Table 1

Factors influencing informed consent in DBS for psychiatry clinical trials with suggestions and recommendations for their mitigation

Challenge categoryQuestionsSuggestions/recommendations
  • 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

  • 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

  • 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

  • DBS, deep brain stimulation.