Ethical Concerns In Health Care

Ethical concerns were respected in every phase of development and implementation of this study. For example, the principles of the Belmont Report (U.S. DHEW, 1979)—which include respect, justice, and beneficence—were adhered in all phases of this study. Moreover, the investigator received permission to perform research in compliance with federal regulations (Hall, Prochazka, & Fink, 2012; Stoljar, 2011). Also, the investigator submitted the application form requesting an expedited review for this study; and, the University of Texas Health Science Center at Houston (See Appendix K), the Committee for the Protection of Human Subjects, and the Memorial Hermann Clinical Innovation and Research Institute (See Appendix L and M) approved it. Memorial
Minimal risk is “...comparing the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life...” (45 CFR 46.303).
This study involved the use of the RASS and CAM-ICU evaluation tools, and accordingly, did not have any impact on patient care, treatment, or outcomes. In fact, this study included data collection only, in which the only one of the 18 HIPAA identifiers— specifically, date—was obtained according to 45 CFR 164.514 (See Appendix N). Therefore, the investigator requested a HIPAA authorization waiver; and the hospital granted it (See Appendix K and L).
The institutions approved the request for a waiver of informed consent since the data were de-identified in line with the policies of the University of Texas Health Science Center at Houston, the Committee for the Protection of Human Subjects, and the Memorial Hermann Clinical Innovation and Research Institute. Therefore, the institutions did not require informed consent documents for this study (See Appendix K and L). Furthermore, the Health and Human Services regulation concerning a waiver of informed consent as outlined in 45 CFR 46.116 (See Appendix