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

> **NIH NIH R00** · WEILL MEDICAL COLL OF CORNELL UNIV · 2020 · $169,360

## 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 organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Ruth Marie Masterson Creber
- **Activity code:** R00 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $169,360
- **Award type:** 3
- **Project period:** 2017-09-28 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130180

## Citation

> US National Institutes of Health, RePORTER application 10130180, Should we return patient reported outcomes to human subjects participants?-exploring ethical obligations (3R00NR016275-05S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10130180. Licensed CC0.

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