# WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES

> **NIH NIH UL1** · WASHINGTON UNIVERSITY · 2020 · $155,917

## Abstract

PROJECT SUMMARY
Protecting human research participants is essential to the clinical research enterprise. When researchers engage
in serious and continuing noncompliance with human subjects research regulations, their institutions must
develop and implement action plans to address their noncompliance. However, developing appropriate and
effective action plans is challenging, and ineffective action plans that do not change researchers' behavior put
the researcher and institution at risk that noncompliance will reoccur.
We propose an 8-month bioethics supplement that will be relevant to institutional officials charged with
addressing human subjects compliance violations and developing action plans in response to these violations.
The research team has expertise in researcher professional development, identifying root causes of
noncompliance, and responsible behavior in research settings. The research team also has experience
developing and conducting a national program intended for researchers referred to the program for
noncompliance and research integrity violations. We propose the following aims:
Aim 1. Determine the procedures institutions utilize to develop action plans for serious and continuing
noncompliance and identify a comprehensive set of root causes and associated actions and activities.
1A. Conduct in-depth interviews about action plan procedures, content, and perceived effectiveness with
36 institutional officials (IOs) who are experienced with handling cases of human subjects noncompliance
to identify root cause-remedial activity linkages and inform the development of the Aim 1B survey.
1B. Administer a survey to institutional officials at all U.S. health science research institutions (n ≈ 170)
to characterize broad action plan development practices, action plan content, and perceived
effectiveness.
Aim 2. Convene 6 experts in responsible research to review Aim 1 results, P.I. Program root cause and
development activities, and relevant professional development literature to create an action plan tool.

## Key facts

- **NIH application ID:** 10131496
- **Project number:** 3UL1TR002345-04S2
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** William G. Powderly
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $155,917
- **Award type:** 3
- **Project period:** 2017-06-19 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10131496

## Citation

> US National Institutes of Health, RePORTER application 10131496, WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES (3UL1TR002345-04S2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10131496. Licensed CC0.

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