# Enhancing the Surrogate Informed Consent Process for Critical Care Research

> **NIH NIH U01** · UNIVERSITY OF COLORADO DENVER · 2020 · $155,497

## Abstract

Critical care research is essential to improve the outcomes of the five million patients admitted annually to
intensive care units (ICUs) in the United States. The need for critical care research is even more evident in the
face of the COVID 19 worldwide epidemic as these patients often required ICU care. However, conducting
critical care research can be challenging. Critically ill patients are often cognitively impaired due to their acute
illness and the use of sedative medications. As a result, most critically ill patients are not competent to consent
for research participation. Therefore, a surrogate is utilized during the informed consent process to protect the
best interests of the patient. Our qualitative interviews with surrogates of critically ill patients revealed that the
informed consent process does not always provide the information that is needed to make an informed
decision. Consequently, surrogates have poor comprehension of study related information and fail to
understand vital information regarding study-related procedures and treatments. Currently, there are no
consensus guidelines for the surrogate informed consent process for critical care research. We have
assembled an optimal team of world-renowned investigators and ethicists to enhance the surrogate informed
consent process. We will initially utilize the NHLBI Prevention and Early Treatment of Acute lung Injury
(PETAL) network to identify surrogates, critical care survivors, investigators and coordinators to identify and
synthesize individual site best practices for the surrogate informed consent process for research participation.
Then we will collaborate with various stakeholders from multiple international critical care research networks to
create universally accepted guidelines. We hypothesize that consensus guidelines will improve the surrogate
informed consent process and allow surrogates to make more informed decisions with less conflict and stress.
Initially, we will conduct iterative qualitative needs assessments with the following stakeholder groups:
surrogates, patients, and research personnel. Subsequently, we will convene a Delphi process of multiple
stakeholders including investigators, coordinators, surrogates, and patients to create consensus guidelines for
the surrogate informed consent process for research participation. Finally, we will utilize a multi-faceted
approach to disseminate our findings and facilitate the implementation of these guidelines in future critical care
trials. In summary, this proposal has the potential to dramatically transform the surrogate consent process for
research participations and ultimately improve the ethical conduct of critical care clinical research.

## Key facts

- **NIH application ID:** 10130345
- **Project number:** 3U01HL123010-07S1
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Adit A. Ginde
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $155,497
- **Award type:** 3
- **Project period:** 2014-06-17 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130345

## Citation

> US National Institutes of Health, RePORTER application 10130345, Enhancing the Surrogate Informed Consent Process for Critical Care Research (3U01HL123010-07S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10130345. Licensed CC0.

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