Recommendations for review questions in brain implant research

Research into investigational neural implants presents unique challenges. These include the lack of alternative treatments, implant-realted decisions, impact on the self of self and physical, psychological, financial, and data-related risks.The questions below aim to help you safeguard the scientific and ethical quality of the study and assess whether study participants are adequately protected. They are based on ethical and legal frameworks as well as scientific literature.

Composition of the study team uitklapper, klik om te openen

• Is there sufficient time and resources dedicated to tailor communication to the participant, such as sign language and braille? (ethical guidelines)
• Is the study team multidisciplinary, combining medical, psychological, and technical expertise to support participants? (scientific literature)
• Have arrangements been made to preserve continuity of (after)care and support in case of team transitions? (scientific literature)

Recruitment and selection of participants uitklapper, klik om te openen

• What is the justification for exclusion criteria? Does harm due to exclusion weight out harm due to inclusion? (ethical guidelines)
• How is assessed whether individuals can handle the burden of the study in the selection of participants? (scientific literature)
• How is the emotional resilience of study participants taken into account during selection to prevent disappointment and psychological harm? (scientific literature)
• How is determined whether study participants have sufficient support from a caregiver, and is additional help provided if a caregiver is not available? (scientific literature)

Information and consent uitklapper, klik om te openen

• How is the information made understandable, repeated over time, and tailored to the changing needs of participants? (legislation and legal regulations)
• How are the expectations of potential participants regarding the goals, burden, and outcomes of the study managed and aligned to prevent misunderstandings and therapeutic misconceptions?
• Are participants informed in advance and repeatedly about post-trial arrangements, such as explantation, aftercare, and possible consequences? (legislation and legal regulations)
• What are the implications of withdrawing from the study (with regard to explantation)? (legislation and legal regulations)
• How is the voluntariness of consent ensured, considering the possible relationship with the study team and the decision-making capacity of the participant? (legislation and legal regulations + ethical guidelines)

Benefits and risks uitklapper, klik om te openen

• Do study endpoints align with what participants consider valuable? (scientific literature)
• What is known about the quality and stability of the material, device, and software, especially in long-term implantation? (legislation and legal regulations)
• What is known about the risks of both long-term implantation and explantation, including physical and psychological aspects? (ethical guidelines)
• Have risks related to exclusion from future implant studies or treatments been considered, for example due to scar tissue formation or outdated hardware? (scientific literature)
• Are there risks for future diagnostic or treatment procedures (eg MRI), and is this communicated to the participant? (scientific literature)
• Is the psychological well-being of participants actively monitored and supported during and after the study? (scientific literature)
• Have measures been taken to prevent privacy risks for both participants and bystanders? (legislation and legal regulations)
• Which protective measures against unwanted media attention, tailored to the preferences of participants, have been implemented? (scientific literature)
• Have the financial risks of participation, such as costs for explantation or aftercare, been identified and minimized? (legislation and legal regulations)
• How are the rights of participants protected in the event of the manufacturer’s bankruptcy? (scientific literature)

Post-trial arrangements uitklapper, klik om te openen

• Are post-trial arrangements, such as aftercare or continued access, in place for all participants, regardless of their individual outcome? (legislation and legal regulations)
• How is ensured that post-trial arrangements align with the individual needs of participants and caregivers? (scientific literature)
• Is post-trial access in place for participants who have experienced benefits? (scientific literature)
• Do participants have a choice regarding explantation during and after the study? (legislation and legal regulations)
• How are financial risks, such as manufacturer bankruptcy, managed with appropriate aftercare? (scientific literature)
• Have agreements been made to collect long-term data on safety and effectiveness after the study concludes? (ethical guidelines)

Contact uitklapper, klik om te openen

If you have any questions, please email k.r.jongsma@umcutrecht.nl.