Date of Award
2024
Document Type
Doctor of Nursing Practice (DNP)
Degree Name
Doctor of Nursing Practice (DNP)
Department
Nursing
Committee Chair
Darlene Showalter
Subject(s)
Informed consent (Medical law), Medical care--Decision making, Clinical trials
Abstract
The informed consent process for research is lengthy and cumbersome. The number of required elements for informed consent and the increasing complexity of clinical trials make it difficult to achieve effective and valid informed consent. There were two aims of this clinical project. The first aim was to implement a standardized checklist for consenters to use during informed consent discussions to increase effective communication and the inclusion of all the required elements of consent. The second aim was to determine if the implementation of a standardized checklist by consenters increased the understanding of the required elements of consent, increased satisfaction with the consent process, and impacted continued enrollment in clinical trials by research participants. To measure effectiveness, the consenters were observed during informed consent discussions and scored using the criteria from the standardized checklist. A standardized assessment tool and satisfaction survey with demographics were implemented with the research participants to measure their level of understanding of the consent information and their overall satisfaction with the informed consent process. Continued clinical trial enrollment by the research participants were collected three months after the informed consent discussion. Pre-intervention data were collected to provide baseline data before implementing the standardized checklist with the consenters. Pre-intervention and post-intervention data were analyzed using Excel and SPSS applying descriptive statistics, non-parametric, and parametric tests. The analyzed results were statistically significant supporting the use of a standardized checklist by consenters during informed consent discussions to increase effective communication, to ensure all elements of consent are included, and to increase understanding of the required elements of consent and satisfaction of the consent process by research participants. It is unclear if the use of the standardized checklist by consenters during informed consent discussions impacted the continued enrollment of research participants in clinical trials. Exclusion of non-therapeutic research studies and participants with limited English proficiency served as a limitation. To enhance understanding of informed consent, future research should include the use of a standardized checklist and a standardized assessment tool with research participants taking part in non-therapeutic studies and participants with limited English proficiency.
Recommended Citation
Hayes, Wendy, "Informed consent for research : a clinical practice change project" (2024). Doctor of Nursing Practice (DNP). 76.
https://louis.uah.edu/uah-dnp/76