May 22, 2026
Comments Related to Resource 1: Considerations in Planning for the Post-Trial Needs of Research Participants who Receive an Investigational Implantable Device
The draft resource appropriately acknowledges the importance of post-trial planning for participants with an investigational implantable device, and that planning will need to vary based on factors such as device type, intended duration of implantation, anticipated need for device removal, level of technical support required, and expected long-term participant needs. However, implantable devices increasingly function within broader technological ecosystems involving software platforms, remote monitoring systems, proprietary replacement components, and specialized clinical expertise. As a result, participants’ post-trial needs may extend beyond management of the device itself.
Utility and usability: The resource provides useful considerations for investigators, IRBs, sponsors, and research teams. Since the framework is intentionally broad to apply across different device types, clinical settings, and study designs, it would be helpful for the resource to explicitly identify additional foreseeable scenarios. These should include, for example, situations in which participants relocate, transition between health systems, lose insurance coverage, or require care from clinicians unfamiliar with the investigational device. The resource should provide explicit guidance regarding continuity of specialized expertise and accountability when investigators change institutions, research teams dissolve, or participants require care outside the original study setting. Post-trial responsibilities may need to extend beyond management of the implanted device itself and include continuity of expertise, sustained technical support, long-term data protection, and planning for evolving uses of technology (Hendriks et al., 2023). Broader discussions of post-trial obligations have similarly emphasized that responsibilities extend beyond access to an intervention and include ensuring appropriate transition to ongoing care and support services (Cho et al., 2018). Medical device evaluation frameworks have recognized that important safety, usability, and performance considerations may emerge over time and at different stages of a device’s use and dissemination (Sedrakyan et al., 2016). Incorporating specific examples that address these considerations would strengthen consistency and improve the practical utility of the resource.
Element 1: Plan/Options for Device Explantation or Remaining In Situ: For studies in which device removal is planned or becomes necessary because of safety concerns, lack of effectiveness, device failure, or end of device life, specifying a timeline alone is insufficient. Long-term experiences with implantable devices suggest that when devices or device components remain in the body for many years, they can affect future MRI use, complicate future medical procedures, and result in too many implanted components remaining in the body over time, in addition to concerns already outlined in the draft, such as infections, replacement procedures, and subsequent interventions (Andreae et al., 2025). Plans should specify how participants will be monitored and managed if explantation is delayed or if devices remain implanted beyond the originally anticipated period, including who will monitor the participant, what clinical or device-related findings would trigger reassessment, and how responsibility will be transferred if care moves outside the original study setting. The resource should also include standardized post-trial documentation for participants and future healthcare providers, including device identification information, details of any components left in the body (e.g., leads, batteries, electrodes), MRI safety status or restrictions, and device-related contact information, particularly when the device or parts of the device remain implanted after study completion.
Element 2: Risks and Potential Benefits: The risk discussion should more explicitly address broader considerations that affect participants after study completion beyond the procedural and device-related risks already described in the draft. Participants can experience psychological effects, changes in self-perception, or device dependence, particularly when devices provide meaningful functional or therapeutic benefit or if devices are discontinued, not approved, recalled, or no longer available after study completion (Hendriks et al., 2019). For devices incorporating software components, analyses of software-related recalls have shown that software defects can affect device function and patient safety, with some issues becoming apparent only after implementation in real-world settings (Ronquillo & Zuckerman, 2017). Participants should also understand that some implantable devices function as platform technologies with applications across multiple diseases and indications. Risks and benefits observed in prior uses of these technologies do not directly apply to the current study population and can introduce additional uncertainty regarding expected outcomes.
Element 3: Anticipated Participants’ Needs: The resource should emphasize practical participant needs that emerge over time. For example, participants may require assistance coordinating care across multiple providers and healthcare systems, particularly when specialized expertise for the investigational device is not easily available. These issues are especially important for an investigational device because there will be few health professionals familiar with it prior to it going to market, and even fewer if the product is never approved or cleared. Practical considerations are also important, such as transport for follow-up care, caregiver responsibilities, accessibility or language needs, influence participants’ ability to receive appropriate support. Participants may also experience psychosocial effects living with an investigational implanted device. While the draft appropriately highlights age-specific considerations, such as pediatric populations, additional consideration should be given to demographic representation across age groups, race, and ethnicity to better reflect the populations likely to use these devices in real-world settings and anticipate potential differences in post-trial needs across subgroups.
Element 4: Plans for Meeting Former Participants’ Needs
The resource should clearly address when and how investigators, institutions, sponsors/manufacturers, or other relevant stakeholders should re-contact former participants and respond to post-trial events that require action. For example, plans should specify how participants will be informed of newly identified safety concerns, device recalls, updated monitoring recommendations, or clinically relevant findings that emerge after study completion. Plans should also describe the expected actions following such events, including additional evaluation, follow-up, or changes in device management.
