Feedback Sought on NIH Draft Resources to Support Participants in Implantable Device Trials

We seek your input on two resources aimed at supporting participants in NIH-funded implantable device clinical trials (NOT-OD-26-061). Comments on this Request for Information are voluntary and should be submitted electronically here until May 25, 2026. 

NIH views clinical research participants as vital partners in turning discovery into health.  Ensuring participant safety, rigorous research, and public trust are NIH’s highest priorities.  

The two new interconnected and complementary resources released today center around 

• Considerations in Planning for the Post-Trial Needs of Research Participants who Receive an Investigational Implantable Device (Section 1)
• Informed Consent for Research Using Investigational Implantable Devices (Section 2) 

Implant clinical trials have been increasingly used to study various medical conditions. But they also present unique ethical considerations and gaps in current clinical practices for participants that can extend beyond the duration of research studies. For instance, participants may face: 

• Ongoing care needs after the study
• Monitoring to reduce potential complications
• Contending with future software and hardware compatibility
• Potential device removal  

Your thoughts on these resources are welcome on any of the following: 

• How useful these resources are
• Their utility to support participants involved in implant clinical trials
• Improving their ability to effectively communicate the potential benefits, risks, and outcomes associated with enrolling in such trials
• Barriers to their voluntary adoption by researchers
• Clarifying existing concepts or others that are missing 
• Input on specific language in the proposed informed consent language 

NIH will consider the input received when finalizing the resources that support these trial participants after the implant study. Please keep in mind: 

• Use of these resources is voluntary
• Not intended to provide guidance on satisfying the regulatory requirements for the Protections of Human Subjects in the revised Common Rule or FDA's regulations governing the protection of human participants
• Not intended to specify requirements for Institutional Review Boards when reviewing trials involving investigational implantable devices