November 26, 2022
Emily Largent, PhD, JD, RN, Monica Taljaard, PhD, Susan Mitchell, MD, MPH introduce a framework for identifying vulnerabilities. Cluster randomized trials (CRT) promise to improve the quality of care and quality of life for people living with dementia (PLWD) in long-term care (LTC) homes. Yet, determining how to safeguard these vulnerable participants’ rights and welfare in CRTs is especially challenging. These trials are becoming more common, requiring a systematic approach in order to ensure protection against participant vulnerabilities.
The authors introduce a framework to identify vulnerabilities in randomized trials, including but not limited to CRTs. Next, they apply the framework to three CRTs involving PLWD in LTC homes, noting vulnerabilities as well as corresponding additional protections that researchers did and might implement without imperiling scientific validity.
Using the proposed framework, researchers and research ethics committees can identify and address vulnerabilities to autonomy, welfare, and justice wrongs arising in these trials. Reassuringly, these additional protections are consistent with and can even promote, rather than imperil, scientific validity. This work will inform a forthcoming extension of the Ottawa Statement that aims to address ethical challenges in CRTs in LTC homes.
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