Each site received the same IRB application. We have received six different responses from the various IRBs and/or administrators. There has got to be a better way.
What’s amazing to me is that when this grant was written, about five years ago, all these hospitals agreed to participate. Now that it’s time to actually do something, they are very slow to get started; slow to hire someone in the position of local research coordinator; slow to get their contracts going; they are even slow to bill so they can receive money that they are owed!
Two of the sites have actually questioned the protocol altogether. They are worried that the surveys we have developed will “incite” parents to sue the hospitals. They are afraid that thinking about the care that was given to children who died is “too risky” for their clinicians. This is a very, very sad state of affairs.
Two of the sites approved the application with minimal fuss. And currently, two of the sites are working through the IRB comments and changes. So nine months worth of work, and all I have to show for it is possibly four sites that will move ahead with this part of the study. If all goes well. It’s very discouraging.
The procedure we are asking the sites to undertake is the following: each time there is a death on the pediatric ICU (which typically takes place about once a week in an average sized PICU), surveys about the care given to the child and family are handed out to the most-involved clinicians in the case, and some information is taken from the child’s medical record about the care the child was given. Then, three months later, the parents are contacted to fill out a similar survey. That’s it. That’s the study. We aren’t giving anyone a drug. We aren’t doing anything physical to anyone. We are handing out surveys and collecting some medical record data. Period.
You would not believe the hoops we need to jump through to get this procedure approved. We need a waiver for this and a waiver for that. A waiver to look at the medical record to get the parent’s contact info. A waiver to collect data from the deceased child’s record. We want to avoid bothering the parents about the medical record, and we need a waiver for that.
A lot of the trouble has to do with HIPAA, which really shouldn’t have to do with research, anyway. The human subjects in this study, pardon my French, are dead. They don’t have rights; they don’t need rights. We are trying to improve end-of-life care. For children. And you’d think we were trying to do something bad, the way these sites are responding.
The IRBs have really over-stepped their bounds. They are supposed to protect human subjects. In this study, the actual human subjects, as I mentioned, are already dead. We are asking people who helped care for the human subjects for their opinions about the care, and also the parents of the human subjects. We are trying to document and improve care. What we are doing is a good thing.
But there is such a fear of death – especially children’s deaths – that the IRBs seem paralyzed by our requests. They are afraid that parents will sue. They can’t see that parents really want to improve the care. Parent want to remember their child in a positive way: they don’t want to sue. They want to help.
And I’m left here, frustrated and angry. Angry at the IRBs who respond in such a disrespectful and belittling manner. Angry at the IRBs, each of which interpret the federal regulations differently, making each application an exercise in futility. Angry at the lawyers who don’t trust parents to complete a survey without suing the hospital.
Angry. And sad.