Ethical issues with BRAIN Initiative are:
A. What benchmarks should be adopted for testing new methods before they are put to use with humans, and who should make such decisions?
B. What level of antecedent evidence is necessary to justify translating preclinical research into work with human subjects?
C. When contemplating testing new methods in people who have brain disorders and diseases, what is the best way to balance decision-making between the patient and legal surrogate in deciding on an acceptable level of risk?
D. Can we maintain social justice when new expensive drugs and therapies are discovered and used in patients with neurodegenerative diseases?
When integrating ethics into neurological research, the key ethical issues are:
A. How might a clinician best determine a patient's competence for understanding the risks and benefits before deciding to participate in research? How can a patient consent to participate in research if the disease affects the very organ that grants consent?
B. Once a patient is involved in a research study, what are best practices for managing unexpected physical or perceived nonphysical harm?
C. Who should control devices that affect mood and the brain’s reward systems? The patient? The doctor?
D. If a device is placed in the brain as part of a research study, what is a researcher's responsibility for continued care of the patient and upkeep of the device? Who owns the data collected by such devices?
Issues with informed consent for brain banking are:
A. Should each and every brain bank employ an informed consent policy, even if the brain bank can waive these requirements under national law or regulations?
B. Can the power of consent be consistently delegated to a medical doctor or a research council?
C. If autopsy is authorized, is the retention and use of organs for research purpose necessarily permitted?
D. No informed consent is need at any times.
Major ethical issues with brain banking are:
A. The rights of the persons donating their tissue and the obligations of the brain bank with regard to respect and observance of such rights
B. Informed consent and confidentiality
C. Protection of personal data and collections of human biologic material and their management
D. Transparency and accountability within the organization of a brain bank
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