Chapter 4

Research Principles and Ethics

As physical therapy and other rehabilitation preparatory programs move to the doctorate level preparation for future clinicians, the issue of research and research ethics is becoming part of everyday practice. Research ethics have been a concern and are highly monitored by the educational programs for students. However, research principles and ethics may not be as routinely examined in many practice settings. This course provided a basic foundation in ethics. The issue of research ethics is a topic for a further, more in-depth course.

Consideration of the role of HIPAA, The Common Rule, and the Belmont Report provide the foundation for research ethics. No longer may students (or clinicians) conduct or plan research or independent “fascination” studies without meeting rigorous research requirements. The idea that students might do “case studies” of real patients as part of their clinical rotation work must be viewed in a research light with more rigorous oversight. In addition, therapists in a clinic may NOT collect data; analyze databases; or reports on cases in any literature without following research protocols and providing informed consent. Recent rulings have also pointed out that even surveys of staff is considered research and that all research participants (even the clinicians) must be fully cognizant of the study and provide appropriate informed consent. This type of informed consent is very different from the informed consent received to evaluate and provide treatment. Any consideration for “research,” database analysis, case study reporting now needs to follow through specified Institutional Review Board (IRB) processes that meet Federal Wide Assurances (FWA). The methods and types of research have become regulated with new legislation on the horizon. Thus, all clinicians need to consider the ramification and ethics of research in the coming years.
  Next: Chapter 5