Imagine for a moment that you were a principal investigator who wanted to study your independently-developed electronic medical record system for clinical use. You have spent billions developing your system, housed it in a high-security fortress with its own power grid, power backup-system, multiple fiber-optic T3 lines that dovetail with large communications contractors. Your experimental system is outfitted with the latest and greatest software innovations to chart patient encounters, transmit lab data and post results, interact with other vendor software manufacturers, and bill patients for procedures performed while collecting huge volumes of patient data in data repositories. You want to prove the EMRs ability to safely care for patients, lower health care costs, and prevent errors. Your hypothesis is that your EMR system does all of these things.
But to gain approval for your study, you must bring it before an Investigational Review Board (IRB) for approval before you can begin your research project. For those unfamiliar, an IRB is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The number one priority of IRBs is to protect human subjects from physical or psychological harm. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are 'scientific', 'ethical', and 'regulatory'.
Interestingly, billions and billions of dollars ride on your study being shown true. You are convinced, I mean convinced, that your EMR will do all the beneficial things your hypothesize with little to no downside. After all, you have strong political and financial backers that agree with you. You have deployed your experimental system to over 40% of the entire US population in preparation for your study. It's time to start, you say.
I wonder, if the readers of this blog were members of the IRB and this study was presented to you, what safeguards would you insist upon to protect patients? Would the study, as proposed, pass muster?
-Wes
Wes,
ReplyDeleteYour post has more layers than a Vidalia onion, and makes me feel like I'm answering an essay in a graduate public health course. Let me take a crack at the parts that resonate with me.
In order to conduct a human study, you will need to seek IRB review and approval. It is the IRB's job to protect the subjects in the trial. Protection of the human subjects of the trial is governed by the principles of the Declaration of Helsinki. Among the most basic of principles governing this process is informed consent.
Let's translate that to your electronic medical records study. How might you achieve informed consent? With a closed proprietary EMR system this might be difficult. Your large vendor may not wish to make their information about their system public (to maintain competitive advantage among other possible reasons). Perhaps there aren't publicly available details about the user interface and processes involved in their system. Perhaps they are a private company without shareholders to answer to. Perhaps they are not regulated by the FDA or other governing bodies. Without all of this information, how could you, the doctor, properly inform your patient of the risks and benefits of your study?
According to Fred Trotter in Hacking Healthcare (http://www.amazon.com/Hacking-Healthcare-Standards-Workflows-Meaningful/dp/1449305024) there are "clauses in most agreements between proprietary EHR vendors and their customers, stipulating that the customer cannot discuss or criticize the product publicly, or even say how much they paid for it." These restrictions would seem to inhibit the scrutiny needed to properly achieve informed consent.
I dunno, Wes. I'm thinking you're gonna have a hard time getting this study approved. I wish you luck, though.
Jay