Unintended Consequences of Healthcare Reform on Clinical Research: The Research Agenda from a Student's Perspective

Introduction

Historic legislation was signed into law by President Obama on March 23, 2010. The Patient Protection and Affordable Care Act (PPACA) is complex and multifaceted, and will have the potential to affect all fields within the realm of the healthcare industry. Nancy Pelosi, Speaker of the House of Representatives, in response to a question about content of the legislation being enacted stated: “If you want to know what's in the bill, you need to pass it.”

Hypothesis

This study hypothesizes that there exists a gap in knowledge about the chasm that will occur with the impact on clinical research as Healthcare Reform is implemented. With the emphasis on “primary care” in the legislation and regulations, can this result in a change of emphasis on clinical research resulting in decreased and/or increased opportunities at the local level? What will these opportunities look like and will there be a prioritizing of fields of study? Will this impact research on healthcare delivery methods and how?

Methods

Qualitative research is an appropriate approach when multiple variables and richness of data exist. The research questions are typically oriented to cases or phenomena, where patterns are sought among unanticipated as well as expected outcomes or relationships. Qualitative research provides practical lessons, which can be generalized to similar and larger populations. Fred Kerling, however, states "There's no such thing as qualitative data. Everything is either 1 or 0." The objective is to find precise measures to document observable data.

The NIH has funded collaboration and discussion on this topic by various experts in the fields of medicine, business, and public health. This Team Building research initiative will occur in May 2011 and report with the presentation in this abstract. This study expands upon the research and the methodologies identified to report on the potential changes in clinical research from healthcare reform implementation. Both qualitative and quantitative methods are presented as well their contribution to the understanding of the impact of Healthcare Reform on clinical research.

Results

The application of and implications for public health demonstrate the difficulty in researching a scientific subject with a dynamic and changing policy and regulatory environment. Through collaboration, evaluative methodologies will be devised and expanded upon. A research agenda on Healthcare Reform as it impacts clinical research will be developed and the necessary actions and resources needed will be summarized. Future challenges will be assessed from multiple viewpoints, including public health.