Ethical issues in consenting vulnerable patients for neuroscience research.

Many subjects cannot give fully informed consent to take part in research by virtue of age or mental capacity. However, it is unacceptable to deny these patients involvement in research by virtue of a lack of capacity to consent to such research. Further, this would hinder the advancement of medical science and technologies that might ultimately benefit these patients. Conversely, it is as unacceptable to discriminate against these patients and their condition as it is to exploit them or expose them to undue risk. Neuroscientific research raises a number of specific ethical issues in this patient population, in particular issues of consent, potential benefits of research, management of incidental findings and the assignment of appropriate controls. This paper examines the dilemmas that surround such ethical issues, and demonstrates that various procedures including informed consent, deferred consent and consent by proxy can be used to consent patients in both the standard medical and research arenas. Researchers, clinicians and regulatory authorities must work together to understand the benefits, limitations, risks and obligations of any research study involving these patients in order to advance medical care.