Element 5: Financial Plan: The financial plan section does a good job of outlining potential sources of support, but it focuses on possible funding arrangements rather than providing a framework for accountability across stakeholders, especially when the funding of the study ends or support structures change. While we understand that NIH may not consider this type of accountability to be an issue for the agency to address, accountability should be addressed by the federal agency that is involved in the investigational device clinical trials, whether the NIH, FDA, or any other agency. Study participants should be made aware of these issues prior to agreeing to participate in the clinical trial of an implanted device.
Therefore, the resource should explicitly clarify responsibility for costs associated with adverse device events or complications occurring during or after the trial period. Prior discussions of implanted device research have highlighted concerns of device abandonment and uncertainty around responsibility for ongoing maintenance and support after studies end (Lázaro-Muñoz et al.). Broader discussions of post-trial responsibilities have similarly emphasized that if financial responsibilities are not clearly stated as part of the informed consent process, they can shift burdens onto participants and exacerbate inequities in access to ongoing care (Iunes et al., 2019). Some examples of more explicit guidance regarding stakeholder responsibilities are as follows:
- Sponsors/manufacturers should support device-specific needs, such as replacement components, software updates, technical support, and management of device failures directly related to the investigational device, during and after the trial.
- Research institutions or study sponsors should be responsible for trial-related monitoring and care occurring within defined post-trial periods.
- Insurers and public payors, including CMS where applicable should support clinically necessary routine medical care or emergency evaluations once devices transition into standard clinical management.
- Dedicated contingency mechanisms should be available, such as reserve or escrow funding models for anticipated long-term needs and circumstances if planned funding or manufacturer support ends.
Element 6: Oversight of Long-Term Care Plans: The resource should address participant attrition and loss to follow-up within long-term oversight planning, since disengagement may limit identification of delayed complications and unmet post-trial needs. Oversight plans should include strategies to support continued engagement, coverage and access to care. Resource 1 should also include patient experiences and patient-reported outcomes, because they provide important information regarding functionality, quality of life, and concerns that may not be captured through traditional clinical endpoints.
Hurdles or barriers to broad use: The voluntary nature of the resource is a potential barrier to broad use. Long-term planning requirements may vary substantially across institutions, creating inconsistency in implementation. Limited funding, uncertainty regarding financial responsibility, and limited infrastructure for extended follow-up can also reduce adoption or the effectiveness of the resource.
Other feedback: Investigational implantable device trials differ from many other forms of research because participants may continue living with the effects and responsibilities of the intervention for years after study completion, including after the device has been modified or is no longer on the market. Post-trial responsibilities should therefore be considered fundamental components of study design rather than optional considerations.
Comments Related to Resource 2: Informed Consent for Research Using Investigational Implantable Devices: Points to Consider & Sample Language Resource
Utility and usability: While the resource provides a strong foundation on informed consent using component-based structure and sample plain language, several sections need operational examples reflecting real-world use. In some areas, the sample language is so broad that it does not fully capture practical issues related to long-term management, evolving risks, and financial or care responsibilities that participants may encounter after implantation.
Component 1 (Introduction/Purpose): The consent language should more clearly explain why a device is considered investigational, including whether it is entirely new, being studied for a new indication, or being used in a new patient population. Participants should understand whether the device has FDA authorization for any use and how the current study differs from those uses. For devices based on prior technologies, the consent should also describe the supporting evidence and important evidence gaps, particularly when human data are limited, to help participants understand the level of uncertainty associated with the investigational device.
Component 2 (Procedures): The procedures section should include use of visual aids where appropriate, since implantation procedures and device configurations are difficult to understand through text alone. Examples should include diagrams or short explanatory videos showing device location, implantation procedures, internal versus external components, and the expected recovery process. Such materials improve participant understanding of the overall treatment pathway and procedural expectations.
Component 3 (Long-Term Practical Considerations): The resource places substantial emphasis on post-trial considerations, but many of these practical issues are relevant throughout study participation and during long-term device use. Participants should receive clear, accessible take-home materials at enrollment and throughout the study, not only at study completion, summarizing device maintenance, restrictions, information needed for future healthcare encounters, travel considerations, and instructions for circumstances such as relocation or transition to new healthcare providers.
Component 4 (Potential Risks): The section does not adequately address uncertainty itself as a risk that participants should understand during informed consent. The consent language should explicitly acknowledge that some risks may emerge only after prolonged use or broader implementation outside research settings. Where relevant, examples should also include risks related to privacy or cybersecurity and the potential impact of future loss of manufacturer support, as these affect device management and long-term care. Patients deserve to know what is known and not known about possible short-term and long-term risks and benefits.
