The Organization has adopted the proposed description of quality improvement projects put forth by the National Bioethics Advisory Commission (NBAC) in its December 19, 2000 draft document. Activities that meet the terms explained in the following statements are considered quality improvement/quality assurance activities (QI/QA) at Hopkins:
…[S]ome data collection and analysis activities in the health services area are not intended to generate scientific knowledge, but rather are used as a management tool to improve the provision of services to a specific health care population (IOM 2000). These activities are not intended to have any application beyond the specific organization in which they are conducted. These activities are generally referred to as program evaluation or quality improvement. But, like public health, because populations are the targets of study and because the methods used in program evaluation or quality improvement are the same as those used in research, it is often difficult to determine whether or not the activity is research that falls under the oversight system.
When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information gained from the evaluation will be used to provide feedback to improve that program, the activity is not human subjects research. The evaluation is a management tool for monitoring and improving the program. Information learned has immediate benefit for the program and/or clients receiving the program or services. When the quality improvement involving human participants is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is research. The systematic comparison of standard or non-standard interventions involving human participants also is research.
It is often difficult to distinguish QA/QI activities and human subjects research activities, especially when data analysis post implementation of a QA/QI activity will occur. It is possible that the same project may have both QA/QI and research components.
At Johns Hopkins, QA/QI activities that will be implemented with the express purpose of prospectively implementing a change in practice that will be evaluated through later research on outcomes will not qualify for a determination as exempt research. Prospective collection of identifiable patient or subject-level data for future research is considered human subjects research, regardless of whether the institution that collects the data will de-identify the data before analysis at Hopkins. Effective October 31, 2007, such projects must be submitted to the JHM IRB for review and not submitted as an exempt application request. Funding applications submitted to support QA/QI activities with a subsequent research component will be reviewed by the Office of Research Administration to assure that participating sites have an OHRP approved assurance on file before contractual arrangements are finalized. In addition, a letter from the director of the health care organization where the activity will take place will be required indicating that the director agrees with the description of the evaluation of the program as submitted in the eIRB application.
The following questions will guide our analysis:
Question 1: Does the description of the proposed activity contemplate that individually-identifiable data elements will be collected or analyzed for any purpose other than providing direct feedback to participating institutions?
Yes – Research
No – QI
Question 2: Does the analytical or evaluative component of the activity change the way that the quality program will be implemented in such a way that risks may be higher for providers or patients who participate (e.g., will providers or patients be randomized to different interventions to permit statistical comparison of outcomes)?
Yes – Research
No – QI
Question 3: Is there funding from an external organization based on a “research paradigm” to carry out the evaluation of the program?
Yes – Research
No - QI