contact near the back (an independant institution called a review board).  If you are uncomfortable asking your MD these questions, direct these questions to the review board.  

I just wanted to give you another option

Jenn

[Sarahsmom46]

I re-read the informed consent paperwork, which is quite extensive, and it DID say that any study related medical complications would be taken care of by the facility.  I would think this would cover me, but then again the study doctor who told me to go to the ER didn't mention a word about who would be paying for it.  I talked to someone I know who is familiar with this research facility and she said that there has been a push over the past couple of years to have patients with insurance pay for more things with their coverage, but nothing like that was stated in the consent neither was it mentioned to me during  the initial consult meeting..

I will see the study doctor next week and plan to bring it up somehow. Its possible I will be told that there's no problem with them paying the bill making this a non-issue. I hope that will be the case.  But, if I do have some push--back when this is brought up then I'm not sure how to deal with it.   I don't want to come off like a complainer or as antagonistic, but don't want to be pushed into feeling helpless and that this is my responsibility.. Any ideas?  

You both are right, there would be no research if people didn't volunteer to be test subjects.  

Thanks you guys.  I really do appreciate your feedback.  

-Julie

[doublevision1]

Sorry to hear this happened, and what a good question you raise.  I'm not in a study; I declined a couple of treatment trials for practical reasons (travel involved).  I did go over the consent forms I would have signed if I'd participated, but don't recall anything specific on this topic.  It would be handled differently here, regardless. Provincal health insurance would cover a medically necessary procedure regardless of the cause.  I would think in a situation like this, in the U.S., either the study facility should be responsible, or the company sponsoring the trial.  Is it a drug company?  You didn't mention what type of trial, doesn't matter I guess, as on principle you ought not bear the financial burden.  However as Sho points out, the answer may lay in the consent form you signed, agreeing to the terms and conditions of participation.  It was good advice about the Review Board; hopefully there is such a body that can assist you with this.  Even if the study facility bears no legal obligation, nor may be inclined to cover this out of the goodness of their hearts, it is in their self-interest to do so.  Not exactly a situation that would encourage other patients to participate, and it's not easy to find study subjects for clinical trials.  I hope this turns out in your favour in the end.
Have you decided to discontinue your participation?  Are you still eligible to continue in light of what occurred medically?

[shoshin]

Did you sign a consent form? Did you get a copy of it?

At least for the trial I'm in (which is a drug trial), they spell out what the drug company will and will not pay for (which is not everything that could go wrong). The consent form also says that if you have any questions about your rights, you should contact the Institutional Review Board. They must have some group like that for your study that you can contact and clarify what is going on.

It doesn't seem like you should have to pay for treatment that you had to have as a result of being in a study, but maybe it's just that there was a mix-up in communication somewhere.

sho