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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

Clinical trials involving implanted investigational medical devices ("implant trials") present unique ethical considerations that extend beyond the typical duration of research studies. Investigational implantable devices are increasingly used to treat various medical conditions (e.g., the use of deep brain stimulation devices for neurological disorders) but differ from other clinical trials in that devices may either remain in the body after trial completion or require surgical removal, with both scenarios carrying additional risks and potential costs. 

Participants may face ongoing care needs including device maintenance (battery replacements, software updates, adjustments), repair of malfunctioning components, monitoring to mitigate complications such as infection, and potential explantation (removal) surgery. Post-trial care remains complex, as investigational devices may not be compatible with commercially available hardware or software, access to replacement parts may become challenging if manufacturers discontinue products or cease operations, and ongoing medical interventions may pose substantial financial burdens that health insurance may not cover. While clinical trials have discrete endpoints, implant trial participants' needs and interests often extend beyond the study's conclusion, making it essential to anticipate post-trial care needs during trial planning to allow for continuity of care.

NIH has developed two interconnected and complementary resources intended to support the research community in navigating these complexities with participants enrolled in implant trials: 1) “Considerations in Planning for the Post-Trial Needs of Research Participants who Receive an Investigational Implantable Device” and 2) “Informed Consent for Research Using Investigational Implantable Devices: Points to Consider & Sample Language Resource.” These documents, when finalized, are not intended to replace any IRB review or guidance but rather are intended to serve as a resource to support adequate post-trial planning and effective communication of the unique risks and considerations of implant trials to prospective participants. Use of these resources is voluntary and there are no requirements or expectations that any portion of the sample consent language be used in an informed consent document for NIH-supported studies. 

Request for Information

NIH will consider all comments submitted on the draft resources, but there are specific areas where NIH would appreciate specific feedback. These areas are detailed on the comment form found at: https://osp.od.nih.gov/comment-form-draft-nih-resources-to-support-implantable-device-trials/

How to Submit a Response

Comments should be submitted electronically to the following webpage: https://osp.od.nih.gov/comment-form-draft-nih-resources-to-support-implantable-device-trials/.  Responses will be accepted through May 25, 2026. Responses to this RFI are voluntary and may be submitted anonymously. You may also voluntarily include your name and contact information with your response. Other than your name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After the Office of Science Policy (OSP) has finished reviewing the responses, the responses may be posted to the OSP website without redaction.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

[email protected]