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?