Practice-based clinical research and ethical decision making--Part II: deciding whether to host a particular research study in your practice.
Due to the growth and expansion of clinical research, particularly research conducted in practice-based settings, all practicing physicians should have a fundamental understanding of clinical research and the differences between clinical care and clinical research. Physicians considering adding clinical research to their everyday practice of medicine should carefully assess the practical and ethical dimensions of this decision on their practice. We discuss a framework that can help physicians assess a study they are considering hosting in their practice for seven requirements for ethical clinical research. Such an assessment can help them determine whether they are comfortable that the study is ethical and whether they can adhere to the requirements of the protocol in an ethically appropriate manner to maintain the ethics of the study. Together with the systems-informed professionalism framework presented in the preceding article, using the seven requirements of ethical clinical research framework can help practicing physicians with ethical decision making regarding incorporating practice-based research into their everyday practice of medicine.
Chen
Donna T
DT
Department of Public Health Sciences, University of Virginia, Charlottesville, 22908, USA.
Worrall
Bradford B
BB
D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D003657:Decision Making / Q000941:ethics*; D032984:Ethics, Research; D019317:Evidence-Based Medicine; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection / Q000941:ethics; D011364:Professional Practice; D018570:Risk Assessment