Should we return patient reported outcomes to human subjects participants?-exploring ethical obligations

NIH RePORTER · NIH · R00 · $169,360 · view on reporter.nih.gov ↗

Abstract

Project Summary/Abstract 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.

Key facts

NIH application ID
10130180
Project number
3R00NR016275-05S1
Recipient
WEILL MEDICAL COLL OF CORNELL UNIV
Principal Investigator
Ruth Marie Masterson Creber
Activity code
R00
Funding institute
NIH
Fiscal year
2020
Award amount
$169,360
Award type
3
Project period
2017-09-28 → 2022-07-31