Strict Ethics Regulation Without Appropriate Institutional Implementation Won’t Protect Decisionally Incapacitated Research Subjects: Lessons fom Sweden
The standard requirement of informed consent cannot be met when potential research subjects are decisionally incapacitated due to e.g. dementia, intellectual disabilities, or other mental health problems. Such research subjects are generally recognized as being in need of special protection, particularly when the relevant research cannot be expected to benefit the participating individuals themsel