# Sustainable Solutions to Translating Best Practices for Informed Consent

> **NIH AHRQ R01** · WASHINGTON UNIVERSITY · 2024 · $391,261

## Abstract

Project Summary/Abstract
Current approaches to informed consent hinder rather than help research recruitment. Informed consent
templates often include legal jargon, technical wording, and numerous repetitive and confusing sections. The
consent process and templates can increase disparities in study participation among racially minoritized
populations, rural-residing populations and older adults. Fortunately, we and colleagues have developed tools
and recommendations to improve understanding and adoption of evidence-informed practices for consent in
clinical trials. Yet these tools and recommendations are not widely used in practice. In this project, we will used
mixed-methods to address this gap between knowledge and practice. We aim to: (1) Engage with key
stakeholders to improve these forms and processes in a way that is feasible, acceptable, and sustainable; (2)
Prepare an improved consent template and process for implementation; (3) Implement and test the consent
template and process in three studies (1 per institution at 3 institutions). We will use Expert Recommendations
for Implementing Change (ERIC) strategies to ready sites for implementation, focusing on strategies to
increase capability, opportunity, and motivation to implement change. A community advisory board will actively
engage in the study for its duration to ensure that each step of the process aligns with their needs. Our strong
study team has expertise in research ethics, health literacy, health communication, health decision making and
implementation science. This study will overcome barriers to translation by providing: (1) A toolkit to facilitate
adoption of an evidence-based informed consent template and process, and (2) a national model for
participant-centered informed consent, meeting regulatory requirements without overburdening participants or
researchers. We will test our intervention’s robustness in different environments with different regulatory
systems for research and unique institutional strengths.

## Key facts

- **NIH application ID:** 10917307
- **Project number:** 5R01HS029310-02
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** MARY C POLITI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2024
- **Award amount:** $391,261
- **Award type:** 5
- **Project period:** 2023-09-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10917307

## Citation

> US National Institutes of Health, RePORTER application 10917307, Sustainable Solutions to Translating Best Practices for Informed Consent (5R01HS029310-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10917307. Licensed CC0.

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