| Patient | Understand and appreciate the therapy-research distinction? Free from external motivation to participate (ie, family, caregivers) Have realistic expectations of trial and its outcomes?
| 1. Discuss research–therapy distinction, before referral to neurosurgeon 2. Evaluate impact of mental illness on family and caregivers before consent acquisition 3. Assess patient expectations of trial outcomes before consent acquisition and reinforce with each patient follow-up
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| Disease | Impacts of ability to reason about the trial? Impacts ability to appreciate the risk of the trial? Is reality testing impaired? Is the disease ego-dystonic/syntonic?
| 4. Neuropsychological testing for every patient enrolled in clinical trial 5. Third party and patient consent are necessary for all psychiatric surgery clinical trials 6. Exclude patients who have diseases with impaired reality testing 7. Exclude patients with ego-syntonic conditions
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| Technology | What are the known and unknown risks of the technology? Is there clinical equipoise? Have these been disclosed fully?
| 8. Disclose both known and unknown trial risks, and compare these with the risks of the standard of care 9. Emphasise possible risks to both body and mind
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