# Research Ethics Challenges, Controversies and Difficulties in Intensive Care Units—A Systematic Review of Theoretical Concepts

## TL;DR

This paper reviews ethical challenges in ICU research involving critically ill patients and highlights the need for alternative consent methods and ethical guidelines.

## Contribution

The study provides a systematic review and checklist of ethical dilemmas specific to ICU research.

## Key findings

- ICU research involves significant ethical challenges during design and implementation.
- Alternative consent methods are needed due to the vulnerability of ICU patients.
- No single paper addressed all identified ethical issues in ICU research.

## Abstract

Background: Research in the intensive care unit (ICU), which involves critically ill patients, families and healthcare professionals, poses significant ethical challenges. The aim of this PRISMA-guided systematic review is to identify major challenges for research ethics in the ICU. Methods: Pubmed and Scopus databases were searched in November-December 2024 for papers discussing theoretical concepts or specific aspects related to ethical issues in ICU research, retaining 70 papers on ICU research challenges, difficulties or controversies. Results: A total of 10 papers described general concepts related to research ethics in the ICU, 16 studies focused on the methodology or some of the study steps, and 6 papers focused on ICU trials, while 38 studies focused on special patient categories or special situations of critical patients. None of the included papers addressed all of the issues we identified regarding the ethical challenges. Conclusions: ICU research is challenging from a moral point of view. Significant ethical difficulties arise during the design and implementation phases, hampering the study's exactness. Being a vulnerable population with limited decision-making capacity and research-associated risks, alternative consent methods need to be considered. This systematic review provides a checklist of aspects that could generate ethical dilemmas and might constitute a starting point in the conduct of research studies, preventing unethical research.