Component 5 (Potential Benefits): The section does not sufficiently distinguish potential participant benefit from broader scientific or societal benefit. Participants should understand that implantation of a device does not necessarily result in direct clinical benefit and that benefits observed in prior studies, related technologies, or different patient populations may not apply to the current study population. The consent language should also clearly communicate uncertainty regarding the magnitude of potential benefit, particularly for investigational devices with limited or with no long-term evidence.
Component 6 (Alternatives): The section does not adequately explain how alternatives differ from study participation in ways that may influence decision-making. Because of the greater uncertainties of the risks and benefits of an implanted device, the consent language should include concise information on major differences between alternatives and the investigational approach, such as expected procedures, follow-up requirements, reversibility, long-term commitments, and potential risks or burdens, rather than only listing available options.
Component 7 (Cost): Consistent with the concerns we raised for Resource 1, this section does not adequately address assignment of responsibility for costs that may arise during long-term use of implanted devices. General statements that “some or all costs covered by health insurance or pay out of pocket” or “you or your insurer will need to cover the costs associated with keeping the device working or removing or replacing the device” do not provide sufficient information for participants to make an informed decision, and could be misleading because patients may be reassured by something that is said to them orally but is not in the written consent document. At the least, this wording results in confusion or uncertainty about the financial implications of study participation. Participants’ understanding of financial responsibilities should not depend on their interpretation of a vague statement about who becomes responsible if sponsor support ends, insurance coverage changes, or costs arise after formal study participation has ended.
Component 8 (Compensation for Research-Related Injury): Consistent with concerns raised in Resource 1 and in Component 7 of Resource 2 regarding financial responsibility and post-trial care, the sample language presents potential compensation pathways but does not specify the scope, duration, and assignment of responsibility for device-related injuries or complications. Participants should receive clear information regarding what injuries are covered, who is financially responsible, whether coverage extends to delayed complications after formal study participation ends, and how institutions will help participants navigate unforeseen situations involving out-of-pocket expenses, insurance denials, or coverage limitations.
Component 9 (Withdrawal): This section should clearly distinguish withdrawal from study versus discontinuation or removal of the implanted device. Participants should understand that leaving the study may not necessarily mean that the device can or should be removed and that continued monitoring, maintenance, or clinical care may still be needed. The consent language should also clarify what support participants can expect if they withdraw from the study while continuing to live with the device.
Hurdles or barriers to broad use: Potential barriers include lengthy or ambiguous consent forms, and variability across institutions. However, we are especially concerned that researchers will be reluctant to explicitly explain the uncertainties of benefits of the device and of issues of financial responsibility because it could reduce the willingness of patients to volunteer to participate. Unfortunately, the alternative is to have vaguely worded consent forms that result in study participants being misled about the likely benefits and financial implications of participating in the study. That in turn would leave participants and their families in uncertain and stressful situations that compromise long-term health and well-being and delay access to urgently needed care, and challenges communicating complex device-related concepts in plain language.
Other feedback: Maintaining plain language, short sentences, visual aids, and approaches that promote participant understanding should remain central to the integrity of the resource. Participants should be supported in understanding not only study participation itself, but also the long-term implications of living with an investigational implanted device.
References:
- Sedrakyan, A., Campbell, B., Merino, J. G., Kuntz, R., Hirst, A., & McCulloch, P. (2016). IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. Bmj, 353.
- Hendriks, S., Hsu, N., Beckel-Mitchener, A. C., Ngai, J., & Grady, C. (2023). Continuing trial responsibilities for implantable neural devices. Neuron, 111(20), 3143-3149.
- Cho, H. L., Danis, M., & Grady, C. (2018). Post-trial responsibilities beyond post-trial access. The Lancet, 391(10129), 1478-1479.
- Andreae, A., Breitenstein, A., & Piccini, J. P. (2025). Long-term management of leadless pacemakers. European Heart Journal Supplements, 27(Supplement_2), ii26-ii38.
- Ronquillo, J. G., & Zuckerman, D. M. (2017). Software‐related recalls of health information technology and other medical devices: Implications for FDA regulation of digital health. The Milbank Quarterly, 95(3), 535-553.
- Lozano, A. M., Lipsman, N., Bergman, H., Brown, P., Chabardes, S., Chang, J. W., … & Krauss, J. K. (2019). Deep brain stimulation: current challenges and future directions. Nature Reviews Neurology, 15(3), 148-160.
- https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562
- Lázaro-Muñoz, G., Pham, M. T., Muñoz, K. A., Kostick-Quenet, K., Sanchez, C. E., Torgerson, L., … & Zuk, P. (2022). Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost. Brain Stimulation, 15(5), 1029-1036.
- Iunes, R., Uribe, M. V., Torres, J. B., Garcia, M. M., Alvares-Teodoro, J., de Assis Acurcio, F., & Junior, A. A. G. (2019). Who should pay for the continuity of post-trial health care treatments?. International Journal for Equity in Health, 18(1), 26.