247071 Unintended Consequences of Healthcare Reform on Clinical Research: The Research Agenda from a Student's Perspective

Tuesday, November 1, 2011: 4:30 PM

Brittany Goettsch, MPH Candiate , Public Health Program, University of California, Irvine, Irvine, CA
Laurie Heinrich, MPH Graduate Student , Program in Public Health, University of California, Irvine, Irvine, CA
Terry L. Schmidt, DrHA , School of Medicine, The Paul Merage School of Business, Program in Public Health, University of California, Irvine, Irvine, CA

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.”


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?


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.


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.

Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice
Public health or related laws, regulations, standards, or guidelines
Public health or related organizational policy, standards, or other guidelines
Public health or related public policy
Public health or related research

Learning Objectives:
1) List and describe multiple methodologies that can be used to evaluate Healthcare Reform legislation as it impacts clinical research. 2) Outline resources needed to implement a research agenda on Healthcare Reform as it impacts clinical research. 3) Prioritize the challenges, from a public health perspective, for integrating research agendas on Healthcare Reform as it impacts clinical research.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a Masters in Public Health Candidate.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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