There is a fundamental gap in understanding to what extent the clinical research enterprise?which includes clinicians, biomedical researchers, administrators, and support services involved in clinical research?has an ethical obligation to return patient-reported outcomes (PROs) data to research participants. The overall objective of the proposed supplement to the parent R00NR016275 is to explore timely ethical questions with both the general public and key stakeholders regarding PROs. We expect that the results of this supplement will inform the development of a larger study that will incorporate a more complex set of questions involving a wider set of stakeholders. Guided by strong preliminary data, this hypothesis will be tested by pursuing the following specific aims: 1) evaluate public perspectives on whether the clinical research enterprise has a moral obligation to return PRO data to human research subjects, and in what format, and 2) evaluate the perspectives of multiple stakeholders within the clinical research enterprise on the moral obligation to return PRO data to human research subjects, and in what format. The research is significant because it will provide insights into the development of preliminary guidelines for the return of PRO data to human research subjects that are ethical, and informed by the participants who are donating their data to research.
The proposed supplement will provide insights into the development of preliminary guidelines for the return of patient-reported outcome data to human research subjects that are ethical, and informed by the participants who are donating their data to research. This program of bioethics research will also inform policies on patient- reported outcomes and have broad implications for research enterprises, regulation, and law. The proposed research is relevant to the part of the NIH?s mission that pertains to improving symptom science and self- management for vulnerable patients with chronic diseases.
|Grossman, Lisa V; Feiner, Steven K; Mitchell, Elliot G et al. (2018) Leveraging Patient-Reported Outcomes Using Data Visualization. Appl Clin Inform 9:565-575|